MedWorm: Aranesp

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)

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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) — 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)

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)

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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)

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)

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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)

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)

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))

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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...

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)

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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)

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)

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

NYT > Health — Thu, 07 Jan 2010 04:13:37 +0100

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

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)

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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)

Anemia Drug Not Helpful For Kidney Disease Patients

Cardiovascular / Cardiology News From Medical News Today — Wed, 30 Dec 2009 08:00:00 +0100

Anemia Drug Not Helpful For Kidney Disease Patients

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

Anemia Drug Not Helpful For Kidney Disease Patients

Cardiovascular / Cardiology News From Medical News Today — Wed, 30 Dec 2009 08:00:00 +0100

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)

Darbepoetin Alfa Fails to Cut Mortality and Cardiac, Renal Events

OncologySTAT Latest News — Tue, 03 Nov 2009 13:48:43 +0100

For patients with chronic kidney disease, type 2 diabetes, and anemia, raising hemoglobin levels with darbepotein alfa does not improve the combined risk of death and major cardiovascular and renal events,... (Source: OncologySTAT Latest News)

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

MedWire News - Diabetes — Tue, 03 Nov 2009 00:00:00 +0100

Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints

Drugs.com - Clinical Trials — Mon, 02 Nov 2009 16:32:14 +0100

Aranesp(R) (Darbepoetin Alfa) Did Not Reduce the Risk of Mortality, Cardiovascular Morbidity, or End Stage Renal Disease Results Show Increased Risk of Stroke Among Patients Treated to a Hemoglobin of 13 g/dL THOUSAND OAKS, Calif., Oct. 30... (Source: Drugs.com - Clinical Trials)

Darbepoetin Alfa Associated with Heightened Stroke Risk

Physician's First Watch current issue — Mon, 02 Nov 2009 12:33:06 +0100

(Source: Physician's First Watch current issue)

Benefits, Risks of Darbepoetin Alfa in Diabetes Assessed

Modern Medicine — Mon, 02 Nov 2009 00:00:00 +0100

In patients with diabetes, chronic kidney disease and anemia, darbepoetin alfa does not reduce death, cardiovascular or renal events, and may be linked to an increased risk of stroke, according to a study published online Oct. 30 in the New England Journal of Medicine. (Source: Modern Medicine)

Anemia Drug May Raise Stroke Risk in Kidney Patients

MedlinePlus Health News — Sun, 01 Nov 2009 14:00:00 +0100

Use of Aranesp should be reserved for the most seriously ill, experts say Source: HealthDay Related MedlinePlus Topics: Anemia, Diabetic Kidney Problems, Drug Safety (Source: MedlinePlus Health News)

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

Nephrology Now — Sun, 01 Nov 2009 00:53:49 +0100

This study is expected to drive much discussion and influence guidelines and clinical practice. © Nephrology Now editors for Nephrology Now, 2009. | Permalink | 2 comments | Add to del.icio.us Post tags: (Source: Nephrology Now)

Treatment of Anemia in Chronic Kidney Disease — Strategies Based on Evidence

Nephrology Now — Sun, 01 Nov 2009 00:53:29 +0100

This editorial provides insight into the interpretation of the TREAT study, “A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease”. © Nephrology Now editors for Nephrology Now, 2009. | Permalink | Add comment! | Add to del.icio.us Post tags: (Source: Nephrology Now)

Darbepoetin Alfa Fails to Cut Cardiac, Renal Events in Type 2

Clinical Endocrinology News — Sun, 01 Nov 2009 00:00:00 +0100

For patients with chronic kidney disease, type 2 diabetes, and anemia, raising hemoglobin levels with darbepoetin alfa does not improve the combined risk of death and major cardiovascular and renal events, according to a multicenter, placebo-controlled trial. (Source: Clinical Endocrinology News)

Anemia Drug May Raise Stroke Risk in Kidney Patients

Forbes.com Health News — Sat, 31 Oct 2009 14:00:00 +0100

Use of Aranesp should be reserved for the most seriously ill, experts say (Source: Forbes.com Health News)

Amgen's Anemic Results

Forbes.com Healthcare News — Sat, 31 Oct 2009 01:40:00 +0100

The company's best-selling Aranesp drug doubles the risk that kidney patients will suffer a stroke. (Source: Forbes.com Healthcare News)

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No TREAT: Darbepoetin alfa fails to reduce CV or renal events in anemic diabetics with CKD

theHeart.org — Sat, 31 Oct 2009 00:41:45 +0100

No differences were seen between groups, except in strokes, which were twice as high in the active treatment group. Anticipated improvements in fatigue scores were modest, and not clinically meaningful, investigators say. (Source: theHeart.org)

No TREAT: Darbepoetin alfa fails to reduce CV or renal events in anemic diabetics with CKD

theHeart.org — Sat, 31 Oct 2009 00:41:45 +0100

No differences were seen between groups, except in strokes, which were twice as high in the active-treatment group. Anticipated improvements in fatigue scores were modest and not clinically... For complete story visit theheart.org. (Source: theHeart.org)

Study Finds Stroke Risk From Anemia Drug Aranesp

ABC News: Health — Sat, 31 Oct 2009 00:41:17 +0100

Aranesp nearly doubles stroke risk in diabetics with anemia and kidney problems, study finds (Source: ABC News: Health)

Study finds stroke risk from anemia drug Aranesp

USATODAY.com Health — Sat, 31 Oct 2009 00:40:50 +0100

A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the ... (Source: USATODAY.com Health)

ASN: No Clinical Benefit for ESA in Anemic Patients with Diabetes, CKD (CME/CE)

MedPage Today Cardiovascular — Sat, 31 Oct 2009 00:40:00 +0100

SAN DIEGO — For patients with type 2 diabetes, chronic kidney disease, and anemia, darbepoetin alfa (Aranesp) failed to improve most clinical outcomes compared with placebo and nearly doubled the risk of stroke, a large, multicenter trial showed. (Source: MedPage Today Cardiovascular)

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Clinical Trial Summary: Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

Cardiosource — Sat, 31 Oct 2009 00:00:00 +0100

States Sue Amgen Over Sales Practices

WSJ.com: Health — Fri, 30 Oct 2009 20:25:49 +0100

Fourteen states sued Amgen alleging the drug-maker provided doctors with retreats and other incentives to prescribe anemia-drug Aranesp. (Source: WSJ.com: Health)

States Sue Amgen Over Sales Practices

WSJ.com: Health — Fri, 30 Oct 2009 20:25:49 +0100

Fourteen states sued Amgen alleging the drug-maker provided doctors with retreats and other incentives to prescribe anemia-drug Aranesp. (Source: WSJ.com: Health)

Aranesp nearly doubles stroke risk in diabetics with anemia and kidney problems, study finds

OrlandoSentinel: Medical Research — Fri, 30 Oct 2009 17:41:00 +0100

A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis. The study is... (Source: OrlandoSentinel: Medical Research)

Anemia Treatment of Patients with Diabetes and Chronic Kidney Disease is No More Effective Than Placebo and Carries Risks

BWH for Journalists — Fri, 30 Oct 2009 00:00:00 +0100

Researchers found no significant differences in deaths, heart attacks, heart failure, or need for dialysis compared to placebo. However, researchers found an increased risk of stroke among those assigned to darbepoetin alfa compared to placebo. (Source: BWH for Journalists)

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Anemia Treatment of Patients with Diabetes and Chronic Kidney Disease is No More Effective Than Placebo and Carries Risks

BWH News — Fri, 30 Oct 2009 00:00:00 +0100

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

New England Journal of Medicine — Fri, 30 Oct 2009 00:00:00 +0100

Background Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin ... (Source: New England Journal of Medicine)

Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints

Amgen News Service — Fri, 30 Oct 2009 00:00:00 +0100

THOUSAND OAKS, Calif., Oct. 30 /PRNewswire-FirstCall/—Amgen (Nasdaq: AMGN) today announced the publication of results from 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. The study, published online today in the New England Journal of Medicine and presented at the annual meeting of the American Society of Nephrology (ASN), failed to meet its primary objectives of demonstrating a reduction in all-cause mortality, cardiovascular morbidity, including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia, or end-stage renal disease (ESRD). (Source: Amgen News Service...

The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure

European Journal of Heart Failure — Thu, 29 Oct 2009 23:07:37 +0100

Conclusion Darbepoetin alfa was well tolerated with an AE profile similar to placebo in HF subjects treated to a target Hb of 14.0 ± 1.0 g/dL. Contrary to recent data in other patient populations, there was no evidence of increased risk of mortality or cardiovascular events. (Source: European Journal of Heart Failure)

Effect of darbepoetin alfa on renal anemia in Japanese hemodialysis patients.

Arzneimittel-Forschung — Thu, 29 Oct 2009 16:28:02 +0100

CONCLUSION: Darbepoetin alfa increases the Hgb value effectively in Japanese hemodialysis patients. Although no serious adverse events were apparent in our short-term analysis, the incidence of hypertension and excessive increase of the Hgb value must be noted. PMID: 19856789 [PubMed - in process] (Source: Arzneimittel-Forschung)

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Meeting New Challenges in the Management of Anemia of Chronic Kidney Disease Through Collaborative Care with Pharmacists (November).

The Annals of Pharmacotherapy — Mon, 12 Oct 2009 23:00:00 +0100

CONCLUSIONS: An approach to CKD-associated anemia management that involves collaboration with pharmacists is essential to achieve patient-specific, cost-effective ESA therapy. PMID: 19826095 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

Maintaining high hemoglobin levels improved the left ventricular mass index and quality of life scores in pre-dialysis Japanese chronic kidney disease patients

Clinical and Experimental Nephrology — Thu, 17 Sep 2009 23:29:49 +0100

Conclusions Targeting a higher Hb around 12 g/dl was more beneficial than targeting conventional Hb in terms of reduction of LVMI and QOL. Further studies to determine the appropriate Hb target are necessary. Content Type Journal ArticleCategory Original ArticleDOI 10.1007/s10157-009-0212-4Authors Hideki Hirakata, Fukuoka Red Cross Hospital 3-1-1 Ogusu Minami-ku Fukuoka Fukuoka 815-8555 JapanYoshiharu Tsubakihara, Osaka General Medical Center Osaka JapanFumitake Gejyo, Niigata University Medical and Dental Hospital Niigata JapanShinichi Nishi, Niigata University Medical and Dental Hospital Niigata JapanYasuhiko Iino, Nippon Medical University Hospital Tokyo JapanYuzou Watanabe, Kasugai Municipal Hospital Kasugai JapanMasashi Suzuki, Shinrakuen Hospital Niigata Jap...

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes

Nephrology Now — Mon, 14 Sep 2009 05:49:57 +0100

While not a peer-reviewed publications, Nephrology Now readers will likely be interested in this preliminary announcements of key findings of the TREAT study which looks at anemia treatment in CKD patients with diabetes. © Nephrology Now editors for Nephrology Now, 2009. | Permalink | Add comment! | Add to del.icio.us Post tags: (Source: Nephrology Now)

Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus [greater than or equal to] 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial

BMC Cancer — Wed, 02 Sep 2009 23:00:00 +0100

Background: Several studies have shown that darbepoetin alfa, an erythropoiesis-stimulating agent (ESA), can reduce transfusions and increase hemoglobin (Hb) levels in patients with chemotherapy-induced anemia (CIA). Recent safety concerns, however, have prompted changes to ESA product information. In the European Union and United States, ESA therapy initiation for CIA is now recommended at a Hb level [less than or equal to]10g/dL. The present exploratory analysis examined how ESA initiation at this Hb level may impact patient care. Methods: Data from a phase 3 randomized trial were retrospectively reanalyzed. CIA patients with nonmyeloid malignancies were randomized 1:1 to 500mcg darbepoetin alfa every three weeks (Q3W) or 2.25mcg/kg darbepoetin alfa weekly (QW) for 15 weeks. A previously...

Pretreatment with darbepoetin attenuates renal injury in a rat model of Cisplatin-induced nephrotoxicity.

The Korean Journal of Internal Medicine — Mon, 31 Aug 2009 23:00:00 +0100

CONCLUSIONS: DPO exhibits a renoprotective effect in experimental cisplatin-induced renal injury, the mechanism of which may involve DPO antiinflammatory and antiapoptotic effects. PMID: 19721861 [PubMed - in process] (Source: The Korean Journal of Internal Medicine)

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Amgen Announces Top-Line Results Of Trial To Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) In CKD Patients With Type-2 Diabetes

Health News from Medical News Today — Wed, 26 Aug 2009 08:00:00 +0100

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy

World Pharma News — Tue, 25 Aug 2009 23:00:00 +0100

Amgen (Nasdaq: AMGN) announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type-2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp((R) )(darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment. (Source: World Pharma News)

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes

Drugs.com - Clinical Trials — Tue, 25 Aug 2009 21:20:10 +0100

THOUSAND OAKS, Calif., Aug. 25 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia... (Source: Drugs.com - Clinical Trials)

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type 2 Diabetes

Amgen News Service — Mon, 24 Aug 2009 23:00:00 +0100

THOUSAND OAKS, Calif.—Aug. 25—Amgen (Nasdaq: AMGN) today announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type 2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp(R) (darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment. (Source: Amgen News Service)

Lipopolysaccharide evokes resistance to erythropoiesis induced by the long-acting erythropoietin analogue darbepoetin alfa in rats.

Anesthesia and Analgesia — Sat, 22 Aug 2009 04:56:16 +0100

CONCLUSION: LPS abolishes erythropoiesis and iron use evoked by DA and this is accompanied by a decrease in hemoglobin concentration and red blood cell concentration. Accordingly, endotoxin suppresses DAs ability to increase erythropoiesis. PMID: 19690235 [PubMed - in process] (Source: Anesthesia and Analgesia)

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Every-Other-Week Darbepoetin Alfa in the Correction and Maintenance of Haemoglobin Levels in Elderly Patients with Chronic Kidney Disease: Post Hoc Subanalysis of Data from Two Clinical Trials

Drugs — Wed, 19 Aug 2009 10:28:38 +0100

(Source: Drugs)

Rationale and design of the oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets trial for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial).

BMC Nephrology — Mon, 27 Jul 2009 23:00:00 +0100

DiscussionThis investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their peritoneal dialysis patients determine whether HIP administration more effectively augments iron stores in ESP-treated PD patients than conventional oral iron supplementation.Trial Registration: Australia New Zealand Clinical Trials Registry number ACTRN12609000432213. (Source: BMC Nephrology)

Rationale and design of the oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets trial for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial).

BMC Nephrology — Mon, 27 Jul 2009 23:00:00 +0100

Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial

European Journal of Heart Failure — Thu, 23 Jul 2009 23:00:00 +0100

Background Patients with heart failure (HF) and anaemia have greater functional impairment, worse symptoms, increased rates of hospital admission, and a higher risk of death, compared with non-anaemic HF patients. Whether correcting anaemia can improve outcomes is unknown. Objective The Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF; Clinical Trials.gov NCT 003 58215) was designed to evaluate the effect of the long-acting erythropoietin-stimulating agent darbepoetin alfa on mortality and morbidity (and quality of life) in patients with HF and anaemia. Methods Approximately 2600 patients with New York Heart Association class II–IV, an ejection fraction ≤40%, and a haemoglobin (Hb) consistently ≤12.0 g/dL but ≥9.0 g/dL will be enrolled. Patients are...

Epogen / Aranesp Class Action Again Dismissed By MDL As FDCA Private Enforcement

LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News — Tue, 07 Jul 2009 11:07:43 +0100

LOS ANGELES - The judge overseeing the Epogen/Aranesp off-label multidistrict litigation on June 17 again denied certification of a class of third-party payers, saying an amended complaint is still a private attempt to enforce violations of the Food, Drug and Cosmetic Act (FDCA) (In Re: Epogen/Aranesp Off-Label Marketing and Sales Practices Litigation, MDL Docket No. 1934, No. 08-ml-01934, C.D. Calif.; See 1/8/09, Page 14). Full story on lexis.com (Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News)

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The Impact of Methodological Approach on Cost Findings in Comparison of Epoetin Alfa with Darbepoetin Alfa(July/August).

The Annals of Pharmacotherapy — Mon, 06 Jul 2009 23:00:00 +0100

CONCLUSIONS: To reduce the risk of potential bias, DCB and different patient characteristics should be taken into account when using retrospective claims data to conduct cost comparisons between agents that have significant differences in dosing schedule. PMID: 19584392 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

Assessing the Quality of Prescribing and Monitoring Erythropoiesis-Stimulating Agents in the Nursing Home Setting

Journal of the American Medical Directors Association — Mon, 29 Jun 2009 16:20:21 +0100

Conclusion: Suboptimal prescribing and monitoring of ESAs were common in the NHs we studied. Future studies are needed to determine if the development and use of computerized decision support systems can improve prescribing and monitoring of ESAs in the NH setting. (Source: Journal of the American Medical Directors Association)

Use of erythropoietin-stimulating agents in breast cancer patients: a risk review.

American Journal of Health-System Pharmacy : AJHP — Sat, 27 Jun 2009 15:29:20 +0100

CONCLUSION: When used in patients with cancer-induced anemia, ESAs should only be given at the lowest dose possible to prevent RBC transfusions. During treatment, hemoglobin levels should be monitored closely and ESA doses need to be adjusted accordingly. PMID: 19535656 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)

[Palliative and Supportive Care] Pooled Analysis of Individual Patient-Level Data From All Randomized, Double-Blind, Placebo-Controlled Trials of Darbepoetin Alfa in the Treatment of Patients With Chemotherapy-Induced Anemia

Journal of Clinical Oncology — Mon, 08 Jun 2009 04:00:00 +0100

Conclusion There seemed to be no association between DA and risk of death or disease progression in this meta-analysis of individual patient data from DA studies conducted in CIA, the approved indication for ESAs in oncology. (Source: Journal of Clinical Oncology)

Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

American Journal of Kidney Diseases — Sun, 07 Jun 2009 23:00:00 +0100

Conclusions: With several-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia. (Source: American Journal of Kidney Diseases)

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Amgen Highlights Data to Be Presented at ASCO

Amgen News Service — Fri, 15 May 2009 04:00:00 +0100

New Vectibix(R) (Panitumumab) Combination Chemotherapy Data New Data Reinforce Importance of Infection Prevention in Chemotherapy Patients Oncology Pipeline Continues to Advance With New Data in Multiple Tumor Types THOUSAND OAKS, Calif. – May 15 – Amgen (Nasdaq: AMGN) today announced it will present new data from the Company’s oncology portfolio of approved and investigational cancer products at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fla. fromMay 29 to June 2, 2009. Data will be presented from several programs, including Vectibix(R) (panitumumab), Neulasta(R) (pegfilgrastim), Aranesp(R) (darbepoetin alfa), denosumab, conatumumab (AMG 655), dulanermin (rhApo2L/TRAIL) and AMG 479. (Source: Amgen News ...

Retrospective Analysis Finds Treatment Of Cancer Chemotherapy Patients With Epoetin Alfa Associated With Lower Drug Cost Than Darbepoetin Alfa

Health News from Medical News Today — Thu, 14 May 2009 08:00:00 +0100

Data from a study of managed-care cancer patients receiving chemotherapy and newly treated with erythropoiesis-stimulating agents (ESAs) found that the cumulative ESA cost with Epoetin alfa (EPO) was 29 percent lower than treatment with darbepoetin alfa (DARB). The analysis, published in the Spring issue of the Journal of Medical Economics, was sponsored by Centocor Ortho Biotech Services, LLC. (Source: Health News from Medical News Today)

Retrospective Analysis Finds Treatment of Cancer Chemotherapy Patients With Epoetin Alfa Associated With Lower Drug Cost Than Darbepoetin Alfa(May 13, 2009)

Johnson and Johnson — Wed, 13 May 2009 08:19:08 +0100

Horsham, PA (May 13, 2009) -- Data from a study of managed-care cancer patients receiving chemotherapy and newly treated with erythropoiesis-stimulating agents (ESAs) found that the cumulative ESA cost with Epoetin alfa (EPO) was 29 percent lower than treatment with darbepoetin alfa (DARB). The analysis, published in the Spring issue of the Journal of Medical Economics (Source: Johnson and Johnson)

Lack of TIMP-1 increases severity of experimental autoimmune encephalomyelitis: Effects of darbepoetin alfa on TIMP-1 null and wild-type mice

Journal of Neuroimmunology — Mon, 11 May 2009 23:00:00 +0100

Abstract: Multiple sclerosis (MS) and experimental autoimmune encephalomyelitis (EAE) are both characterized by the infiltration of myelin-reactive T cells that trigger oligodendrocyte death associated with axonal loss and neurodegeneration in the CNS. Proteolysis of the cerebral vascular extracellular matrix (ECM) resulting in blood-brain barrier (BBB) breakdown is thought to facilitate infiltration of autoreactive T cells in both of these demyelinating disorders. Increased matrix metalloprotease (MMP) activity coupled with reduced levels of tissue inhibitor of metalloproteases (TIMPs) contribute to a loss of BBB integrity. Erythropoietin induces expression of TIMP-1 in endothelial cells suggesting this property may account in part for its ability to maintain BBB integrity and efficacy in...

Anemia Drugs May Raise Death Risk in Cancer Patients

MedlinePlus Health News — Fri, 01 May 2009 15:23:57 +0100

Latest findings support recent label warnings for Procrit, Aranesp, experts say . Source: HealthDay (Source: MedlinePlus Health News)

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Effects of Darbepoetin Alfa on Plasma Mediators of Oxidative and Nitrosative Stress in Anemic Patients With Chronic Heart Failure Secondary to Ischemic or Idiopathic Dilated Cardiomyopathy

The American Journal of Cardiology — Wed, 15 Apr 2009 04:00:00 +0100

This study investigated the effects of darbepoetin alfa on plasma markers of oxidative and nitrosative stress in patients with CHF with anemia. Thirty patients with CHF (LV ejection fraction [LVEF] (Source: The American Journal of Cardiology)

Erythropoiesis stimulating agents and techniques: a challenge for doping analysts.

Current Medicinal Chemistry — Sat, 11 Apr 2009 13:49:06 +0100

Authors: Jelkmann W Recombinant human erythropoietin (rHuEPO) engineered in Chinese hamster ovary (CHO) cell cultures (Epoetin alfa and Epoetin beta) and its hyperglycosylated analogue Darbepoetin alfa are known to be misused by athletes. The drugs can be detected by isoelectric focusing (IEF) and immunoblotting of urine samples, because "EPO" is in reality a mixture of isoforms and the N-glycans of the recombinant products differ from those of the endogenous hormone. However, there is a plethora of novel erythropoiesis stimulating agents (ESAs). Since the originator Epoetins alfa and beta are no longer protected by patent in the European Union, rHuEPO biosimilars have entered the market. In addition, several companies in Asia, Africa and Latin America produce copied rHuEPOs for clinic...

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

American Journal of Kidney Diseases — Sat, 28 Mar 2009 04:08:28 +0100

(Source: American Journal of Kidney Diseases)

3: Hemoglobin (Hb) Variability in Subjects With Chronic Kidney Disease (CKD) Not on Dialysis (NOD): An Analysis of Darbepoetin Alfa Clinical Trial Data

American Journal of Kidney Diseases — Sat, 28 Mar 2009 03:57:24 +0100

(Source: American Journal of Kidney Diseases)

Class Effect of Erythropoietin Therapy on Hemoglobin A1c in a Patient with Diabetes Mellitus and Chronic Kidney Disease Not Undergoing Hemodialysis

Pharmacotherapy: Official Journal of the American College of Clinical Pharmacy — Thu, 26 Mar 2009 04:00:00 +0100

We describe a 64-year-old man with diabetes, chronic kidney disease, and anemia who was treated consecutively with epoetin alfa and darbepoetin alfa and experienced a temporal reduction in A1C level to a nadir of 4.4%. Throughout approximately 3 years of treatment with these erythropoietin analogs, the patient's total daily dose of insulin was reduced in response to his decreasing A1C values, despite elevated blood glucose levels and the absence of patient-reported hypoglycemic events. Five months after the patient's erythropoietin therapy was discontinued, his A1C value increased to 8.8%, leading us to conclude that management of the insulin dose may have been different without the falsely lowered A1C levels. Use of the Naranjo adverse drug reaction probability scale indicated a probable ...

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Drug safety profile of darbepoetin alfa for anemia of chronic kidney disease

Expert Opinion: Expert Opinion on Drug Safety: Table of Contents — Mon, 23 Mar 2009 13:30:59 +0100

Expert Opinion on Drug Safety , March 2009, Vol. 8, No. 2, Pages 145-153. (Source: Expert Opinion: Expert Opinion on Drug Safety: Table of Contents)

Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients

Nephrology — Thu, 12 Mar 2009 04:00:00 +0100

Conclusion: There is a possibility that s.c. administration of darbepoetin alfa is more efficacious than i.v. administration, but a definite benefit cannot be demonstrated with the current sample size. A bigger sample size is needed to confirm the result. (Source: Nephrology)

Aranesp - Darbepoetin Alfa

About.com Breast Cancer — Sat, 07 Mar 2009 05:00:00 +0100

Aranesp (darbepoetin alfa) is a drug given to patients who have chemotherapy-induced anemia (low red blood cell count). An injection of Aranesp stimulates red blood cell production, with a synthetic version of erythropoietin, a protein made in your kidneys. Learn about how it works, possible side effects, and recommendations during treatment. (Source: About.com Breast Cancer)

Current and Upcoming Erythropoiesis-Stimulating Agents, Iron Products, and Other Novel Anemia Medications

Advances in Chronic Kidney Disease — Sun, 01 Mar 2009 05:00:00 +0100

In conclusion, the development of effective therapies for the treatment of anemia has been a highly active field, both scientifically and economically, over the last two decades. (Source: Advances in Chronic Kidney Disease)

Amgen Faces Whistleblower Suit

WSJ.com: Health — Fri, 27 Feb 2009 20:36:18 +0100

A whistleblower lawsuit against Amgen accuses the biotechnology company of illegal marketing of its blockbuster drugs Enbrel and Aranesp. (Source: WSJ.com: Health)

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Current and upcoming erythropoiesis-stimulating agents, iron products, and other novel anemia medications.

Advances in Chronic Kidney Disease — Tue, 24 Feb 2009 16:38:17 +0100

Identification of Darbepoetin Alfa in Human Plasma by Liquid Chromatography Coupled to Mass Spectrometry for Doping Control

International Journal of Sports Medicine — Thu, 29 Jan 2009 13:17:20 +0100

Int J Sports Med 2009; 30: 80-86DOI: 10.1055/s-0028-1103283AbstractDarbepoetin alfa (DPO) or Novel Erythropoiesis Erythropoiesis Stimulating Protein (NESP), an analog of recombinant human erythropoietin (rhEPO), is abused as a blood doping agent along with the latter in human sports. This paper describes a new method for unequivocal identification of DPO in human plasma. The analyte was extracted from plasma by immunoaffinity separation with anti-rhEPO antibodies, digested by trypsin followed by PNGase F, and analyzed by liquid chromatography coupled to tandem mass spectrometry. The deglycosylated tryptic peptide, T, was employed in DPO identification using liquid chromatographic retention time and major product ions of the T peptide. The limit of detection of this method for DPO was 0.1&#...

RICO, Consumer Class Claims Involving Epogen, Aranesp Dismissed For Now By MDL

LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News — Sat, 10 Jan 2009 04:12:28 +0100

LOS ANGELES - Seven third-party payer plaintiffs cannot base Racketeer Influenced and Corrupt Organizations Act and California consumer law claims on alleged violations of the Food, Drug and Cosmetic Act (FDCA), a California federal judge ruled Dec. 17 in dismissing for now a class action involving the alleged off-label promotion of Amgen's anemia drugs Epogen and Aranesp (In Re: Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, MDL No. 1934, No. 09-ml-1934, C.D. Calif.; 2008 U.S. Dist. LEXIS 105233; See 4/17/08, Page 29). Full story on lexis.com (Source: LexisNexis® Mealey's™ Emerging Drugs & Devices Legal News)

Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations.

NDT Plus — Thu, 01 Jan 2009 00:00:00 +0100

Authors: Carrera F, Burnier M The introduction of erythropoiesis-stimulating agents (ESAs) into everyday clinical practice has greatly improved the care of patients with chronic kidney disease. ESAs have reduced the need for blood transfusions, improved survival, decreased cardiovascular complications and enhanced patient quality of life. The longer acting ESA, darbepoetin alfa (Aranesp(R)), which can be administered less frequently than traditional ESAs, provides further benefits to both patients and healthcare professionals relative to the epoetins. Clinical studies have shown that darbepoetin alfa administered once every 2 weeks or once every month allows enhanced convenience and cost savings with no compromise in efficacy, while maintaining patients within target haemoglobin ranges...

Future perspectives on treatment with erythropoiesis-stimulating agents in high-risk patients.

NDT Plus — Thu, 01 Jan 2009 00:00:00 +0100

Authors: Anker SD, Toto R Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Anaemia has been associated with adverse outcomes in CKD populations, and the ability to modify this parameter with the use of erythropoiesis-stimulating agents has been a topic of much debate. Data on the effects of anaemia correction on cardiovascular outcomes and survival in CKD have been both discordant and controversial. It is hoped that the ongoing Trial to Reduce cardiovascular Events with Aranesp Therapy (TREAT) will help to redress the current clinical gaps and the uncertainty over the optimal management of anaemia in patients with CKD and type 2 diabetes mellitus....

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Darbepoetin alfa in the treatment of chemotherapy-induced anaemia

Expert Opinion: Expert Opinion on Biological Therapy: Table of Contents — Sat, 20 Dec 2008 04:56:37 +0100

Expert Opinion on Biological Therapy , Early Online, Vol. 0, No. 0. (Source: Expert Opinion: Expert Opinion on Biological Therapy: Table of Contents)

Intravenous C.E.R.A. Maintains Stable Haemoglobin Levels in Patients on Dialysis Previously Treated With Darbepoetin alfa: Results From STRIATA, A Randomized Phase III Study

Medscape Nephrology Headlines — Tue, 09 Dec 2008 15:02:08 +0100

Extending the administration interval of erythropoiesis-stimulating agents represents an opportunity to improve the efficiency of anemia management in patients with chronic kidney disease. Nephrology Dialysis Transplantation (Source: Medscape Nephrology Headlines)

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Drugs.com - FDA MedWatch Alerts — Tue, 02 Dec 2008 05:00:00 +0100

Audience: Oncologists, other healthcare professionals[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs.... (Source: Drugs.com - FDA MedWatch Alerts)

A monocentric observational study of darbepoetin alfa in anemic hepatitis-C-virus transplant patients treated with ribavirin.

Mon, 01 Dec 2008 05:00:00 +0100

CONCLUSIONS: Darbepoetin alfa was found to be efficient and well tolerated in correcting renal anemia in transplant recipients treated with ribavirin for active hepatitis C. PMID: 19338488 [PubMed - indexed for MEDLINE] (Source: Experimental and Clinical Transplantation : official journal of the Middle East Society for Organ Transplantation)

Anemia in heart failure: To treat or not to treat?

Current Treatment Options in Cardiovascular Medicine — Sun, 23 Nov 2008 06:49:59 +0100

Opinion statement Anemia is a prevalent comorbidity in chronic heart failure (CHF). As studies have demonstrated close links between anemia and a poorer prognosis, there has been an interest in developing treatment strategies for this condition. Anemia is closely associated with disease severity and may be secondary to multiple modifiable causes; therefore, the initial strategies should always include a thorough search for etiology and should focus on optimizing heart failure treatment. Recently, more specific therapies have been assessed, namely erythropoiesis-stimulating agents and iron supplementation therapy. Studies evaluating erythropoietin in heart failure have demonstrated conflicting results to date, with smaller, singlecenter studies seeming to show a clinical be...

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A comparison of haemoglobin levels and doses in haemodialysis patients treated with subcutaneous or intravenous darbepoetin alfa: a German prospective, randomized, multicentre study

Nephrology Dialysis Transplantation — Fri, 21 Nov 2008 05:00:00 +0100

Conclusions. Our data suggest that the darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment. (Source: Nephrology Dialysis Transplantation)

Randomized study of darbepoetin alfa and recombinant human erythropoietin for treatment of renal anemia in chronic renal failure patients receiving peritoneal dialysis.

J Formos Med Assoc — Sat, 01 Nov 2008 04:00:00 +0100

Conclusion: Both darbepoetin alfa and r-HuEPO safely maintain hemoglobin levels within the target range in peritoneal dialysis patients. PMID: 18971153 [PubMed - in process] (Source: J Formos Med Assoc)

Darbepoetin Alfa Prevents Progressive Left Ventricular Dysfunction and Remodeling in Non-Anemic Dogs with Heart Failure.

Am J Physiol Heart C... — Fri, 24 Oct 2008 04:00:00 +0100

This study examined the effects of chronic monotherapy with darbepoetin alfa (DARB) on LV function and remodeling in non-anemic dogs with advanced HF. HF (LV ejection fraction, EF ~25%) was produced in 14 dogs by intracoronary microembolizations. Dogs were randomized to once a week subcutaneous injection of DARB (1.0 microg/kg, n=7) or to no therapy (HF, n=7). All the procedures were performed during cardiac catheterization under general anesthesia and sterile conditions. LV end diastolic (EDV) and end-systolic volumes (ESV) and EF were measured before initiating therapy and at the end of 3 months of therapy. mRNA and protein expression of caspase-3, hypoxia inducible factor-1 alfa (HIF-1alpha) and bone marrow-derived stem cell (BMSC) marker c-Kit were determined in LV tissue. In HF dogs, ...

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Supportive Care in Cancer — Sat, 18 Oct 2008 10:53:07 +0100

Conclusion Adherence to European guidelines for DA treatment was good, and Q3W DA treatment was in synchronisation with Q3W chemotherapy in the majority of the patients, thereby reproducing the findings of a recent phase III study. Content Type Journal ArticleCategory Short CommunicationDOI 10.1007/s00520-008-0517-yAuthors K. Pat, University Hospital Gasthuisberg Respiratory Oncology Unit (Pulmonology) and Leuven Lung Cancer Group Herestraat 49 3000 Leuven BelgiumB. Anrys, University Hospital Gasthuisberg Respiratory Oncology Unit (Pulmonology) and Leuven Lung Cancer Group Herestraat 49 3000 Leuven BelgiumD. Verhulst, Cliniques de l’Europe (Ste Elisabeth) Brussels BelgiumF. Van Aelst, H. Hart Ziekenhuis Roeselare-Menen BelgiumK. Van Eygen, AZ Groeninghe Kortrijk Belg...

Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study

Nephrology Dialysis Transplantation — Wed, 15 Oct 2008 04:00:00 +0100

Conclusions. Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA. (Source: Nephrology Dialysis Transplantation)

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Erythropoietins: A common mechanism of action.

Experimental Hematology — Mon, 13 Oct 2008 04:00:00 +0100

Authors: Elliott S, Pham E, Macdougall IC Clinical development of erythropoiesis-stimulating agents (ESAs) revolutionized the management of anemia. The major clinical benefits of ESAs are effective treatment of anemia and avoidance of blood transfusion risks. Erythropoietin (EPO) interacts directly with the EPO receptor on the red blood cell (RBC) surface, triggering activation of several signal transduction pathways, resulting in the proliferation and terminal differentiation of erythroid precursor cells and providing protection from RBC precursor apoptosis. The magnitude of increase in RBC concentration in response to administration of recombinant human EPO products (rhEPO) is primarily controlled by the length of time EPO concentrations are maintained, not by the EPO concentration l...

Anemia and the potential role of erythropoiesis-stimulating agents in heart failure

Current Heart Failure Reports — Fri, 10 Oct 2008 08:18:33 +0100

Abstract The recognition of the high prevalence and the independent prognostic role of anemia in heart failure (HF) has contributed to intensification of the search for an effective treatment. A central role of erythropoietin in cardiorenal anemia syndrome has been proposed. Several clinical trials have established the safety and efficacy of erythropoiesis-stimulating agents in correcting anemia in patients with HF. The recognition of the pleiotropic effect of erythropoietin has expanded targets of therapy. The ongoing outcomes trial with darbepoetin alfa will determine the role of this novel therapy in the treatment of HF. Content Type Journal ArticleDOI 10.1007/s11897-008-0014-0Authors Haroon A. FarazSyed F. ZafarJalal K. Ghali, Wayne State University University Heal...

Phase II Randomized Study of Dose-Dense Docetaxel and Cisplatin Every 2 Weeks With Pegfilgrastim and Darbepoetin Alfa With and Without the Chemoprotector BNP7787 in Patients With Advanced Non-small Cell Lung Cancer (CALGB 30303).

Journal of Thoracic Oncology — Wed, 01 Oct 2008 11:16:42 +0100

Page: 1159DOI: 10.1097/JTO.0b013e318186fb0dAuthors: Miller, Antonius A. MD *; Wang, Xiaofei F. PhD +; Gu, Lin MS +; Hoffman, Philip MD ++; Khatri, Jamil MD [S]; Dunphy, Frank MD +; Edelman, Martin J. MD [//]; Bolger, Michael MD [P]; Vokes, Everett E. MD ++; Green, Mark R. MD #; for the Cancer and Leukemia Group B (CALGB) (Source: Journal of Thoracic Oncology)

Anemia Drugs Linked To Stroke Study Deaths: FDA

MedlinePlus Health News — Fri, 26 Sep 2008 18:00:00 +0100

Procrit, Aranesp already bear warning labels due to cancer concerns, experts note. Source: HealthDay (Source: MedlinePlus Health News)

Population pharmacokinetics of darbepoetin alfa in peritoneal dialysis and non-dialysis patients with chronic kidney disease after single subcutaneous administration

European Journal of Clinical Pharmacology — Mon, 22 Sep 2008 07:42:31 +0100

Conclusion The present analysis indicated that weight is a significant covariate for CL/f and V1/f. However, dosage adjustment according to weight is not necessary for subcutaneous administration of darbepoetin alfa in CKD patients. Content Type Journal ArticleCategory Pharmacokinetics and DispositionDOI 10.1007/s00228-008-0561-zAuthors Kazuki Kawakami, Kirin Pharma Company Ltd. Product Development Division 26–1 Jingumae 6-chome Shibuya-ku, Tokyo 150–8011 JapanHirotaka Takama, Kirin Pharma Company Ltd. Product Development Division 26–1 Jingumae 6-chome Shibuya-ku, Tokyo 150–8011 JapanDaisuke Nakashima, Kirin Pharma Company Ltd. Product Development Division 26–1 Jingumae 6-chome Shibuya-ku, Tokyo 150–8011 JapanHideji Tanaka, Kirin Pharma Company Ltd. Product...

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Intravenous Iron Improves Treatment Response In Cancer Related Anemia

Cancer / Oncology News From Medical News Today — Tue, 16 Sep 2008 08:00:00 +0100

For patients with chemotherapy-induced anemia, adding intravenous iron to treatment with the drug darbepoetin alfa results in a faster and more potent improvement in response with lower doses of the drug, according to data presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. Anemia is a common problem in cancer patients, caused by a combination of factors including the malignancy itself, plus the effects of chemotherapy. (Source: Cancer / Oncology News From Medical News Today)

Intravenous iron improves treatment response in cancer-related anemia

Huliq Health News — Mon, 15 Sep 2008 13:50:20 +0100

Intravenous iron improves treatment response in cancer-related anemia

EurekAlert! - Cancer — Mon, 15 Sep 2008 04:00:00 +0100

(European Society for Medical Oncology) For patients with chemotherapy-induced anemia, adding intravenous iron to treatment with the drug darbepoetin alfa results in a faster and more potent improvement in response with lower doses of the drug, according to data presented at the 33rd Congress of the European Society for Medical Oncology in Stockholm. (Source: EurekAlert! - Cancer)

Recommendation of the scientific societies on the treatment of anaemia in cancer patients

Clinical and Translational Oncology — Mon, 08 Sep 2008 20:37:59 +0100

Abstract At present, anaemia in the patients with cancer remains a problem of the first magnitude and of increasing interest due to the high incidence, the major knowledge of its physiopathology, the negative impact on the quality of life of the patient, the influence on the evolution of the disease and its treatments and, finally to the progressive development of new alternatives of treatment, especially the erythropoietic agents. For all this, it becomes necessary to consider the treatment of the anemia of the patients with cancer as a basic part of their support treatment. The erythropoietic agents have demonstrated in the last years that constitute a therapeutic alternative to obtain an increase of the levels of hemoglobin in the patients with anticancer treatments, co...

Effects of Aerobic Exercise Training in Anemic Cancer Patients Receiving Darbepoetin Alfa: A Randomized Controlled Trial.

The Oncologist — Mon, 08 Sep 2008 04:00:00 +0100

Conclusions. Aerobic exercise training did not improve QoL or fatigue beyond the established benefits of DAL but it did result in favorable improvements in exercise capacity and a more rapid Hb response with lower dosing requirements. Our results may be useful to clinicians despite the more recent restrictions on the indications for ESAs. PMID: 18779540 [PubMed - as supplied by publisher] (Source: The Oncologist)

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Use and prescribing patterns for erythropoiesis-stimulating agents in inpatient and outpatient hospital settings.

American Journal of Health-System Pharmacy : AJHP — Fri, 05 Sep 2008 15:59:34 +0100

CONCLUSION: ESA use differed between outpatient and inpatient settings in indication, frequency of administration, and specialty of the prescriber. PMID: 18768997 [PubMed - in process] (Source: American Journal of Health-System Pharmacy : AJHP)

The TREAT Study Answers a Question, Not the Question

American Journal of Kidney Diseases — Mon, 01 Sep 2008 04:00:00 +0100

This study compares the harm from not treating progressive anemia against the potential benefit and competing harm from ESA therapy. It should answer whether ESA therapy in patients with diabetes with CKD is better than nothing. (Source: American Journal of Kidney Diseases)

In Reply

American Journal of Kidney Diseases — Mon, 01 Sep 2008 04:00:00 +0100

The clinical use of erythropoiesis-stimulating agents (ESAs) in nondialysis patients with chronic kidney disease (CKD) with moderate anemia has so outpaced research that my position to request robust risk-benefit clinical outcomes data from a randomized placebo-controlled trial engenders controversy. Dr Coyne's letter concerning my invited editorial, “Critical Missing Data on Erythropoiesis-Stimulating Agents in CKD: First Beat Placebo,” illustrates my point. Apparently Dr Coyne, himself an investigator in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), is so firmly convinced based on the available soft surrogate data that this therapy is indicated for nondialysis patients with diabetes with CKD (estimated glomerular filtration rate ≥ 20 to ≤ 60 mL/min) and ...

Amgen Alters Anemia Drug Discounts

NYT > Health — Thu, 28 Aug 2008 15:54:27 +0100

The company is halting some pricing practices that critics say were contributing to overuse of its flagship anemia drug Aranesp at a time of mounting concerns about the product’s safety. (Source: NYT > Health)

Amgen to Stop Offering Discounts on Anemia Drug

NYT > Health — Thu, 28 Aug 2008 04:18:04 +0100

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Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Drugs.com - FDA MedWatch Alerts — Fri, 08 Aug 2008 04:00:00 +0100

Audience: Oncologists, other healthcare professionals[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing... (Source: Drugs.com - FDA MedWatch Alerts)

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Drugs.com - FDA MedWatch Alerts — Fri, 08 Aug 2008 04:00:00 +0100

Anemia and Chronic Heart Failure: Implications and Treatment Options

Journal of the American College of Cardiology — Mon, 04 Aug 2008 04:00:00 +0100

Anemia is a common comorbidity in patients with heart failure and is associated with worse long-term outcomes. Although the cause of anemia in heart failure is unclear, the weight of evidence suggests that renal dysfunction, along with neurohormonal and proinflammatory cytokine activation in heart failure, favors the development of anemia of chronic disease, with defective iron utilization, inappropriate erythropoietin production, and depressed bone marrow function. Similarly, the mechanisms by which anemia worsens heart failure outcomes are unknown but may be related to increased myocardial workload. If anemia is a mediator and not just a marker of poor outcomes, correcting anemia could become an important and novel therapeutic target to improve long-term outcomes in such patients. Indeed...

FDA Commands Amgen to Change Darbepoetin Alfa (Aranesp) Label

MedPage Today Hematology/Oncology — Thu, 31 Jul 2008 20:28:51 +0100

ROCKVILLE, Md. -- Flexing new regulatory muscle, the FDA has ordered a reluctant Amgen to make a label change stating that darbepoetin alfa (Aranesp), the erythropoiesis- stimulating agent, should not be used in patients undergoing curative chemotherapy. (Source: MedPage Today Hematology/Oncology)

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

FDA MedWatch — Thu, 31 Jul 2008 19:00:00 +0100

FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. (Source: FDA MedWatch)

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FDA Issues Complete Response Letters Ordering Safety Labeling Changes Under FDAAA for Aranesp, Epogen, and Procrit

Drugs.com - Pharma News — Thu, 31 Jul 2008 12:25:05 +0100

Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp) This information reflects FDA's current... (Source: Drugs.com - Pharma News)

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Drugs.com - FDA MedWatch Alerts — Thu, 31 Jul 2008 04:00:00 +0100

Audience: Oncologists, other healthcare professionals[Posted 07/31/2008] Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of... (Source: Drugs.com - FDA MedWatch Alerts)

Amgen Raises Forecast on Improved Sales and Successful Trial

NYT > Health — Tue, 29 Jul 2008 04:36:53 +0100

Amgen reported a far better than expected quarterly profit as sales of its anemia drug Aranesp rebounded from the preceding quarter. (Source: NYT > Health)

Amgen and Ortho Biotech Settle Antitrust Suit

HSMN NewsFeed — Sat, 12 Jul 2008 04:30:00 +0100

THOUSAND OAKS, Calif.--(HSMN NewsFeed)--Amgen (NASDAQ:AMGN ) today announced that it has reached an agreement to settle its outstanding antitrust litigation with Ortho Biotech Products L.P. (Ortho Biotech). Ortho Biotech, a subsidiary of Johnson & Johnson ... Biopharmaceuticals, Oncology, LitigationAmgen, Ortho Biotech, Johnson & Johnson, Neupogen, Aranesp (Source: HSMN NewsFeed)