Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from a retrospective study of nearly 375,000 type 2 diabetes patients evaluating the incidence of events related to cardiovascular disease (CVD) and all-cause hospitalizations among initiators of BYETTA (exenatide) injection compared to initiators of other commonly used diabetes medications. These findings were presented at the American Heart Association Scientific Sessions in Chicago.
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.
Date: November 17, 2010
Source: Eli Lilly and Company
