MedWorm: Aranesp

Novartis announces termination of ALTITUDE study

Nephrology Now — Fri, 23 Dec 2011 04:24:00 +0100

Novartis announced the termination of the ALTITUDE study in high-risk patients with diabetes and renal impairment. The study was designed to determine if aliskiren could reduce cardiovascular and renal morbidity and mortality, compared with placebo, when added to conventional treatment (including ACEi or ARB). Based on the recommendation from the Data Monitoring committee, it was felt patients were unlikely to benefit from aliskiren added in addition to standard therapy. More importantly, the aliskiren arm had more frequent adverse events, including non-fatal stroke, renal complications, hyperkalemia and hypotension. The peer reviewed publication has not yet been published. The full text link provides the Novartis press release. : ACLASTA (zoledronic acid 5mg/100mL) solution for int...

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Erythropoietin mimetic compound AGEM400(HES) binds to the same receptor as erythropoietin but displays a different spectrum of activities.

Cytokine — Sat, 03 Dec 2011 05:00:00 +0100

This study intended to compare the effects of a novel compound called AGEM400(HES), consisting of a dimeric EMP conjugated to hydroxyethyl starch (HES), to those of recombinant EPO. AGEM400(HES) efficiently stimulated erythropoiesis in vitro and efficiently stimulated survival of EPO-dependent cell line UT7/EPO. It also efficiently induced phosphorylation of signaling proteins in these models. However, AGEM400(HES) was shown to have weak or absent effects on survival of, and signaling in, three different EPO-responsive hematopoietic cell lines. In the latter models, when added in excess to moderate concentrations of EPO, AGEM400(HES) inhibited the activity of EPO in a fashion indicating receptor binding competition between EPO and AGEM400(HES). It was furthermore shown, using stably transf...

C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis

Nephrology Dialysis Transplantation — Fri, 25 Nov 2011 05:00:00 +0100

Conclusion. C.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients. (Source: Nephrology Dialysis Transplantation)

The Effect of High-Flux Hemodialysis on Hemoglobin Concentrations in Patients with CKD: Results of the MINOXIS Study.

Clinical Journal of the American Society of Nephrology : CJASN — Thu, 17 Nov 2011 05:00:00 +0100

ConclusionOver 1 year, high-flux dialysis had no superior effects on hemoglobin levels or markers of inflammation, oxidative stress, and nutritional status. These data do not support the hypothesis that enhanced convective toxin removal would improve patient outcome. PMID: 22096040 [PubMed - as supplied by publisher] (Source: Clinical Journal of the American Society of Nephrology : CJASN)

Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of

Medical Oncology — Sat, 12 Nov 2011 16:54:39 +0100

Abstract Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anemia (CIA). Safety concerns have prompted changes to the ESA-product information, which now recommends initiating ESAs at hemoglobin (Hb) levels <10 g/dL (US) or ≤10 g/dL (EU). The present exploratory analysis of a DA trial examined how baseline-Hb levels at ESA initiation affect transfusion rates, Hb response, and safety outcomes in CIA patients. Data were retrospectively analyzed from a phase 3 trial of CIA patients randomised to 500 mcg DA every 3 weeks (Q3 W) or to 2.25 mcg/kg DA weekly (QW) for 15 weeks. In the current analysis, data were reanalyzed by baseline-Hb categories of <9 g/dL (n = 12...

Anti-erythropoietin and anti-thrombopoietin antibodies induced after administration of recombinant human erythropoietin.

International Immunopharmacology — Mon, 31 Oct 2011 04:00:00 +0100

Authors: Shin SK, Pack SP, Oh JG, Kang NK, Chang MH, Chung YH, Kim SJ, Lee JW, Heo TH Abstract Recombinant human erythropoietin (rhEPO) has been successfully used for correcting renal anemia. However, recent studies have raised some concerns about the safety of rhEPO treatment due to its immunogenic side effect - pure red cell aplasia (PRCA). We now report a case of development of anti-EPO neutralizing antibodies (Abs) implicated in thrombocytopenia as well as erythrocytopenia. A 35-year-old man had a history of administering rhEPO (epoetin alfa, epoetin beta and darbepoetin alfa) for 2years to treat renal anemia. The hematological parameters were collected. Anti-EPO, anti-platelet, and anti-thrombopoietin (TPO) Ab assays were performed to test the presence of autoreactive Abs. Aft...

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Erythropoiesis-stimulating agents in renal medicine.

The Oncologist — Sun, 09 Oct 2011 21:40:02 +0100

Authors: Locatelli F, Del Vecchio L Abstract The four currently available erythropoiesis-stimulating agents (ESAs), the main drugs for correcting anemia in patients with chronic kidney disease (CKD), are epoetin alfa, epoetin beta, darbepoetin alfa, and continuous erythropoietin receptor activator. The last two have much longer half-lives, which means they can be administered less frequently. The expiry of the patents for epoetin alfa and epoetin beta some years ago opened up the way for the production of a number of biosimilars that are now marketed in the European Union. Because biosimilars cannot be identical to their originator, a complex and still-evolving regulatory policy has been generated, but there are still a number of issues concerning international naming, automatic su...

Anemia in chronic heart failure: Can we treat? What to treat?

Heart Failure Reviews — Fri, 07 Oct 2011 05:47:19 +0100

This article aims to review the aspects of anemia in chronic HF that are relevant for making treatment decisions, beginning with the definition of anemia and its incidence and prevalence of anemia in patients with chronic HF. Considering the etiology and prognostic impact of anemia in chronic HF, several treatment options will be considered. The latter are the application of erythropoiesis-stimulating agents (erythropoietin or darbepoetin alfa) or in the application of intravenous iron (e.g., iron carboxymaltose). According to the results seen in the FAIR-HF trial, iron supplementation should be particularly considered to improve symptoms and quality of life. Intravenous iron application may result in higher compliance and much faster treatment response than oral iron. The RED-HF stu...

Predictors of fatal and nonfatal cardiovascular events in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia: An analysis of the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin-alfa) Therapy (TREAT)

American Heart Journal — Sat, 01 Oct 2011 04:00:00 +0100

Conclusion: In patients with diabetes, CKD, and anemia, cardiovascular risk is most strongly predicted by age, history of HF, C-reactive protein, urinary protein/creatinine ratio, abnormal electrocardiogram, and 2 specific cardiac biomarkers, serum N-terminal pro B-type natriuretic peptide and troponin T, which are elevated in many. These findings suggest ways to improve cardiovascular risk stratification of patients with predialysis CKD, support the concept of cardiorenal syndrome, and may help target therapy. (Source: American Heart Journal)

Hematopoietic Growth Factors in Myelodysplastic Syndromes

Seminars in Oncology — Thu, 29 Sep 2011 01:01:00 +0100

Hematopoietic growth factors (HGFs) continue to be the most widely prescribed class of medications for patients with myelodysplastic syndromes (MDS), despite the advent of disease-modifying therapies for MDS (eg, azacitidine, decitabine, and lenalidomide) and the current absence of an MDS-specific US Food and Drug Administration (FDA)-approved indication for any of the HGFs. Erythropoiesis-stimulating agents (ESAs: epoetin alfa, darbepoetin alfa), myeloid growth factors (MGFs: filgrastim, pegfilgrastim, sargramostim), and the newest group of HGFs, thrombopoiesis-stimulating agents (TSAs: romiplostim, eltrombopag), can increase peripheral blood counts in some patients, and may ameliorate some of the signs and symptoms of MDS-associated bone marrow failure. Although HGFs are generally consid...

Darbepoetin alfa (KRN321) is safe and effective when administered subcutaneously once every 2 or 4 weeks to patients on peritoneal dialysis in Japan

Clinical and Experimental Nephrology — Tue, 06 Sep 2011 08:53:50 +0100

Conclusions The efficacy and safety of KRN321 when administered subcutaneously for 28 weeks to PD patients were confirmed. It was suggested that the quality of life of patients can be improved by treatment with KRN321 due to the reduced frequency of administration. Content Type Journal ArticleCategory Original ArticlePages 1-9DOI 10.1007/s10157-011-0527-9Authors Minoru Kubota, Department of Renal Diseases, Division of Internal Medicine, Oji Hospital, 2-14-13 Oji, Kita-ku, Tokyo, 114-0002 JapanMakoto Hiramatsu, Okayama Saiseikai General Hospital, Okayama, JapanMasato Yamakawa, Minato Health Co-operative Association General Hospital, Nagoya, JapanShunichi Fukuhara, Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University, K...

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PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel {+/-} darbepoetin alfa in primary breast cancer--results at the time of surgery

Annals of Oncology — Mon, 29 Aug 2011 23:00:00 +0100

Conclusion: Dose-dense and -intensified neoadjuvant chemotherapy with Edd->Tdd->CMF was potentially superior to EC->T in terms of pCR. Primary use of DA did not affect pCR. (Source: Annals of Oncology)

PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer--outcome on prognosis

Annals of Oncology — Mon, 29 Aug 2011 23:00:00 +0100

Conclusion: Neoadjuvant dose-intensified chemotherapy compared with standard chemotherapy did not improve DFS, whereas the addition of darbepoetin might have detrimental effects on DFS. (Source: Annals of Oncology)

Association Between Cardiac Biomarkers and the Development of ESRD in Patients With Type 2 Diabetes Mellitus, Anemia, and CKD

American Journal of Kidney Diseases — Mon, 08 Aug 2011 04:00:00 +0100

Conclusions: In ambulatory patients with type 2 diabetes, anemia, and CKD, TnT and NT-pro-BNP levels frequently are elevated. These cardiac-derived biomarkers enhance prediction of ESRD beyond established risk factors. Measurement of TnT and NT-pro-BNP may improve the identification of patients with CKD who are likely to require renal replacement therapy, supporting a link between cardiac injury and the development of ESRD. (Source: American Journal of Kidney Diseases)

ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 05 Jul 2011 05:00:00 +0100

Updated Date: Jul 5, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

FDA: New Warning for Procrit, Epogen, Aranesp

MedicineNet Cancer General — Mon, 27 Jun 2011 07:00:00 +0100

Title: FDA: New Warning for Procrit, Epogen, AranespCategory: Health NewsCreated: 6/25/2011 11:01:00 AMLast Editorial Review: 6/27/2011 (Source: MedicineNet Cancer General)

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F.D.A. Urges Less Use of Anemia Drugs

NYT — Sat, 25 Jun 2011 04:36:32 +0100

Regulators said that there were no risk-free doses of Epogen, Aranesp and Procrit and that doctors should use the medicines only in patients suffering from severe anemia. (Source: NYT)

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FDA: New Warning for Procrit, Epogen, Aranesp

WebMD Health — Fri, 24 Jun 2011 22:52:06 +0100

New data show that the way Procrit, Epogen, and Aranesp are used in patients with chronic kidney disease puts them at risk of heart attacks, stroke, and death. More conservative dosing is needed. (Source: WebMD Health)

F.D.A. Urges Less Use of Anemia Drugs

NYT Health — Fri, 24 Jun 2011 22:50:04 +0100

Regulators said that there were no risk-free doses of Epogen, Aranesp and Procrit and that doctors should use the medicines only in patients suffering from severe anemia. (Source: NYT Health)

FDA Recommends More Conservative Dosing of ESAs

Forbes.com Healthcare News — Fri, 24 Jun 2011 17:08:05 +0100

The FDA today said that it was recommending more conservative dosing of ESAs (erythropoiesis-stimulating agents) in patients with chronic kidney disease (CKD). The possible beneficial effects of the drugs to decrease the need for transfusions in CKD patients should be weighed against the increased risk of cardiovascular events, the FDA said. ESA therapy should be given at the lowest possible dose to reduce the need for transfusions. Currently available ESAs include epoetin alfa, marketed as Epogen (Amgen) and Procrit (J&J) and darbepoetin alfa, marketed as Aranesp, (Amgen). (Source: Forbes.com Healthcare News)

FDA: New Warning for Procrit, Epogen, Aranesp

WebMD Health — Fri, 24 Jun 2011 05:00:00 +0100

Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Drugs.com - FDA MedWatch Alerts — Fri, 24 Jun 2011 04:00:00 +0100

Audience: Nephrology, Oncology Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of... (Source: Drugs.com - FDA MedWatch Alerts)

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Amgen Announces Modifications to U.S. Prescribing Information for Use of Erythropoiesis-Stimulating Agents in Chronic Kidney Disease

Amgen News Service — Thu, 23 Jun 2011 23:00:00 +0100

Modified Labeling Provides Different Treatment Guidance for Patients on Dialysis and Not on Dialysis Changes to Prescribing Information Include Modification to the Boxed Warning THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), in patients with chronic kidney disease (CKD). The modified language, including changes to the Boxed Warning, provides important new information for the treatment of patients with CKD who are on dialysis, as well as those not on dialysis, to inform prescribers and patients of safety ri...

Assessing the effect of darbepoetin alfa on patient-reported fatigue in chemotherapy-induced anemia in four randomized, placebo-controlled clinical trials

Quality of Life Research — Sun, 05 Jun 2011 05:46:20 +0100

Conclusions Darbepoetin alfa improved hemoglobin which was associated with improved fatigue across the 4 trials. Clinically, meaningful improvement in fatigue was seen in 2 trials. More complex statistical analysis models of treatment may assist in understanding the effects of erythropoiesis-stimulating agents on patient-reported outcomes. Content Type Journal ArticlePages 1-11DOI 10.1007/s11136-011-9946-zAuthors Dennis A. Revicki, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USADonald Stull, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USAMargaret Vernon, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USAMichael Rader, Union State Bank Cancer Center, N...

Effect of darbepoetin alfa on endothelial progenitor cells and vascular reactivity in chronic kidney disease

Vascular Medicine recent issues — Wed, 01 Jun 2011 23:00:00 +0100

In conclusion, the administration of darbepoetin alfa for 4 weeks increased a subset of EPCs, improved endothelial function and increased cell proliferation, including those with diabetes, which is consistent with a favorable improvement in vascular health. (Source: Vascular Medicine recent issues)

Impact on Health-Related Quality of Life in Kidney Transplant Recipients with Late Posttransplant Anemia Administered Darbepoetin Alfa: Results from the STRATA Study

Transplantation Proceedings — Tue, 31 May 2011 23:00:00 +0100

Abstract: Posttransplant anemia (PTA) is a common, multifactorial condition that has a substantial negative impact on patients' health-related quality of life (HRQOL). Erythropoietin-stimulating agents are an effective treatment for PTA, but there is little research on HRQOL in posttransplant patients. This multicenter, prospective study enrolled adults with PTA (hemoglobin [Hb] < 11.0 g/dL). Subjects (n = 66) received subcutaneous darbepoetin alfa every 2 weeks for 24 weeks. Hb and patient-reported outcomes using the Short Form (SF)-36 questionnaire were assessed. Mean (standard deviation) Hb concentration increased from 9.9 (1.2) g/dL at baseline to 11.7 (1.3) g/dL during the evaluation period (14 to 24 weeks). At baseline, SF-36 scores in all the eight domains were lower (worse) compare...

Treatment of Anemia With Epoetin in Kidney Transplant Recipients

Therapeutic Apheresis and Dialysis — Mon, 30 May 2011 17:27:43 +0100

AbstractThe aim of this study was to analyze the prevalence and efficacy of renal anemia treated with epoetin in maintenance kidney transplant recipients in Slovenia. By the end of 2009, 107 out of 537 patients (19.9%) had been treated with epoetin. A cohort of 49 patients (45.8%) were analyzed in detail: 11 patients received epoetin alfa, 18 epoetin beta, 10 darbepoetin alfa, and 10 patients received methoxy polyethylene glycol‐epoetin beta. The median epoetin dose was 0.36 µg/kg body weight per week. The median serum laboratory parameters were as follows: hemoglobin 120 g/L, hematocrit 0.36, ferritin 332 ng/mL, transferrin saturation 34%, serum creatinine 145 µmol/L, serum albumin 41 g/L, intact parathyroid hormone 79 ng/L, and C‐reactive protein 3 mg/L. We concluded ...

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Effectiveness of darbepoetin alfa in a cohort of oncology patients with chemotherapy-induced anaemia. Relationship between variation in three fatigue-specific quality of life questionnaire scores and change in haemoglobin level

Clinical and Translational Oncology — Mon, 30 May 2011 17:05:22 +0100

Conclusions DA 500 μg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF. Content Type Journal ArticlePages 341-347DOI 10.1007/s12094-011-0664-3Authors Gaspar Esquerdo, Unidad de Oncología Médica, Hospital General de Elda, Ctra. Elda-Sax, Ptda. La Torreta, s/n, ES-03600 Elda, Alicante, SpainCristina Llorca, Unidad de Oncología Médica, Hospital General de Elda, Ctra. Elda-Sax, Ptda. La Torreta, s/n, ES-03600 Elda, Alicante, SpainJosé Manuel Cervera, Unidad de Oncología Médica, Hospital General de Elda, Ctra. Elda-Sax, Ptda. La Torreta, s/n, ES-03600 Elda, Alicante, SpainDavid Orts, Unidad de...

Quality of life, physical function and mri t2* in elderly low risk mds patients treated to a haemoglobin level of ≥120 g/l with darbepoetin alfa +/‐ filgrastim or erythrocyte transfusions

European Journal of Haematology — Sun, 29 May 2011 23:00:00 +0100

Conclusions: In elderly anemic MDS patients an increment in haemoglobin is associated with improved QoL, whether induced by growth factor treatment or transfusion therapy. (Source: European Journal of Haematology)

[Strategy feasibility of darbepoetin alfa administration every other week: 2005-2007 experience in a dialysis unit.]

Nephrologie and Therapeutique — Thu, 26 May 2011 23:00:00 +0100

Authors: Rottembourg JB, Dansaert A Darbepoetin alfa is a recombinant erythropoiesis-stimulating agent, with a longer half-life leaving the possibility to extending dosing administration in haemodialysis patients. A protocol of injection every 2weeks was initiated in the dialysis unit. From 2005 to 2007, 176 dialysis patients were studied with a target haemoglobin level between 11 and 12.5g/dL: the median haemoglobin level was ranged from 11.32 and 11.72g/dL during the study with a median darbepoetin alfa dose injected between 60 and 64μg per injection (0.46 to 0.47μg/kg per week). The mean number of dose changes was three per year per patient. The diabetic population did not differ from the general population in terms of haemoglobin levels and doses of darbepoetin alfa. Ten percent ...

Positive Outcomes of High Hemoglobin Target in Patients With Chronic Kidney Disease Not on Dialysis: A Randomized Controlled Study

Therapeutic Apheresis and Dialysis — Tue, 24 May 2011 23:00:00 +0100

AbstractCorrecting anemia in patients with chronic kidney disease (CKD) to higher hemoglobin (Hb) levels may be associated with increased risk. No optimal target for Hb has been established. This controlled study examined 321 patients with CKD who were not on dialysis, had a Hb level of <10 g/dL, and a serum creatinine of 2.0 to 6.0 mg/dL. They were randomized into two target Hb groups: 161 to high Hb (11.0–13.0 g/dL) to receive darbepoetin alfa and low Hb to 160 (9.0–11.0 g/dL) to receive recombinant erythropoietin. The study lasted 48 weeks. Of 154 and 153 patients with adverse events, cardiovascular adverse events developed in 42 and 51 patients in the high and low Hb groups, respectively, with no significant difference in the incidence. All quality of life scores impro...

Macrocytosis may be associated with mortality in chronic hemodialysis patients: a prospective study

BioMed Central — Tue, 10 May 2011 23:00:00 +0100

Conclusions: Macrocytosis may be associated with mortality in stable, chronic hemodialysis patients. Future studies will need to be conducted to confirm this finding. (Source: BioMed Central)

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Darbepoetin alfa controversies, from dosage issues to safety concerns: the larger lesson.

Oncology (Williston Park, N.Y.) — Fri, 29 Apr 2011 23:00:00 +0100

Authors: Glaspy JA PMID: 21710839 [PubMed - in process] (Source: Oncology (Williston Park, N.Y.))

Darbepoetin Alfa Controversies, From Dosage Issues to Safety Concerns: the Larger Lesson

Cancer Network — Wed, 27 Apr 2011 12:00:00 +0100

Over the intervening years, several clinical trials of ESAs in cancer patients have reported a lower survival and/or increased tumor progression in patients receiving ESAs than in untreated controls. (Source: Cancer Network)

Darbepoetin alfa for the treatment of anaemia in alpha‐ or beta‐ thalassaemia intermedia syndromes

British Journal of Haematology — Sun, 17 Apr 2011 23:00:00 +0100

(Source: British Journal of Haematology)

176 Observational Study of Anemic Patients With Pre-Dialysis Chronic Kidney Disease (CKD) Converting From Darbepoetin Alfa (Darb) to Epoetin Alfa (EPO)

American Journal of Kidney Diseases — Mon, 28 Mar 2011 15:22:44 +0100

(Source: American Journal of Kidney Diseases)

160 Comparison of Epoetin Alfa and Darbepoetin Alfa Dosing Patterns and Costs in a Chronic Kidney Disease Population Treated in the Hospital Inpatient and Outpatient Setting

American Journal of Kidney Diseases — Mon, 28 Mar 2011 15:22:42 +0100

(Source: American Journal of Kidney Diseases)

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25 Epoetin Alfa and Darbepoetin Alfa Costs by Dominant Dosing Interval in Chronic Kidney Disease Not on Dialysis

American Journal of Kidney Diseases — Mon, 28 Mar 2011 15:22:31 +0100

(Source: American Journal of Kidney Diseases)

Extended dosing of darbepoetin alfa in peritoneal dialysis patients

BMC Nephrology — Thu, 24 Mar 2011 00:00:00 +0100

Conclusion: In this large observational study, PD patients were able to maintain mean hemoglobin concentrations >11.0 g/dL after conversion to extended dosing of darbepoetin alfa Q2W, with no mean dose increase. (Source: BMC Nephrology)

Amgen Rises On Medicare's Decision Not To Decide

Forbes.com Healthcare News — Wed, 16 Mar 2011 20:53:49 +0100

Amgen shares are up 2.4% on a decision by Medicare not to make a decision regarding how doctors should use its anemia drug Aranesp in kidney dialysis patients. Johnson & Johnson, which sells the Amgen-developed drug Procrit, could also benefit. (Source: Forbes.com Healthcare News)

ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 15 Mar 2011 05:00:00 +0100

Updated Date: Mar 15, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Outcomes of erythropoiesis-stimulating agents in cancer patients with chemotherapy-induced anemia

Supportive Care in Cancer — Sun, 27 Feb 2011 06:43:18 +0100

Conclusions These findings reported that patients with CIA achieved more favorable clinical and economic outcomes if initiated with EPO 40,000 U vs. DARB 500 mcg. Content Type Journal ArticlePages 1-7DOI 10.1007/s00520-010-1083-7Authors Chris L. Pashos, United BioSource Corporation, 430 Bedford Street, Lexington, MA 02420, USAKay Larholt, Abt Bio-Pharma Solutions, Inc., Lexington, MA USAKimberly A. Fraser, United BioSource Corporation, 430 Bedford Street, Lexington, MA 02420, USAR. Scott McKenzie, Centocor Ortho Biotech Services, LLC, Horsham, PA USAMekré Senbetta, Centocor Ortho Biotech Services, LLC, Horsham, PA USACatherine Tak Piech, Centocor Ortho Biotech Services, LLC, Horsham, PA USA Journal Supportive Care in CancerOnline ISSN 1433-7339Print...

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ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 22 Feb 2011 05:00:00 +0100

Updated Date: Feb 22, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Darbepoetin alfa suppresses tumor necrosis factor-α-induced endothelin-1 production through antioxidant action in human aortic endothelial cells: Role of sialic acid residues.

Free Radical Biology and Medicine — Thu, 17 Feb 2011 00:00:00 +0100

Authors: Yang WS, Chang JW, Han NJ, Park SK Recombinant human erythropoietin (r-HuEPO) is widely used to correct anemia in end-stage renal disease patients, who commonly suffer from atherosclerosis. Endothelin-1 (ET-1) has been implicated in the pathogenesis of atherosclerosis. Here, we tested whether darbepoetin alfa, a hypersialylated analogue of r-HuEPO, regulates tumor necrosis factor-α (TNF-α)-induced ET-1 production in human aortic endothelial cells, and sought to identify the signal pathways involved. Darbepoetin alfa attenuated TNF-α-induced ET-1 production. It also diminished TNF-α-induced reactive oxygen species (ROS) accumulation and subsequent activation of c-Jun NH(2)-terminal kinase (JNK), which requlates the DNA-binding activities of both AP-1 and NF-κB required for...

Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis

Nephrology Now — Tue, 08 Feb 2011 07:21:26 +0100

This study is a post-hoc analysis of the Multiple Outcomes of Raloxifene Evaluation Trial, a double-masked, placebo-controlled randomized clinical trial of post-menopausal women with osteoporosis who were randomized to raloxifene or placebo. Compared with those in the placebo group, participants on raloxifene had a significantly slower yearly rate of decrease in eGFR. : A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease High Dose Epoetin Beta in the First Weeks Following Renal Transplantation and Delayed Graft Function: Results of the Neo-PDGF Study Routine Preoperative Vascular Ultrasound Improves Patency and Use of Arteriovenous Fistulas for Hemodialysis: A Randomized Trial (Source: Nephrology Now)

ARANESP (Darbepoetin Alfa) Injection, Solution [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Tue, 11 Jan 2011 05:00:00 +0100

Updated Date: Jan 11, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Darbepoetin Alfa Impact on Health Status in Diabetes Patients with Kidney Disease: A Randomized Trial.

Clinical Journal of the American Society of Nephrology : CJASN — Thu, 06 Jan 2011 00:00:00 +0100

Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision. PMID: 21212421 [PubMed - as supplied by publisher] (Source: Clinical Journal of the American Society of Nephrology : CJASN)

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Addition of Darbepoetin Alfa to Dose-Dense Chemotherapy: Results From a Randomized Phase II Trial in Small-Cell Lung Cancer Patients Receiving Carboplatin Plus Etoposide.

Clinical Lung Cancer — Sat, 01 Jan 2011 00:00:00 +0100

Authors: Nagel S, Kellner O, Engel-Riedel W, Guetz S, Schumann C, Gieseler F, Schuette W Darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), is used in cancer patients as a supportive care for anemia. For small-cell lung cancer (SCLC), several studies have shown that the administration of ESAs does not affect survival but decreases the need for blood transfusions and improves the quality of life (QOL) of patients receiving chemotherapy. The present randomized phase II study assessed the feasibility, efficacy, and safety of the administration of darbepoetin alfa to patients with SCLC receiving dose-dense (every 2 weeks) standard chemotherapy consisting of carboplatin plus etoposide, pegfilgrastim prophylactically. Seventy-four chemotherapy-naive patients with limited or extensi...

Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Patients With Chemotherapy-Associated Anemia [Palliative and Supportive Care]

Journal of Clinical Oncology — Wed, 29 Dec 2010 00:00:00 +0100

Conclusion In patients with CAA, addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo. (Source: Journal of Clinical Oncology)

Fungal Peritonitis in Peritoneal Dialysis Patients: Successful Prophylaxis with Fluconazole, as Demonstrated by Prospective Randomized Control Trial

Nephrology Now — Mon, 27 Dec 2010 06:34:34 +0100

This randomized controlled trial compared oral fluconazole 200 mg given every 2nd day versus placebo in patients being treated for PD peritonitis, exit site infection or tunnel infection. A statistically significant reduction in secondary fungal peritonitis was noted in patients on prophylaxis. : Peritoneal Dialysis-Related Infections Recommendations: 2010 Update | NOW FREE FULL TEXT A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High-Risk Kidney Transplant Recipients (Source: Nephrology Now)

Acetaminophen Increases Blood Pressure in Patients With Coronary Artery Disease.

Nephrology Now — Mon, 27 Dec 2010 06:33:37 +0100

In this small randomized, double-blind, placebo-controlled, crossover study, acetaminophen was documented to increased ambulatory blood pressure in patients with coronary artery disease. : Intensive Blood-Pressure Control in Hypertensive Chronic Kidney Disease The Effect of Rosuvastatin on Insulin Sensitivity and Pancreatic Beta-Cell Function in Nondiabetic Renal Transplant Recipient A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease (Source: Nephrology Now)

Conversion from Epoetin Alfa to Darbepoetin Alfa for Management of Anaemia in a Community Chronic Kidney Disease Centre: A Retrospective Cohort Study

Clinical Drug Investigation — Tue, 21 Dec 2010 16:17:33 +0100

(Source: Clinical Drug Investigation)

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Amgen Highlights Data to Be Presented at American Society of Hematology Annual Meeting

Amgen News Service — Thu, 02 Dec 2010 00:00:00 +0100

Final Results From The Largest And Longest Study Of Nplate® For The Treatment Of Adult Chronic ITP To Be Presented Amgen Expands Amgen FIRST STEP™ Program Co-Pay Coupon Benefits To Help Patients With Out-of-Pocket Costs For Neulasta® And Nplate® THOUSAND OAKS, Calif., Dec. 2, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced that it will present data from several key Nplate® (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla. Results from six studies evaluating Nplate in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) add to the growing body of data supporting the use of Nplate in this setting, including the final efficacy and sa...

Asialoerythropoietin to Protect the Failing Heart: Is it Possible to Run With the Hare and Hunt With the Hounds?⁎

Journal of the American College of Cardiology — Thu, 25 Nov 2010 02:19:58 +0100

Anemia is commonly observed in patients with renal failure and chronic heart failure (HF). Its presence is associated with a lower quality of life and an impaired survival (). As a logical next step it was thought that correction of anemia would result in an improved outcome. Although erythropoietin (EPO) has been successfully used in clinical practice for more than 2 decades, the relationships among anemia, EPO treatment, and outcome seems to be more complex than first thought. A meta-analysis by Phrommintikul et al. () showed that EPO treatment in anemic patients with renal failure, which was targeted to achieve higher hemoglobin values, was associated with increased mortality and higher risk of hypertension and thrombosis. Recently published results of the TREAT (Trial to Reduce Cardiov...

Adding iron to darbepoetin treatment no benefit in iron-replete patients with cancer

NeLM - News — Tue, 23 Nov 2010 00:00:00 +0100

Source: J Clin Oncol Area: News A controlled trial found that in iron-replete patients with non-myeloid malignancies, adding oral or parenteral iron to darbepoetin therapy had no beneficial effects. In patients with chemotherapy-associated anaemia, functional iron deficiency is thought to reduce the response to drugs that stimulate erythropoiesis. This trial investigated whether adding intravenous iron therapy to treatment with darbepoetin improved response. It involved patients who were undergoing chemotherapy for non-myeloid malignancies and had haemoglobin levels of less than 11gm/dl. All received darbepoetin alfa once every 3 weeks and were randomly assigned to receive either ferric gluconate 187.5 mg IV every 3 weeks, oral daily ferrous sulphate 325 mg, or oral placebo for...

Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial

Nephrology Dialysis Transplantation — Mon, 22 Nov 2010 00:00:00 +0100

Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa. (Source: Nephrology Dialysis Transplantation)

Dosing strategies for conversion of haemodialysis patients from short‐acting erythropoiesis stimulating agents to once‐monthly C.E.R.A.: experience from the MIRACEL study

International Journal of Clinical Practice — Mon, 22 Nov 2010 00:00:00 +0100

Conclusion: Switching haemodialysis patients from shorter‐acting ESA to once‐monthly C.E.R.A. using pre‐filled syringes is straightforward, and Hb levels remain stable. Starting dose recommendations and dose changes correlated well with the clinical setting. Collateral factors such as infection or aggravating concomitant medical conditions should be taken into account. (Source: International Journal of Clinical Practice)

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Phase I/II randomised study of a novel erythropoiesis-stimulating agent (AMG 114) for the treatment of anaemia with concomitant chemotherapy in patients with non-myeloid malignancies

Medical Oncology — Wed, 03 Nov 2010 07:50:44 +0100

Abstract AMG 114 is a novel, hyperglycosylated erythropoiesis-stimulating agent. In preclinical studies, AMG 114 demonstrated increased potency and longer half-life than darbepoetin alfa and epoetin alfa. This phase I/II, randomised, double-blind, placebo-controlled, dose-escalation study evaluated safety, pharmacokinetics, and efficacy of AMG 114 in patients with non-myeloid malignancies and chemotherapy-induced anaemia. Patients were randomised (1:5) to receive subcutaneous placebo or AMG 114 Q3W for 6 weeks in 3 dose cohorts of 15 μg (cohort A1), 50 μg (cohort A2), or 200 μg (cohort A3). Safety endpoints included incidence of adverse events and dose-limiting toxicities (DLTs). The PK profile of AMG 114 was evaluated. Efficacy was assessed by change...

Erythropoietic Response and Outcomes in Kidney Disease and Type 2 Diabetes

Nephrology Now — Mon, 01 Nov 2010 22:05:16 +0100

This study assessed the relationship between initial responsiveness to darbepoetin alfa and outcomes in patients with chronic kidney disease and type 2 diabetes mellitus. A poor initial hematopoietic response was associated with an increased risk of death or cardiovascular events. : Treatment of Anemia in Chronic Kidney Disease — Strategies Based on Evidence A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus (Source: Nephrology Now)

A Prospective Protocol-Based Trial of Darbepoetin Alfa Therapy to Correct the Early Anemia Following Renal Transplantation

Transplantation Proceedings — Mon, 01 Nov 2010 00:00:00 +0100

Abstract: Anemia is a common complication accompanying renal transplantation. The evaluation and therapy for posttransplant anemia (PTA) are not standardized and remain controversial. This was a prospective, protocol-driven attempt at early PTA evaluation and management by transplant nurse coordinators. Between 1 and 2 months posttransplantation, 75 consecutive recipients were evaluated for the presence and causes of anemia. Anemic patients were given standard doses of darbepoetin alfa (DA) for 3 months. Response to therapy and patient outcomes were evaluated over 15 months. Twenty-five (33%) of all patients were anemic, including 32% who were erythropoietin (EPO)-deficient and 68% with relative EPO resistance. No patient with early PTA showed an elevated EPO level or increased reticulocyt...

Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial

BMC Cancer — Sun, 24 Oct 2010 23:00:00 +0100

Conclusion: Darbepoetin alfa, when administered synchronously with chemotherapy, on an EDS appears to be similarly efficacious to darbepoetin alfa weekly dosing with no unexpected adverse events. This study provides prospective data on how multiple dosing regimens available with darbepoetin alfa can be synchronized with chemotherapy administered across a range of dosing schedules.Trial registration: ClinicalTrials.gov Identifier NCT00144131. (Source: BMC Cancer)

Kidney Patients Not On Dialysis, FDA Advisers Recommend Continuation Of Aranesp (Darbepoetin Alfa)

Health News from Medical News Today — Mon, 18 Oct 2010 22:00:00 +0100

An FDA Advisory Committee has recommended the continued use of Aranesp (Darbepoetin alfa), a synthetic form of erythropoietin used to treat anemia in patients with mild to moderate chronic (long-term) kidney disease. Although the Advisory Committee's recommendations are not binding, the FDA usually goes along with what their members say. The Committee voted 15 in favor with 1 abstention not to withdraw the medication. They had met after studies involving 4,000 participants showed that the risk of stroke for those taking Aranesp was equal to those on a placebo... (Source: Health News from Medical News Today)

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FDA Panel Votes for No Change to ESA Label

MedPage Today Public Health — Mon, 18 Oct 2010 21:00:00 +0100

ADELPHI, Md. (MedPage Today) -- A panel of outside experts has voted 15-1, with one abstention, to recommend that the FDA allow continued use of darbepoetin alpha (Aranesp) for chronic kidney disease patients who are not on dialysis. (Source: MedPage Today Public Health)

Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today

Amgen News Service — Sun, 17 Oct 2010 23:00:00 +0100

THOUSAND OAKS, Calif., Oct 18, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp(R) Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today’s meeting of the Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC). (Source: Amgen News Service)

Panel to Vote on Limiting Use of ESA

MedPage Today Public Health — Thu, 14 Oct 2010 19:05:02 +0100

WASHINGTON (MedPage Today) -- FDA reviewers said that Amgen's recent trial of darbepoetin alpha (Aranesp) failed to show a benefit for the drug -- and actually increased risk in certain patients with chronic kidney disease. (Source: MedPage Today Public Health)

FDA to Seek Panel Advice On Anti-Anemia Drugs

WSJ.com: Health — Thu, 14 Oct 2010 16:08:07 +0100

The FDA will ask another advisory panel for advice on the use of Amgen's Aranesp and similar drugs for patients with chronic kidney disease, in the face of concerns about cardiovascular problems. (Source: WSJ.com: Health)

Standout Options Trading in Amgen (AMGN, TEVA)

BioHealth Investor — Fri, 01 Oct 2010 12:13:08 +0100

Amgen Inc. (NASDAQ: AMGN) has seen some unusual options trading and it appears to be based around some upcoming FDA events and on its trends. Joe Kunkle of OptionsHawk.com noted, “The January $52.50/$47.50 ratio put spread for 3,500X7,000 at $0.95 was an opening trade on September 30 after checking the open interest, and a bearish one with shares at $55.20. Shares of the Biotech giant trade 10.22X earnings, 3.5X sales, and 9.2X cash flow, but have generally underperformed despite the valuation, and have now rallied more than 8% off lows to resistance at $56.50, already rolling over below the 200 day EMA.” We recently noted how the upcoming reviews could offer Amgen a “Genetech-like Drug Arsenal” if the approvals were met and if the tests go positive. Kunkle also...

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Anemia Drugs Are Recalled

NYT Health — Fri, 24 Sep 2010 17:08:43 +0100

Amgen and Johnson & Johnson announced are recalling various lots of their anemia drugs, Epogen and Procrit, because extremely thin, barely visible glass flakes have been found in the vials. (Source: NYT Health)

Effects of CERA (continuous erythropoietin receptor activator) in patients with advanced non-small-cell lung cancer (NSCLC) receiving chemotherapy: results of a phase II study

Annals of Oncology — Wed, 22 Sep 2010 02:54:54 +0100

Conclusion: In this phase II study in patients with stage IIIB or IV NSCLC receiving chemotherapy, none of the four treatment arms showed an adequate increase in mean Hb level. (Source: Annals of Oncology)

Poor response to darbepoetin alfa linked to elevated adverse events seen in TREAT

MedWire News - Heart Failure — Mon, 20 Sep 2010 05:26:18 +0100

Results from an analysis of the TREAT study suggest that diabetes patients with chronic kidney disease and moderate anemia who had a poor response to the anemia drug darbepoetin alfa were more likely to have an adverse cardiovascular outcome than those with a better response, despite receiving a higher mean dose. (Source: MedWire News - Heart Failure)

Anemia Drugs Could Pose Threat to Some Kidney Patients

MedlinePlus Health News — Thu, 16 Sep 2010 13:55:35 +0100

Study finds 'poor responders' to meds like Aranesp at higher risk for heart trouble, death Source: HealthDay Related MedlinePlus Pages: Anemia, Kidney Diseases, Medicines (Source: MedlinePlus Health News)

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First Response to ESAs Marker for Outcome in CKD (CME/CE)

MedPage Today Cardiovascular — Thu, 16 Sep 2010 13:34:38 +0100

(MedPage Today) -- A poor initial response to darbepoetin alfa (Aranesp) appears to increase risk of cardiovascular events and death in nondialysis chronic kidney disease, type 2 diabetes, and anemia, researchers found. (Source: MedPage Today Cardiovascular)

Erythropoietic response and outcomes in kidney disease and type 2 diabetes

NeLM - News — Wed, 15 Sep 2010 23:00:00 +0100

Source: N Engl J Med Area: News Studies of erythropoiesis-stimulating agents (ESAs) comparing lower and higher haemoglobin targets in patients with chronic kidney disease suggest that targeting of a lower haemoglobin range may avoid ESA-associated risks. However, such strategies are confounded by each patient's individual hematopoietic response The Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) found no reduction in the risk of cardiovascular or renal events or death in patients with anaemia, diabetes, and chronic kidney disease, not undergoing dialysis, who were receiving darbepoetin alfa, as compared with those receiving placebo. The study did find a near doubling in the risk of stroke. In this paper, data from TREAT were analysed to assess the link betwee...

Anemia Drugs Could Pose Threat to Some Kidney Patients

The Doctors Lounge - Cardiology — Wed, 15 Sep 2010 22:00:00 +0100

Study finds 'poor responders' to meds like Aranesp at higher risk for heart trouble, death (Source: The Doctors Lounge - Cardiology)

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to Reduce Cardiovascular Events with Aranesp(R) Therapy (TREAT) Study

Nephrology Dialysis Transplantation — Tue, 24 Aug 2010 21:53:19 +0100

The European Renal Best Practice (ERBP), which are issued by ERA–EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006–07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp® Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes...

Dr Reddy's Launches Darbepoetin Alfa In India Under The Brand Name 'Cresp®' World's First Generic Darbepoetin Alfa And The Only One In India

Health News from Medical News Today — Sat, 21 Aug 2010 09:00:00 +0100

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) announced the launch of Cresp®' the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Cresp® has been approved in India for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy. Darbepoetin alfa is a modified version of epoetin alfa (rHuEPO), which is engineered to have a longer half life, increasing (up to 3 times) the time it remains in the blood... (Source: Health News from Medical News Today)

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Final results of a phase I/II pilot study of capecitabine with or without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer

BMC Cancer — Sun, 15 Aug 2010 23:00:00 +0100

Conclusions: Administration of capecitabine monotherapy after sequential dose-dense epirubicin and paclitaxel is feasible in node-positive EBC, while the combination of capecitabine and vinorelbine as used here caused more DLTs.Trial registration: Current Controlled Trials ISRCTN38983527. (Source: BMC Cancer)

Darbepoetin alfa 300 or 500 [mu]g once every 3 weeks with or without intravenous Iron in patients with chemotherapy-induced anemia

American Journal of Hematology — Tue, 27 Jul 2010 23:00:00 +0100

This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 [mu]g with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 [mu]g (n = 62), darbepoetin alfa 300 [mu]g plus IV iron (n = 60), darbepoetin alfa 500 [mu]g (n = 60), or darbepoetin alfa 500 [mu]g plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels [le]10 g dL-1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin ([ge]11 g dL-1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT...

Corrigendum to 'Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial' [Eur J Heart Fail 2009;11:795-801]

European Journal of Heart Failure — Thu, 24 Jun 2010 16:35:07 +0100

(Source: European Journal of Heart Failure)

Amgen is Acquiring… But Who? (AMGN)

BioHealth Investor — Fri, 18 Jun 2010 13:46:06 +0100

Amgen Inc. (NASDAQ: AMGN) is on the acquisition path. Yesterday at a Goldman Sachs conference, CEO Kevin Sharer said that Amgen is aggressively looking for acquisition targets on an international diversification basis. These acquisitions are not meant to be game changers and will not be any mega-deal as Sharer said that he won’t be betting the company’s future on any single deal. The company was also noted as seeking to invest its growing offshore cash position on an intelligent basis and not in any companies that needed to be fixed or turned around with current problems. As far as too much diversification, that might not be expected either. Sharer shared that the clinical diagnostics acquisition belief does not really fit with the core operations of the company because i...

Vascular endothelial growth factor is crucial for erythropoietin-induced improvement of cardiac function in heart failure

Cardiovascular Research — Fri, 11 Jun 2010 16:08:02 +0100

Conclusion VEGF is crucial for EPO-induced improvement of cardiac function in HF. EPO fosters VEGF expression predominantly in cardiomyocytes, which in turn stimulates myocardial endothelial proliferation and incorporation of EPCs. (Source: Cardiovascular Research)

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Diabetes, Anemia and CKD: Why TREAT?

Current Diabetes Reports — Thu, 10 Jun 2010 17:42:47 +0100

Abstract The triad of diabetes mellitus, anemia, and chronic kidney disease (CKD) define a group of patients at high risk for death and cardiovascular complications. The approval of epoetin alfa in 1989 transformed the treatment of anemia in patients with CKD. However, evidence has emerged from randomized controlled trials that correcting anemia with erythropoiesis-stimulating agents in CKD patients is associated with increased risk. Most recently, the TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) study of anemic type 2 diabetic patients with CKD reported that treatment with darbepoetin conferred no benefit in mortality or in attenuating cardiovascular or renal events. Instead, there was a twofold higher rate of stroke and thromboembolic complications ...

Systematic Review: Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease

Nephrology Now — Sun, 06 Jun 2010 08:12:00 +0100

This meta-analysis confirms that targeting higher hemoglobin levels in CKD increases risks for stroke, hypertension, and vascular access thrombosis and probably increases risks for death, serious cardiovascular events, and end-stage renal disease. : Asymmetrical Dimethylarginine Is Associated with Renal and Cardiovascular Outcomes and All-cause Mortality in Renal Transplant Recipients A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. (Source: Nephrology Now)

Randomized Phase 2 Dose-finding Study of Weekly Administration of Darbepoetin Alfa in Anemic Patients with Lung or Ovarian Cancer Receiving Multicycle Platinum-containing Chemotherapy

Japanese Journal of Clinical Oncology — Thu, 27 May 2010 16:15:24 +0100

Conclusions Darbepoetin alfa alleviated anemia caused by platinum-based chemotherapy, and the dosage of 2.25 µg/kg was the lowest dose that met the clinically effective dose criteria when administered once weekly. (Source: Japanese Journal of Clinical Oncology)

ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 17 May 2010 05:00:00 +0100

Updated Date: May 17, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Effect of B-Vitamin Therapy on Progression of Diabetic Nephropathy: A

Nephrology Now — Sun, 02 May 2010 00:54:22 +0100

This RCT examined compared a strategy of homocysteine reduction using folic acid, vitamin B6, and vitamin B12 versus placebo in patient with diabetic nephropathy. The active therapy arm experienced a greater decrease in GFR and an increase in vascular events.: A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease Interventions for bone disease in children with chronic kidney disease. Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events (Source: Nephrology Now)

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Effect of B-Vitamin Therapy on Progression of Diabetic Nephropathy

Nephrology Now — Sun, 02 May 2010 00:54:22 +0100

The FDA’s Perspective on the Risk for Rapid Rise in Hemoglobin in Treating CKD Anemia: Quo Vadis

Nephrology Now — Sun, 02 May 2010 00:46:34 +0100

In response to the publication of “Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy” (TREAT), the US Food and Drug Administration has elected to reevaluate the use of erythropoiesis-stimulating agents in the treatment of anemia secondary to chronic kidney disease. This commentary by Dr. Ajay Singh provides insight into the challenges involved with interpreting the current body of evidence in this controversial topic.: Does TREAT Give the Boot to ESAs in the Treatment of CKD Anemia? Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. Erythropoiesis-Stimulating Agents — Time for a Reevaluation (Source: Nephrology Now)

Recalls and Safety Alerts: Risk Management Program for Procrit, Epogen and Aranesp

Food and Drug Adminstration (FDA): Patient Safety News — Sat, 01 May 2010 04:00:00 +0100

FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure tha... (Source: Food and Drug Adminstration (FDA): Patient Safety News)

Treatment of anemia with darbepoetin alfa in heart failure.

Congestive Heart Failure — Fri, 30 Apr 2010 23:00:00 +0100

Authors: Abraham WT, Anand IS, Klapholz M, Ponikowski P, Scarlata D, Wasserman SM, van Veldhuisen DJ Anemia is common in heart failure (HF) patients. A prespecified pooled analysis of 2 randomized, double-blind, placebo-controlled studies evaluated darbepoetin alfa (DA) in 475 anemic patients with HF (hemoglobin [Hb], 9.0-12.5 g/dL). DA was administered subcutaneously every 2 weeks and titrated to achieve and maintain a target Hb level of 14.0+/-1.0 g/dL. By week 27, mean (SD) Hb concentrations did not increase with placebo but increased with DA from 11.5 (0.7) to 13.3 (1.3) g/dL. Hazard ratios (HRs) for DA compared with placebo for all-cause death or first HF hospitalization (composite end point), all-cause death, and HF hospitalization by month 12 were 0.67 (95% confidence interval [...

TREAT: Implications for Guideline Updates and Clinical Care

American Journal of Kidney Diseases — Thu, 22 Apr 2010 23:00:00 +0100

Commentary on Pfeffer MA, Burdmann EA, Chen CY, et al; for the TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361(21):2019-2032. (Source: American Journal of Kidney Diseases)

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133: Hematologic Outcomes and Dosing Patterns in Anemic Patients With Pre-Dialysis Chronic Kidney Disease (CKD) Switching From Darbepoetin Alfa (DARB) to Epoetin Alfa (EPO)

American Journal of Kidney Diseases — Thu, 25 Mar 2010 16:09:49 +0100

(Source: American Journal of Kidney Diseases)

Nitric Oxide Synthase Mediates the Ability of Darbepoetin Alfa to Improve the Cognitive Performance of STOP Null Mice

Neuropsychopharmacology — Wed, 24 Mar 2010 00:00:00 +0100

Authors: Kosuke Kajitani, Michael Thorne, Michel Samson & George S Robertson Keywords: Behavioral Science; Cognition; Darbepoetin alfa; nitric oxide; novel objective recognition task; Psychopharmacology; schizophrenia; Schizophrenia/Antipsychotics; STOP null mouse (Source: Neuropsychopharmacology)

Former InterMune CEO Convicted of Wire Fraud; Further Troubles for Sequenom: Investigations, Shareholder Lawsuit Follow Alleged Mishandling of Data on Fetal Test; Amgen Sued over Aranesp Sales Practices; ZymoGenetics Can Resume Marketing Campaign; Congressional Members Request Drug Price Inquiries; Steps Forward in Decode Bankruptcy Case

Biotechnology Law Report — Fri, 19 Mar 2010 00:21:09 +0100

Biotechnology Law Report Dec 2009, Vol. 28, No. 6: 729-731. (Source: Biotechnology Law Report)

ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Mon, 01 Mar 2010 05:00:00 +0100

Updated Date: Mar 1, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Aranesp (Darbepoetin Alfa) - updated on RxList

RxList - New and Updated Drug Monographs — Thu, 25 Feb 2010 07:00:00 +0100

Aranesp (Darbepoetin Alfa) drug description - FDA approved labeling for prescription drugs and medications at RxList (Source: RxList - New and Updated Drug Monographs)

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Reply: The Impact of Methodological Approach on Cost Findings in Comparison of Epoetin Alfa with Darbepoetin Alfa(March).

The Annals of Pharmacotherapy — Tue, 23 Feb 2010 00:00:00 +0100

Authors: Song X, Long SR, Marder WD, Sullivan SD, Kallich J PMID: 20179261 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

Comment: The Impact of Methodological Approach on Cost Findings in Comparison of Epoetin Alfa with Darbepoetin Alfa(March).

The Annals of Pharmacotherapy — Tue, 23 Feb 2010 00:00:00 +0100

Authors: Lefebvre P, Vekeman F, Cremieux PY PMID: 20179253 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

FDA clamps down on ESA prescriptions

Cancer Network — Thu, 18 Feb 2010 13:30:01 +0100

Concerned that erythropoiesis-stimulating agents may actually undo what chemotherapy has done, promoting tumor progression or recurrence and shortening overall survival, the FDA is clamping down on these products, marketed by Amgen as Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and by Centocor Ortho Biotech Products as Procrit (epoetin alfa). (Source: Cancer Network)

Centocor Ortho Biotech Products And Amgen Finalize ESA Risk Evaluation And Mitigation Strategy (REMS) With FDA

Cancer / Oncology News From Medical News Today — Wed, 17 Feb 2010 10:00:00 +0100

Centocor Ortho Biotech Products, L.P. and Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include PROCRIT® (Epoetin alfa), Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa)... (Source: Cancer / Oncology News From Medical News Today)

FDA Announces New Safety Plan For Agents Used To Treat Chemotherapy-Related Anemia

Health News from Medical News Today — Wed, 17 Feb 2010 10:00:00 +0100

The U.S. Food and Drug Administration approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy. ESAs, which include epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc... (Source: Health News from Medical News Today)

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Centocor Ortho Biotech Products And Amgen Finalize ESA Risk Evaluation And Mitigation Strategy (REMS) With FDA

Health News from Medical News Today — Wed, 17 Feb 2010 10:00:00 +0100

Darbepoetin Alfa and Chronic Kidney Disease

New England Journal of Medicine — Wed, 17 Feb 2010 00:00:00 +0100

To the Editor: Pfeffer et al. (Nov. 19 issue)1 report on the Trial to Reduce Cardiovascular Events with Aranesp Therapy ... (Source: New England Journal of Medicine)

Centocor Ortho Biotech Products and Amgen Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA

HSMN NewsFeed — Tue, 16 Feb 2010 18:51:08 +0100

Companies to Launch ESA APPRISE Oncology Program on March 24, 2010 for Patients with Cancer Medication Guide Available for All Indications HORSHAM, Pa., Feb. 16 (HSMN NewsFeed) -- Centocor Ortho Biotech Products, L.P. and Amgen Inc. today announced... Biopharmaceuticals, Oncology, FDACentocor Ortho Biotech, Amgen, erythropoiesis, EPOGEN, Aranesp, Procrit (Source: HSMN NewsFeed)

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

FDA MedWatch — Tue, 16 Feb 2010 15:55:00 +0100

FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer. (Source: FDA MedWatch)

Centocor Ortho Biotech Products and Amgen Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA(Feb 16, 2010)

Johnson and Johnson — Tue, 16 Feb 2010 15:30:18 +0100

Horsham, PA (February 16, 2010) – Centocor Ortho Biotech Products, L.P. and Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include PROCRIT® (Epoetin alfa), Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers. ..... (Source: Johnson and Johnson)

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Centocor Ortho Biotech Products And Amgen Finalize ESA Risk Evaluation And Mitigation Strategy (REMS) With FDA

Pharmaceutical Online News — Tue, 16 Feb 2010 09:09:00 +0100

Centocor Ortho Biotech Products, L.P. and Amgen Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include PROCRIT (Epoetin alfa), Aranesp (darbepoetin alfa) and EPOGEN (Epoetin alfa). (Source: Pharmaceutical Online News)

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

Drugs.com - FDA MedWatch Alerts — Tue, 16 Feb 2010 05:00:00 +0100

Audience: Oncological and nephrological healthcare professionals and patients FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a... (Source: Drugs.com - FDA MedWatch Alerts)

Amgen and Centocor Ortho Biotech Products Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA

Amgen News Service — Tue, 16 Feb 2010 00:00:00 +0100

THOUSAND OAKS, Calif., Feb 16, 2010 /PRNewswire via COMTEX/—Amgen Inc. (Nasdaq: AMGN) and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp(R) (darbepoetin alfa), EPOGEN(R) (Epoetin alfa) and PROCRIT(R) (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers. (Source: Amgen News Service)

ARANESP (Darbepoetin Alfa) Solution ARANESP (Darbepoetin Alfa) Injection, Solution [AMGEN INC]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 12 Feb 2010 05:00:00 +0100

Updated Date: Feb 12, 2010 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Doping control analysis of recombinant human erythropoietin, darbepoetin alfa and methoxy polyethylene glycol-epoetin beta in equine plasma by nano-liquid chromatography-tandem mass spectrometry.

Analytical and Bioanalytical Chemistry — Thu, 11 Feb 2010 00:00:00 +0100

Authors: Yu NH, Ho EN, Wan TS, Wong AS Recombinant human erythropoietin (rhEPO), darbepoetin alfa (DPO) and methoxy polyethylene glycol-epoetin beta (PEG-EPO) are synthetic analogues of the endogenous hormone erythropoietin (EPO). These erythropoiesis-stimulating agents have the ability to stimulate the production of red blood cells and are commercially available for the treatment of anaemia in humans. These drugs are understood to have performance-enhancing effects on human athletes due to their stimulation of red blood cell production, thereby improving delivery of oxygen to the muscle tissues. Although their effect on horses has not been proven, these substances were thought to be similarly performance enhancing and have indeed been applied covertly to horses. As such, these protein...

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Discovery and basic pharmacology of erythropoiesis-stimulating agents (ESAs), including the hyperglycosylated ESA, darbepoetin alfa: an update of the rationale and clinical impact

European Journal of Clinical Pharmacology — Mon, 01 Feb 2010 18:01:46 +0100

Abstract Cloning of the human erythropoietin (EPO) gene and development of the first recombinant human erythropoietin (rHuEPO) drug were truly breakthroughs. This allowed a deeper understanding of the structure and pharmacology of rHuEpo, which in turn inspired the discovery and development of additional erythropoiesis-stimulating agents (ESAs). In vivo specific activity and serum half-life of rHuEPO are influenced by the amount and structure of the attached carbohydrate. Increased numbers of sialic acids on carbohydrate attached to rHuEPO correlated with a relative increase in in-vivo-specific activity and increased serum half-life. The effect of increasing the number of sialic-acid-containing carbohydrates on in-vivo-specific activity was explored. Initial research focuse...

Effects of Darbepoetin Alfa with exercise in cancer patients undergoing chemotherapy: an explorative study

Scandinavian Journal of Medicine and Science in Sports — Sun, 31 Jan 2010 00:00:00 +0100

Fatigue is frequent in cancer patients undergoing chemotherapy. Erythropoietins (EPO) have shown well-documented effects on these patients, and administered in pharmacological doses, may reduce the need for transfusion of blood cells and improve quality of life (QoL). An explorative, descriptive, non-randomised intervention study using semi-structured interviews was conducted with the aim to gain an insight into the effects and experiences associated with EPO treatment in combination with a structured 6-week physical exercise intervention. Sixteen cancer patients with evidence of disease, who had received at least one cycle chemotherapy, participated. Participants received 500 [mu]g Darbepoetin Alfa (DA) every 3 weeks during the intervention. Four typologies of patients were identified wit...

Use of latent growth curve models for assessing the effects of darbepoetin alfa on hemoglobin and fatigue

Contemporary Clinical Trials — Mon, 25 Jan 2010 00:00:00 +0100

Abstract: Background:: The relationship between darbepoetin alfa and fatigue in chemotherapy-induced anemia (CIA) patients is complex because of patients receiving transfusions and the mediating effect of hemoglobin. Latent growth models (LGMs) were used to examine simultaneously relationships among drug exposure, fatigue outcomes, covariates, and mediating factors.Methods:: Data from four CIA studies (AMG 20010145: small cell lung cancer, n=547; AMG 980297: lung cancer, n=288; AMG 20000161: lymphoproliferative malignancies, n=339; AMG 20030232: non-myeloid malignancies, n=320) were analyzed separately. Patients reported fatigue using the FACT-Fatigue. The effect of darbepoetin alfa on FACT-F changes mediated through hemoglobin changes was examined with LGMs controlling for transfusions, a...

[Direct medical cost of erythropoiesis-stimulating agents in anaemia treatment of chronic renal failure patient: A literature review.]

Nephrologie & Therapeutique — Thu, 21 Jan 2010 00:00:00 +0100

CONCLUSION: The costs associated with the prices of acquisition of the ASE, negotiated by the structure of care, represent the most important part of the direct medical costs. PMID: 20097148 [PubMed - as supplied by publisher] (Source: Nephrologie & Therapeutique)

Amgen Shares Dip On Anemia Drug Concerns

Drugs.com - Pharma News — Fri, 08 Jan 2010 14:45:29 +0100

From Associated Press (January 7, 2010) NEW YORK--Shares of Amgen Inc. fell Thursday over concerns that the Food and Drug Administration’s plan to re-examine the safety of anemia drugs could pressure sales of leading anemia treatments Aranesp... (Source: Drugs.com - Pharma News)

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F.D.A. Plans Safety Check of 3 Drugs for Anemia

NYT — Thu, 07 Jan 2010 06:19:57 +0100

The agency said it would examine Epogen, Aranesp and Procrit after a clinical trial suggested that high doses might cause strokes. (Source: NYT)

ARANESP PFS (darbepoetin alfa) - Revised SPC

NeLM - SPC Changes — Mon, 04 Jan 2010 00:00:00 +0100

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes Revised SPC includes changes to: Section 4.2 (Posology and method of administration) - paediatric patients with chronic renal failure, maintenance phase: clarification of dosing. Section 5.1 (Pharmacodynamic Properties) - section on chronic renal failure added. (Source: NeLM - SPC Changes)

Trick or TREAT? More Condemning Evidence Against ESAs

Geriatric Nursing — Fri, 01 Jan 2010 00:00:00 +0100

The recent publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) serves confounding and perhaps condemning evidence against the use of erythroid stimulating agents (ESAs) in predialysis patients with chronic kidney disease. However, the additional value of the TREAT results is questionable, given the design of the trial and the background evidence surrounding the use of ESAs that has amassed since 2006. This objective of this commentary is to summarize and interpret the TREAT trial in light of current practice and recent literature and to provide a suggested approach to the use of ESAs in the long-term care population going forward. (Source: Geriatric Nursing)

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

American Journal of Hematology — Fri, 01 Jan 2010 00:00:00 +0100

(Source: American Journal of Hematology)

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Anemia Drug Not Helpful For Kidney Disease Patients

Health News from Medical News Today — Wed, 30 Dec 2009 08:00:00 +0100

An international study authored by a UT Southwestern Medical Center researcher has concluded that the anemia drug darbepoetin alfa works no better than a placebo in several other applications previously thought to be promising. Darbepoetin alfa is one of a class of drugs used to increase red blood cells in patients with type 2 diabetes, chronic kidney disease and anemia, but in a study of 4,038 patients, it did little to reduce cardiovascular problems, death or even the need for dialysis... (Source: Health News from Medical News Today)

Timing of the administration of intravenous darbepoetin alfa during the dialysis session: Does it impact efficacy?

Dialysis and Transplantation — Mon, 28 Dec 2009 00:00:00 +0100

Darbepoetin alfa (DA) is an erythropoietin-stimulating agent (ESA) preferably administered through intravenous (IV) route in hemodialysis (HD) patients. Although some in vitro studies suggest the possibility of partial adsorption of ESAs in dialysis membranes (Mb) and lines, these data are not clinically confirmed.This 12-month, prospective, single-center cross-over study assessed the impact of the time of IV DA injection during HD on hemoglobin (Hgb) level and ESA dosing. A total of 90 HD patients received IV DA once every other week (Q2W), delivered at 2 possible time points: the middle or end of the HD session. After 6 months, the injection time point was crossed over to the other timing modality for another 6 months.Demographics for both groups of patients were similar. Mean Hgb level ...

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The efficacy of monthly administration of darbepoetin alfa in Saudi hemodialysis patients

Dialysis and Transplantation — Mon, 28 Dec 2009 00:00:00 +0100

Erythropoiesis-stimulating agents have improved the outcome and quality of life in patients with chronic kidney disease.We investigated the efficacy and safety of conversion of hemodialysis patients from epoetin beta to darbepoetin alfa administered once a month.The study included 26 patients. Their mean age was 47.0 6 17.13 years with a mean hemodialysis duration of 55.8 ± 14.0 months. The study was carried out in 2 consecutive phases of 12 weeks each. The mean initial dose of darbepoetin was 57 ± 10.0 mg biweekly. After maintaining target hemoglobin (Hgb) levels - (11-12 g/L) - with the biweekly injections, we shifted our patients to a once-monthly dose schedule.The mean weekly darbepoetin dose increased from 28.75 ± 4.2 mg during the biweekly phase to 38.5 ± 3.9 mg after switching t...

Aransesp SureClick (darbepoetin alfa) - Revised SPC

NeLM - SPC Changes — Thu, 24 Dec 2009 00:00:00 +0100

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes Revised SPC includes changes to: Section 4.2 - Posology and method of administration - paediatric patients with chronic renal failure, maintenance phase: clarification of dosing Section 5.1 - Pharmacodynamic Properties - section on chronic renal failure added (Source: NeLM - SPC Changes)

Anemia drug not helpful for kidney disease patients

EurekAlert! - Medicine and Health — Tue, 22 Dec 2009 05:00:00 +0100

(UT Southwestern Medical Center) An international study authored by a UT Southwestern Medical Center researcher has concluded that the anemia drug darbepoetin alfa works no better than a placebo in several other applications previously thought to be promising. (Source: EurekAlert! - Medicine and Health)

Amgen Issues Statement on Update to U.S. Prescribing Information for Erythropoiesis-Stimulating Agents (ESAs)

Amgen News Service — Wed, 16 Dec 2009 00:00:00 +0100

On December 16, 2009, Amgen updated the boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), to reflect an increased risk of stroke when ESAs are administered to chronic renal failure patients to target hemoglobin levels of 13 g/dL and above. The update was made based on results from the recently completed clinical study, TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double-blind, placebo-controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type-2 diabetes. In addition, the Warnings section has been updated to include a description of TREAT and t...

Intravenously administered darbepoetin alfa once a week could maintain hemoglobin level more efficiently than once every 2 weeks in patients on hemodialysis

Clinical and Experimental Nephrology — Fri, 04 Dec 2009 21:16:48 +0100

Conclusion Administration of darbepoetin alfa Q2W could maintain Hb level similarly to to that obtained QW, but we did not confirm efficiency at a higher dose requirement or blood pressure elevation. Content Type Journal ArticleCategory Original ArticleDOI 10.1007/s10157-009-0251-xAuthors Hiroshi Nagaya, Tosei General Hospital Department of Nephrology and Rheumatology 160 Nishioiwake-cho Seto Aichi 489-8642 JapanDaijo Inaguma, Tosei General Hospital Department of Nephrology and Rheumatology 160 Nishioiwake-cho Seto Aichi 489-8642 JapanAkimitsu Kitagawa, Tosei General Hospital Department of Nephrology and Rheumatology 160 Nishioiwake-cho Seto Aichi 489-8642 JapanMinako Murata, Tosei General Hospital Department of Nephrology and Rheumatology 160 Nishioiwake-cho Seto Aich...

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Intravenously administered darbepoetin alfa once a week could maintain hemoglobin level more efficiently than once every 2 weeks in patients on hemodialysis

Clinical and Experimental Nephrology — Fri, 04 Dec 2009 21:16:48 +0100

A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. F1000 Ranking: "Exceptional" and Changes Clinical Practice"

Medscape Today Headlines — Mon, 30 Nov 2009 17:52:15 +0100

Guidelines on darbepoetin treatment for renal anemia must be changed immediately. Faculty of 1000 Medicine (Source: Medscape Today Headlines)

Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

Medscape Today Headlines — Wed, 25 Nov 2009 12:04:33 +0100

The TREAT trial tested the hypothesis that the use of erythropoiesis-stimulating agents would improve outcomes in patients with diabetes and chronic kidney disease who were also anemic. The American College of Cardiology's Cardiosource (Source: Medscape Today Headlines)

Darbepoetin Alfa and History of Thromboembolic Events [CORRESPONDENCE]

Journal of Clinical Oncology — Wed, 18 Nov 2009 23:02:37 +0100

(Source: Journal of Clinical Oncology)

A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease

New England Journal of Medicine — Wed, 18 Nov 2009 00:00:00 +0100

Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. This placebo-controlled trial randomly assigned such patients to receive darbepoetin alfa or placebo. The two composite end points were death or cardiovascular disease and death or end-stage renal disease. Darbepoetin alfa did not reduce either outcome and was associated with an increased risk of stroke. (Source: New England Journal of Medicine)

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CME: A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease

New England Journal of Medicine — Wed, 18 Nov 2009 00:00:00 +0100

(No abstract is available for this citation) (Source: New England Journal of Medicine)

Video Day in Review from AHA 2009 with Dr. Melissa Walton-Shirley: Monday, November 16

Medscape Today Headlines — Tue, 17 Nov 2009 17:07:56 +0100

Join Dr. Walton-Shirley for a review of ARBITER 6-HALTS, Primary PCI in Massachusetts, high ionizing radiation, soybeans and omega-3 fatty acid, video games, anemia and transfusion, and darbepoetin alfa. Medscape Cardiology (Source: Medscape Today Headlines)

AHA: Stroke, VTE More Common with Darbepoetin (CME/CE)

MedPage Today Nephrology — Tue, 17 Nov 2009 14:05:56 +0100

ORLANDO (MedPage Today) -- Treating patients with diabetes, kidney disease and anemia with the colony stimulating factor darbepoetin (Aranesp) to improve their hemoglobin levels appears to cause more problems than it solves, researchers reported here. (Source: MedPage Today Nephrology)

Anemia TREATment fails to yield CV benefits, ups stroke risk

MedWire News - Cardiology — Tue, 17 Nov 2009 00:00:00 +0100

The risks of using the erythropoiesis-stimulating agent, darbepoetin alpha, to treat anemia in patients with Type 2 diabetes and chronic kidney disease far outweigh any modest benefits, according to data from the Trial to Reduce Cardiovascular Events with Aranesp Therapy. (Source: MedWire News - Cardiology)

Clinical Trial Summary: Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT — Presented at AHA 2009)

Cardiosource — Mon, 16 Nov 2009 08:00:00 +0100

Although erythropoiesis-stimulating agents (ESAs) are widely used in patients with anemia and chronic kidney disease (CKD) who are not on dialysis, randomized data to support this approach are not available. The TREAT trial sought to test the hypothesis that the use of ESAs in patients with diabetes. . . (Source: Cardiosource)

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CHOICE, an international, observational study to examine current practice use of darbepoetin alfa in the management of chemotherapy-induced anaemia

European Journal of Integrative Medicine — Fri, 13 Nov 2009 13:55:30 +0100

Introduction: In February 2008, the European product label for darbepoetin alfa (DA) in the treatment of chemotherapy-induced anaemia (CIA) was changed to stipulate target haemoglobin (Hb) values between 10 and 12g/dL. EORTC guidelines on ESA use state similar Hb target levels. The primary aim of this study is to assess adherence to the recommended Hb target range in patients (pts) receiving DA in routine clinical practice.Methods: This prospective, multicenter, observational study evaluated the routine clinical practice use of DA in 11 European countries in pts with various non-myeloid malignancies (breast, colorectal, ovarian and lung cancer) at any time during chemotherapy treatment. Key outcome measures were Hb levels and the requirement for red blood cell (RBC) transfusions.Results: 3...

Anemia treatment fails to improve outcomes in Type 2 diabetics with CKD

MedWire News - Cardiology — Wed, 04 Nov 2009 13:57:49 +0100

Results from the TREAT study show that darbepoetin alfa treatment for anemia does not improve cardiovascular or renal outcomes or related mortality of patients with Type 2 diabetes, chronic kidney disease, and moderate anemia. (Source: MedWire News - Cardiology)

C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: The ARCTOS extension study

Hemodialysis International — Wed, 04 Nov 2009 00:00:00 +0100

C.E.R.A., a continuous erythropoietin receptor activator is approved for the treatment of anemia in patients with chronic kidney disease (CKD). The ARCTOS (administration of C.E.R.A. in CKD patients to treat anemia with a twice-monthly schedule) phase 3 study demonstrated the efficacy and safety of C.E.R.A. in correcting anemia when administered once every 2 weeks (Q2W) subcutaneously in patients with CKD not on dialysis. We assessed the feasibility and long-term safety of converting patients who responded to treatment with C.E.R.A. Q2W to C.E.R.A. once every 4 weeks (Q4W) during a 24-week extension period. After the core ARCTOS study period (28 weeks), 296 patients entered the 24-week extension period. At week 29, patients who responded to C.E.R.A. Q2W during the core period were rerandom...

Treating Anemia Does Not Reduce the Risk for Cardiovascular or Renal Events in Diabetics With Renal Disease

Medscape Today Headlines — Tue, 03 Nov 2009 16:51:28 +0100

Anemia treatment with darbepoetin alfa is no better than placebo at reducing mortality, heart failure, heart attacks, or dialysis need in patients with diabetes, anemia, and chronic kidney disease. Medscape Medical News (Source: Medscape Today Headlines)