Combined Analysis of Three Large Interventional Trials With Gliptins Indicates Increased Incidence of Acute Pancreatitis in Patients With Type 2 Diabetes

• Published in: Diabetes care Vol. 40; no. 2; pp. 284 - 286
• Main Authors: Tkáč, Ivan, Raz, Itamar
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.02.2017
• Subjects: Acute Disease; Adamantane - administration & dosage; Adamantane - adverse effects; Adamantane - analogs & derivatives; Cardiovascular system; Clinical trials; Diabetes Mellitus, Type 2 - drug therapy; Dipeptides - administration & dosage; Dipeptides - adverse effects; Dipeptidyl-Peptidase IV Inhibitors - administration & dosage; Dipeptidyl-Peptidase IV Inhibitors - adverse effects; Humans; Incidence; Medical treatment; Pancreatitis - chemically induced; Pancreatitis - epidemiology; Piperidines - administration & dosage; Piperidines - adverse effects; Randomized Controlled Trials as Topic; Risk assessment; Sitagliptin Phosphate - administration & dosage; Sitagliptin Phosphate - adverse effects; Uracil - administration & dosage; Uracil - adverse effects; Uracil - analogs & derivatives
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc15-1707

Data on the possible relationship of gliptin treatment with the incidence of acute pancreatitis have been controversial. The aim of the current study was to combine data on the incidence of acute pancreatitis from three large randomized controlled trials. Three trials designed to test cardiovascular safety and efficacy of add-on treatment with a gliptin were included in the analysis, as follows: SAVOR-TIMI 53 (saxagliptin), EXAMINE (alogliptin), and TECOS (sitagliptin). The trials included 18,238 gliptin-treated patients and 18,157 placebo-treated patients. Data were combined using a random-effects model meta-analysis. The incidence of acute pancreatitis was significantly increased in the gliptin-treated patients when compared with the control groups (odds ratio 1.79 [95% CI 1.13-2.82], P = 0.013). The difference in the absolute risk was small (0.13%). Treatment with gliptins significantly increased the risk for acute pancreatitis in a combined analysis of three large controlled randomized trials.