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| |  Vildagliptin Therapy Shows No Evidence of Increasing Pancreatitis Risk in Patients With Diabetes: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 3, 2009 -- A meta-analysis, presented here at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), shows no evidence of an increased risk of pancreatitis with the use of vildagliptin in the treatment of type 2 diabetes. Patients with type 2 diabetes may be at increased risk of pancreatitis compared with patients without diabetes, but whether the use of pharmacological agents exacerbate this risk remains unclear. “We evaluated a very large data base and the results show no risk of pancreatitis due to treatment with vildagliptin,” said presenter and researcher Wolfgang Kothny, MD, Novartis Pharmaceuticals, East Hanover, New Jersey, on October 2. For the study, Dr. Kothny and colleagues pooled safety data from 24 phase 2 and 3 double-blind controlled studies ranging in duration from 12 weeks to more than 104 weeks. Vildagliptin monotherapy studies and combination studies were included. Data from 7,087 patients receiving vildagliptin 50 mg QD or BID and 4,880 patients receiving placebo or active controls were included in the statistical analysis of pancreatitis-related adverse events (AEs). Results showed that the odds ratio for pancreatitis-related AEs was <1 for vildagliptin 50 mg QD (0.90) and for vildagliptin 50 mg BID (0.78), indicating no increased risk, relative to all comparators. “Overall pancreatitis-related adverse events were very infrequent, with no evidence of an increased risk following vildagliptin treatment,” the authors concluded. Funding for this study was provided by Novartis Pharmaceuticals. [Presentation title: Vildagliptin Therapy Is Not Associated With an Increased Risk of Pancreatitis. Abstract 769]
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