Assessing the Association Between Dipeptidyl Peptidase 4 Inhibitor Use and Inflammatory Bowel Disease Through Drug Adverse Event Reporting.

Abstract

Inflammatory bowel disease (IBD), including Crohn disease (CD) and ulcerative colitis (UC), is an autoimmune digestive system disease (1). A recent cohort study using the U.K. Clinical Practice Research Datalink (CPRD) involving 7,231 dipeptidyl peptidase 4 inhibitor (DPP4i) users with 49 IBD cases indicated that new use of DPP4is over a median duration of 1.6 years was associated with IBD risk in patients with type 2 diabetes compared with other noninsulin antihyperglycemic drugs (hazard ratio 1.75, 95% CI 1.22, 2.49) (2). Current evidence regarding the effect of DPP4is on IBD risk is very limited. We thus performed a disproportionality analysis using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, which contains all adverse events spontaneously reported to the Food and Drug Administration since 2004 (3). We downloaded the FAERS data files from 2004 1st quarter to 2017 3rd quarter, used generic and trade names to identify DPP4is (sitagliptin, saxagliptin, linagliptin, alogliptin, and vildagliptin) and comparator drugs, and identified outcomes using Medical Dictionary for Regulatory Activities terms. The primary outcome was IBD (both CD and UC), and secondary outcomes were CD and UC, separately. The safety signal of DPP4is and IBD was assessed by reporting odds ratio (ROR) using two-by-two contingency tables (4). A signal was defined as an ROR of ≥2. The data were analyzed by SAS 9.4 …