Amylin Pharmaceuticals, Inc., Eli Lilly and Company Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA(R) Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia(
In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin). BYETTA was also associated with a lower incidence of all-cause hospitalizations than insulin, TZDs and sulfonylureas; a comparable incidence versus metformin and a higher incidence than Januvia.
The study used data accrued over nearly four years from the IMS LifeLink Health Plan Claims Database, comprised of medical and pharmaceutical claims for more than 65 million patients from 98 health plans across the U.S. The incidence of CVD-related events was assessed in approximately 22,000 patients who were treated with BYETTA relative to nearly 353,000 patients who were treated with other diabetes therapies. Baseline lipid levels, blood pressure, obesity and evidence of prior cardiovascular disease were higher in patients treated with BYETTA than patients treated with most other therapies.
"Heart disease and stroke account for nearly two-thirds of deaths in people with type 2 diabetes, so it is critically important for us to understand how treatment may affect cardiovascular risk, either positively or negatively," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "Our EXSCEL cardiovascular outcomes study will further explore this area and the role of exenatide."
EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is designed to determine if there are favorable cardiovascular effects of exenatide treatment, using the investigational product BYDUREON (exenatide extended-release for injectable suspension), compared to standard of care with traditional diabetes medications. The study is underway and will include approximately 9,500 patients, with results expected as early as 2016.
Study Design and Findings
The study presented today was designed to assess the relative incidence rate of first CVD-related events in a real-world setting among adult patients with type 2 diabetes. Analyses included patients initiating a new prescription for a diabetes therapy between June 1, 2005, and March 31, 2009, without a prescription for the same agent in the prior nine months. Patients were followed until one of the following occurred: CVD event (acute myocardial infarction, stroke or coronary revascularization procedure), insurance disenrollment or study end. An intention-to-treat analysis of CVD events was adjusted for more than 300 potential differences in clinical and demographic characteristics using propensity-score-weighted methods.
Based on the hazard ratio (HR) and 95 percent confidence interval (CI), BYETTA-treated patients were less likely to have had a CVD event than patients treated with insulin (HR=0.72; CI, 0.66-0.79; P less than 0.0001), TZDs (HR=0.92; CI, 0.85-1.00; P less than 0.05) or sulfonylureas (HR=0.91; CI, 0.83-0.99; P less than 0.05); they were equally likely to have had a CV event compared to patients treated with Januvia (HR=1.00; CI, 0.9-1.12; P greater than 0.05) or metformin (HR=1.01; CI, 0.93-1.09; P greater than 0.05). BYETTA-treated patients had a significantly lower incidence of all-cause hospitalization than patients treated with insulin (HR=0.70; CI, 0.68-0.73; P less than 0.0001), TZDs (HR=0.94; CI, 0.91-0.98; P less than 0.05) or sulfonylureas (HR=0.89; CI, 0.86-0.92; P less than 0.0001); a comparable incidence to patients treated with metformin (HR=1.02; CI, 0.99-1.06; P greater than 0.05) and a higher incidence than patients treated with Januvia (HR=1.10; CI, 1.05-1.16; P less than 0.001). The observed differences between therapies in this study may have resulted from decreased CVD risk from BYETTA, increased CVD risk with certain other diabetes medications or some combination of each of these.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an estimated 285 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)
About BYETTA® (exenatide) injection
BYETTA was the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. 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 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. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a TZD, with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in April 2005 and has been used by more than 1.3 million patients since its introduction. See important safety information below. Additional information about BYETTA is available at www.BYETTA.com.
Important Safety Information for BYETTA® (exenatide) injection
Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems, and should be used with caution in people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Severe allergic reactions can happen with BYETTA.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.
These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For additional important safety information about BYETTA, please see the full Prescribing Information (www.byetta.com/pi) and Medication Guide (www.byetta.com/mg).
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego. Further information on Amylin Pharmaceuticals is available at www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly seeks to provide patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been an industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products, visit www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at 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/or the revenues generated from BYETTA, may be affected by competition; unexpected new data; safety and technical issues; the study results mentioned in this press release not being predictive of real-world results; clinical trials, including the EXSCEL trial mentioned in this press release, not being completed in a timely manner, not confirming previous results, not being predictive of real-world use, or not achieving the intended clinical endpoints; label expansion requests not 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 development and commercialization of pharmaceutical products, including those inherent in the collaboration with and dependence upon Amylin and/or Lilly. These and additional risks and uncertainties are described more fully in Amylin's and Lilly's most recent SEC filings, including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.
BYETTA® is a registered trademark and BYDUREON is a trademark of Amylin Pharmaceuticals, Inc. All other marks are the marks of their respective owners.
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(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010. Accessed November 12, 2010.
(ii) Diabetes Statistics. American Diabetes Association. Available at http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed November 12, 2010.
(iii) Direct and Indirect Costs of Diabetes in the United States. American Diabetes Association. Available at: http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html. Accessed November 12, 2010.
(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company