Retrospective Analysis Included More Than 778,000 Patients with Type 2 Diabetes
SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a retrospective analysis of more than 778,000 patients that showed the addition of BYETTA® (exenatide) injection to pre-existing diabetes treatment regimens was associated with a reduced likelihood of heart failure, especially among patients receiving insulin. These findings will be presented in a poster session at the 71st Scientific Sessions of the American Diabetes Association in San Diego on June 25 from 11:30 a.m. to 1:30 p.m. PDT.
The retrospective analysis used data from the GE Healthcare Centricity electronic medical record to analyze the likelihood of heart failure for BYETTA in combination with certain other diabetes treatments compared with control groups of patients not treated with BYETTA. Across all therapies, patients who received BYETTA were 54 percent less likely to experience heart failure compared to patients not treated with BYETTA.
"Compared with the general population, people with diabetes have an increased risk of heart disease, with at least double the risk of developing heart failure. That's why it is imperative that we understand the role diabetes treatments may play in patients' cardiovascular health," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "In addition to retrospective analyses like this one, our EXSCEL cardiovascular outcomes study is underway to thoroughly and prospectively evaluate cardiovascular effects of exenatide."
EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is designed to determine if there are favorable cardiovascular effects of exenatide treatment, using BYDUREON™ (exenatide extended-release for injectable suspension), compared to standard of care with traditional diabetes medications. The study began in 2010 and will include approximately 9,500 patients, with results expected as early as 2016. BYDUREON is the proposed brand name for an investigational, once-weekly formulation of exenatide, the active ingredient in BYETTA.
Analysis Design and Findings
This retrospective matched cohort analysis used data obtained from the national Medical Quality Improvement Consortium of more than 14,000 healthcare providers from ambulatory medical practices with the GE Healthcare Centricity electronic medical record. Heart failure was defined as heart failure diagnosis (ICD-9 code 428.xx) and a brain natriuretic peptide concentration of greater than 100 pg/mL. A total of 778,408 patients with type 2 diabetes receiving a prescription for BYETTA, insulin (any type) and/or another glucose-lowering therapy prescribed serially or concomitantly between January 2005 and September 2010 were identified. (The use of BYETTA with basal insulin is currently under FDA review and not yet an approved indication.) Patients receiving BYETTA were randomly matched to those not receiving BYETTA based on gender, age, follow-up time and use of thiazolidinediones. The weighted Charlson Comorbidity Index was used to adjust for disease severity.
Patients who received BYETTA in combination with insulin and another therapy were 57 percent less likely to develop heart failure than those receiving insulin in combination with another therapy (odds ratio [OR]=0.43, 95 percent CI=0.35-0.53, n=50,330). With BYETTA plus other non-insulin therapies, the likelihood was 31 percent lower than with the other therapies alone, though this finding was not statistically significant (OR=0.69, 95 percent CI=0.44-1.07, n=53,446). Across all therapies, patients receiving BYETTA were 54 percent less likely to develop heart failure (OR=0.46, 95 percent CI=0.38-0.56, n=103,776) than the control group of patients not receiving BYETTA.
Diabetes affects nearly 26 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 more than $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 glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone 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 currently recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 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 postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA. 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. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Consider alternative therapy if this occurs. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.
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.
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 analysis 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.
(i) Diabetes Statistics. American Diabetes Association. Available at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed June 17, 2011.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010. Accessed June 17, 2011.
(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 June 17, 2011.
(iv) Saydah SH, Fradkin J, 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. 2008;31 Suppl 1;S61-78.
(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.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company