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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
DC Field | Value | Language |
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dc.contributor.author | 유태현 | - |
dc.contributor.author | 한승혁 | - |
dc.date.accessioned | 2024-03-22T05:56:07Z | - |
dc.date.available | 2024-03-22T05:56:07Z | - |
dc.date.issued | 2023-03 | - |
dc.identifier.issn | 2211-9132 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198296 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Elsevier Korea | - |
dc.relation.isPartOf | KIDNEY RESEARCH AND CLINICAL PRACTICE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hyuk Huh | - |
dc.contributor.googleauthor | Yong Soo Kim | - |
dc.contributor.googleauthor | Wookyung Chung | - |
dc.contributor.googleauthor | Yong Lim Kim | - |
dc.contributor.googleauthor | Yaerim Kim | - |
dc.contributor.googleauthor | Seungyeup Han | - |
dc.contributor.googleauthor | Yeonsoon Jung | - |
dc.contributor.googleauthor | Ki Young Na | - |
dc.contributor.googleauthor | Kyu Beck Lee | - |
dc.contributor.googleauthor | Yun Kyu Oh | - |
dc.contributor.googleauthor | Hyeong Cheon Park | - |
dc.contributor.googleauthor | Seung Hyeok Han | - |
dc.contributor.googleauthor | Tae Hyun Yoo | - |
dc.contributor.googleauthor | Yeong Hoon Kim | - |
dc.contributor.googleauthor | Soo Wan Kim | - |
dc.contributor.googleauthor | Kang Wook Lee | - |
dc.contributor.googleauthor | Hayne Cho Park | - |
dc.contributor.googleauthor | Sung Gyun Kim | - |
dc.contributor.googleauthor | Hyunsuk Kim | - |
dc.contributor.googleauthor | Chang Hwa Lee | - |
dc.contributor.googleauthor | Kyongtae T Bae | - |
dc.contributor.googleauthor | Kook Hwan Oh | - |
dc.contributor.googleauthor | Curie Ahn | - |
dc.contributor.googleauthor | Hyun Jin Ryu | - |
dc.contributor.googleauthor | Yong Chul Kim | - |
dc.identifier.doi | 10.23876/j.krcp.22.024 | - |
dc.contributor.localId | A02526 | - |
dc.contributor.localId | A04304 | - |
dc.relation.journalcode | J01942 | - |
dc.identifier.eissn | 2211-9140 | - |
dc.identifier.pmid | 36634967 | - |
dc.subject.keyword | Clinical trial phase IV | - |
dc.subject.keyword | Polycystic kidney autosomal dominant | - |
dc.subject.keyword | Tolvaptan | - |
dc.contributor.alternativeName | Yoo, Tae Hyun | - |
dc.contributor.affiliatedAuthor | 유태현 | - |
dc.contributor.affiliatedAuthor | 한승혁 | - |
dc.citation.volume | 42 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 216 | - |
dc.citation.endPage | 228 | - |
dc.identifier.bibliographicCitation | KIDNEY RESEARCH AND CLINICAL PRACTICE, Vol.42(2) : 216-228, 2023-03 | - |
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