title: Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.
abstract: OBJECTIVE
  Lubiprostone is an activator of the type 2 chloride channel that facilitates spontaneous bowel movement (SBM). We performed phase 3 studies to determine whether lubiprostone increases the frequency of SBM in patients with chronic idiopathic constipation (CIC) in Japan, and whether long-term administration of lubiprostone increases the quality of life of patients with CIC.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled, phase 3 trial of lubiprostone. Patients with CIC (n = 124) were assigned randomly to groups given placebo (n = 62) or lubiprostone (48 μg/day; n = 62) for 4 weeks. The primary efficacy end point was the change from baseline in the weekly average number of SBMs after 1 week of administration. In a long-term study of efficacy and safety, 209 patients with CIC were given lubiprostone (24 μg twice daily) for 48 weeks.
  
  
  RESULTS
  Daily administration of lubiprostone induced a significantly greater change, from baseline, in the weekly average number of SBMs at week 1 (increase of 3.7 ± 2.8), compared with placebo (increase of 1.3 ± 1.8; P < .001). The frequency of SBMs during each week of the study period was significantly higher after subjects began receiving lubiprostone than at baseline (P < .0001 at all weeks). Long-term administration of lubiprostone significantly increased scores from the Short-Form health survey and irritable bowel syndrome quality-of-life questionnaire, compared with baseline. We did not observe any severe adverse reactions to lubiprostone.
  
  
  CONCLUSIONS
  In phase 3 studies in Japan, lubiprostone increased the weekly average number of SBMs and increased the quality of life of patients with CIC. Clinical Trial Notification of the Japanese Regulatory Authorities: 20-3296 and 20-3300.
authors.affiliation: Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.
authors.forename: Shin
authors.initials: S
authors.lastname: Fukudo
authors.affiliation: Department of Medicine, Kurokawa Hospital, Miyagi, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Hongo
authors.affiliation: Division of Psychosomatic Medicine, Hoshigaoka Maternal Hospital, Nagoya, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kaneko
authors.affiliation: Department of Surgery, Takano Hospital, Kumamoto, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takano
authors.affiliation: Sucampo AG, Zug, Switzerland.
authors.forename: Ryuji
authors.initials: R
authors.lastname: Ueno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D005769:Gastrointestinal Motility / Q000187:drug effects*; D006801:Humans; D007422:Intestines / Q000187:drug effects* / Q000502:physiology*; D007564:Japan; D000068238:Lubiprostone / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005765:Gastrointestinal Agents; D010919:Placebos; D000068238:Lubiprostone
keywords: Functional Disorder; IBS; Intestine; QOL; Rome III Criteria; Small-Bowel Transit