Prucalopride

(Motegrity®)

Prucalopride

Drug updated on 10/29/2024

Dosage FormTablet (oral; 1 mg, 2 mg)
Drug ClassSerotonin-4 (5-HT4) receptor agonist
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Prucalopride demonstrated significant effectiveness in increasing spontaneous bowel movements (SBMs) per week across various doses (1 mg, 2 mg, 4 mg), with the 1 mg dose showing the greatest effect. It was moderately effective for managing non-opioid-related constipation in cancer patients and exhibited comparable efficacy with other treatments such as sodium picosulfate and velusetrag for increasing SBMs and complete spontaneous bowel movements (CSBMs).
  • Prucalopride ranked second in responder rates for achieving ≥3 SBMs per week and ranked first at 12 weeks for preventing failure to achieve an increase of ≥1 CSBM per week over baseline. It was notably effective in elderly patients for short-term constipation management and showed moderate benefits in patients with systemic sclerosis, although data for this group were limited.
  • Comparative effectiveness showed that prucalopride was similarly effective to osmotic and stimulant laxatives for treating constipation, while bisacodyl was the most effective for increasing bowel movements but presented safety concerns. Probiotics combined with mosapride demonstrated superior responder rates, and polyethylene glycol (PEG) was found effective and safe for long-term use in elderly patients.
  • Prucalopride was associated with higher treatment-emergent adverse events (TEAEs) at 2 mg and 4 mg doses, while the 1 mg dose showed no statistically significant increase in adverse events. Bisacodyl, although effective, had significant safety concerns, including abdominal pain and a higher total number of adverse events.
  • Polyethylene glycol (PEG) demonstrated reasonable safety for long-term use, particularly in elderly patients, and prucalopride had a better safety profile compared to bisacodyl, which ranked lowest in terms of safety.
  • Prucalopride demonstrated effectiveness in elderly patients for short-term management of constipation and was explored for chronic constipation in systemic sclerosis (SSc) patients, although no specific effectiveness data were detailed for SSc. Cancer patients benefited moderately from prucalopride for managing non-opioid-related constipation, while its use in opioid-induced constipation was less effective compared to osmotic or stimulant laxatives.

Product Monograph / Prescribing Information

Document TitleYearSource
Motegrity (prucalopride) Prescribing Information.2020Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines