FDA expected to raise the bar on diabetes drugs
The FDA concerns from the ADVANCE trial that glucose control did not address concern (weight gain and cardiovascular problems. ) All diabetic drugs and combination of diabetic drugs in the trial except one were implicated. Byetta
Byetta is the only diabetes drug on the market that can offer substantial and sustained weight loss, decreased blood pressure, lowered triglycerides, lowered LDL cholesterol with increased HDL cholesterol, and improved beta cell health in addition to substantial improvements in both fasting and postprandial blood sugar.
From this years ADA -
BYETTA® Treatment has "sustained improvements" For Three And A Half Years Associated With Reductions In Cardiovascular Risk Factors In People With Type 2 Diabetes
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a study that showed 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).(1,2)
"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."
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.
