Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: A randomized, placebo-controlled and dose-finding study

S. Fukudo, M. Hongo, H. Kaneko, R. Ueno

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64 Citations (Scopus)

Abstract

Background Lubiprostone is a prostone analog with a novel mechanism of action involving type-2 chloride channel activation. The aim of this work was to perform a dose-finding study for lubiprostone for the treatment of constipation with or without irritable bowel syndrome (IBS) in Japan. Methods A total of 170 patients (128 without IBS and 42 with IBS) with chronic idiopathic constipation (CIC) randomly received a placebo (n=42) or 16μg (n=41), 32μg (n=43), or 48μg (n=44) of lubiprostone daily for 2weeks. Key Results There was a statistically significant and dose-dependent increase in change from baseline in the weekly average number of spontaneous bowel movements at week 1 (placebo: 1.5±0.4; 16μg: 2.3±0.4, 32μg: 3.5±0.5; and 48μg: 6.8±1.1, per week, mean±SE; P<0.0001). These primary endpoint results were significant on stratified analysis when patients were limited to those without IBS (P<0.0001). The primary endpoint in patients with IBS treated with 48μg of lubiprostone was significantly better than those given placebo (P=0.0086). Dose dependency was also seen for the secondary efficacy endpoints. Lubiprostone produced no serious side effects. Conclusions & Inferences Our results suggest that lubiprostone produced a steady and effective improvement in the symptoms of CIC with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population.

Original languageEnglish
Pages (from-to)544-e205
JournalNeurogastroenterology and Motility
Volume23
Issue number6
DOIs
Publication statusPublished - 2011 Jun

Keywords

  • Chronic idiopathic constipation
  • Irritable bowel syndrome
  • Lubiprostone
  • Rome iii criteria
  • Type 2 chloride channel

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

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