BYDUREON(TM) Safety and Tolerability Pooled Summary Data Presented at ADA 2010
ORLANDO, Fla., June 26, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced results of an analysis of pooled safety data from three completed randomized controlled trials that showed the investigational product BYDUREON™ (exenatide extended-release for injectable suspension), dosed once weekly, was generally well-tolerated with a low discontinuation rate due to serious adverse events similar to pooled comparators in patients with type 2 diabetes. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.
Safety data from the DURATION-1, -2 and -3 trials involving patients on either BYDUREON or pooled data from comparator groups including Januvia® (sitagliptin), Actos® (pioglitazone HCI) or Lantus® (insulin glargine) were analyzed. The overall incidence rates of adverse events (AEs), serious AEs and discontinuations due to serious AEs were similar for BYDUREON versus pooled comparators. AEs occurred in 77 percent of patients receiving BYDUREON versus 71 percent for pooled comparators; serious AEs were 4 percent for BYDUREON versus 5 percent for pooled comparators; and discontinuations due to serious AEs were less than 1 percent for both groups. Discontinuation for nausea was similar in BYDUREON (0.7 percent) and pooled comparator (0.5 percent) cohorts. Hypoglycemic events were lower with BYDUREON, and compo