Clinical outcomes before and after prucalopride treatment: an observational study in patients with chronic idiopathic constipation in the USA

Abstract

Introduction: This real-world US-based claims study compared constipation-related symptoms and complications 6 months before and after prucalopride initiation in adults with chronic idiopathic constipation (CIC).

Methods: This observational, retrospective cohort analysis used the IBM MarketScan® Commercial Claims and Encounters and the Medicare Supplemental databases (January 2015-June 2020). Prucalopride-treated patients (≥18 years old) who had ≥1 constipation-related International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code during the baseline or study period were included. The proportions of patients with constipation-related symptoms (abdominal pain, abdominal distension [gaseous], incomplete defecation, and nausea) and constipation-related complications (anal fissure and fistula, intestinal obstruction, rectal prolapse, hemorrhoids, perianal venous thrombosis, peri-anal/peri-rectal abscess, and rectal bleeding) were examined. Constipation-related symptoms and complications were identified using ICD-10-CM, ICD-10-Procedure Coding System, or Current Procedural Terminology codes. Data were stratified by age (overall, 18-64 years, ≥65 years).

Results: This study included 690 patients: mean (standard deviation) patient age was 48.0 (14.7) years and 87.5% were women. The proportions of patients overall with constipation-related symptoms decreased 6 months after prucalopride initiation (abdominal pain [50.4% vs 33.3%, P<0.001]; abdominal distension [gaseous] [23.9% vs 13.3%, P<0.001]; and nausea [22.6% vs 17.7%, P<0.01]; no improvements observed for incomplete defecation). Similarly, the proportions of patients overall with constipation-related complications decreased 6 months after prucalopride initiation (intestinal obstruction [4.9% vs 2.0%, P<0.001]; hemorrhoids [10.7% vs 7.0%, P<0.05]; and rectal bleeding [4.1% vs 1.7%, P<0.05]).

Discussion: This study suggests that prucalopride may be associated with improved constipation-related symptoms and complications 6 months after treatment initiation.