The safety and efficacy of tolvaptan in the treatment of patients with autosomal dominant polycystic kidney disease: A systematic review and meta-analysis

Nefrologia (Engl Ed). 2023 Nov-Dec;43(6):731-741. doi: 10.1016/j.nefroe.2023.04.002. Epub 2023 May 5.

Abstract

Background: The irreversible progression of autosomal dominant polycystic kidney disease (ADPKD) to end-stage renal disease (ESRD) is delayed by tolvaptan. Therefore, we aim to systematically estimate and evaluate the efficacy and safety of tolvaptan in the treatment of ADPKD.

Methods: Two reviewers independently searched all published randomized controlled trials studies in PubMed, EMBASE, Web of Science and Cochrane databases, extracted data, assessed bias risk and rated the quality of evidence. Data were analyzed by the RevMan software.

Results: We identified 8 trials including 2135 patients. Both of the decline of estimated glomerular filtration rate (eGFR) [MD=1.89, 95% CI (0.74, 3.04), P=0.001] and total kidney volume (TKV) [MD=-3.32, 95% CI (-4.57, -2.07), P<0.001] were delayed in tolvaptan group compared with placebo group in ADPKD patients. The use of tolvaptan delayed TKV progression in the different-month subgroups [MD=-69.99, 95% CI (-91.05, -48.94), P<0.001]. Tolvaptan reduced renal pain [RR=0.66, 95% CI (0.54, 0.81), P<0.001] and hematuria events [RR=0.55, 95% CI (0.41, 0.74), P<0.001] in ADPKD patients. However, the prevalence of thirst [RR=2.75, 95% CI (2.34, 3.24), P<0.001] and nocturia events [RR=3.01, 95% CI (1.27, 7.11), P=0.01] were increased in tolvaptan group. There is no significant difference of hypertension events [RR=0.92, 95% CI (0.82, 1.03), P=0.13] in tolvaptan group compared placebo group.

Conclusions: This meta-analysis suggests that tolvaptan may improve clinical progression in patients with ADPKD without significantly increasing the risk of adverse reactions.

Keywords: ADPKD (autosomal dominant polycystic kidney disease); ERPAD (enfermedad renal poliquística autosómica dominante); TKV (total kidney volume); Tolvaptan; VRT (volumen renal total); eGFR (estimated glomerular filtration rate); eGFR (tasa de filtración glomerular estimada).

Publication types

  • Meta-Analysis
  • Systematic Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antidiuretic Hormone Receptor Antagonists / adverse effects
  • Benzazepines / adverse effects
  • Humans
  • Kidney
  • Polycystic Kidney, Autosomal Dominant* / complications
  • Polycystic Kidney, Autosomal Dominant* / drug therapy
  • Tolvaptan / therapeutic use

Substances

  • Tolvaptan
  • Antidiuretic Hormone Receptor Antagonists
  • Benzazepines