Systematic Review of Gastrointestinal Symptoms in Patients with Atrial Fibrillation Treated with Pharmacologic Therapies for the Prevention of Stroke

Abstract

Purpose: Antithrombotic therapies have been shown to decrease the risk of stroke in patients with atrial fibrillation (AF) although optimal therapy requires long term adherence. The propensity of antithrombotic therapies to cause gastrointestinal (GI) adverse events and subsequent discontinuation of therapy is of concern. To our knowledge, no systematic evaluations have been conducted to evaluate GI symptoms and discontinuation of therapy due to GI symptoms from randomized controlled trials (RCTs) of pharmacologic stroke prevention in AF. Methods: Two independent investigators conducted systematic literature searches in Medline and Central from the earliest possible date through July 2010. To be included, RCTs had to evaluate an adult population with non-valvular AF or flutter, be published as full text in English, and report data on the incidence of at least one GI symptom of interest. Incidence and incidence densities with 95 percent confidence intervals were calculated for each GI symptom and qualitatively summarized. Results: A total of 14 unique trials (n=4433) met inclusion criteria with a reported mean age ranging from 65 to 84 years. Six trials including 14 treatment arms evaluated the incidence of non-distinct GI symptoms. Two trials including 7 treatment arms evaluated the incidence of upper GI symptoms. Four trials including 9 treatment arms evaluated the incidence of diarrhea. One trial including two treatment arms evaluated the incidence of nausea. Four trials including 12 treatment arms evaluated the incidence of discontinuation of therapy due to GI symptoms. The incidence range of each GI symptom per treatment group is reported in the Table below.Table: No Caption available.Conclusion: There is a paucity of data reported in RCTs on the incidence of GI symptoms and the discontinuation of therapy due to these symptoms in patients with AF who receive antithrombotic therapy for stroke prevention. Since GI symptoms are common in this predominantly elderly population and antithrombotic therapies increase the incidence of these symptoms, potentially leading to non-adherence treatment failure, future RCTs should make greater efforts to collect and report data on these endpoints. Disclosure: Grant/Research support from Ortho-McNeil Jannsen. This research was supported by an industry grant from Ortho-McNeil-Jannsen.