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PANCREATITIS IN PATIENTS TREATED WITH EXENATIDE OR SITAGLIPTIN [10-LB]
Herrera V, Aubert R, Tully L, Tao Z, Stettin G, Bhandari I, Pendergrass M; Franklin Lakes, NJ
Several recent case studies have described episodes of severe acute pancreatitis in patients treated with exenatide, including hemorrhagic or necrotizing pancreatitis.1-3
Although some of these reports have described the onset of pancreatitis shortly after beginning exenatide,1
the low incidence of this adverse event has made it difficult to determine whether there is a causal association between pancreatitis and exenatide treatment. In 2007, the US Food and Drug Administration (FDA) issued an alert about an apparent risk of pancreatitis in association with the use of exenatide, which was based primarily on 36 reports of pancreatitis that were believed to be linked to exenatide use, and which included 2 fatalities.2,4
However, some authors have noted that it is difficult to discern whether there is a causal relationship between exenatide therapy and pancreatitis from these data.2
For example, selection criteria for these patients were generally not defined, computed tomography scans only were performed in approximately 33% of the patients, and approximately 90% had other risk factors for pancreatitis.2
In this presentation, the investigators examined the incidence of pancreatitis among patients with type 2 diabetes who used treatment regimens that included exenatide or another oral incretin-based agent (sitagliptin) using a pharmacy database containing claims data for 13 million patients. The presenters focused on patients between the ages of 18 and 63 who had at least 2 pharmacy claims for oral hypoglycemic regimens, who were not using insulin, and who did not have claims data suggesting pancreatic disease, alcohol abuse, or hepatitis before beginning treatment. The investigators identified a total of 9260 patients who were treated with exenatide and 2143 patients who were treated with sitagliptin. They also identified another 112 218 control patients who were using other oral diabetes regimens that did not include exenatide or sitagliptin. The average age of patients in all 3 groups was approximately 54 years. Over a follow-up period of 540 days, an episode of pancreatitis was noted for 41 patients (0.44%) in the exenatide group, 6 patients (0.28%) in the sitagliptin group, and 438 patients (0.39%) in the control group.
Although this was a retrospective analysis of pharmacy claims data and not a prospective, randomized study, the results suggest that the incidence of pancreatitis is very low and similar for patients who used both incretin mimetics and for control patients using other oral diabetes therapies. The FDA recommends that patients who use exenatide should be advised about potential signs and symptoms of pancreatitis (eg, persistent and severe abdominal pain with or without vomiting), and that exenatide should be promptly discontinued for patients with suspected pancreatitis.5 If pancreatitis is confirmed, antidiabetic therapy should continue with an alternate therapy.
References
1. Denker PS, Dimarco PE. Exenatide (exendin-4)-induced pancreatitis: a case report. Diabetes Care. 2006;29:471.
2. Ayoub WA, Kumar AA, Naguib HS, Taylor HC. Exenatide induced acute pancreatitis. Endocr Pract. 2009:1-16.
3. Ahmad SR, Swann J. Exenatide and rare adverse events. N Engl J Med. 2008;358:1970-1971.
4. Bell DSH. FDA updates alert for exenatide. Endocrine Today Web site. Available at: http://www.endocrinetoday.com/view.aspx?rid=30500. Accessed September 21, 2009.
5. United States Food and Drug Administration. Byetta (exenatide). Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical Products/ucm079781.htm. Accessed September 21, 2009.
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