Effectiveness Not Established

Prucalopride

for Constipation

Prucalopride is a selective, high-affinity 5-HT4 agonist that targets impaired motility in the gastrointestinal tract. This drug has been examined for the treatment of constipation.

Research Evidence Summaries

Quigley, E.M., Vandeplassche, L., Kerstens, R., & Ausma, J. (2009). Clinical trial: The efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation—A 12-week, randomized, double-blind, placebo-controlled study. Alimentary Pharmacology and Therapeutics, 29, 315–328.

Study Purpose

To evaluate the effectiveness and safety of prucalopride, a 5-HT4 receptor agonist, in patients with chronic constipation.

Intervention Characteristics/Basic Study Process

Patients with self-reported chronic constipation for at least six months could enroll in the study. The 12-week study procedure comprised a two-week placebo run-in period to determine frequency of bowel movements (BMs). Patients with two or fewer spontaneous complete BMs per week were randomized to one of three treatment groups (2-mg prucalopride, 4-mg prucalopride, or placebo), with study medication taken once daily with breakfast for 10 weeks.

Sample Characteristics

  • The study reported on a sample of 641 patients.
  • Mean patient age was 47.9 years (range 18–95).
  • The sample comprised 555 women (87%) and 86 men (13%).
  • Patients were aged older than 18 years and had a history of self-reported chronic constipation for six months or less that was not caused by drug use, surgery, or organic disorders of the large intestine.

Setting

  • Multi-site
  • United States

Study Design

This was a randomized, double-blind, placebo-controlled, parallel-group phase III trial.

Measurement Instruments/Methods

  • Patient diary
  • Patient global assessments
  • Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
  • Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
  • Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36)

Results

  • Significantly more patients in the prucalopride 2-mg (23.9%) and 4-mg (23.5%) groups reported three or more spontaneous complete BMs per week compared with the placebo group (12.1%) over the 12-week study period (p ≤ 0.01).
  • Significantly more patients in the prucalopride 2-mg (42.6%) and 4-mg (46.6%) groups reported an increase from baseline of at least one spontaneous complete BM per week compared with the placebo group (27.5%) over the 12-week study period (p ≤ 0.001).
  • Patients in both prucalopride groups had an increased percentage of normal consistency BMs (p ≤ 0.05), had no straining (p ≤ 0.01), used significantly fewer laxatives per week (p ≤ 0.01), used fewer enemas per week (p ≤ 0.05), rated their treatment effectiveness better (p ≤ 0.001), and rated their constipation as less severe (p ≤ 0.001) compared with the placebo group.
  • The most common adverse events were headache, nausea, abdominal pain, diarrhea, and flatulence.

Conclusions

Prucalopride 2-mg and 4-mg administration improved the frequency, consistency, and quality of defecation and led to complete bowel evacuation in adults with chronic constipation.

Limitations

  • Patients who had cancer or were receiving opioid therapy were excluded from the study.
  • Eighty-seven percent of the participants were women.

Nursing Implications

Prucalopride (2 mg or 4 mg daily) appeared effective in the treatment of chronic constipation in adults. Research for applicability in patients with cancer is warranted.

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