Safety and efficacy of tolvaptan in real‑world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW‑PKD surveillance.

• Tác giả: Yasuhiko Fukuta, Satoshi Komaniwa, Toshio Mochizuki, Satoru Muto, Kyoko Suzue, Toshiki Tanaka, Yuko Yamashige
• Ngôn ngữ: eng
• Ký hiệu phân loại: 069.50289 Collections and exhibits of museum objects
• Thông tin xuất bản: Japan : Clinical and experimental nephrology , 2025
• Bộ sưu tập: NCBI
• ID: 105462

Tóm tắt

 BACKGROUND: Tolvaptan, a vasopressin type 2 receptor antagonist, has been used to treat autosomal dominant polycystic kidney disease in Japan since 2014. METHODS: This long-term, real-world, post-marketing surveillance (PMS) was conducted in Japan from March 2014 to March 2022. Safety was assessed based on adverse drug reactions (ADRs). For efficacy, changes in the slope of total kidney volume (TKV) and estimated glomerular filtration rate (eGFR) were assessed before and during the administration of tolvaptan. RESULTS: A total of 1676 patients were enrolled, with mean TKV (n = 1000) of 2149 ± 1339 mL and eGFR (n = 1641) of 44.4 ± 21.7 mL/min/1.73 m CONCLUSION: There were no major problems with the safety of tolvaptan treatment, and efficacy in limiting TKV increase in this PMS was comparable to the previous, pivotal randomized control trials. Trial registration ClinicalTrials.gov
  NCT02847624.