Prucalopride in the treatment of chronic constipation in patients from the Asia-Pacific region: A randomized, double-blind, placebo-controlled study

Abstract

Background The study evaluated efficacy and safety of the 2mg dose of prucalopride compared to placebo in patients with chronic constipation (CC) from the Asia-Pacific region. Methods Randomized, placebo-controlled, parallel-group, phase III study with 2-week run-in, 12-week treatment phase, and 1-week follow-up. Adult patients with CC (≤2 spontaneous bowel movements per week) received 2mg prucalopride or placebo, once-daily, for 12weeks. Primary efficacy measure was percentage of patients with average of ≥3 spontaneous complete bowel movements (SCBMs) per week (Responders) during the 12-week treatment. A key secondary endpoint was Responders during first 4weeks of treatment. Other efficacy assessments were based on patient diaries, their assessments of symptoms and quality of life, and investigator's assessment on efficacy of treatment. Safety assessments included adverse events, laboratory values, and cardiovascular events. Key Results Efficacy and safety were evaluated for 501 patients who received study drug. On the primary endpoint, prucalopride was significantly more effective than placebo with 83 (33.3%) vs 26 (10.3%) patients having a weekly average of ≥3 SCBMs during the 12-week treatment (P <0.001). Respective percentages were 34.5%vs 11.1% over first 4weeks (P <0.001). On other secondary endpoints, clinical improvement was generally larger and statistically superior (P <0.001) in the prucalopride group. Most frequently reported adverse events were diarrhea, nausea, abdominal pain, and headache. Conclusion & Inferences Prucalopride 2mg given once-daily significantly improved bowel function, associated symptoms, and satisfaction in CC over a 12-week treatment period, and was safe and well tolerated by patients in the Asia-Pacific region. © 2012 Blackwell Publishing Ltd.