Gut Liver.
2015 Mar;9(2):208-213. 10.5009/gnl14290.
Factors Predictive of Treatment-Emergent Adverse Events of Prucalopride: An Integrated Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials
- Affiliations
-
- 1Division of Gastroenterology, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. somchai.lee@mahidol.ac.th
- 2Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
- 3Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
- 4Division of Gastroenterology, Department of Internal Medicine, Wonkwang University College of Medicine, Digestive Disease Research Institute, Iksan, Korea.
- 5Department of Clinical and Experimental Medicine, Translational Research Center for GastroIntestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
- 6Division of Gastroenterology and Hepatology, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA.
- 7Department of Statistical Programming, Janssen Research & Development, Shanghai, China.
- 8Regional Medical Affairs, Janssen Asia-Pacific, Singapore.
- KMID: 2380766
- DOI: http://doi.org/10.5009/gnl14290
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.
Keyword
MeSH Terms
-
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
Benzofurans
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