Risk Factors for Adverse Events in Patients with Chronic Constipation Following Lubiprostone Administration

Abstract

Introduction: Lubiprostone is an effective treatment of chronic constipation (CC). However, as with other stimulant or osmotic laxatives, adverse events (AEs) can make it difficult to continue treatment. This article investigates AE risk factors associated with lubiprostone. Methods: We retrospectively analyzed all 1,338 Japanese patients with CC treated at our hospital from October 2013 to July 2017. All patients were diagnosed with constipation as defined by the Roma III criteria. Enrolled patients received lubiprostone orally (24 or 48 mcg daily), after which we investigated the incidence of AEs. The causative factors for diarrhea and nausea, the most common AEs, were examined by the backward logistic regression model. Results: 208 (15.5%) experienced at least one AE. No serious AEs were associated with the study drug. The AEs reported by > 1% of patients overall were diarrhea (6.1%) and nausea (4.2%). We performed a multivariate logistic regression using a backward variable selection method to investigate AE risk factors. Factors associated with higher incidence of diarrhea were patient age of 65 years or more [Odds ratio: (95% CI); P value] [2.09: (1.05-4.16); 0.035]. Factors associated with greater likelihood of nausea included female gender [1.99: (1.10-3.61); 0.023], and the chief complaint was a patient complaining of abdominal pain and fullness [2.07: (1.01-4.22); 0.046]. Conclusions: Understanding AE risk factors can help avoid unnecessary AEs and promote more effective treatment.