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KMID : 1102220230420020216
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Kidney Research and Clinical Practice
2023 Volume.42 No. 2 p.216 ~ p.228
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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 period
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Huh Hyuk
Kim Yong-Soo
Chung Woo-Kyung
Kim Yong-Lim
Kim Yae-Rim
Han Seung-Yeup
Jung Yeon-Soon
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 Hyun-Suk
Lee Chang-Hwa
Bae Kyong-Tae T.
Oh Kook-Hwan
Ahn Cu-Rie
Ryu Hyun-Jin
Kim Yong-Chul
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Abstract
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Background: Tolvaptan reduces height-adjusted total kidney volume (htTKV) and renal function decline in autosomal dominant polycystic kidney disease (ADPKD). This study was aimed at investigating the efficacy and safety of tolvaptan in Korean patients with ADPKD 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 progression. 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 serious 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 osmolality (Uosm), the greater the decrease in htTKV (β, 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 (β, ?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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KEYWORD
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Clinical trial phase IV, Polycystic kidney autosomal dominant, Tolvaptan
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