Efficacy and Safety of Tenapanor in Hemodialysis Patients with Hyperphosphatemia: A Systematic Review and Meta-Analysis of Short-Term Randomized Controlled Trials.

Abstract

Introduction: Tenapanor is currently seen as a promising treatment for hyperphosphatemia in hemodialysis patients. Although previous meta-analysis has investigated its efficacy and safety, the potential impact of tenapanor remained a topic of further investigation. This meta-analysis aimed to provide an updated and thorough assessment of tenapanor efficacy in reducing serum phosphate levels and its safety in hemodialysis patients, integrating new evidence, and refining the analysis of treatment outcomes.

Methods: In this systematic review and meta-analysis, we searched online databases up to August 2024 for studies evaluating the efficacy and safety of tenapanor in hemodialysis patients. Only short-term randomized controlled trials (4-8 weeks) comparing tenapanor with placebo were included. The primary outcome was the change in serum phosphate levels from baseline. Safety was assessed based on data regarding drug-related adverse effects (AEs), including diarrhea and other gastrointestinal AEs.

Results: Among the selected 8 clinical trials with a total of 1,001 patients, tenapanor showed a significant reduction in serum phosphate levels from baseline compared to placebo (mean difference: -1.39 mg/dL; 95% confidence interval [CI]: -1.94, 0.84; p < 0.0001). A greater number of patients in the tenapanor group were able to achieve target serum phosphate levels of ≤5.5 mg/dL (relative risk: 2.80; 95% CI: 1.70, 4.61; p < 0.0001). Drug-related AEs, gastrointestinal AEs, and diarrhea were more severe in the tenapanor group compared to the placebo.

Conclusion: In summary, the results indicate that tenapanor effectively lowers serum phosphate levels in hemodialysis patients and facilitates achievement of target levels, although drug-related side effects were common. However, these findings are based exclusively on short-term trials (4-8 weeks). Further long-term studies are needed to confirm the sustained efficacy and safety of tenapanor.