Evaluating the Safety and effectivenesS in adult KorEaN patients treated with Tolvaptan for management of autosomal domInAnt poLycystic kidney disease (ESSENTIAL): short-term outcomes during the titration periodopen access
- Authors
- Huh, Hyuk; Kim, Yong Soo; Chung, Wookyung; Kim, Yong Lim; Kim, Yaerim; Han, Seungyeup; Jung, Yeonsoon; Na, Ki Young; Lee, Kyu Beck; Oh, Yun Kyu; Park, Hyeong Cheon; Han, Seung Hyeok; Yoo, Tae Hyun; Kim, Yeong Hoon; Kim, Soo Wan; Lee, Kang Wook; Park, Hayne Cho; Kim, Sung Gyun; Kim, Hyunsuk; Lee, Chang Hwa; Bae, Kyongtae T.; Oh, Kook Hwan; Ahn, Curie; Ryu, Hyun Jin; Kim, Yong Chul
- Issue Date
- Mar-2023
- Publisher
- KOREAN SOC NEPHROLOGY
- Keywords
- Clinical trial phase IV; Polycystic kidney autosomal dominant; Tolvaptan
- Citation
- KIDNEY RESEARCH AND CLINICAL PRACTICE, v.42, no.2, pp.216 - 228
- Journal Title
- KIDNEY RESEARCH AND CLINICAL PRACTICE
- Volume
- 42
- Number
- 2
- Start Page
- 216
- End Page
- 228
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/87978
- DOI
- 10.23876/j.krcp.22.024
- ISSN
- 2211-9132
- Abstract
- Background: Tolvaptan reduces height-adjusted total kidney volume (htTKV) and renal function decline in autosomal dominant poly -cystic kidney disease (ADPKD). This study was aimed at investigating the efficacy and safety of tolvaptan in Korean patients with ADP-KD during the titration period.Methods: This study is a multicenter, single-arm, open-label phase 4 study. We enrolled 108 patients with ADPKD (age, 19-50 years) with an estimated glomerular filtration rate (eGFR) of >30 mL/min/1.73 m2 and factors defined as indicative of rapid disease progres-sion. After tolvaptan titration, we evaluated efficacy and side effects and assessed factors associated with the effects.Results: After titration for 4 weeks, eGFR and htTKV decreased by 6.4 +/- 7.9 mL/min/1.73 m2 and 16 +/- 45 mL/m, respectively. No se-rious adverse drug reactions were observed during the titration period. The greatest eGFR decline was observed in the first week, with a starting tolvaptan dose of 45 mg. Multivariate linear regression for htTKV decline showed that the greater the change in urine osmo-lality (Uosm), the greater the decrease in htTKV (beta, 0.436; p = 0.009) in the 1D group stratified by the Mayo Clinic image classification. Higher baseline eGFR was related to a higher htTKV reduction rate in the 1E group (beta, -0.642; p = 0.009).Conclusion: We observed short-term effects and safety during the tolvaptan titration period. The decline of htTKV can be predicted as a short-term effect of tolvaptan by observing Uosm changes from baseline to end of titration in 1D and baseline eGFR in 1E groups.
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