ORIGINAL ARTICLE Efficacy and Safety of Lubiprostone in Patients with Chronic Constipation Charles F. Barish • Douglas Drossman • John F. Johanson • Ryuji Ueno Received: 14 July 2009 / Accepted: 20 November 2009 / Published online: 11 December 2009 Ó Springer Science+Business Media, LLC 2009 Abstract Aims The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation. Methods This multicenter, parallel-group trial enrolled 237 patients with chronic constipation and randomized them to 4 weeks of double-blind treatment with oral lubi- prostone 24 mcg or placebo twice daily. The primary efficacy endpoint was the number of spontaneous bowel movements (SBMs) after 1 week of treatment. Secondary evaluations included SBMs at weeks 2, 3, and 4; percent- age of patients with a SBM within 24 h of first study dose; stool consistency; degree of straining; constipation sever- ity; abdominal bloating and discomfort; global treatment effectiveness; and safety assessments. Results Lubiprostone-treated patients experienced greater mean numbers of SBMs at week 1 compared with placebo (5.89 versus 3.99, P = 0.0001), with significantly greater percentages having SBMs within 24 h of the first dose (61.3% versus 31.4%, P \ 0.0001). At each assessment, SBM frequency and percentages of full responders (C4 SBM per week) were significantly greater among lubipro- stone-treated patients compared with placebo (P B 0.0171). Lubiprostone-treated patients reported significant improvements in stool consistency, straining, and consti- pation severity at all weeks, and in abdominal bloating at week 1. Patient assessments of treatment effectiveness were significantly greater with lubiprostone compared with placebo at all weeks (P \ 0.0004). Gastrointestinal-related disorders were the most common adverse events in both treatment groups. Conclusions In patients with chronic constipation, lubi- prostone produced a bowel movement in the majority of individuals within 24 h of initial dosing, with sustained improvement in frequency as well as other constipation symptoms over 4 weeks of treatment. Keywords Lubiprostone Á Chronic constipation Á Stool frequency Á Bowel movement Introduction Chronic constipation is a common disorder in the USA, with prevalence rates ranging from 2% to 27%, depending on the diagnostic criteria used; however, most studies estimate a prevalence of approximately 15% [1], with This study was funded, designed, conducted, and supervised by the sponsor, Sucampo Pharma Americas, Inc., Bethesda, MD. Amitiza Ò is a registered trademark of Sucampo Pharma Americas, Inc. Dulcolax Ò is a registered trademark of Boehringer Ingelheim GmbH. Fleet Enema Ò is a registered trademark of C. B. Fleet Company. SAS Ò is a registered trademark of SAS Institute Inc. C. F. Barish (&) Wake Gastroenterology, Wake Research Associates, 3100 Blue Ridge Road Suite 300, Raleigh, NC, USA e-mail: CFBgastro@aol.com D. Drossman University of North Carolina Center for Functional GI and Mobility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA e-mail: drossman@med.unc.edu J. F. Johanson University of Illinois College of Medicine, Rockford, IL, USA e-mail: johnfj@uic.edu R. Ueno Sucampo Pharma Americas Inc., 4520 East–West Highway, 3rd Floor, Bethesda, MD, USA e-mail: rueno@sucampo.com 123 Dig Dis Sci (2010) 55:1090–1097 DOI 10.1007/s10620-009-1068-x