BYETTA(R) Treatment for Three and a Half Years Associated with Sustained Improvements in Blood Glucose Control in People with Type 2 Diabetes
Chicago (ots/PRNewswire)
- Study also showed added benefits of reductions in cardiovascular risk factors and progressive weight loss -
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a study that showed BYETTA(R) (exenatide) injection in conjunction with common oral medication sustained improvements in blood sugar levels through three and a half years of therapy. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.
In this study, 151 people with type 2 diabetes who had taken part in a 30-week placebo-controlled trial were followed in open-label extension studies for three and a half years. Participants using exenatide (10 mcg) twice daily with common oral medication (metformin and/or a sulphonylurea) showed sustained reductions in blood sugar as measured by HbA1c (-0.8 +/- 0.1 percent) and fasting blood glucose (-1.3 +/- 0.2 mmol/L [-24 +/- 4 mg/dL]), consistent with findings from previous studies.
People with type 2 diabetes are at increased risk for various cardiovascular problems, including high blood pressure and cholesterol. Secondary study endpoints examined the potential benefits of exenatide for weight loss and cardiovascular risk factor reduction over three and a half years. Treatment with exenatide in combination with common oral medications was associated with progressive weight loss (-5.3 +/- 0.5 kg [-11.7 +/- 1.1 lbs]), improved triglyceride levels (0.50 +/- 0.14 mmol/L [-44.4 +/- 12.1 mg/dL] or 12 percent), and lower systolic and diastolic blood pressure (-3.5 +/- 1.2 mmHg or 2 percent and -3.3 +/- 0.8 mmHg or 4 percent, respectively). Results also showed an increase in HDL, or "good" cholesterol levels after three and a half years (+0.22 +/- 0.02 mmol/L [+8.5 +/- 0.6 mg/dL] or 24 percent) and a decrease in LDL, or "bad" cholesterol levels (-0.31 +/- 0.07 mmol/L [-11.8 +/- 2.9 mg/dL] or 6 percent).(1,2)
"The sustained improvements in blood glucose control seen with exenatide are well documented," said David Kendall, Executive Director, Medical Affairs, Amylin Pharmaceuticals, Inc. "The secondary study endpoints suggesting that exenatide may have effects on cardiovascular disease risk factors provide interesting areas for further study."
Exenatide was generally well-tolerated in this study, and the side effects were consistent with those seen in previous studies. In clinical trials and post-approval adverse event reports, the most common side effect is nausea, most of which was mild to moderate, affecting approximately half of patients and usually decreases over time.
About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs for the treatment of type 2 diabetes called incretin mimetics. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved in the European Union as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin and/or a sulphonylurea, two common oral diabetes medications. BYETTA provides sustained HbA1c control, low incidence of hypoglycaemia when used with metformin and progressive weight loss.
Important Safety Information for BYETTA(R) (exenatide) injection
In clinical studies, the most common side effects were hypoglycaemia (low blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomiting and diarrhea. For the full list of all side effects reported with BYETTA, see the Package Leaflet. BYETTA should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.
About Diabetes
Diabetes affects an estimated 246 million adults worldwide and more than 48 million in Europe.(3,4) Approximately 90 to 95 percent of those affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta cells to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(5) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(4) In virtually every developed society, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation, as well as death through its effects on cardiovascular disease (70-80 percent of people with diabetes die of cardiovascular disease).(6) The calculated estimates of the costs of diabetes care in Europe amount to 42.8 billion International Dollars per year.(7)
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,700 employees nationwide. For more information about Amylin, visit http://www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.
This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition, unexpected new data, technical issues, clinical trials not confirming previous results or predicting future results, label expansion requests not being submitted in a timely manner or receiving regulatory approval, or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed United States Securities and Exchange Commission documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to update these forward-looking statements.
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REFERENCES
(1) Kendall D, Blonde L, Mac S, Guan X, Holcombe J, Okerson T, Kim D, and Bhole D. "Improvements in Cardiovascular Risk Factors Accompanied Improved Glycemic Control Weight Reduction in Patients With Type 2 Diabetes Treated With Exenatide for 3.5 y." Abstract 0557-P.
(2) American Heart Association. "LDL and HDL Cholesterol: What's Bad and What's Good?" Available at: http://www.americanheart.org/presenter.jhtml?identifier=180. Accessed June 14, 2007.
(3) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2 FD3-87B73F80BC22682A. Accessed June 14, 2007.
(4) The International Diabetes Federation, Prevalence / All diabetes. Available athttp://www.eatlas.idf.org/Prevalence/All_diabetes/.
(5) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(6) The International Diabetes Federation, Complications. Available at http://www.eatlas.idf.org/Complications/
(7) The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003: 186.
Web site: http://www.lilly.com http://www.amylin.com
Contact:
Derin Denham of Eli Lilly and Company, office, +1-317-277-6749, cell,
+1-317-370-1435 or Alice Bahner Izzo of Amylin, office,
+1-858-642-7272, cell, +1-858-232-9072; Photo:
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