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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 (2026): 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

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

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

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 (2026): 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

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.

Adjuvant Resveratrol Reduces Albuminuria and Serum Transforming Growth Factor-β Without Improving Glomerular Filtration Rate in Diabetic Kidney Disease: A 12-Week Randomized Controlled Trial Eva Julita; Zulkhair Ali; Yulianto Kusnadi; Legiran
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 10 No. 7 (2026): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v10i7.1627

Background: Diabetic kidney disease (DKD) progresses through inflammation and fibrosis, with transforming growth factor-β (TGF-β) as the principal profibrotic mediator and albuminuria as a clinical surrogate of glomerular injury. Methods: We conducted a 12-week, double-blind, placebo-controlled randomized trial at Dr. Mohammad Hoesin General Hospital, Palembang, between October 2025 and January 2026 to evaluate adjuvant resveratrol on serum TGF-β, urinary albumin-to-creatinine ratio (UACR), and estimated glomerular filtration rate (eGFR). Results: Of 61 randomized adults with DKD on standard care, 54 were analyzed (resveratrol n=27 received 25 mg twice daily, derived from Polygonum cuspidatum in 95% lecithin; placebo n=27). Within the resveratrol group, serum TGF-β fell from 123.7 to 77.1 pg/mL (p=0.008) and UACR from 94.1 to 89.8 mg/g (p=0.017); within placebo, UACR rose from 81.9 to 112 mg/g (p=0.029) while TGF-β change was non-significant (p=0.428). Between-group ΔUACR was significant (p<0.001), whereas ΔTGF-β (p=0.303) and ΔeGFR (p=0.567) were not. Multivariable linear regression identified resveratrol as an independent predictor of UACR reduction (B=−394.12 mg/g; 95% CI −659.53 to −128.71; p=0.004; adjusted R²=0.129). Baseline TGF-β was the dominant predictor of ΔTGF-β (B=−0.81; p<0.001; adjusted R²=0.701), and baseline LFG stage predicted ΔeGFR (B=−4.76; p=0.021). Mild bloating was reported in 14.8% of resveratrol versus 11.1% of placebo recipients; no serious adverse events occurred. Conclusion: Adjuvant low-dose resveratrol reduces albuminuria and serum TGF-β over 12 weeks in DKD without short-term improvement in eGFR, supporting an antifibrotic biomarker signal that warrants longer trials.

Adjuvant Resveratrol Reduces Albuminuria and Serum Transforming Growth Factor-β Without Improving Glomerular Filtration Rate in Diabetic Kidney Disease: A 12-Week Randomized Controlled Trial Eva Julita; Zulkhair Ali; Yulianto Kusnadi; Legiran
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 10 No. 7 (2026): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v10i7.1627

Background: Diabetic kidney disease (DKD) progresses through inflammation and fibrosis, with transforming growth factor-β (TGF-β) as the principal profibrotic mediator and albuminuria as a clinical surrogate of glomerular injury. Methods: We conducted a 12-week, double-blind, placebo-controlled randomized trial at Dr. Mohammad Hoesin General Hospital, Palembang, between October 2025 and January 2026 to evaluate adjuvant resveratrol on serum TGF-β, urinary albumin-to-creatinine ratio (UACR), and estimated glomerular filtration rate (eGFR). Results: Of 61 randomized adults with DKD on standard care, 54 were analyzed (resveratrol n=27 received 25 mg twice daily, derived from Polygonum cuspidatum in 95% lecithin; placebo n=27). Within the resveratrol group, serum TGF-β fell from 123.7 to 77.1 pg/mL (p=0.008) and UACR from 94.1 to 89.8 mg/g (p=0.017); within placebo, UACR rose from 81.9 to 112 mg/g (p=0.029) while TGF-β change was non-significant (p=0.428). Between-group ΔUACR was significant (p<0.001), whereas ΔTGF-β (p=0.303) and ΔeGFR (p=0.567) were not. Multivariable linear regression identified resveratrol as an independent predictor of UACR reduction (B=−394.12 mg/g; 95% CI −659.53 to −128.71; p=0.004; adjusted R²=0.129). Baseline TGF-β was the dominant predictor of ΔTGF-β (B=−0.81; p<0.001; adjusted R²=0.701), and baseline LFG stage predicted ΔeGFR (B=−4.76; p=0.021). Mild bloating was reported in 14.8% of resveratrol versus 11.1% of placebo recipients; no serious adverse events occurred. Conclusion: Adjuvant low-dose resveratrol reduces albuminuria and serum TGF-β over 12 weeks in DKD without short-term improvement in eGFR, supporting an antifibrotic biomarker signal that warrants longer trials.

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