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| |  Exenatide Treatment in Type 2 Diabetes Shows No Increased Relative Risk of Pancreatitis: Presented at EASD By Bruce Sylvester VIENNA, Austria -- October 2, 2009 -- Exenatide therapy for type 2 diabetes does not lead to an increased risk of acute pancreatitis when compared with other antidiabetic therapies, according to results from a retrospective study presented here on September 30 at the 45th Annual Meeting of the European Society for the Study of Diabetes (EASD). “Looking at a large database, we found no increased signal for pancreatitis among patients treated with exenatide,” stated lead investigator Gary Bloomgren, MD, Amylin Pharmaceuticals, San Diego, California. “Using a large, geographically diverse, US healthcare insurance-claims database, we conducted a retrospective, cohort study to estimate the absolute and relative risk of acute pancreatitis in patients who initiated exenatide relative to those who initiated other antidiabetic drugs. This represents an interim analysis of claims data to be further validated through medical records review,” the researchers wrote. Eligible subjects for this study had been enrolled in the chosen healthcare plan for at least 9 continuous months (September 1, 2004, to December 31, 2007) and had no history of chronic or acute pancreatitis. Evaluable pancreatitis subjects were those with a primary diagnosis of acute pancreatitis associated with an emergency room visit or hospitalisation during follow-up. The investigators used standard statistical tools to estimate the incidence rate, rate ratio, and 95% confidence intervals (CIs) comparing periods of current, recent, and past use of exenatide to periods of current, recent, and past use of other antidiabetic drugs. Patients using exenatide (n = 25,719; 80% between the ages of 40 to 64 years) were more likely to be female (56% vs 49%) and had a higher baseline prevalence of claims for type 2 diabetes (84% vs 59%), obesity (16% vs 8%), and cardiovascular risk factors (hyperlipidaemia 77% vs 54%; hypertension 64% vs 49%) than initiators of other antidiabetic drugs. Also, exenatide initiators were more likely to use multiple diabetes drugs than other antidiabetic drug initiators. The multiple diabetes drugs used included hypoglycaemic agents such as biguanides 60% vs 20%; insulin-release stimulant type 48% vs 18%; insulin-response enhancer 46% vs 13%; as well as insulins 24% vs 9%, lipotropics 61% vs 38%, and angiotensin-converting enzyme [ACE] inhibitors 39% vs 27%. The major finding of the analysis was that, compared with other antidiabetic drugs, the relative rate of acute pancreatitis for exenatide was 0.9 (95% CI, 0.6-1.3) for current use, 0.9 (95% CI, 0.4-2.1] for recent use, and 1.4 (95% CI, 0.9-2.3) for past use. “These data suggest that use of exenatide was not associated with an increased rate of acute pancreatitis compared with other antidiabetic drugs,” the authors concluded. Funding for this study was provided by Amylin Pharmaceuticals. [Presentation title: Incidence of Acute Pancreatitis in Exenatide Initiators Compared to Other Antidiabetic Drug Initiators: A Retrospective, Cohort Study. Abstract 6]
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