Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 1 mg, 2 mg) |
Drug Class | Serotonin-4 receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
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Summary
- Motegrity (prucalopride) is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Postoperative Return of Bowel Function: Prucalopride significantly reduced the time to stool (mean difference: 36.82 hours, 95% CI: 59.4 to 14.24 hours lower). No statistically significant differences were observed for time to flatus, time to oral tolerance, incidence of PPOI, or length of stay (very low certainty evidence).
- Gastroparesis: Prucalopride and other 5-HT4 agonists significantly improved Gastroparesis Cardinal Symptom Index (GCSI) scores (mean difference: 4.283, 95% CI: 1.380 to 7.186, p<0.05) and gastric emptying time (GET) (mean difference: 2.534, 95% CI: 1.695 to 3.373, p<0.05).
- Chronic Idiopathic Constipation (CIC): Prucalopride significantly increased the frequency of spontaneous bowel movements (SBMs) per week across different doses: 1mg (OR: 2.40, 95% CI: 1.32 to 4.37), 2mg (OR: 2.55, 95% CI: 1.93 to 3.36), and 4mg (OR: 2.51, 95% CI: 1.92 to 3.28).
- No significant differences in postoperative complications and adverse events were observed in individual studies (very low certainty evidence).
- In gastroparesis, pooled rates of total adverse events were higher with 5-HT4 agonists (mean difference: 6.975, 95% CI: 1.042 to 46.684, p<0.05), though diarrhea, abdominal pain, and headaches were comparable to placebo.
- In chronic idiopathic constipation, treatment-emergent adverse events (TEAEs) were significantly higher with prucalopride at 2mg (RR 1.20, 95% CI 1.09 to 1.33) and 4mg (RR 1.14, 95% CI 1.07 to 1.22), but not significant at 1mg (RR 1.17, 95% CI 0.94 to 1.44).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Motegrity (prucalopride) Prescribing Information. | 2020 | Takeda Pharmaceuticals America, Inc., Lexington, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
American gastroenterological association-american college of gastroenterology clinical practice guideline: pharmacological management of chronic idiopathic constipation. | 2023 | Gastroenterology |
2022 Seoul consensus on clinical practice guidelines for functional constipation. | 2023 | Neurogastroenterology & Motility |
ACG clinical guideline: Gastroparesis. | 2022 | The American Journal of Gastroenterology |
European society of neurogastroenterology and motility guidelines on functional constipation in adults. | 2019 | Neurogastroenterology & Motility |