MedWorm: Byetta

Bydureon (Exenatide) - updated on RxList

RxList - New and Updated Drug Monographs — Thu, 02 Feb 2012 07:00:00 +0100

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

MedWorm Sponsor Message: Find the best January Sales in the UK.

Monthly Roundup - January 2012

Drugs.com - Pharma News — Tue, 31 Jan 2012 22:01:03 +0100

Bydureon Approved: First Once-A-Week Treatment for Type 2 Diabetes Amylin Pharmaceuticals received FDA-approval of Bydureon (exenatide extended-release for injectable suspension), a once-a-week, 2 mg injection used in conjunction with diet and... (Source: Drugs.com - Pharma News)

Bydureon: An Easy, Effective New Treatment for Type 2 DiabetesBydureon: An Easy, Effective New Treatment for Type 2 Diabetes

Medscape Today Headlines — Tue, 31 Jan 2012 20:33:00 +0100

How will the new once-weekly exenatide formulation fit into the overall diabetes armamentarium? Dr. Anne Peters offers a short overview. Medscape Diabetes & Endocrinology (Source: Medscape Today Headlines)

FDA approves first once-weekly treatment for type 2 diabetes

Drug Topics - Top News — Tue, 31 Jan 2012 05:00:00 +0100

FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) — the first once-weekly treatment for type 2 diabetes. (Source: Drug Topics - Top News)

Exenatide or sitagliptin not linked to acute renal failure in diabetes

MedWire News - Diabetes — Tue, 31 Jan 2012 00:00:00 +0100

Use of exenatide or sitagliptin in treating diabetes does not appear to be associated with an increased risk for acute renal failure relative to use of metformin, sulfonylureas, or thiazolidinediones, show study findings. (Source: MedWire News - Diabetes)

Once-weekly exenatide okayed by FDA for type 2 diabetes

theHeart.org — Mon, 30 Jan 2012 22:30:00 +0100

The FDA approved the once-weekly version of exenatide for type 2 diabetes with a list of required postmarketing studies on the potential for cardiovascular events and medullary thyroid carcinoma. (Source: theHeart.org)

Amylin and Alkermes diabetes drug wins FDA approval

Drug Development Technology — Mon, 30 Jan 2012 00:00:00 +0100

Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) for the treatment of type 2 diabetes. (Source: Drug Development Technology)

Amylin's Once-Weekly Diabetes Injection Finally Wins FDA Approval

Health News from Medical News Today — Sat, 28 Jan 2012 23:00:00 +0100

On Friday, the US Food and Drug Administration finally approved Amylin Pharmaceutical's diabetes drug Bydureon, which provides glycemic control for diabetes type 2 in a once-weekly injection. The approval follows two earlier rejections in 2010, when the FDA asked the company to go back and carry out a new trial of the drug's effect on heart rhythm. The company describes Bydureon (exenatide extended-release for injectable suspension) as the first of its kind. It is a once-a- week version of Byetta, the company's 7-year-old diabetes drug that has to be injected twice a day... (Source: Health News from Medical News Today)

Once-Weekly Exenatide Okayed by FDA for T2DM After Long LookOnce-Weekly Exenatide Okayed by FDA for T2DM After Long Look

Medscape Today Headlines — Sat, 28 Jan 2012 01:04:35 +0100

MedWorm Sponsor Message: Find the best January Sales in the UK.

FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes

Drugs.com - New Drug Approvals — Sat, 28 Jan 2012 01:01:54 +0100

SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) – the... (Source: Drugs.com - New Drug Approvals)

Once-Weekly Diabetes Treatment Gets FDA OK

MedPage Today Public Health — Fri, 27 Jan 2012 21:22:39 +0100

WASHINGTON (MedPage Today) -- The delay is over for the diabetes drug Bydureon (exenatide extended-release), with FDA approval making it the first once-weekly treatment for type 2 disease. (Source: MedPage Today Public Health)

FDA Approves BYDUREON™ - The First And Only Once-Weekly Treatment For Type 2 Diabetes

Pharmaceutical Online News — Fri, 27 Jan 2012 08:58:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. (Source: Pharmaceutical Online News)

Exenatide and Sitagliptin Are Not Associated with Increased Risk of Acute Renal Failure: A Retrospective Claims Analysis

Diabetes, Obesity and Metabolism — Mon, 23 Jan 2012 05:00:00 +0100

Conclusion Our study revealed an increased incidence of ARF in diabetic versus non‐diabetic patients but no association between use of exenatide or sitagliptin and ARF. Due to the limitations of this observational analysis, we cannot exclude the possibility of a very small increased risk. (Source: Diabetes, Obesity and Metabolism)

Glucagon-like peptide-1 (GLP-1) receptor agonism improves metabolic, biochemical and histopathological indices of nonalcoholic steatohepatitis (NASH) in mice.

American Journal of Physiology. Gastrointestinal and Liver Physiology — Thu, 19 Jan 2012 05:00:00 +0100

Authors: Trevaskis JL, Griffin PS, Wittmer C, Neuschwander-Tetri BA, Brunt EM, Dolman CS, Erickson MR, Napora J, Parkes DG, Roth JD Abstract These preclinical studies aimed to (1) increase our understanding the dietary induction of NASH, and, (2) further explore the utility and mechanisms of GLP-1 receptor (GLP-1R) agonism in treating NASH. We compared the effects of a high trans-fat (HTF) or high lard fat (HLF) diet on key facets of NAFLD/NASH in Lep(ob)/Lep(ob) and C57BL6J (B6) mice. Although HLF-fed mice experienced overall greater gains in weight and adiposity, the addition of trans-fat better mirrored pathophysiologic features of NASH (e.g., hepatic steatosis and fibrosis). Administration of AC3174, an exenatide analog and GLP-1R agonist, to Lep(ob)/Lep(ob) and B6 mice attenua...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

SMC accepts once-weekly exenatide (Bydureon®) for restricted use

NeLM - Drug Specific Reviews — Tue, 17 Jan 2012 05:00:00 +0100

Source: Scottish Medicines Consortium (SMC) Area: Evidence > Drug Specific Reviews The Scottish Medicines Consortium (SMC) has accepted exenatide once weekly (Bydureon®) for use within NHS Scotland as a third-line treatment option for type 2 diabetes mellitus, as part of combination therapy. The economic case for its second line use in combination with metformin in place of a sulphonylurea has not been made. The drug advice summarises the efficacy, safety and cost-effectiveness data submitted by the company and considered by the Committee. Please see the link below for details. (Source: NeLM - Drug Specific Reviews)

Diabetes drug may be effective for weight-loss

USATODAY.com Health — Sun, 15 Jan 2012 20:00:00 +0100

Medicines such as Byetta may help users shed pounds, but more study is needed, experts say. (Source: USATODAY.com Health)

Effects of intravenous exenatide in type 2 diabetic patients with congestive heart failure: a double-blind, randomised controlled clinical trial of efficacy and safety

Diabetologia — Fri, 13 Jan 2012 16:55:51 +0100

Conclusions/interpretation Infusion of exenatide in male type 2 diabetic patients with CHF increased the CI as a result of chronotropy, with concomitant favourable effects on PCWP and reasonable tolerability of the drug. The clinical implications of using exenatide in patients with CHF are still not clear and further studies are warranted. Trial registration: www.isrctn.org/ISRCTN47533126 Funding: This study was funded through the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and the Karolinska Institute, by the Swedish Society for Medical Research, the Swedish Society of Medicine, Stiftelsen Serafimerlasarettet, the Swedish Heart and Lung foundation, Eli Lilly Amylin Alliance, ...

NICE issues final appraisal determination on prolonged-release exenatide for type 2 diabetes

NeLM - News — Fri, 13 Jan 2012 05:00:00 +0100

Source: NICE Area: News NICE has published a Final Appraisal Determination (FAD) on the use of prolonged-release exenatide in combination with oral antidiabetic therapy for the treatment of type 2 diabetes. The recommendations made are as follows: 1.1 Prolonged-release exenatide in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) is recommended as a treatment option for people with type 2 diabetes as described in NICE clinical guideline 87; that is, when control of blood glucose remains or becomes inadequate (HbA1c ? 7.5% [59 mmol/mol] or other higher level agreed with the individual), and the person has: . a body mass index (BMI) ? 35 kg/m2 in those of European family origin (with appropriat...

Diabetes drug 'may aid weight loss'

NHS News Feed — Thu, 12 Jan 2012 18:00:00 +0100

Conclusion This was a large, well-conducted systematic review that combined the results of trials investigating whether glucagon-like peptide-1 receptor (GLP-1R) agonists produce weight loss in overweight or obese people with or without type 2 diabetes. As the researchers described, a particular strength of their review was that they were able to obtain additional data on weight loss and other outcomes that had not been included in the original trial publications. They say that since outcomes are less likely to be described if they are less significant, this reduces the risk of reporting bias. The review found that GLP-1R agonists were associated with weight loss in both people with and without diabetes. However, it is most important to note that these drugs are currently licensed only for...

MedWorm Sponsor Message: Find the best January Sales in the UK.

Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of RCTs

NeLM - News — Thu, 12 Jan 2012 05:00:00 +0100

Source: BMJ Area: News This systematic review with meta-analyses found that treatment that treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists leads to weight loss in overweight or obese patients with or without type 2 diabetes mellitus. GLP-1 is a hormone in the gut that is secreted from the intestine in response to meal ingestion. Treatment with GLP-1 increases the endogenous secretion of insulin induced by meal ingestion and inhibits glucagon secretion, thereby improving glucose homoeostasis. GLP-1 based therapy was recently introduced as a new treatment for patients with type 2 diabetes mellitus. There are currently 2 GLP-1R agonists licensed in the UK - exenatide (twice daily and once weekly formulations) and liraglutide. The researchers conducted the systema...

Clinical Relevance of Anti‐exenatide Antibodies: Safety, Efficacy, and Cross‐reactivity with Long‐term Treatment.

Diabetes, Obesity and Metabolism — Wed, 11 Jan 2012 05:00:00 +0100

Conclusions Low titer anti‐exenatide antibodies were common with exenatide treatment (32% exenatide BID, 45% exenatide QW patients), but had no apparent effect on efficacy. Higher titer antibodies were less common (5% exenatide BID, 12% exenatide QW) and within that titer group, increasing antibody titer was associated with reduced average efficacy that was statistically significant for exenatide QW. Other than injection‐site reactions, anti‐exenatide antibodies did not impact the safety of exenatide. (Source: Diabetes, Obesity and Metabolism)

Acute administration of GLP‐1 receptor agonists induces hypolocomotion but not anxiety in mice

Acta Neuropsychiatrica — Wed, 11 Jan 2012 05:00:00 +0100

Conclusion We conclude that the two clinically approved GLP‐1 receptor agonists induce very similar suppression of motor activity and stimulation of corticosterone release in mice. (Source: Acta Neuropsychiatrica)

Certain Diabetes Drugs Might Aid Weight Loss

MedlinePlus Health News — Wed, 11 Jan 2012 00:00:00 +0100

Medicines such as Byetta may help users shed pounds, but more study is needed, experts say Source: HealthDay Related MedlinePlus Pages: Diabetes Medicines, Weight Control (Source: MedlinePlus Health News)

GLP-1 Receptor Agonists and the Thyroid: C-Cell Effects in Mice Are Mediated via the GLP-1 Receptor and not Associated with RET Activation.

Endocrinology — Tue, 10 Jan 2012 05:00:00 +0100

Authors: Madsen LW, Knauf JA, Gotfredsen C, Pilling A, Sjögren I, Andersen S, Andersen L, de Boer AS, Manova K, Barlas A, Vundavalli S, Berg Nyborg NC, Bjerre Knudsen L, Moelck AM, Fagin JA Abstract Liraglutide and exenatide are glucagon-like peptide receptor (GLP-1R) agonists used in the treatment of type 2 diabetes. Both molecules have been associated with the development of thyroid C-cell tumors after lifetime exposure in rodents. Previously, it has been reported that these tumors are preceded by increased plasma calcitonin and C-cell hyperplasia. We can now document that the murine C-cell effects are mediated via GLP-1R. Thus, 13 wk of continuous exposure to GLP-1R agonists was associated with marked increases in plasma calcitonin and in the incidence of C-cell hyperplasia in ...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Liraglutide: Short lived effect on gastric emptying – long lasting effects on body‐weight

Diabetes, Obesity and Metabolism — Fri, 06 Jan 2012 05:00:00 +0100

Conclusion: The data suggest that the “gastric inhibitory” GLP‐1 receptors in rats are subject to desensitization/tachyphylaxis but that this effect is dependent on full 24h exposure as obtained by liraglutide. The body‐weight lowering effects of GLP‐1 receptor stimulation are not subject to desensitization. These data indicate that regulation of appetite signals in the brain, and not gastric emptying, is the main mechanism for liraglutide induced weight loss. (Source: Diabetes, Obesity and Metabolism)

Improvement of psoriasis during exenatide treatment in a patient with diabetes.

Diabetes and Metabolism — Fri, 06 Jan 2012 05:00:00 +0100

CONCLUSION: There was a major and rapid improvement in psoriasis in our patient with T2D following treatment with exenatide. A possible mechanism might be through direct modulation of the immune system by GLP-1 receptor agonists. PMID: 22227407 [PubMed - as supplied by publisher] (Source: Diabetes and Metabolism)

Bydureon: long‐acting exenatide for once‐weekly injection

Prescriber — Sun, 01 Jan 2012 05:00:00 +0100

AbstractBydureon is a long‐acting formulation of exenatide administered as a once‐weekly injection. The authors present the clinical data relating to its efficacy and adverse effects compared with twice‐daily exenatide and other treatments used in type 2 diabetes and discuss its potential role in management. Copyright © 2012 Wiley Interface Ltd (Source: Prescriber)

Lilly And Amylin Mutually Agree To End Diabetes Alliance And Transition Exenatide Responsibility To Amylin

Health News from Medical News Today — Thu, 22 Dec 2011 09:00:00 +0100

Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) ("Amylin") and Eli Lilly and Company (NYSE: LLY) ("Lilly") today announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies. As part of the agreement, the parties will transition full responsibility for the worldwide development and commercialization of exenatide to Amylin, starting in the United States (U.S.) on November 30, 2011, and progressing to all markets by the end of 2013... (Source: Health News from Medical News Today)

Weight change in people with type 2 diabetes: secular trends and the impact of alternative antihyperglycaemic drugs

Diabetes, Obesity and Metabolism — Thu, 22 Dec 2011 05:00:00 +0100

Conclusions: There was a continual increase in body weight in people with T2DM over time, and considerable differences in the impact on weight using alternative treatment regimens. At the same time, glycaemic control remained relatively unchanged. (Source: Diabetes, Obesity and Metabolism)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Preventive Effects of Exenatide on Endothelial Dysfunction Induced by Ischemia-Reperfusion Injury via KATP Channels.

Arteriosclerosis, Thrombosis and Vascular Biology — Thu, 08 Dec 2011 05:00:00 +0100

CONCLUSIONS: The present study demonstrates that subcutaneous exenatide protects IR-induced endothelial dysfunction through opening of K(ATP) channels in human IR injury model. PMID: 22155457 [PubMed - as supplied by publisher] (Source: Arteriosclerosis, Thrombosis and Vascular Biology)

Noninsulin Treatment of Type 2 Diabetes Mellitus in Geriatric Patients: A Review.

Clinical Therapeutics — Wed, 30 Nov 2011 05:00:00 +0100

CONCLUSIONS: The selection of noninsulin treatments in older patients with T2DM should be individualized based on patient assessment and on careful evaluation of the potential benefits (glycemic and extraglycemic) and risks (ie, hypoglycemia, weight gain, cardiovascular risks). More clinical trials in older patients, especially those aged ≥65 years, with T2DM are needed. PMID: 22136979 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)

Glucagon-like peptide-1 activates endothelial nitric oxide synthase in human umbilical vein endothelial cells.

Acta Pharmacologica Sinica — Mon, 28 Nov 2011 05:00:00 +0100

Conclusion:GLP-1 upregulated the activity and protein expression of eNOS in HUVECs through the GLP-1R-dependent and GLP-1(9-36)-related pathways. GLP-1 may prevent or delay the formation of atherosclerosis in diabetes mellitus by improving the function of eNOS. PMID: 22120969 [PubMed - as supplied by publisher] (Source: Acta Pharmacologica Sinica)

[Incretin-based therapy for treating patients with type 2 diabetes].

Orvosi Hetilap — Sun, 20 Nov 2011 21:38:30 +0100

Authors: Jermendy G Abstract In the last couple of years, a new class of antidiabetic drugs became available for the clinical practice. Due to the intensive research, several new drugs reached the market. Among the incretinmimetics both the GLP-1 (glucagon like peptide-1)-receptor agonist exenatide and the GLP-1-analogue liraglutide can be used for treatment. As for incretin enhancers (dipeptidyl-peptidase-4 [DPP-4]-inhibitors), sitagliptin, vildagliptin and saxagliptin are available in Hungary, linagliptin will be introduced to the market in the near future. In clinical practice, any incretin-based new drugs can be used for treating patients with type 2 diabetes, preferably in combination with metformin. The clinical experiences with these new drugs are reviewed focusing on both t...

The Pharmacologic Basis for Clinical Differences Among GLP-1 Receptor Agonists and DPP-4 Inhibitors

Postgraduate Medicine Online — Tue, 15 Nov 2011 16:03:17 +0100

Javier Morales, MD DOI: 10.3810/pgm.2011.11.2508 Abstract: The incretin system plays an important role in glucose homeostasis, largely through the actions of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). Unlike GIP, the actions of GLP-1 are preserved in patients with type 2 diabetes mellitus, which has led to the development of injectable GLP-1 receptor (GLP-1R) agonists and oral dipeptidyl peptidase-4 (DPP-4) inhibitors. GLP-1R agonists—which can be dosed to pharmacologic levels—act directly upon the GLP-1R. In contrast, DPP-4 inhibitors work indirectly by inhibiting the enzymatic inactivation of native GLP-1, resulting in a modest increase in endogenous GLP-1 levels. GLP-1R agonists generally lower the fasting and postprandial g...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Exenatide injection approved by FDA as adjunct therapy to insulin glargine

Modern Medicine — Fri, 11 Nov 2011 05:00:00 +0100

FDA has approved exenatide injection (Byetta, Amylin Pharmaceuticals Inc. and Eli Lilly and Co.) as an add-on therapy to insulin glargine for patients with type 2 diabetes who are not achieving adequate glycemic control with the basal insulin analogue alone. (Source: Modern Medicine)

Amylin and Lilly to dissolve diabetes agreement

Pharmaceutical Technology — Thu, 10 Nov 2011 19:36:23 +0100

Amylin Pharmaceuticals and Eli Lilly are to dissolve their agreement surrounding diabetes medications Byetta and Bydureon.Post to:Delicious Digg reddit Facebook StumbleUpon (Source: Pharmaceutical Technology)

The effects of exenatide BID on metabolic control, medication use, and hospitalization in patients with type 2 diabetes mellitus in clinical practice: a systematic review

Diabetes, Obesity and Metabolism — Thu, 10 Nov 2011 05:00:00 +0100

Conclusions: In this review of observational studies, exenatide initiation was associated with significant reductions in clinically relevant outcomes. Improvements in A1C, FG, weight, and SBP in the observational studies in this review were consistent with improvements observed in controlled clinical trials. (Source: Diabetes, Obesity and Metabolism)

Exenatide as a Weight-Loss Therapy in Extreme Pediatric Obesity: A Randomized, Controlled Pilot Study.

Obesity — Thu, 10 Nov 2011 05:00:00 +0100

The objective of this pilot study was to evaluate the effects of exenatide on BMI (primary endpoint) and cardiometabolic risk factors in nondiabetic youth with extreme obesity. Twelve children and adolescents (age 9-16 years old) with extreme obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m(2)) were enrolled in a 6-month, randomized, open-label, crossover, clinical trial consisting of two, 3-month phases: (i) a control phase of lifestyle modification and (ii) a drug phase of lifestyle modification plus exenatide. Participants were equally randomized to phase-order (i.e., starting with control or drug therapy) then crossed-over to the other treatment. BMI, body fat percentage, blood pressure, lipids, oral glucose tolerance tests (OGTT), adipokines, plasma biomarkers of endoth...

MedWorm Sponsor Message: Find the best January Sales in the UK.

The effects of exenatide bid on metabolic control, medication use and hospitalization in patients with type 2 diabetes mellitus in clinical practice: a systematic review

Diabetes, Obesity and Metabolism — Thu, 10 Nov 2011 05:00:00 +0100

The objective of this systematic review was to assess the published literature on the effectiveness of exenatide twice daily (exenatide) in clinical practice, specifically its effects on haemoglobin A1c (A1C), fasting glucose (FG), weight, systolic blood pressure (SBP), medication use, hospitalization and cardiovascular disease (CVD) outcomes. A systematic literature search using the MEDLINE database of English language literature published between January 2005 and May 2011 was performed. The review included retrospective or prospective observational studies that included 100 or more patients per treatment group. A total of 15 studies meeting the inclusion criteria were identified. The studies revealed significant reductions of −0.4 to −0.9% in A1C, −10 mg/dl in FG, −2 to −11 kg ...

Exenatide has potent anti-inflammatory effects

MedWire News - Diabetes — Thu, 10 Nov 2011 00:00:00 +0100

Exenatide has a rapid anti-inflammatory effect in Type 2 diabetes patients, US researchers report. (Source: MedWire News - Diabetes)

Lilly And Amylin End Their Bad Marriage

Forbes.com Healthcare News — Tue, 08 Nov 2011 18:10:18 +0100

Six months after a bitter dispute led to an unusual court battle, Eli Lilly and Amylin Pharmaceuticals are getting divorced. The two drugmakers announced they are ending their venture to develop and market diabetes meds, and Amylin will take control of the twice-a-day Byetta drug, as well as Bydureon, a once-weekly injectable that is designed to supplant the older drug. (Source: Forbes.com Healthcare News)

Prescriptions Blog: Amylin and Eli Lilly Part Ways Over Diabetes Drug

NYT Health — Tue, 08 Nov 2011 17:08:22 +0100

The smaller company objected to Eli Lilly's work with what it considered a competing diabetes drug. (Source: NYT Health)

Lilly and Amylin Mutually Agree to End Diabetes Alliance and Transition Exenatide Responsibility to Amylin

Drugs.com - Pharma News — Tue, 08 Nov 2011 12:41:46 +0100

Agreement Will Resolve All Litigation Between the Two Companies SAN DIEGO and INDIANAPOLIS, Nov. 8, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) ("Amylin") and Eli Lilly and Company (NYSE: LLY) ("Lilly") today announced an... (Source: Drugs.com - Pharma News)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Lilly And Amylin Mutually Agree To End Diabetes Alliance And Transition Exenatide Responsibility To Amylin

Pharmaceutical Online News — Tue, 08 Nov 2011 09:43:00 +0100

Amylin, Lilly end diabetes partnership

Cardiovascular Business News — Tue, 08 Nov 2011 07:50:09 +0100

Amylin Pharmaceuticals and Eli Lilly have decided to terminate their alliance for exenatide (Byetta) and resolve the outstanding litigation between the companies. As part of the agreement, the companies will transition full responsibility for the global development and commercialization of exenatide to Amylin, starting in the U.S. on Nov. 30, and progressing to all markets by the end of 2013. (Source: Cardiovascular Business News)

Effect of additional treatment with EXenatide in patients with an acute myocardial infarction (EXAMI): study protocol for a randomized controlled trial

Trials — Tue, 08 Nov 2011 05:00:00 +0100

DiscussionIf the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction.Trial registration: www.clinicaltrials.gov; unique identifier NCT01254123 (Source: Trials)

Study Shows Exenatide (Byetta) Has Rapid, Powerful Anti-Inflammatory Effect

Health News from Medical News Today — Fri, 04 Nov 2011 08:00:00 +0100

Exenatide, a drug commonly prescribed to help patients with type 2 diabetes improve blood sugar control, also has a powerful and rapid anti-inflammatory effect, a University at Buffalo study has shown. The study of the drug, marketed under the trade name Byetta, was published recently in the Journal of Clinical Endocrinology and Metabolism... (Source: Health News from Medical News Today)

BYETTA (Exenatide) Injection [Amylin Pharmaceuticals, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Thu, 03 Nov 2011 05:00:00 +0100

Updated Date: Nov 3, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

MedWorm Sponsor Message: Find the best January Sales in the UK.

The role of glp‐1 mimetics and basal insulin analogues in type 2 diabetes mellitus: guidance from studies of liraglutide

Diabetes, Obesity and Metabolism — Thu, 03 Nov 2011 04:00:00 +0100

In people with type 2 diabetes mellitus (T2DM), the incretin effect is reduced, but the recent advent of DPP‐4 inhibitors and GLP‐1 agonists/analogues has enabled restoration of at least some of the function of the incretin system, with accompanying improvements in glycaemic control. Two GLP‐1 receptor agonists/analogues are currently approved for the treatment of T2DM – exenatide (Byetta®, Eli Lilly and Co.) and liraglutide (Victoza®, Novo Nordisk); a once‐weekly formulation of exenatide (Bydureon®, Eli Lilly & Co.) has also been approved by the European Medicines Agency.The National Institute for Health and Clinical Excellence (NICE) has recently published guidance on the use of liraglutide in T2DM, based on evidence from the Liraglutide Effect and Action in Diabetes (LE...

Exenatide (Byetta) Has Rapid, Powerful Anti-inflammatory Effect, UB Study Shows

Diabetes News from dLife.com — Wed, 02 Nov 2011 16:07:52 +0100

November 2, 2011 (University at Buffalo) — Anti-inflammatory effect occurs independently of weight loss. Exenatide, a drug commonly prescribed to help patients with type 2 diabetes improve blood sugar control, also has a powerful and rapid anti-inflammatory effect, a University at Buffalo study has shown. The study of the drug, marketed under the trade name Byetta, was published recently in the Journal of Clinical Endocrinology and Metabolism. read more (Source: Diabetes News from dLife.com)

Exenatide (Byetta) has rapid, powerful anti-inflammatory effect, UB study shows

EurekAlert! - Medicine and Health — Wed, 02 Nov 2011 04:00:00 +0100

(University at Buffalo) Exenatide, a drug commonly prescribed to help patients with Type 2 diabetes improve blood sugar control, also has a powerful and rapid anti-inflammatory effect, a University at Buffalo study has shown. (Source: EurekAlert! - Medicine and Health)

Effect of Exenatide on Gastric Emptying and Graft Survival in Islet Allograft Recipients

Transplantation Proceedings — Tue, 01 Nov 2011 04:00:00 +0100

Conclusions: Long-term exenatide administration up to 4 years was safe in islet transplant recipients, even in the presence of delayed gastric emptying. The effects of exenatide were acute and reversible when the agent was withdrawn. The main difficulty with the use of exenatide in islet transplant subjects is their poor tolerability, although the physiological effects are clearly evident even at low doses. Approximately 63% of total subjects under exenatide treatment discontinued the drug due to nausea and vomiting. The use of new GLP1 analogs with longer half lives and fewer side effects may help to attain higher GLP1 levels, therefore improving islet function and survival. (Source: Transplantation Proceedings)

Weekly Exenatide Similar to Daily Liraglutide

Clinical Endocrinology News — Tue, 01 Nov 2011 04:00:00 +0100

Major Finding: The mean change in HbA1c from baseline to week 26 was slightly but not significantly lower, when liraglutide- vs. exenatide-treated patients were compared (−1.48% vs. −1.28%, respectively). (Source: Clinical Endocrinology News)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

FDA Approves New Indication for Exenatide

Clinical Endocrinology News — Tue, 01 Nov 2011 04:00:00 +0100

The Food and Drug administration has approved a new indication for fixed-dose exenatide injections. The medication's manufacturers, Amylin and Eli Lilly, announced that the exenatide injections, marketed as Byetta, had been approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione, for adults with type 2 diabetes who are not achieving adequate glycemic control on long-acting insulin alone. (Source: Clinical Endocrinology News)

Cost and effectiveness of exenatide combined with insulin, compared to exenatide combined with oral hypoglycaemic agents

Practical Diabetes International — Tue, 01 Nov 2011 04:00:00 +0100

AbstractThere have been few studies investigating the use of GLP‐1 agonists in patients with insulin‐treated type 2 diabetes and none looking at the costing. We compared the efficacy and relative cost of adding exenatide treatment to patients with type 2 diabetes receiving either oral hypoglycaemic agents (OHAs) or insulin.Patients were recruited from West Suffolk Hospital Diabetes Centre. Data were acquired retrospectively from 207 patients completing six months of treatment.Of 207 patients, 188 demonstrated good clinical progress with a mean HbA1c reduction of 1.6% (p<0.0001) and weight loss of 6.9kg (p<0.0001). Nineteen patients discontinued exenatide as HbA1c reduction did not achieve the NICE target (0.4%; p=0.29), but they did achieve significant weight loss (5.6kg; p<0....

Rational therapy for Diabetes: Early recognition of adverse effects and avoidance of disruptive false alarms

Diabetes/Metabolism Research and Reviews — Tue, 01 Nov 2011 04:00:00 +0100

AbstractCorresponding to the uncontrolled diabetes pandemic, significant effort has been invested in developing new therapeutic options. Nevertheless, all medicines have possible adverse effects. Recently, a trend of 'scrutinizing' novel hypoglycemic drug side effects based on scant scientific data has emerged. With recent publications highlighting possible dangers of rosiglitazone, insulin glargine, sitagliptin, exenatide and most recently, pioglitazone, it seems that all means are valid and every data base is suitable, even if specifically defined as inadequate for the purpose of data analysis. Use of such data may lead authors to draw erroneous conclusions that may be granted unwarranted impact upon publication in leading scientific journals and eventually lead patients and misinformed ...

Short-Term Exenatide Treatment Leads to Significant Weight Loss in a Subset of Obese Women Without Diabetes.

Diabetes Care — Mon, 31 Oct 2011 04:00:00 +0100

CONCLUSIONSShort-term exenatide treatment was associated with modest weight loss and decreased waist circumference in a cohort of obese nondiabetic women. A subset of individuals demonstrated robust weight loss that was detected very early in the course of treatment. PMID: 22040840 [PubMed - as supplied by publisher] (Source: Diabetes Care)

FDA Okays Exenatide as Adjunct to Insulin GlargineFDA Okays Exenatide as Adjunct to Insulin Glargine

Medscape Today Headlines — Mon, 24 Oct 2011 17:55:24 +0100

The FDA has approved exenatide for patients with type 2 diabetes receiving the basal insulin analogue whether or not they also are receiving metformin alone or in combination with a thiazolidinedione. Medscape Medical News (Source: Medscape Today Headlines)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Byetta Receives Expanded Approval from FDA, as Reported by...

PRWeb: Medical Pharmaceuticals — Sun, 23 Oct 2011 07:26:50 +0100

The U.S. Food and Drug Administration recently approved Byetta, a Type 2 diabetes medication created by Amylin Pharmaceuticals, Inc., for use in concert with insulin glargine—the most popular type of...(PRWeb October 22, 2011)Read the full story at http://www.prweb.com/releases/Diabetes/Byetta/prweb8901706.htm (Source: PRWeb: Medical Pharmaceuticals)

FDA approves licence extension for use of exenatide in type 2 diabetes in the United States

NeLM - News — Fri, 21 Oct 2011 04:00:00 +0100

Source: BioSpace Area: News BioSpace reports that the United States Food and Drug Administration (U.S FDA) has approved a new indication for exenatide (Byetta®) injection. The licence extension covers use of the drug as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycaemic control on insulin glargine alone. The approval is based on a study in which patients with type 2 diabetes (n=261) receiving insulin glargine, with or without metformin and/or a TZD, were randomised to receive exenatide or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, HbA1C decreased by 1.7 percentage points in patient...

Byetta (exenatide) Approved In Combination With Glargine For Type 2 Diabetes

Health News from Medical News Today — Fri, 21 Oct 2011 00:00:00 +0100

Byetta (exenatide) injection has been approved by the FDA as add-on treatment for use with insulin glargine, together with exercise and diet for diabetes type 2 patients who are not responding well enough to glargine alone. Byetta's add-on therapy is for those on glargine with metformin and/or a TZD (thiazolidinedione) or without. A pivotal study found that with exenatide patients achieved better glycemic control without gaining weight or increased hypoglycemia risk, compared to those on just glargine. John Buse, M.D., Ph.D... (Source: Health News from Medical News Today)

FDA Okays Byetta Plus Insulin Glargine

MedPage Today Public Health — Thu, 20 Oct 2011 18:18:06 +0100

WASHINGTON (MedPage Today) -- The FDA has approved a new indication for the type 2 diabetes drug exenatide (Byetta) as an add-on therapy with insulin glargine, diet, and exercise for adult patients. (Source: MedPage Today Public Health)

Byetta Approved for Use with Insulin Glargine in the U.S.

Drugs.com - New Drug Approvals — Thu, 20 Oct 2011 14:10:18 +0100

SAN DIEGO and INDIANAPOLIS, Oct. 19, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for Byetta (exenatide) injection. Byetta is... (Source: Drugs.com - New Drug Approvals)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

BYETTA® Approved For Use With Insulin Glargine In The U.S.

Pharmaceutical Online News — Wed, 19 Oct 2011 08:52:00 +0100

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for BYETTA® (exenatide) injection. (Source: Pharmaceutical Online News)

The association of pancreatitis with antidiabetic drug use: gaining insight through the FDA pharmacovigilance database

Acta Diabetologica — Wed, 19 Oct 2011 05:56:03 +0100

Abstract In patients with diabetes, disease per se, co-morbidities and drugs, including novel agents acting on the incretin system, have all been associated with pancreatitis with controversial data. We investigated the publicly available FDA Adverse Event Reporting System (FDA_AERS) database to gain insight into the possible association between antidiabetic agents and pancreatitis. To this aim, a case/non-case method was retrospectively performed on the FDA_AERS database (2004–2009 period). Cases were defined as reports of pancreatitis according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. All other reports associated with antidiabetics were considered non-cases. The Reporting Odds Ratio (RORs), with corresponding 95% confidential interval (...

Evaluating the Long-Term Cost-Effectiveness of Liraglutide Versus Exenatide BID in Patients With Type 2 Diabetes Who Fail to Improve With Oral Antidiabetic Agents.

Clinical Therapeutics — Wed, 19 Oct 2011 04:00:00 +0100

CONCLUSIONS: Long-term projections indicated that liraglutide was associated with benefits in life expectancy, QALYs, and reduced complication rates versus exenatide. Liraglutide was cost-effective from a health care payer perspective in Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria. Clinicaltrials.gov identifier: NCT 00518882. PMID: 22018679 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)

Exenatide Exerts a Potent Antiinflammatory Effect.

The Journal of Clinical Endocrinology and Metabolism — Wed, 19 Oct 2011 04:00:00 +0100

Conclusions:Exenatide exerts a rapid antiinflammatory effect at the cellular and molecular level. This may contribute to a potentially beneficial antiatherogenic effect. This effect was independent of weight loss. PMID: 22013105 [PubMed - as supplied by publisher] (Source: The Journal of Clinical Endocrinology and Metabolism)

Once-weekly diabetes drug backed in draft NICE guidance

HealthcareRepublic Pharmacist News — Tue, 18 Oct 2011 10:17:00 +0100

Once-weekly type-2 diabetes drug exenatide has been recommended for third-line use in draft guidance from NICE. (Source: HealthcareRepublic Pharmacist News)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Insulin avoidance and treatment outcomes among patients with a professional driving licence starting glucagon‐like peptide 1 (GLP‐1) agonists in the Association of British Clinical Diabetologists (ABCD) nationwide exenatide and liraglutide audits

Diabetic Medicine — Tue, 11 Oct 2011 04:00:00 +0100

(Source: Diabetic Medicine)

Glucagon-like peptide analogues for type 2 diabetes mellitus.

Cochrane Database of Systematic Reviews — Tue, 11 Oct 2011 01:20:04 +0100

CONCLUSIONS: GLP-1 agonists are effective in improving glycaemic control. PMID: 21975753 [PubMed - in process] (Source: Cochrane Database of Systematic Reviews)

Exenatide could be a sweet option for T2DM in the US

PharmacoEconomics and Outcomes News — Mon, 10 Oct 2011 03:06:48 +0100

(Source: PharmacoEconomics and Outcomes News)

Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen (exenatide) - Revised SPC

NeLM - SPC Changes — Wed, 05 Oct 2011 04:00:00 +0100

Source: eMC (electronic Medicines Compendium) Area: Other Library Updates > SPC Changes There have been significant updates to several sections of the SPC, the following sections have all been updated: Change to section 2 - Qualitative and quantitative composition Change to section 3 - Pharmaceutical form Change to section 4.1 - Therapeutic indications Change to section 4.2 - Posology and method of administration Change to section 4.4 - Special warnings and precautions for Use Change to section 4.5 - Interaction with other medicinal products and other forms of interaction Change to section 4.6 - Pregnancy and Lactation Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 5.2 - Pharmacokinetic Properties Change...

GLP‐1 signals via ERK in peripheral nerve and prevents nerve dysfunction in diabetic mice

Diabetes, Obesity and Metabolism — Thu, 29 Sep 2011 06:56:11 +0100

Conclusions: These data show that the peripheral nerve of diabetic rodents exhibits functional GLP‐1R and suggest that GLP‐1R‐mediated ERK‐signalling in sciatic nerve of diabetic rodents may protect large motor fibre function and small C fibre structure by a mechanism independent of glycaemic control. (Source: Diabetes, Obesity and Metabolism)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Effects of exenatide twice daily versus sitagliptin on 24‐h glucose, glucoregulatory and hormonal measures: a randomized, double‐blind, crossover study

Diabetes, Obesity and Metabolism — Thu, 29 Sep 2011 06:56:09 +0100

Conclusion: Compared to sitagliptin, exenatide showed significantly lower average 24‐h glucose, 2‐h PPG, glucagon, caloric intake and improved HOMA‐B. (Source: Diabetes, Obesity and Metabolism)

Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial

Diabetologia — Thu, 29 Sep 2011 06:07:14 +0100

Conclusions/interpretation In type 2 diabetes mellitus, combined pioglitazone and exenatide therapy is associated with a reduction in plasma FGF21 levels, as well as a greater decrease in hepatic fat than that achieved with pioglitazone therapy. In DIO mice, exendin-4 treatment reduces hepatic triacylglycerol and FGF21 protein, and enhances hepatic AMPK phosphorylation, suggesting an improvement of hepatic FGF21 resistance. Trial registration number: ClinicalTrials.gov NCT 01432405 Funding: American Diabetes Association, the Ron MacDonald Foundation at St Luke’s Episcopal Hospital, Amylin Pharmaceuticals, Eli-Lilly, NIH Molecular Medicine Scholars Training Grant, NIH Diabetes and Endocrinology Research Center (DERC) at Baylor College of Medicine, and the T...

Popular diabetes drugs may raise pancreatic cancer risk, study suggests

USATODAY.com Health — Fri, 23 Sep 2011 22:14:36 +0100

People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer, ... (Source: USATODAY.com Health)

Pancreatic Cancer Reports Increase With 2 Diabetes Drugs Pancreatic Cancer Reports Increase With 2 Diabetes Drugs

Medscape Today Headlines — Fri, 23 Sep 2011 14:32:27 +0100

Study sparks controversy, raises questions about the long-term safety of the newer diabetes drugs sitagliptin and exenatide. Medscape Medical News (Source: Medscape Today Headlines)

GLP-1 increases myocardial blood flow but not glucose uptake

MedWire News - Diabetes — Fri, 23 Sep 2011 00:00:00 +0100

Exenatide infusion does not increase myocardial glucose uptake in Type 2 diabetes patients, but seems to increase myocardial blood flow through a separate mechanism, suggest findings presented at the 47th annual meeting of the European Association for the Study of Diabetes in Lisbon, Portugal. (Source: MedWire News - Diabetes)

MedWorm Sponsor Message: Find the best January Sales in the UK.

BYETTA (Exenatide) Injection [Amylin Pharmaceuticals, Inc.]

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

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

Who Defends Those Lilly & Novo Nordisk Diabetes Meds?

Forbes.com Healthcare News — Mon, 19 Sep 2011 20:09:12 +0100

The scene at the European Association for the Study of Diabetes being held in Lisbon this week has included a heated debate over the extent to which a particular type of diabetes medicine called GLP-1 therapies can increase the risk of pancreatic and thyroid cancer. These include Byetta, which is sold by Eli Lilly and its partner, Amylin Pharmaceuticals, and Victoza, which is marketed by Novo Nordisk. (Source: Forbes.com Healthcare News)

Possible Link Between Two Diabetes Drugs And Pancreatic Cancer

Health News from Medical News Today — Sat, 17 Sep 2011 07:00:00 +0100

Two newer drugs used to treat Type 2 diabetes could be linked to a significantly increased risk of developing pancreatitis and pancreatic cancer, and one could also be linked to an increased risk of thyroid cancer, according to a new UCLA study. Researchers from the Larry L. Hillblom Islet Research Center at UCLA examined the U.S. Food and Drug Administration's database for adverse events reported between 2004 and 2009 among patients using the drugs sitagliptin and exenatide... (Source: Health News from Medical News Today)

EASD: Once-Weekly Exenatide Flops Against Liraglutide (CME/CE)

MedPage Today Cardiovascular — Thu, 15 Sep 2011 20:28:15 +0100

LISBON (MedPage Today) -- A trial failed to prove that once-weekly injections of exenatide (Bydureon) were equal to daily injections of liraglutide (Victoza) in reducing glycosylated hemoglobin A1c in type 2 diabetes patients, researchers reported here. (Source: MedPage Today Cardiovascular)

Linagliptin: A Novel Xanthine-Based Dipeptidyl Peptidase-4 Inhibitor for Treatment of Type II Diabetes Mellitus.

Current Diabetes Reviews — Thu, 15 Sep 2011 04:00:00 +0100

Authors: Ghatak SB, Patel DS, Shanker N, Srivastava A, Deshpande SS, Panchal SJ Abstract Type 2 diabetes mellitus causes significant morbidity and mortality on account of its progressive nature and results in considerable burden on healthcare resources. Current treatment strategies have only limited long-term efficacy and tolerability given the progressive nature of the disease leading to inadequate glycemic control and are also associated with undesirable side effects such as weight gain, hypoglycemia and gastrointestinal distress. In the light of these existing limitations, exploring new treatment targets and new therapies have become the need of the hour at present. The incretin pathway, in particular, glucagon-like peptide (GLP-1), plays an important pathological role in the de...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Clinical Implications of Exenatide as a Twice-Daily or Once-Weekly Therapy for Type 2 Diabetes

Postgraduate Medicine Online — Thu, 15 Sep 2011 04:00:00 +0100

Vanita R. Aroda, MD and Mary Beth DeYoung, PhD DOI: 10.3810/pgm.2011.09.2479 Abstract: Exenatide (exendin-4) is a 39-amino acid peptide belonging to the glucagon-like peptide-1 (GLP-1) receptor agonist class that has been demonstrated to improve glycemic control in patients with type 2 diabetes mellitus. Exenatide can be injected twice daily (ExBID) before meals or once weekly (ExQW) when encompassed within dissolvable poly-(D,L-lactide-co-glycolide) microspheres. The primary difference between these formulations is the plasma concentration of exenatide over time, with the long-acting form providing continuous delivery. Clinical trials have examined the similarities and differences in the efficacy and safety/tolerability outcomes of these formulations. In 2 clinical studies spanning ...

Cardiovascular Safety of Diabetes Drugs: The Way ForwardCardiovascular Safety of Diabetes Drugs: The Way Forward

Medscape Today Headlines — Wed, 14 Sep 2011 21:15:58 +0100

The long shadow cast by the rosiglitazone controversy, as well as newer cancer concerns with pioglitazone, exenatide, and sitagliptin, are prompting calls for a revised approach to "signal detection" as well as to the conduct and reporting of clinical trials. Heartwire (Source: Medscape Today Headlines)

Cardiovascular safety of diabetes drugs: The way forward

theHeart.org — Wed, 14 Sep 2011 14:15:31 +0100

Analyses Find Type 2 Diabetes Patients Treated With BYDUREON™ Experienced Reduction In Cardiovascular Risk Factors: Results Presented At EASD 20

Health News from Medical News Today — Tue, 13 Sep 2011 08:00:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced new analyses from the DURATION-3 and -4 trials demonstrating patients treated with the investigational medication BYDUREON™ (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments... (Source: Health News from Medical News Today)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Analyses Find Type 2 Diabetes Patients Treated With BYDUREON Experienced Reduction In Cardiovascular Risk Factors: Results Presented At EASD 2011

Pharmaceutical Online News — Mon, 12 Sep 2011 06:34:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced new analyses from the DURATION-3 and -4 trials demonstrating patients treated with the investigational medication BYDUREON™ (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular risk factors, in comparison to patients who received commonly prescribed diabetes treatments. (Source: Pharmaceutical Online News)

Experts targeting obesity raise hope of drugs to stop us feeling hungry

Guardian Unlimited Science — Sat, 10 Sep 2011 23:35:43 +0100

Breakthroughs in our understanding of digestion suggest it will soon be possible to suppress the appetiteThe hour is late and you sit down for dinner with a friend. Both of you are hungry. You demolish your starter along with a few of chunks of bread and then dig into your main course. Your partner begins to slow down, but you plough on. Your eat everything on your plate and then order a dessert. Only after you have scoffed that do you stop, aware that you have lost your appetite and at last feel full. If nothing else, your performance explains why you are so much rounder and heavier than your companion.Such diversity in eating habits reveals a simple culinary truth: that some people find it easier to stop eating than others. Somehow the chemicals in their digestive systems react more quic...

Weight Beneficial Treatments for Type 2 Diabetes.

The Journal of Clinical Endocrinology and Metabolism — Wed, 07 Sep 2011 04:00:00 +0100

Conclusions:Weight-beneficial agents should be considered in patients, particularly obese patients, who fail to reach glycemic targets on metformin therapy. We propose the following treatment choices based on potential weight benefit and blood glucose increment: long-acting GLP-1 agonists (liraglutide), DPP-4 inhibitors, bile acid sequestrants, amylin analogs, and basal insulin for patients with elevated fasting plasma glucose; and short-acting (exenatide) or long-acting GLP-1 agonists, amylin analogs, DPP-4 inhibitors, acarbose, and bile acid sequestrants for patients with elevated postprandial glucose. The weight-sparing effects of insulin detemir, notably in patients with high body mass index, should also be considered when initiating insulin therapy. PMID: 21900381 [PubMed - as sup...

Cardiovascular outcomes associated with a new once‐weekly GLP‐1 receptor agonist vs. traditional therapies for type 2 diabetes: a simulation analysis

Diabetes, Obesity and Metabolism — Wed, 07 Sep 2011 01:45:31 +0100

Conclusions: This analysis shows that the novel drug EQW has the potential to greatly reduce CV events through its combined effects on glycaemia, weight and other CV risk factors. (Source: Diabetes, Obesity and Metabolism)

NPC Rapid Review: Once-weekly exenatide injection launched in UK

NeLM - News — Thu, 01 Sep 2011 23:00:00 +0100

Source: NPC Area: News This NPC Rapid Review discusses the recent launch of Bydureon?® - a once-weekly formulation of exenatide subcutaneous injection. Bydureon is indicated for the treatment of type 2 diabetes in adult patients in combination with metformin, a sulphonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. The NPC Rapid review notes, "As yet, there are no data that show that exenatide reduces the risk of macrovascular or microvascular events." It also adds that NICE guidance for the product is expected in February 2012 and in the interim "local decision-making bodies may need to consider whether weekly administration mi...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Exenatide Curbed Hyperglycemia in Cardiac ICU

Clinical Endocrinology News — Thu, 01 Sep 2011 04:00:00 +0100

Major Finding: Patients admitted to the cardiac ICU with hyperglycemia who were treated with IV exenatide achieved a target fasting blood glucose level of less than 140 mg/dL in a mean of 3.9 hours with no severe hypoglycemic episodes. (Source: Clinical Endocrinology News)

Effects of Exenatide on Measures of {beta}-Cell Function After 3 Years in Metformin-Treated Patients With Type 2 Diabetes.

Diabetes Care — Wed, 31 Aug 2011 23:00:00 +0100

CONCLUSIONS EXE and GLAR sustained HbA(1c) over the 3-year treatment period, while EXE reduced body weight and GLAR increased body weight. Following the 3-year treatment with EXE, the DI was sustained after a 4-week off-drug period. These findings suggest a beneficial effect on β-cell health. PMID: 21868779 [PubMed - in process] (Source: Diabetes Care)

BYETTA (Exenatide) Injection [Amylin Pharmaceuticals, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Wed, 31 Aug 2011 05:00:00 +0100

Updated Date: Aug 31, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

Achieving a clinically relevant composite outcome of an HbA1c of

Diabetes, Obesity and Metabolism — Sat, 27 Aug 2011 15:43:05 +0100

Conclusions: As assessed by the composite outcome of HbA1c <7%, no hypoglycaemia and no weight gain, liraglutide was clearly superior to the other commonly used therapies. However, the long‐term clinical impact of this observation remains to be demonstrated. (Source: Diabetes, Obesity and Metabolism)

Beyond glucose lowering: Glucagon-like peptide-1 receptor agonists, body weight and the cardiovascular system.

Diabetes and Metabolism — Tue, 23 Aug 2011 23:00:00 +0100

CONCLUSION: These compounds may play an important role in the treatment of patients with T2DM as their potential effects go beyond glucose-lowering (weight loss, potential improvement of cardiovascular risk factors). However, to better understand their place in the management of T2DM, further experimental and clinical prospective studies are required. PMID: 21871831 [PubMed - as supplied by publisher] (Source: Diabetes and Metabolism)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Contribution of insulin deficiency and insulin resistance to the development of type 2 diabetes: nature of early stage diabetes

Acta Diabetologica — Mon, 22 Aug 2011 16:05:45 +0100

We examined insulin secretion impairment and insulin resistance in overweight patients with T2D who had metformin failure, with elevated HbA1c at maximal metformin dose. Patients (N = 1,039) were examined at entry to the European Exenatide (EUREXA) clinical trial of add-on exenatide versus sulphonylurea. Mean (±SD) age was 57 ± 10 years, and BMI was 32.4 ± 4.1 kg/m2. All patients underwent an oral glucose tolerance test; HOMA-IR, HOMA-B, ∆I 30/∆G 30, disposition index and pro-insulin/insulin ratio were evaluated in relation to stratified HbA1c levels (≤7.3, >7.3–8.2, >8.2%) and duration of diabetes (<3, ≥3–<6, ≥6 years) using non-parametric analysis of variance. Patients overall had a wide range of imp...

BYETTA (Exenatide) Injection [Physicians Total Care, Inc.]

DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) — Fri, 12 Aug 2011 05:00:00 +0100

Updated Date: Aug 12, 2011 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))

BYDUREON™ FDA Action Date Set For January 28, 2012

Pharmaceutical Online News — Wed, 10 Aug 2011 05:41:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the companies' BYDUREON™ (exenatide extended-release for injectable suspension) resubmission. (Source: Pharmaceutical Online News)

Drug makers back Bydureon with FDA reply letter

Cardiovascular Business News — Tue, 02 Aug 2011 14:16:23 +0100

In a response to the FDA’s resubmittal of a complete response letter regarding Bydureon, a weekly exenatide injection indicated to treat type 2 diabetes, the drug's makers Amylin Pharmaceuticals, Eli Lilly and Alkermes said that they have submitted a reply letter and expect to receive an updated Prescription Drug User Free Act (PDUFA) action date from the agency within the next two weeks. (Source: Cardiovascular Business News)

Exenatide Delivery Device Shows Promise

Clinical Endocrinology News — Sun, 31 Jul 2011 23:00:00 +0100

SAN DIEGO – Treatment with the investigational device ITCA 650 delivering exenatide at 20 mcg/day and dose escalation to 60 mcg/day was well tolerated and led to significant reductions in hemoglobin A1c and body weight in patients with type 2 diabetes, results from a phase II, 48-week extension study showed. (Source: Clinical Endocrinology News)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Weekly Exenatide to Get New FDA Review

MedPage Today Primary Care — Thu, 28 Jul 2011 16:02:28 +0100

(MedPage Today) -- Manufacturers of a weekly-injection formulation of the diabetes drug exenatide (Bydureon) -- rejected last year by the FDA -- said they have submitted new data to the agency that they hope will allay its concerns. (Source: MedPage Today Primary Care)

Exenatide/liraglutide: Gastrointestinal symptoms and tiredness: 4 case reports

Reactions — Wed, 20 Jul 2011 16:58:58 +0100

(Source: Reactions)

Glucagon-Like Peptide-1 Receptor Activation Inhibits Growth and Augments Apoptosis in Murine CT26 Colon Cancer Cells.

Endocrinology — Mon, 18 Jul 2011 23:00:00 +0100

Authors: Koehler JA, Kain T, Drucker DJ Obesity, accompanying or independent of type 2 diabetes mellitus (T2DM), is associated with higher rates of malignancy. Hence, there is considerable interest in understanding whether therapies used to treat obese patients with T2DM impact cancer cell growth. Glucagon-like peptide-1 (GLP-1) is produced in enteroendocrine cells and secreted after meal ingestion. GLP-1 regulates blood glucose through multiple mechanisms, principally inhibition of glucagon and stimulation of insulin secretion. GLP-1 also exerts independent effects promoting cell growth and survival, and sustained activation of GLP-1 receptor (GLP-1R) signaling in rodent thyroid glands leads to C-cell hyperplasia and medullary thyroid cancer. Hence, whether therapies based on GLP-1R a...

Encapsulation of Exenatide in Poly-(d,l-Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

Diabetes Technology — Wed, 13 Jul 2011 20:35:59 +0100

Diabetes Technology & Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology)

Exenatide Improves Glycemic Variability Assessed by Continuous Glucose Monitoring in Subjects with Type 2 Diabetes

Diabetes Technology — Wed, 13 Jul 2011 20:35:52 +0100

Diabetes Technology & Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Exenatide: Battling High Blood Sugar?

Dr. Weil Q and A — Tue, 12 Jul 2011 22:11:11 +0100

I have type 2 diabetes. What can you tell me about the drug exenatide? Can it really help with blood sugar control? (Source: Dr. Weil Q and A)

Exenatide TQT Study Showed No Prolongation Of QT Interval

Health News from Medical News Today — Fri, 08 Jul 2011 15:00:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the U.S. Food and Drug Administration (FDA) in support of the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes... (Source: Health News from Medical News Today)

Once-weekly exenatide doesn't prolong QT: study

Modern Medicine — Thu, 07 Jul 2011 23:00:00 +0100

LOS ANGELES (Reuters) - A trial of a long-acting formulation of exenatide, being developed by Amylin Pharmaceuticals, Eli Lilly and Alkermes, found no link between the drug and changes in heart rhythms, the companies said. (Source: Modern Medicine)

Exenatide tQT Study Showed No Prolongation Of QT Interval

Pharmaceutical Online News — Thu, 07 Jul 2011 04:13:00 +0100

Implantable exenatide provides injection-free alternative for Type 2 diabetes

MedWire News - Diabetes — Thu, 07 Jul 2011 00:00:00 +0100

Glycated hemoglobin levels and body weight can be reduced effectively in patients with Type 2 diabetes using an implantable device that allows continuous dosing with exenatide for 3 months, say researchers. (Source: MedWire News - Diabetes)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Exenatide Once-Weekly Clinical Development: Safety and Efficacy Across a Range of Background Therapies

Diabetes Technology — Wed, 06 Jul 2011 18:59:15 +0100

Diabetes Technology & Therapeutics , Vol. 0, No. 0. (Source: Diabetes Technology)

Efficacy and Safety of Long-Acting Glucagon-Like Peptide-1 Receptor Agonists Compared with Exenatide Twice Daily and Sitagliptin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis (July/August).

The Annals of Pharmacotherapy — Mon, 04 Jul 2011 23:00:00 +0100

CONCLUSIONS Compared with other incretin-based therapies, LA-GLP-1RAs produce greater improvement in A1C and FPG. They provide lesser effect on PPG, similar reduction in body weight, and result in a potentially favorable adverse event profile compared with exenatide twice daily. PMID: 21730278 [PubMed - as supplied by publisher] (Source: The Annals of Pharmacotherapy)

Extended-release exenatide may reduce CV event risk

MedWire News - Diabetes — Mon, 04 Jul 2011 00:00:00 +0100

A once-weekly formulation of the glucagon-like peptide, exenatide, may decrease cardiovascular event risk in patients with Type 2 diabetes through combined effects on various risk factors, modeling of NHANES data suggests. (Source: MedWire News - Diabetes)

Novel GLP‐1 mimetics in diabetes: lixisenatide and albiglutide

Future Prescriber — Thu, 30 Jun 2011 23:00:00 +0100

AbstractLixisenatide and albiglutide are glucagon‐like peptide‐1 (GLP‐1) agonists in clinical development that are similar to exenatide and liraglutide. This review critically considers the emerging evidence on the pharmacology, efficacy, safety and potential roles these two agents may have in clinical practice. (Source: Future Prescriber)

The development of non-peptide glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes.

Archives of Pharmacal Research — Thu, 30 Jun 2011 23:00:00 +0100

In this report, the authors provide a review on the development of non-peptide GLP-1 receptor agonists and introduce a novel agonist DA-15864. PMID: 21811909 [PubMed - in process] (Source: Archives of Pharmacal Research)

MedWorm Sponsor Message: Find the best January Sales in the UK.

ADA: Tiny Pump Helps Improve Glycemic Control (CME/CE)

MedPage Today Cardiovascular — Thu, 30 Jun 2011 14:11:40 +0100

SAN DIEGO (MedPage Today) -- A matchstick-sized implantable subcutaneous pump that delivers a steady flow of the GLP-1 agonist exenatide (Byetta) maintained improvements in glycemic control over a year, researchers said here. (Source: MedPage Today Cardiovascular)

Conference report: Lixisenatide non-inferior to exenatide in type 2 diabetes?

NeLM - News — Tue, 28 Jun 2011 23:00:00 +0100

Source: Reuters Health, BioSpace Area: News Reuters Health and BioSpace have reported briefly on the results of a study evaluating lixisenatide versus exenatide in patients with type 2 diabetes inadequately controlled on oral antidiabetics or basal insulin, which are to be presented at the American Diabetes Association's 71st Scientific Sessions. The GetGoal-X study randomised 634 individuals to open-label treatment with once-daily lixisenatide or twice-daily exenatide (doses of both increased stepwise to a maximum daily dose of 20mcg). The mean age of participants was 57.4 years, and they had a mean disease duration of 6.8 years, with a mean HbA1c of 8.0% at baseline. Some of the main findings reported included the following: .&nb...

ER Exenatide Shows Efficacy in Type 2 DiabetesER Exenatide Shows Efficacy in Type 2 Diabetes

Medscape Today Headlines — Tue, 28 Jun 2011 20:54:15 +0100

Patients with type 2 diabetes treated with once-weekly extended-release (ER) exenatide experienced significant benefits, compared with insulin glargine; once-monthly exenatide was also effective. Medscape Medical News (Source: Medscape Today Headlines)

Lyxumia (lixisenatide) as Good as Byetta (exenatide) in Type 2 DiabeticsLyxumia (lixisenatide) as Good as Byetta (exenatide) in Type 2 Diabetics

Medscape Diabetes Headlines — Mon, 27 Jun 2011 23:05:08 +0100

A trial of Sanofi's experimental once-daily drug for type 2 diabetes, Lyxumia (lixisenatide), found it worked as well as Byetta (exenatide), a similar drug sold by Amylin and Eli Lilly and Co that is injected twice a day. Reuters Health Information (Source: Medscape Diabetes Headlines)

Sanofi diabetes drug shown to work as well as Byetta

Reuters: Health — Mon, 27 Jun 2011 19:35:14 +0100

SAN DIEGO (Reuters) - A trial of Sanofi's experimental once-daily drug for Type 2 diabetes, Lyxumia, found that it worked as well as Byetta, a similar drug sold by Amylin and Eli Lilly and Co that is injected twice a day. (Source: Reuters: Health)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Exenatide May Produce Weight Loss In Obese Youth

Health News from Medical News Today — Mon, 27 Jun 2011 17:00:00 +0100

SAN DIEGO - The glucagon-like peptide 1 receptor agonist exenatide decreases body mass index (BMI) and body weight and improves risk factors for diabetes in children and adolescents who are extremely obese, according to the results of a small study reported at the 71st Scientific Sessions of the American Diabetes Association (ADA). Aaron S. Kelly, PhD, University of Minnesota in Minneapolis, and colleagues evaluated the effects of six months of exenatide or placebo treatment on body mass index (BMI) and other cardiometabolic risk factors in 12 extremely obese girls without diabetes... (Source: Health News from Medical News Today)

New Data Show Victoza(R) Helped Reduce Blood Sugar When Patients With Type 2 Diabetes Switched From Sitagliptin Or Exenatide

Health News from Medical News Today — Mon, 27 Jun 2011 09:00:00 +0100

Today at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA), Novo Nordisk presented data from two extension studies which show that Victoza® (liraglutide [rDNA origin] injection), taken once-daily, in combination with metformin and/or sulfonylurea, helped patients with type 2 diabetes improve blood sugar control when they were switched to liraglutide from either exenatide or sitagliptin1,2. Although not a weight loss product, the data also demonstrated that patients experienced significant weight loss when switched from sitagliptin to Victoza®2... (Source: Health News from Medical News Today)

New Data Shows Victoza(R) Helped Reduce Blood Sugar When Patients With Type 2 Diabetes Switched From Sitagliptin Or Exenatide

Health News from Medical News Today — Mon, 27 Jun 2011 08:00:00 +0100

Novo Nordisk will present data from two extension studies at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA) which show that Victoza® (liraglutide [rDNA origin] injection), taken once-daily, in combination with metformin and/or sulfonylurea, helped patients achieve blood sugar control after switching from other commonly used type 2 diabetes therapies. Although not a weight loss product, the data also demonstrate that patients experienced weight loss when switched from sitagliptin to Victoza®... (Source: Health News from Medical News Today)

Analysis Shows BYDUREON™ Was Not Associated With Clinically Relevant QT Prolongation In Patients With Type 2 Diabetes

Health News from Medical News Today — Sat, 25 Jun 2011 07:00:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced results from an analysis of the DURATION-1 study that showed the investigational type 2 diabetes medication BYDUREON™ (exenatide extended-release for injectable suspension) was not associated with clinically relevant QT prolongation in patients with type 2 diabetes. These findings will be presented in a poster session at the 71st Scientific Sessions of the American Diabetes Association in San Diego on Saturday, June 25 from 11:30 a.m. to 1:30 p.m. PDT... (Source: Health News from Medical News Today)

Lyxumia (lixisenatide) as good as Byetta (exenatide) in type 2 diabetics

Modern Medicine — Fri, 24 Jun 2011 23:00:00 +0100

SAN DIEGO (Reuters) - A trial of Sanofi's experimental once-daily drug for type 2 diabetes, Lyxumia (lixisenatide), found it worked as well as Byetta (exenatide), a similar drug sold by Amylin and Eli Lilly and Co that is injected twice a day. (Source: Modern Medicine)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Sanofi diabetes drug shown to work as well as Byetta

Reuters: Health — Fri, 24 Jun 2011 21:30:55 +0100

Diabetes Drug Bydureon Gets EU ApprovalDiabetes Drug Bydureon Gets EU Approval

Medscape Diabetes Headlines — Wed, 22 Jun 2011 22:42:21 +0100

Eli Lilly and Co and Amylin Pharmaceuticals Inc said European health regulators approved their type 2 diabetes drug Bydureon (extended-release exenatide). Reuters Health Information (Source: Medscape Diabetes Headlines)

Safety, efficacy and tolerability of exenatide in combination with insulin in the Association of British Clinical Diabetologists nationwide exenatide audit*

Diabetes, Obesity and Metabolism — Wed, 22 Jun 2011 17:11:41 +0100

Conclusions: Addition of exenatide to obese, insulin‐treated patients can improve glycaemia and weight. Adverse events were statistically but probably not clinically significantly higher, but combination treatment was less well tolerated. Overall, exenatide was less effective in lowering HbA1c among insulin‐treated patients, although significant number of insulin‐treated patients still achieved significant HbA1c, weight and insulin reductions. Further research into identifying obese, insulin‐treated patients who will tolerate and benefit from exenatide treatment is urgently needed. (Source: Diabetes, Obesity and Metabolism)

Once-weekly type 2 diabetes drug gains EU nod

Cardiovascular Business News — Wed, 22 Jun 2011 08:27:22 +0100

Eli Lilly, along with Amylin Pharmaceuticals and Alkermes, has announced that the European Commission has granted marketing authorization to Bydureon (exenatide 2 mg powder and solvent for prolonged release suspension for injection). (Source: Cardiovascular Business News)

European Commission approves prolonged-release exenatide (Bydureon®) for type 2 diabetes

NeLM - News — Tue, 21 Jun 2011 23:00:00 +0100

Source: BioSpace Area: News According to a BioSpace report, the European Commission has granted marketing authorization to exenatide prolonged release suspension for injection (Bydureon®), making it the first once-weekly treatment for type 2 diabetes to be approved in the EU. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, already approved and available in the UK as Byetta® (administered twice daily). This new formulation is based on biodegradable microsphere technology and offers a continuous release of exenatide with just one weekly dose. It is indicated for the treatment of type 2 diabetes in adult patients in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione. ...

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Bydureon Receives Marketing Authorization in Europe

HSMN NewsFeed — Tue, 21 Jun 2011 13:14:59 +0100

First and Only Once-Weekly Type 2 Diabetes Medication Delivers Powerful Glycemic Control in a Single Dose INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., June 21, 2011 (HSMN NewsFeed) -- Eli Lilly and Company (NYSE:LLY ), together with Amylin Pharmaceutic... Biopharmaceuticals, Endocrinology, RegulatoryAmylin Pharmaceuticals, Eli Lilly, Alkermes, BYDUREON, exenatide, diabetes (Source: HSMN NewsFeed)

Amylin Pharmaceuticals To Present Promising New Data On The Company's Diabetes Programs At ADA 2011

Health News from Medical News Today — Tue, 21 Jun 2011 07:00:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection, and its investigational diabetes drug candidates BYDUREON™ (exenatide extended-release for injectable suspension) and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28. The Company will also host an investor presentation and webcast on Sunday, June 26 at 7:30 PM PT/10:30 PM ET... (Source: Health News from Medical News Today)

Diabetes drug Bydureon (extended-release exenatide) gets EU approval

Modern Medicine — Mon, 20 Jun 2011 23:00:00 +0100

BANGALORE (Reuters) - Eli Lilly and Co and Amylin Pharmaceuticals Inc said European health regulators approved their type 2 diabetes drug Bydureon (extended-release exenatide). (Source: Modern Medicine)

Effects of Combined Exenatide and Pioglitazone Therapy on Hepatic Fat Content in Type 2 Diabetes.

Obesity — Wed, 08 Jun 2011 23:00:00 +0100

We examined the effects of combined pioglitazone (peroxisome proliferator-activated receptor-γ (PPAR-γ) agonist) and exenatide (GLP-1 receptor agonist) therapy on hepatic fat content and plasma adiponectin levels in patients with type 2 diabetes (T2DM). Twenty-one T2DM patients (age = 52 ± 3 years, BMI = 32.0 ± 1.5, hemoglobin A(1c) (HbA(1c)) = 8.2 ± 0.4%) on diet and/or metformin received additional treatment with either pioglitazone 45 mg/day for 12 months (n = 10) or combined therapy with pioglitazone (45 mg/day) and exenatide (10 µg subcutaneously twice daily) for 12 months (n = 11). At baseline, hepatic fat content and plasma adiponectin levels were similar between the two treatment groups. Pioglitazone reduced fasting plasma glucose (FPG) (P < 0.05), fasting free fatty ac...

The GLP-1 mimetic exenatide potentiates insulin secretion in healthy cats

Domestic Animal Endocrinology — Tue, 07 Jun 2011 17:01:09 +0100

In conclusion, exenatide affects insulin secretion in cats in a glucose-dependent manner, similar to its effect in other species. Although this effect was not accompanied by a greater ability to dispose of an intravenous glucose infusion, other potentially beneficial effects of exenatide on pancreatic β cells, mainly increasing their proliferation and survival, should be investigated in cats. (Source: Domestic Animal Endocrinology)

MedWorm Sponsor Message: Find the best January Sales in the UK.

Anti-Inflammatory Properties of Exenatide in Human Pancreatic Islets.

Cell Transplantation — Mon, 06 Jun 2011 23:00:00 +0100

In conclusion, we describe anti-inflammatory and cytoprotective properties of Exenatide in human islets. Exenatide-mediated PI-9 expression, the only known Granzyme B inhibitor, unveils potential immunoregulatory properties. PMID: 21669040 [PubMed - as supplied by publisher] (Source: Cell Transplantation)

Peptide complex containing GLP-1 exhibited long-acting properties in the treatment of type 2 diabetes

Diabetes Research and Clinical Practice — Mon, 06 Jun 2011 04:00:00 +0100

In this study, the stability of the complex was investigated, and the physiological functions of the GLP-1/peptide 1 complex were compared to those of exenatide and liraglutide in animals. The results indicated that the GLP-1/peptide 1 complex remarkably raised the half-life of GLP-1 in vivo and showed better glucose tolerance and higher HbA1c reduction than exenatide and liraglutide in rodents. Based upon these results, it is suggested that the GLP-1/peptide 1 complex might be utilized as a possible potent anti-diabetic drug in the treatment of type 2 diabetes mellitus. (Source: Diabetes Research and Clinical Practice)

Exenatide improves weight loss insulin sensitivity and β-cell function following administration to a type 2 diabetic HIV patient on antiretroviral therapy.

Annales d'Endocrinologie — Sun, 05 Jun 2011 23:00:00 +0100

Authors: Oriot P, Hermans MP, Selvais P, Buysschaert M, de la Tribonnière X The use of retroviral drugs in the treatment of infection by human immunodeficiency virus (HIV) is associated, especially for first generations, with side effects such as lipodystrophy, fatty liver and insulin resistance, which may trigger secondary diabetes or worsen existing diabetes. The use of Glucagon-Like Peptide-1 in obese patients with type 2 diabetes on HIV retroviral as an alternative to insulin therapy is not documented; we report the case of a 47-year-old treated with exenatide when insulin was discontinued. During the first year of treatment, exenatide, in combination with metformin and repaglinide, led to a weight loss of 14kg and fat mass and waist circumference were respectively reduced from 31...

GLP‐1 signals via ERK in peripheral nerve and prevents nerve dysfunction in diabetic mice.

Diabetes, Obesity and Metabolism — Wed, 01 Jun 2011 23:00:00 +0100

Conclusions: These data demonstrate that the peripheral nerve of diabetic rodents exhibits functional GLP‐1R and suggest that GLP‐1R‐mediated ERK‐signaling in sciatic nerve of diabetic rodents may protect large motor fibre function and small C fibre structure by a mechanism independent of glycaemic control. (Source: Diabetes, Obesity and Metabolism)

Response at 3 months to insulin dose decisions made at exenatide initiation in the Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit

Diabetes Research and Clinical Practice — Wed, 01 Jun 2011 23:00:00 +0100

Abstract: It is uncertain what should be done with insulin dose if starting exenatide. In the ABCD nationwide exenatide audit, many patients with type 2 diabetes had worsened glycaemia when insulin was stopped. If starting exenatide, insulin should not be stopped but weaned off only if there is significant glycaemic response. (Source: Diabetes Research and Clinical Practice)

MedWorm Sponsor Message: Please support the Doctors In Chains campaign for the medics tortured and sentenced for up to 15 years in Bahrain. #FreeDoctors

Effects of a Single Dose of Exenatide on Appetite, Gut Hormones, and Glucose Homeostasis in Adults with Prader-Willi Syndrome.

The Journal of Clinical Endocrinology and Metabolism — Tue, 31 May 2011 23:00:00 +0100

Conclusions: Our pilot study demonstrates that exenatide is well tolerated in PWS patients. It increases satiety independently of measured appetite hormones, exerting glucose lowering, and insulinotropic effects similarly in PWS and OBESE patients. Larger prospective studies should investigate whether chronic exenatide administration will reduce hyperphagia and overweight in PWS patients without side effects. PMID: 21632815 [PubMed - as supplied by publisher] (Source: The Journal of Clinical Endocrinology and Metabolism)

Cardiovascular outcomes associated with a new once‐weekly GLP‐1 receptor agonist versus traditional therapies for type 2 diabetes: A simulation analysis

Diabetes, Obesity and Metabolism — Mon, 30 May 2011 16:49:37 +0100

Conclusions – This analysis shows that the novel drug exenatide once‐weekly has the potential to greatly reduce cardiovascular events through its combined effects on glycemia, weight, and other cardiovascular risk factors. (Source: Diabetes, Obesity and Metabolism)

Amylin, Lilly, Boehringer Bicker Over Diabetes Medication Sales Force

Health News from Medical News Today — Thu, 26 May 2011 17:00:00 +0100

A Southern California Court has placed a restraining order against Eli Lilly on behalf of Amylin Pharmaceuticals, disallowing the pharma giant to use the same sales force to sell both Byetta (exenatide) and competing Tradjenta (linagliptin) made by Boehringer Ingelheim. Lilly must keep all information about the joint partnership with Amylin confidential to sales reps. Byetta is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program... (Source: Health News from Medical News Today)

Amylin Pharmaceuticals Obtains Temporary Restraining Order Against Eli Lilly

Pharmaceutical Online News — Thu, 26 May 2011 10:15:00 +0100

The U.S. District Court restrained Lilly from proceeding with its plans to use the same sales force to sell both exenatide and Boehringer Ingelheim GmbH's competitive linagliptin. (Source: Pharmaceutical Online News)