Prucalopride, a selective 5-HT4 receptor agonist, has demonstrated significant efficacy and safety in treating chronic constipation (CC) among patients in the Asia-Pacific region. A phase 3, randomized, double-blind, placebo-controlled study evaluated the 2 mg dose of prucalopride in 501 patients across multiple sites, revealing substantial improvements in bowel function, associated symptoms, and overall patient satisfaction over a 12-week treatment period.
Efficacy of Prucalopride in Chronic Constipation
The study's primary endpoint, the percentage of patients with an average of 3 or more spontaneous complete bowel movements (SCBMs) per week, was significantly higher in the prucalopride group (33.3%) compared to the placebo group (10.3%) (P < 0.001). This therapeutic gain of 23.0% highlights the clinical relevance of prucalopride in managing CC. A key secondary endpoint, responders during the first 4 weeks of treatment, also showed a significant difference, with 34.5% in the prucalopride group versus 11.1% in the placebo group (P < 0.001).
Impact on Bowel Symptoms and Quality of Life
Beyond the primary endpoint, prucalopride demonstrated improvements across various secondary efficacy measures. Patients reported a greater average increase of ≥1 SCBM per week and a shorter time to first SCBM after initiating treatment. Assessments using the Patient Assessment of Constipation-Symptom (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires revealed significant improvements in stool symptoms, abdominal symptoms, rectal symptoms, and overall quality of life compared to placebo (P < 0.001).
Safety and Tolerability
Prucalopride was found to be safe and well-tolerated among the study participants. The most frequently reported adverse events in the prucalopride group included diarrhea (22.1%), headache (12.4%), nausea (11.6%), and abdominal pain (6.8%), which were generally mild to moderate in severity and transient. The incidence of serious adverse events was low and comparable between the prucalopride (1.2%) and placebo (2.0%) groups.
Study Design and Patient Population
The study enrolled men and women aged 18–65 years with a history of CC for ≥6 months. Participants were randomized to receive either prucalopride 2 mg or placebo once daily for 12 weeks. Bisacodyl was allowed as a rescue medication if patients did not have a bowel movement for ≥3 consecutive days. Efficacy evaluations were based on patient diaries, symptom questionnaires, and investigator assessments.
Conclusion
The findings from this phase 3 trial support the efficacy and safety of prucalopride 2 mg as a valuable treatment option for chronic constipation in the Asia-Pacific region. The drug significantly improved bowel function, alleviated associated symptoms, and enhanced patients' quality of life, with a favorable safety profile.
