TY - JOUR
T1 - Chronic constipation-associated symptoms in Asians and non-Asians, and effects of 12-week prucalopride treatment
T2 - A pooled analysis of 4 randomized, placebo-controlled trials
AU - Choi, Suck Chei
AU - Zou, Duowu
AU - Ke, Mei Yun
AU - Leelakusolvong, Somchai
AU - Tack, Jan
AU - Quigley, Eamonn M M
AU - Liu, Andy
AU - Kim, JinYong
N1 - This article is protected by copyright. All rights reserved.
PY - 2014/12/15
Y1 - 2014/12/15
N2 - AIM: To evaluate the efficacy of prucalopride (2 mg/day), a novel selective high-affinity 5-hydroxytryptamine type-4 receptor agonist, in relieving chronic constipation-associated symptoms in Asians and non-Asians.METHODS: This integrated analysis included pooled data from 4 phase-III, multicenter, randomized, double-blind, placebo-controlled studies (NCT00488137, NCT00483886, NCT00485940, NCT01116206) of patients treated with prucalopride 2 mg and placebo. Efficacy in relieving chronic constipation-associated symptoms was evaluated based on improvements in the 'Patient Assessment of Constipation Symptoms' scores. Change from baseline in each symptom score was analyzed using an analysis of covariance model, with treatment, study, and baseline spontaneous bowel movement frequency as factors, and baseline value for each symptom score as covariates for each subgroup of interest: Asian and non-Asian.RESULTS: Overall, 1782 patients (26.7% Asians; 73.3% non-Asians), predominantly women (89.3%), were included. Prucalopride significantly improved bloating, hard stool, and straining (P<0.001, for all), compared with placebo (mean [standard deviation]) in Asians (bloating: -0.5 [0.73], -0.3 [0.73]; hard stool: -0.5 [0.82], -0.2 [0.77]; straining: -0.6 [0.78], -0.4 [0.75]) and non-Asians (bloating: -0.4 [0.71], -0.2 [0.67]; hard stool: -0.3 [0.78], -0.2 [0.79]; straining: -0.3 [0.71], -0.2 [0.69]) irrespective of symptom severity. However, abdominal pain was not significantly relieved in Asians (P=0.103) compared with non-Asians (P<0.001). The most common treatment-emergent adverse events were headache, nausea, diarrhea, and abdominal pain.CONCLUSIONS: Prucalopride 2 mg/day was found to be well-tolerated and efficacious in relieving all chronic constipation-associated symptoms in both Asians and non-Asians, except for abdominal pain in Asians, over 12 weeks, regardless of their severity.
AB - AIM: To evaluate the efficacy of prucalopride (2 mg/day), a novel selective high-affinity 5-hydroxytryptamine type-4 receptor agonist, in relieving chronic constipation-associated symptoms in Asians and non-Asians.METHODS: This integrated analysis included pooled data from 4 phase-III, multicenter, randomized, double-blind, placebo-controlled studies (NCT00488137, NCT00483886, NCT00485940, NCT01116206) of patients treated with prucalopride 2 mg and placebo. Efficacy in relieving chronic constipation-associated symptoms was evaluated based on improvements in the 'Patient Assessment of Constipation Symptoms' scores. Change from baseline in each symptom score was analyzed using an analysis of covariance model, with treatment, study, and baseline spontaneous bowel movement frequency as factors, and baseline value for each symptom score as covariates for each subgroup of interest: Asian and non-Asian.RESULTS: Overall, 1782 patients (26.7% Asians; 73.3% non-Asians), predominantly women (89.3%), were included. Prucalopride significantly improved bloating, hard stool, and straining (P<0.001, for all), compared with placebo (mean [standard deviation]) in Asians (bloating: -0.5 [0.73], -0.3 [0.73]; hard stool: -0.5 [0.82], -0.2 [0.77]; straining: -0.6 [0.78], -0.4 [0.75]) and non-Asians (bloating: -0.4 [0.71], -0.2 [0.67]; hard stool: -0.3 [0.78], -0.2 [0.79]; straining: -0.3 [0.71], -0.2 [0.69]) irrespective of symptom severity. However, abdominal pain was not significantly relieved in Asians (P=0.103) compared with non-Asians (P<0.001). The most common treatment-emergent adverse events were headache, nausea, diarrhea, and abdominal pain.CONCLUSIONS: Prucalopride 2 mg/day was found to be well-tolerated and efficacious in relieving all chronic constipation-associated symptoms in both Asians and non-Asians, except for abdominal pain in Asians, over 12 weeks, regardless of their severity.
U2 - 10.1111/1751-2980.12219
DO - 10.1111/1751-2980.12219
M3 - Article
C2 - 25495559
SN - 1751-2972
JO - Journal of Digestive Diseases
JF - Journal of Digestive Diseases
ER -