Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 50 mg) |
| Drug Class | Sodium/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.
Summary
- Tenapanor (Ibsrela) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. It significantly reduces serum phosphorus levels in hemodialysis patients with hyperphosphatemia, demonstrating considerable efficacy.
- The information was derived from three systematic reviews/meta-analyses studies that provided insights into the drug's efficacy and safety compared to other medications designated for similar conditions.
- In terms of IBS-C management, Tenapanor is superior to a placebo in alleviating abdominal bloating. However, Linaclotide demonstrated higher efficacy, especially in improving abdominal bloating, according to both pairwise and network meta-analysis data.
- For chronic idiopathic constipation treatment, several medications, including Tenapanor, were found superior to placebo. Specifically, stimulant laxatives such as Bisacodyl and Sodium Picosulfate, along with Prucalopride, showed outstanding efficacy based on achieving three or more complete spontaneous bowel movements per week criterion.
- Among different population types and subgroups considered: 1. Hemodialysis Patients with Hyperphosphatemia benefit from Tenapanor despite its notable adverse effect profile.
- IBS-C Patients have several effective options, including Tenapanor alongside Linaclotide, Lubiprostone, and Tegaserod.
- Chronic Idiopathic Constipation patients might prefer treatments like laxatives or Prucalopride depending on their response over varying durations and severity of symptoms.
- Despite its benefits in symptom management and phosphorus level reduction, particularly among hemodialysis patients suffering from hyperphosphatemia and those diagnosed with IBS-C, it is important to consider its gastrointestinal side effects, which are significant.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ibsrela (tenapanor) Prescribing Information. | 2022 | Ardelyx Inc., Waltham, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of tenapanor in hemodialysis patients with hyperphosphatemia: a systematic review and meta-analysis of randomized placebo-controlled trials | 2023 | Therapeutic Apheresis and Dialysis |
| Systematic review and network meta-analysis: efficacy of licensed drugs for abdominal bloating in irritable bowel syndrome with constipation. | 2021 | Alimentary Pharmacology and Therapeutics |
| Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis. | 2019 | The Lancet Gastroenterology & Hepatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| AGA clinical practice guideline on the pharmacological management of irritable bowel syndrome with constipation. | 2022 | Gastroenterology |