NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced interim results from a retrospective study including nearly 260,000 patients that showed the risk of acute pancreatitis among patients initiating therapy with BYETTA(R) (exenatide) injection was not increased compared to patients initiating other antidiabetic therapies. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.
The retrospective study used data accrued over three years from a large, geographically diverse U.S. health care insurance claims database to examine the risk of acute pancreatitis in more than 25,000 patients who were treated with BYETTA relative to nearly 235,000 patients who were treated with other antidiabetes medications. After propensity score adjustments were made to reduce bias between the cohorts, use of BYETTA was not associated with an increased rate of acute pancreatitis compared to the other antidiabetes medications, based on the rate ratio (RR) and 95 percent confidence interval (CI) for current (RR 0.9; CI 0.6-1.3), recent (RR 0.9; CI 0.4-2.1) and past (RR 1.4; CI 0.9-2.3) use of BYETTA.
"Based on these retrospective data reflecting BYETTA use over a three-year period, we found no evidence for a higher risk of acute pancreatitis associated with the use of BYETTA compared to other common antidiabetes therapies," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. "We plan to further validate this interim analysis of claims data through medical records review."
Amylin and Lilly are working to better understand the relationship between BYETTA and pancreatitis described in some spontaneously reported cases. In keeping with the companies' focus on patient safety, Amylin and Lilly continue to pursue a drug safety program that includes thorough investigation of individual spontaneous case reports along with clinical and epidemiologic studies. Within the detection limits of this initial epidemiology study, Amylin and Lilly have not observed an increased incidence of pancreatitis associated with BYETTA compared to other treatments for diabetes and thus believe a definite causal relationship between BYETTA and pancreatitis has not been proved. Patients and health care professionals should refer to product labeling for guidance regarding the use of BYETTA.
Study Design and Findings
Eligible patients were enrolled in the health care plan for at least a continuous nine-month baseline period with no history of chronic or acute pancreatitis prior to initiation of a new antidiabetic therapy. Propensity scores for BYETTA initiation were developed from baseline characteristics (proxies for diabetes severity, cardiovascular disease, known acute pancreatitis risk factors and empirically derived variables), which were obtained from nine months of claims data prior to cohort entry. Cases of acute pancreatitis were defined by a primary diagnosis of acute pancreatitis associated with an emergency room visit or hospitalization during follow-up. Initiators of BYETTA (n=25,719; 80 percent age 40-64 years old) were more likely to be female (56 vs. 49 percent) and had a higher baseline prevalence of claims for type 2 diabetes (84 vs. 59 percent), obesity (16 vs. 8 percent) and cardiovascular risk factors (hyperlipidemia 77 vs. 54 percent; hypertension 64 vs. 49 percent) than initiators of other antidiabetes medications. In addition, BYETTA initiators were more likely to use multiple antidiabetes medications. These results are undergoing further validation by medical records review.
About Diabetes
Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and results in 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 support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)
About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved incretin mimetic 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 approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control and low incidence of hypoglycemia when used with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction. For full prescribing information, visit http://www.byetta.com/.
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.
If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of 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 full prescribing information, visit http://www.byetta.com/. 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, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (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, California. Further information about Amylin Pharmaceuticals is available at 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 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, http://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, 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; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials or the study mentioned in this press release not 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'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.
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(i) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed March 28, 2009.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed March 28, 2009.
(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed March 28, 2009.
(iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes." JAMA: 291(3), January 21, 2004.
(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.
Amylin Pharmaceuticals, Inc.
CONTACT: Anne Erickson of Amylin, +1-858-754-4443, cell,
+1-858-349-3195, anne.erickson@amylin.com; or Kindra Strupp of Lilly,
+1-317-277-5170, cell, +1-317-554-9577, kstrupp@lilly.com
Web Site: http://www.amylin.com/
http://www.byetta.com/
http://www.lillydiabetes.com/
http://www.lilly.com/
