P5071 - Fast and Frequent: How Effective Is Prucalopride in Chronic Constipation? A Systematic Review and Meta-Analysis of Randomized Controlled Trial

Mangesh Kritya, MBBS¹, Bandhul Hans, MD², Shanmukh Lingamsetty, MBBS³, Priyanshi Maurya, MD⁴, Sai Prasad, MD⁵, Siddharth Agarwal, MD⁶, Anirudha Chatterjee, MD², Brooke Corning, MD²
1Houston Methodist Research Institute, Houston, TX; 2University of Texas Medical Branch, Galveston, TX; 3Beth Israel Deaconess Medical Center, Boston, MA; 4University of Missouri - Kansas City School of Medicine, Kansas City, MO; 5Cleveland Clinic Foundation, Cleveland, OH; 6Landmark Medical Center, Woonsocket, RI

Introduction: Prucalopride is used for chronic constipation, but efficacy has varied across studies. We compared its standard dose to placebo and assessed different doses to explore potential dose-response trends

Methods: A systematic search of the PubMed database identified 7 randomized controlled trials (RCTs) evaluating efficacy of prucalopride in adult patients with chronic constipation. Included patients had an average of ≤2 spontaneous complete bowel movements (SCBMs) per week over the prior 6 months. Efficacy was assessed over a 12-week period using both objective and patient-reported outcomes. Continuous outcomes were depicted using bar graphs. Binary outcomes were pooled using a random-effects model with 95% confidence intervals (CIs), applying the inverse variance method. Inter-study heterogeneity was assessed using the I² statistic and the DerSimonian–Laird method

Results: We included seven RCTs comprising 3,389 patients, of whom 2,020 were randomized to receive prucalopride. The mean age was 48.1 years, 76.1% were women, and the average duration of constipation was 16.1 years. Approximately 80% had an inadequate response to prior treatments, and 66% reported fewer than one bowel movement per week at baseline. In pooled analyses, prucalopride 2 mg significantly increased the likelihood of achieving ≥3 SCBMs/week compared to placebo (RR 2.22, 95% CI 1.73–2.85; I² = 57.4%), with a comparable effect for the 4 mg dose (RR 2.25, 95% CI 1.75–2.90; I² = 0%). For achieving increase by ≥1 SCBM/week, both 2 mg and 4 mg remained effective versus placebo (RR 1.65 and 1.85, respectively). Direct comparisons between 4 mg and 2 mg showed no significant difference for either endpoint (RR 1.02 for ≥3 SCBMs/week; RR 1.07 for ≥1 SCBM/week).

Prucalopride was also associated with greater reduction in patient-perceived constipation severity and constipation-related quality of life, measured through changes in PAC-SYM scores, with values ranging from –0.6 to –0.83 for 2 mg and –0.51 to –0.71 for 4 mg, compared to –0.13 to –0.75 for placebo. Additionally, the median time to first bowel movement was shorter with prucalopride, ranging from 1.3 to 4.7 days for 2 mg and 1.0 to 2.1 days for 4 mg, compared to 4.2 to 20.5 days with placebo

Discussion: In this meta-analysis of RCTs, prucalopride was consistently associated with improved bowel function and symptom relief in patients with chronic constipation. Both 2mg and 4mg doses demonstrated comparable efficacy, with no clear evidence of a dose-response relationship


Figure: Table 1: Summary of pooled Risk-ratios


Figure: Figure 1: Graph showing mean changes in the PAC-SYM scores across studies for different doses of prucalopride and placebo
Figure 2: Graph showing median days to first SCBM after treatment initiation across studies for different doses of prucalopride and placebo

Disclosures:
Mangesh Kritya indicated no relevant financial relationships.
Bandhul Hans indicated no relevant financial relationships.
Shanmukh Lingamsetty indicated no relevant financial relationships.
Priyanshi Maurya indicated no relevant financial relationships.
Sai Prasad indicated no relevant financial relationships.
Siddharth Agarwal indicated no relevant financial relationships.
Anirudha Chatterjee indicated no relevant financial relationships.
Brooke Corning indicated no relevant financial relationships.

Mangesh Kritya, MBBS¹, Bandhul Hans, MD², Shanmukh Lingamsetty, MBBS³, Priyanshi Maurya, MD⁴, Sai Prasad, MD⁵, Siddharth Agarwal, MD⁶, Anirudha Chatterjee, MD², Brooke Corning, MD². P5071 - Fast and Frequent: How Effective Is Prucalopride in Chronic Constipation? A Systematic Review and Meta-Analysis of Randomized Controlled Trial, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.