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All Journal Bioscientia Medicina : Journal of Biomedicine and Translational Research Bioscientia Medicina : Journal of Biomedicine and Translational Research
Eva Julita
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Biochemistry, Genetics & Molecular Biology Immunology & microbiology Medicine & Pharmacology Neuroscience

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Beyond Phosphate Binding: A Systematic Review and Meta-Analysis on the Efficacy and Safety of the Novel Paracellular Phosphate Inhibitor, Tenapanor, for Hyperphosphatemia in Dialysis Patients Eva Julita; Ian Effendi; Zulkhair Ali; Novadian; Suprapti
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 10 No. 1 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v10i1.1492

Abstract

Background: Hyperphosphatemia is a critical driver of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) undergoing dialysis. Current management, reliant on phosphate binders, is hampered by high pill burden and poor adherence. Tenapanor, a first-in-class, minimally-absorbed sodium/hydrogen exchanger 3 (NHE3) inhibitor, reduces paracellular phosphate absorption. We performed a systematic review and meta-analysis of all available Phase 3 trials to quantify its efficacy and safety. Methods: We searched PubMed, Embase, and Cochrane CENTRAL through October 2025 for Phase 3 clinical trials evaluating tenapanor for hyperphosphatemia in dialysis patients. Data were extracted from 6 eligible studies (N=1573). We conducted separate random-effects meta-analyses for different study designs: 1) parallel-group monotherapy vs. placebo, 2) withdrawal-design monotherapy vs. placebo, 3) parallel-group add-on therapy vs. placebo, and 4) safety (diarrhea incidence) vs. placebo. Efficacy was measured by Mean Difference (MD) in serum phosphate change; safety by Risk Ratio (RR). Results: Tenapanor demonstrated significant efficacy across all study designs. In parallel-group monotherapy (1 study, N=167), tenapanor was superior to placebo (MD: -1.89 mg/dL; 95% CI: -2.36 to -1.42). In withdrawal-design studies (2 RCTs, N=373), tenapanor maintained serum phosphate levels significantly better than placebo (Pooled MD: -0.75 mg/dL; 95% CI: -1.05 to -0.45; I2=0%). As an add-on therapy (1 RCT, N=235), tenapanor provided additional phosphate reduction versus binders alone (MD: -0.65 mg/dL; 95% CI: -0.96 to -0.35). Tenapanor significantly increased the risk of diarrhea versus placebo (3 RCTs, N=521; Pooled RR: 4.10; 95% CI: 2.50 to 6.72; I2=30%), which was the primary adverse event leading to discontinuation. Conclusion: Tenapanor represents a new mechanistic paradigm for hyperphosphatemia management. It is a highly effective phosphate-lowering agent, both as monotherapy and add-on therapy, but is associated with a significant, mechanism-based risk of gastrointestinal side effects.
Effectiveness of Renal Denervation Therapy in Persistent Hypertension: A Meta-Analysis Mulia, Deddy Primadona; Syahpri Putra Wangsa; Kgs. M. Yusuf Arief Akbar; Edy Nur Rachman; Chairil Makky; Eva Julita; Zulkhair Ali; Novadian Suhaimi; Suprapti Slamet; Ian Effendi
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 8 No. 8 (2024): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v8i8.1049

Abstract

Background: Persistent hypertension is a global health problem that requires effective therapy. Renal denervation (RDN) therapy is emerging as a promising new option. This meta-analysis aims to evaluate the effectiveness of RDN in patients with persistent hypertension. Methods: We performed a systematic search in PubMed, Scopus, and the Cochrane Library for studies evaluating the effectiveness of RDN in patients with persistent hypertension. Data were extracted and analyzed using a random effects model. Results: A total of 12 studies with a total of 1,024 patients were included in this meta-analysis. RDN demonstrated significant reductions in systolic and diastolic blood pressure compared with controls (MD -12.3 mmHg [95% CI -15.8 to -8.8] for systolic blood pressure and MD -6.1 mmHg [95% CI -8.2 to -4.0] for blood pressure diastolic). The effectiveness of RDN is higher in patients with more severe hypertension and in patients who are unresponsive to antihypertensive drugs. Conclusion: RDN is an effective therapy for persistent hypertension, especially in patients with more severe hypertension and in patients who are unresponsive to antihypertensive drugs.
Effectiveness of Renal Denervation Therapy in Persistent Hypertension: A Meta-Analysis Mulia, Deddy Primadona; Syahpri Putra Wangsa; Kgs. M. Yusuf Arief Akbar; Edy Nur Rachman; Chairil Makky; Eva Julita; Zulkhair Ali; Novadian Suhaimi; Suprapti Slamet; Ian Effendi
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 8 No. 8 (2024): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v8i8.1049

Abstract

Background: Persistent hypertension is a global health problem that requires effective therapy. Renal denervation (RDN) therapy is emerging as a promising new option. This meta-analysis aims to evaluate the effectiveness of RDN in patients with persistent hypertension. Methods: We performed a systematic search in PubMed, Scopus, and the Cochrane Library for studies evaluating the effectiveness of RDN in patients with persistent hypertension. Data were extracted and analyzed using a random effects model. Results: A total of 12 studies with a total of 1,024 patients were included in this meta-analysis. RDN demonstrated significant reductions in systolic and diastolic blood pressure compared with controls (MD -12.3 mmHg [95% CI -15.8 to -8.8] for systolic blood pressure and MD -6.1 mmHg [95% CI -8.2 to -4.0] for blood pressure diastolic). The effectiveness of RDN is higher in patients with more severe hypertension and in patients who are unresponsive to antihypertensive drugs. Conclusion: RDN is an effective therapy for persistent hypertension, especially in patients with more severe hypertension and in patients who are unresponsive to antihypertensive drugs.
Beyond Phosphate Binding: A Systematic Review and Meta-Analysis on the Efficacy and Safety of the Novel Paracellular Phosphate Inhibitor, Tenapanor, for Hyperphosphatemia in Dialysis Patients Eva Julita; Ian Effendi; Zulkhair Ali; Novadian; Suprapti
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 10 No. 1 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v10i1.1492

Abstract

Background: Hyperphosphatemia is a critical driver of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) undergoing dialysis. Current management, reliant on phosphate binders, is hampered by high pill burden and poor adherence. Tenapanor, a first-in-class, minimally-absorbed sodium/hydrogen exchanger 3 (NHE3) inhibitor, reduces paracellular phosphate absorption. We performed a systematic review and meta-analysis of all available Phase 3 trials to quantify its efficacy and safety. Methods: We searched PubMed, Embase, and Cochrane CENTRAL through October 2025 for Phase 3 clinical trials evaluating tenapanor for hyperphosphatemia in dialysis patients. Data were extracted from 6 eligible studies (N=1573). We conducted separate random-effects meta-analyses for different study designs: 1) parallel-group monotherapy vs. placebo, 2) withdrawal-design monotherapy vs. placebo, 3) parallel-group add-on therapy vs. placebo, and 4) safety (diarrhea incidence) vs. placebo. Efficacy was measured by Mean Difference (MD) in serum phosphate change; safety by Risk Ratio (RR). Results: Tenapanor demonstrated significant efficacy across all study designs. In parallel-group monotherapy (1 study, N=167), tenapanor was superior to placebo (MD: -1.89 mg/dL; 95% CI: -2.36 to -1.42). In withdrawal-design studies (2 RCTs, N=373), tenapanor maintained serum phosphate levels significantly better than placebo (Pooled MD: -0.75 mg/dL; 95% CI: -1.05 to -0.45; I2=0%). As an add-on therapy (1 RCT, N=235), tenapanor provided additional phosphate reduction versus binders alone (MD: -0.65 mg/dL; 95% CI: -0.96 to -0.35). Tenapanor significantly increased the risk of diarrhea versus placebo (3 RCTs, N=521; Pooled RR: 4.10; 95% CI: 2.50 to 6.72; I2=30%), which was the primary adverse event leading to discontinuation. Conclusion: Tenapanor represents a new mechanistic paradigm for hyperphosphatemia management. It is a highly effective phosphate-lowering agent, both as monotherapy and add-on therapy, but is associated with a significant, mechanism-based risk of gastrointestinal side effects.
Co-Authors Chairil Makky Edy Nur Rachman Ian Effendi Kgs. M. Yusuf Arief Akbar Mulia, Deddy Primadona Novadian Novadian Suhaimi Suprapti Suprapti Slamet Syahpri Putra Wangsa Zulkhair Ali