J Neurogastroenterol Motil.  2014 Oct;20(4):458-468. 10.5056/jnm14029.

Effect of Prucalopride in the Treatment of Chronic Constipation in Asian and Non-Asian Women: A Pooled Analysis of 4 Randomized, Placebo-controlled Studies

• Ke M
• Tack J
• Quigley EM
• Zou D
• Choi SC
• Leelakusolvong S
• Liu A
• Kim J

• KMID: 2381209
• DOI: http://doi.org/10.5056/jnm14029

Abstract

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 > or = 3 spontaneous complete bowel movements (SCBMs)/week; average increases of > or = 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 > or = 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 > or = 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.

Keyword

Asian women; Chronic constipation; Non-Asian women; Prucalopride; Serotonin 5-HT4 receptor agonists

MeSH Terms

Abdominal Pain
Asian Continental Ancestry Group*
Constipation*
Female
Gastrointestinal Diseases
Humans
Serotonin
Serotonin 5-HT4 Receptor Agonists
Serotonin
Serotonin 5-HT4 Receptor Agonists