TY - JOUR
T1 - Efficacy and Safety of Prucalopride in Chronic Constipation
T2 - An Integrated Analysis of Six Randomized, Controlled Clinical Trials
AU - Camilleri, Michael
AU - Piessevaux, Hubert
AU - Yiannakou, Yan
AU - Tack, Jan
AU - Kerstens, René
AU - Quigley, Eamonn M.M.
AU - Ke, Mei Yun
AU - Da Silva, Susana
AU - Levine, Amy
N1 - Funding Information:
Writing assistance for the manuscript was provided by Vivienne Stein-Rostaing, PhD, and Libby Beake, MBBS, of PharmaGenesis London, London, UK, with funding from Shire.
Publisher Copyright:
© 2016, The Author(s).
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Background: Prucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated. Aim: To evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials. Methods: Data were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials. Results: Overall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women. Conclusion: The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.
AB - Background: Prucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated. Aim: To evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials. Methods: Data were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials. Results: Overall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women. Conclusion: The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.
KW - Constipation
KW - Efficacy
KW - Prucalopride
KW - Safety
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U2 - 10.1007/s10620-016-4147-9
DO - 10.1007/s10620-016-4147-9
M3 - Article
C2 - 27056037
AN - SCOPUS:84964078937
SN - 0163-2116
VL - 61
SP - 2357
EP - 2372
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 8
ER -