Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 15 mg, 30 mg, 45 mg, 60 mg and 90 mg) |
Drug Class | Selective 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
- Jynarque (tolvaptan) is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
- This summary is based on the review of three systematic review(s)/meta-analysis(es). 3. eGFR Decline: Tolvaptan significantly delays eGFR decline in ADPKD patients compared to placebo, with a mean difference (MD) ranging from 1.27 (95% CI [1.24, 1.29], P < 0.01) to 1.89 (95% CI [0.74, 3.04], P = 0.001). [1-3]
- Total Kidney Volume (TKV) Increase: Tolvaptan significantly inhibits the increase in TKV in ADPKD patients compared to placebo, with MD values between -2.70 (95% CI [-3.10, -2.30]) and -3.32 (95% CI [-4.57, -2.07], P < 0.001).
- Renal Pain and Hematuria: Tolvaptan reduces the incidence of renal pain (OR = 0.71, 95% CI [0.58, 0.87], P < 0.01) and hematuria (OR = 0.68, 95% CI [0.51, 0.89], P < 0.01) in ADPKD patients.
- Adverse Events: Tolvaptan is associated with an increased incidence of thirst (OR = 8.48, 95% CI [4.53, 15.87], P < 0.01; RR = 2.75, 95% CI [2.34, 3.24], P < 0.001), polyuria (OR = 4.71, 95% CI [2.17, 10.24], P < 0.01), hepatic injury (OR = 4.56, 95% CI [2.51, 8.29], P < 0.01), and nocturia (RR = 3.01, 95% CI [1.27, 7.11], P = 0.01).
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jynarque (tolvaptan) Prescribing Information. | 2020 | Otsuka America Pharmaceutical, Inc., Rockville, MD |
Systematic Reviews / Meta-Analyses
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 |