Tenapanor

(Ibsrela®)

Tenapanor

Drug updated on 10/29/2024

Dosage FormTablet (oral; 50 mg)
Drug ClassSodium/hydrogen exchanger 3 (NHE3) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Tenapanor 50 mg twice daily was shown to be effective in reducing abdominal bloating in patients with Irritable Bowel Syndrome with Constipation (IBS (irritable bowel syndrome)-C), demonstrating superiority over placebo. For Chronic Idiopathic Constipation, Tenapanor was also effective in increasing complete spontaneous bowel movements (CSBMs).
  • Comparison with Other Drugs: In treating IBS-C, linaclotide 290 microg once daily had a relative risk (RR) of failure to achieve improvement in abdominal bloating of 0.78 (95% CI (confidence interval) 0.74-0.83), indicating its effectiveness; similarly, diphenyl methane laxatives ranked first for achieving CSBMs with an RR of 0.55 (95% CI 0.48-0.63).
  • Patient Considerations: Trials for prucalopride involved many patients who previously did not respond to other laxatives, suggesting it may be particularly beneficial for those with resistant chronic idiopathic constipation. The generalizability of findings may be limited as some studies included patients with milder symptoms, especially in the context of diphenyl methane laxatives.
  • Safety Outcomes: The studies did not provide specific safety outcomes for Tenapanor in the context of either abdominal bloating in IBS-C or chronic idiopathic constipation. However, bisacodyl was ranked last in terms of safety for total adverse events and abdominal pain (P-score 0.08), while prucalopride did not have any specific safety concerns highlighted.
  • Additional Considerations: There is an indication of a lack of detailed safety profiles for linaclotide, lubiprostone, and tegaserod as well, suggesting that further safety data may be necessary to fully understand the risks associated with these treatments.
  • The studies focus on patients with Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation, highlighting that some trials included patients with milder symptoms for diphenyl methane laxatives, which may affect the generalizability of the results, while others targeted non-responders to previous laxatives, indicating that prucalopride may be most efficacious for more resistant cases of chronic idiopathic constipation.

Product Monograph / Prescribing Information

Document TitleYearSource
Ibsrela (tenapanor) Prescribing Information.2022Ardelyx Inc., Waltham, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines