Mei Yun KeJan TackEamonn M.M. QuigleyDuowu ZouSuck Chei ChoiSomchai LeelakusolvongAndy LiuJin Yong KimPeking Union Medical CollegeKU LeuvenMethodist Hospital HoustonSecond Military Medical UniversityWonkwang UniversityMahidol UniversityJanssen Research and DevelopmentJanssen Asia-Pacific2018-11-092018-11-092014-01-01Journal of Neurogastroenterology and Motility. Vol.20, No.4 (2014), 458-46820930887209308792-s2.0-84907577197https://repository.li.mahidol.ac.th/handle/20.500.14594/34811© 2014 The Korean Society of Neurogastroenterology and Motility. Background/Aims: To compare the efficacy and safety of prucalopride, a novel selective high-affinity 5-hydroxytryptamine type 4 receptor agonist, versus placebo, in Asian and non-Asian women with chronic constipation (CC). Methods: Data of patients with CC, receiving once-daily prucalopride 2-mg or placebo for 12-weeks, were pooled from 4 double-blind, randomized, phase-III trials (NCT00488137, NCT00483886, NCT00485940 and NCT01116206). The efficacy endpoints were: average of ≥ 3 spontaneous complete bowel movements (SCBMs)/week; average increases of ≥ 1 SCBMs/week; and change from baseline in each CC-associated symptom scores (bloating, abdominal pain, hard stool and straining). Results: Overall, 1,596 women (Asian [26.6%], non-Asian [73.4%]) were included in this analysis. Significantly more patients in the prucalopride group versus placebo experienced an average of ≥ 3 SCBMs/week in Asian (34% vs. 11%, P < 0.001) and non-Asian (24.6% vs. 10.6%, P < 0.001) subgroups. The number of patients reporting an increase of ≥ 1 SCBMs/week from baseline was significantly higher in the prucalopride group versus placebo among both Asian (57.4% vs. 28.3%, P < 0.001) and non-Asian (45.3% vs. 24.0%, P < 0.001) subgroups. The difference between the subgroups was not statistically significant. Prucalopride significantly reduced the symptom scores for bloating, hard stool, and straining in both subgroups. Conclusions: Prucalopride 2-mg once-daily treatment over 12-weeks was more efficacious than placebo in promoting SCBMs and improvement of CC-associated symptoms in Asian and non-Asian women, and was found to be safe and well-tolerated. There were numeric differences between Asian and non-Asian patients on efficacy and treatment emergent adverse events, which may be partially due to the overlap with functional gastrointestinal disorders in non-Asian patients.Mahidol UniversityMedicineArticleSCOPUS10.5056/jnm14029