BYETTA For Treatment Of Reductions In Cardiovascular Risk Factors In People With Type 2 Diabetes

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BYETTA (exenatide) injection sustained improvements in blood sugar levels and progressive weight loss through three and a half years of therapy.

BYETTA treatment was also associated with improvements in cardiovascular risk factors in people with type 2 diabetes. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.

People with type 2 diabetes are at increased risk for various cardiovascular problems, including high blood pressure and cholesterol. In this study, 151 people with type 2 diabetes who had taken part in a 30-week placebo-controlled trial were followed in open-label extension studies. After three and a half years, participants using BYETTA (10 mcg) twice daily with oral medication showed sustained reductions in blood sugar as measured by A1C (-0.8 +/- 0.1 percent) and fasting blood glucose (-24 +/- 4 mg/dL), consistent with findings from previous studies.

Treatment with BYETTA in combination with common oral medications was also associated with progressive weight loss (-11.68 +/- 1.1 lbs), improved triglyceride levels (-44.4 +/- 12.1 mg/dL or 12 percent), and lower systolic and diastolic blood pressure (-3.5 +/- 1.2 mmHg or 2 percent and -3.3 +/- 0.8 mmHg or 4 percent, respectively). Results also showed an increase in HDL, or "good" cholesterol levels after three and a half years (+8.5 +/- 0.6 mg/dL or 24 percent) and a decrease in LDL, or "bad" cholesterol levels (-11.8 +/- 2.9 mg/dL or 6 percent).

"The sustained improvements in blood glucose control and the secondary benefits of progressive weight loss seen with BYETTA are well documented," said David Kendall, Executive Director, Medical Affairs, Amylin Pharmaceuticals, Inc. "These studies document that BYETTA may have additional and important effects on cardiovascular disease risk factors providing interesting areas for further study, including additional metabolic advantages of weight loss in people with diabetes."

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BYETTA was generally well-tolerated in this study, and the side effects were consistent with those seen in previous studies. In clinical trials and post-approval adverse event reports, the most common side effect is mild-to- moderate nausea, which affects fewer than half of patients and usually decreases over time.

BYETTA is indicated for use as an adjunctive therapy for people with type 2 diabetes who are not achieving blood sugar control using metformin, a sulfonylurea, or a thiazolidinedione. Over three million prescriptions have been written in the U.S. since being approved by the Food and Drug Administration (FDA) in 2005.

BYETTA is the first in a class of drugs for the treatment of type 2 diabetes called incretin mimetics. 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, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss.

Diabetes affects more than 20 million in the United States and an estimated 246 million adults worldwide.(3,4) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.

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.

BYETTA improves glucose (blood sugar) control in patients with type 2 diabetes who are taking 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 with the stomach or food digestion, or those who have severe kidney disease. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.

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 most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

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