Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials.
- Author:
Somchai LEELAKUSOLVONG
1
;
Meiyun KE
;
Duowu ZOU
;
Suck Chei CHOI
;
Jan TACK
;
Eamonn M M QUIGLEY
;
Andy LIU
;
Jinyong KIM
Author Information
- Publication Type:Original Article ; Research Support, Non-U.S. Gov't
- Keywords: Adverse events; Chronic constipation; Predictors; Prucalopride
- MeSH: Abdominal Pain/*chemically induced; Adult; Aged; Aged, 80 and over; Asian Continental Ancestry Group/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
- From:Gut and Liver 2015;9(2):208-213
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported 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 patients treated with prucalopride 2 mg or placebo were analyzed. 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 associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences 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 experience 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. CONCLUSIONS: 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.
