Patients with chronic idiopathic constipation (CIC) and moderate to very severe abdominal bloating who were treated with prucalopride had greater improvement in abdominal bloating symptoms than those who received placebo, according to a study in the American Journal of Gastroenterology.
Investigators conducted a post-hoc analysis of data from 6 phase 3 and 4 randomized, double-blind, placebo-controlled trials to determine the effect of prucalopride on abdominal bloating and health-related quality of life (HRQOL) in patients with CIC and moderate to very severe bloating.
Participants’ scores on the Patient Assessment of Constipation Symptoms questionnaire were a secondary endpoint in each study and were assessed at weeks 0, 2, 4, 8, and 12.
A total of 1931 of 2484 patients with CIC (77.7%; prucalopride, n=957; placebo, n=974) had moderate to very severe bloating at baseline with a mean bloating score of 2.8 (SD, 0.7). Participants had a mean age of 46.7 (SD, 15.0) years, 79% were women, and their mean duration of constipation was 17.0 (SD, 14.5) years.
The proportion of bloating responders (defined as improvement of ≥1 point in abdominal bloating score at week 12 vs baseline) was higher in the prucalopride group compared with the placebo group (62.1% vs 49.6%, respectively). The rate was also higher in participants who received prucalopride vs placebo, respectively, among women (63.0% vs 48.6%), men (58.7% vs 53.5%), those aged <65 years (63.2% vs 49.4%), those aged ≥65 years (54.4% vs 50.8%), and regardless of primary complaint at baseline.
The differences in the proportions of responders in the prucalopride and placebo groups were similar for those with baseline abdominal bloating severity scores of 2, 3, and 4 (12.8%, 13.7%, and 10.5%, respectively).
Abdominal bloating responders also had greater improvement at week 12 in the overall Patient Assessment of Constipation Quality of Life (PAC-QOL) score and subcomponent scores than nonresponders in all of the included studies. A clinically meaningful difference (>1-point decrease) was found in the overall PAC-QOL score in responders (difference of -1.1080), but not in nonresponders (difference of -0.1522).
The investigators noted that the descriptive nature of the analyses limits their findings and that treatment-related improvements in other CIC symptoms may have contributed to the improvements in the PAC-QOL scores.
“These data highlight the connection between relieving abdominal bloating, the most bothersome symptom for many patients with CIC, and improvement in the overall HRQOL,” the investigators commented.
Disclosure: The clinical trials included in this analysis were funded by Shire International GmbH, Johnson and Johnson and Movetis, and Shire-Movetis NV or Janssen Research and Development. This analysis was funded by Shire Human Genetic Therapies, Inc, a Takeda company. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Staller K, Hinson J, Kerstens R, et al. Efficacy of prucalopride for chronic idiopathic constipation: an analysis of participants with moderate to very severe abdominal bloating. Am J Gastroenterol. Published online September 29, 2021. doi: 10.14309/ajg.0000000000001521