Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 15 mg, 30 mg, 45 mg, 60 mg and 90 mg) |
Drug Class | Vasopressin V2-receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Effectiveness of Tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) Patients: Tolvaptan significantly delays the decline in estimated glomerular filtration rate (eGFR) compared to placebo (mean difference (MD) 1.27, 95% confidence interval (CI) 1.24-1.29, P < 0.01) and inhibits the increase in total kidney volume (TKV) (MD -3.01, 95% CI -3.55 to -2.47, P < 0.01). It also reduces the incidence of renal pain (odds ratio (OR) 0.71, 95% CI 0.58-0.87, P < 0.01), urinary tract infection (OR 0.69, 95% CI 0.54-0.89, P < 0.01), haematuria (OR 0.68, 95% CI 0.51-0.89, P < 0.01), and hypertension (OR 0.66, 95% CI 0.52-0.82, P < 0.01).
- Comparative Efficacy of Other Agents: Somatostatin analogs inhibit TKV growth more effectively than both placebo (MD -5.69, 95% CI -7.34 to -4.03) and tolvaptan (MD -2.99, 95% CI -4.69 to -1.29). Tyrosine kinase inhibitors and mTOR inhibitors also inhibit TKV growth relative to placebo, though specific comparisons to tolvaptan were not detailed. Metformin shows a trend toward preserving renal function, but this result was not statistically significant (standardized mean difference (SMD) 0.28, 95% CI -0.05 to 0.61, p = 0.09).
- Tolvaptan was associated with a higher incidence of adverse events, including thirst (OR 8.48, 95% CI 4.53-15.87, P < 0.01), polyuria (OR 4.71, 95% CI 2.17-10.24, P < 0.01), and hepatic injury (OR 4.56, 95% CI 2.51-8.29, P < 0.01).
- The studies did not provide specific safety data for other drugs in comparison to tolvaptan.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jynarque (tolvaptan) Prescribing Information. | 2020 | Otsuka America Pharmaceutical, Inc., Princeton, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of tolvaptan versus placebo in the treatment of patients with autosomal dominant polycystic kidney disease: a meta-analysis | 2023 | International Urology and Nephrology |
Comparative Efficacy of Pharmacological Treatments for Adults With Autosomal Dominant Polycystic Kidney Disease: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials | 2022 | Frontiers in Pharmacology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A practical guide for treatment of rapidly progressive ADPKD with tolvaptan. | 2018 | Journal of the American Society of Nephrology |