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
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