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 US 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 favourable 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.

The study presented 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 dis-enrollment 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.

Byetta was the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. It 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. It is not insulin and should not be taken instead of insulin and it is not recommended to be taken with insulin. It 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). It was approved in April 2005 and has been used by more than 1.3 million patients since its introduction.

Byetta has been associated with acute pancreatitis, including fatal and non-fatal haemorrhagic or necrotizing pancreatitis. The risk for getting low blood sugar is higher if it is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. It 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.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines.

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.