Factors predictive of treatment-emergent adverse events of prucalopride: an integrated analysis of four randomized, double-blind, placebo-controlled trials.

Abstract

BACKGROUND/AIMS:

This integrated analysis aimed to identify the factors associated with the most frequently re-ported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks.

METHODS:

Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on pa-tients treated with prucalopride 2 mg or placebo were ana-lyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model.

RESULTS:

Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly as-sociated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differ-ences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to expe-rience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. Con-clusions Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians. (Gut Liver, 2015;9208-213).

• Authors: Somchai Leelakusolvong, MeiYun Ke, Duowu Zou, Suck Chei Choi, Jan Tack, Eamonn M M Quigley, Andy Liu, Jin Yong Kim
• Journal: Gut and liver (Gut Liver) Vol. 9 Issue 2 Pg. 208-13 (Mar 2015) ISSN: 2005-1212 [Electronic] Korea (South)
• PMID: 25534573 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Benzofurans
• prucalopride

Topics

• Abdominal Pain (chemically induced)
• Adult
• Aged
• Aged, 80 and over
• Asian People (statistics & numerical data)
• Benzofurans (adverse effects)
• Clinical Trials, Phase III as Topic
• Constipation (drug therapy, ethnology)
• Diarrhea (chemically induced)
• Double-Blind Method
• Female
• Headache (chemically induced)
• Humans
• Male
• Middle Aged
• Multicenter Studies as Topic
• Nausea (chemically induced)
• Randomized Controlled Trials as Topic
• Regression Analysis