USA: A new study shows that participants with chronic idiopathic constipation (CIC) suffering moderate to severe abdominal bloating who were treated with prucalopride improved more than those who were treated with placebo. Improvements were seen regardless of participant age, gender, baseline bloating severity, or major complaint at baseline, and were related to better HRQOL.
The findings of this study were published in the American Journal of Gastroenterology on 29th September 2021.
The study was conducted by Kyle Staller and the team in order to assess the effect of prucalopride on abdominal bloating in people with chronic idiopathic constipation (CIC) who had moderate to severe bloating at the start.
This study was randomized, double-blind, placebo-controlled trials, where data from 5 phase 3 and 1 phase 4 were assessed. At weeks 0, 2, 4, 8, and 12, the Patient Assessment of Constipation Symptoms scores was evaluated. Participants were included if they had a baseline (week 0) abdominal bloating score of moderate (2), severe (3), or very severe (4). Furthermore, the proportion of bloating responders in the prucalopride and placebo groups was determined.
Participants who did not have a bloating score at week 12 were classified as non-responders. Other inclusions were responder analyses, which were carried out on participants who had moderate to severe bloating at the start of the study. Participants were further classified according to their gender, age (65 or 65 years old), baseline bloating score, and primary complaint at baseline.
The results of the study came out as follows;
At week 12, the proportion of bloating responders in the prucalopride arm was greater than in the placebo arm (62.1% vs 49.6% ).
Bloating responder rates were also higher in the prucalopride arm than in the placebo arm among women (63.0% vs 48.6%), men (58.7% vs 53.5%), participants younger than 65 years old (63.2% vs 49.4%), and participants 65 and older (54.4% vs 50.8%), regardless of main complaint at baseline.
For patients with baseline abdominal bloating severity levels of 2, 3, and 4, differences in responder proportions between the prucalopride and placebo groups were similar (12.8% , 13.7% , and 10.5% respectively).
Improvements in abdominal bloating were detected beginning at week 2, the earliest measurement time point, and were larger in the prucalopride arm than in the placebo arm throughout the 12-week assessment period.
In conclusion, these findings underscore the link between reducing abdominal bloating, which is the most troublesome symptom for many CIC patients, and improved overall HRQOL. In order to ensure patient-centric CIC studies in the future, stomach bloating might be included as a coprimary objective in future trials of patients with CIC.
Reference:
Staller, K., Hinson, J., Kerstens, R., Spalding, W., & Lembo, A. (2021). Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. In American Journal of Gastroenterology: Vol. Publish Ahead of Print. Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.14309/ajg.0000000000001521