Drug updated on 3/28/2024
| Dosage Form | Tablet (oral: 3 mg) |
| Drug Class | Guanylate cyclase-C agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
Summary
- Plecanatide (Trulance) is indicated for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.
- Four systematic reviews/meta-analyses were reviewed to gather information about plecanatide's efficacy and safety profile.
- A network meta-analysis comparing various therapies for chronic idiopathic constipation found that all drugs, including plecanatide, were superior to placebo; however, long-term relative efficacy remains unknown due to data extraction at the 12-week time point.
- In a review assessing adverse events in randomized controlled trials (RCTs) of licensed drugs versus placebo for IBS-C or diarrhea-predominant IBS (IBS-D), it was noted that patients receiving active drug had a statistically significantly higher risk of any adverse event and withdrawal due to an adverse event compared with those on placebo; specific rates varied by individual drug but only diarrhea or headache was significantly more common with active drug in IBS-C trials.
- Another analysis evaluating guanylate cyclase-C agonists like linaclotide and plecanatide found both drugs efficacious in treating CIC as well as IBS-C; while total numbers of adverse events were larger with these agents than placebo, no significant differences between them regarding odds ratios for efficacy, diarrhea occurrence or study withdrawals related to diarrhea were observed based on meta-regression results.
- Despite their effectiveness against CIC and IBS-C symptoms according to RCTs included within these analyses, both linaclotide and plecanatide have been associated with increased incidence of certain side effects such as abdominal pain which may impact patient tolerance during therapy course; hence clinicians should consider this when making prescribing decisions involving these medications especially over longer durations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Trulance (Plecanatide) Prescribing Information. | 2021 | Salix Pharmaceuticals, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Adverse events in trials of licensed drugs for irritable bowel syndrome with constipation or diarrhea: Systematic review and meta- analysis. | 2021 | Neurogastroenterology & Motility |
| Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis. | 2019 | The Lancet. Gastroenterology & Hepatology |
| Efficacy of secretagogues in patients with irritable bowel syndrome with constipation: systematic review and network meta-analysis. | 2018 | Gastroenterology |
| Efficacy and tolerability of guanylate cyclase-C agonists for irritable bowel syndrome with constipation and chronic idiopathic constipation: a systematic review and meta-analysis. | 2018 | The American Journal of Gastroenterology |