{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T01:38:46Z","timestamp":1768009126352,"version":"3.49.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2021,7,6]],"date-time":"2021-07-06T00:00:00Z","timestamp":1625529600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,7,6]],"date-time":"2021-07-06T00:00:00Z","timestamp":1625529600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009155","name":"Otsuka America Pharmaceutical","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009155","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Nephrol"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Tolvaptan is a vasopressin type 2 receptor antagonist and has been used to treat autosomal dominant polycystic kidney disease (ADPKD) since 2014. There has been limited real-world data on the safety and efficacy of tolvaptan.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This post-marketing surveillance was conducted to evaluate the long-term safety and the efficacy of tolvaptan in Japanese patients with ADPKD in real-world clinical settings. The baseline characteristics of 1630 patients treated with tolvaptan are reported. Safety analysis comprises evaluation of adverse drug reactions (ADRs). The efficacy evaluation includes percent change in total kidney volume (TKV) and change in estimated glomerular filtration rate (eGFR) before and after tolvaptan treatment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Mean age was 49.7\u2009\u00b1\u200911.2\u00a0years and 843 (51.7%) patients were male. Baseline TKV was 2158\u2009\u00b1\u20091346\u00a0mL and eGFR was 44.4\u2009\u00b1\u200921.7\u00a0mL\/min\/1.73\u00a0m<jats:sup>2<\/jats:sup>. The majority of CKD patients were stage G3b (27.0%) and G4 (30.1%). Frequently reported ADRs were hepatic function abnormal (8.3%), thirst (8.2%), and hyperuricaemia (6.9%). The frequency of ALT elevation (&gt;\u200930 and\u2009&gt;\u200990\u00a0IU\/L) was slightly high (32.9 and 8.3%) to previous studies. After tolvaptan treatment, the annual rate of percentage change in TKV reduced from 11.68%\/year to 2.73%\/year (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). Similar results were also obtained for the effect on change in eGFR from \u2212\u00a03.31 to \u2212\u00a02.28\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup>\/year after initiation of tolvaptan treatment (<jats:italic>P<\/jats:italic>\u2009=\u20090.0403).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>There were no major problems with safety of tolvaptan treatment and comparable efficacy for TKV and eGFR was observed in relation to the previous pivotal two randomized control trials in this post-marketing surveillance.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10157-021-02100-0","type":"journal-article","created":{"date-parts":[[2021,7,6]],"date-time":"2021-07-06T06:02:56Z","timestamp":1625551376000},"page":"1231-1239","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOW-PKD surveillance"],"prefix":"10.1007","volume":"25","author":[{"given":"Toshio","family":"Mochizuki","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoru","family":"Muto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4557-0886","authenticated-orcid":false,"given":"Masateru","family":"Miyake","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiki","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenchyi","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,7,6]]},"reference":[{"key":"2100_CR1","doi-asserted-by":"publisher","first-page":"1287","DOI":"10.1016\/S0140-6736(07)60601-1","volume":"369","author":"VE Torres","year":"2007","unstructured":"Torres VE, Harris PC, Pirson Y. 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Ltd., Chugai Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., MSD K.K., and JMS Co., Ltd. Satoru Muto belongs to an endowed department sponsored by Otsuka Pharmaceutical Co. Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study is being conducted in compliance with the Ministerial Ordinance on Standards for Conducting Post-marketing Surveys and Studies on Drugs; MHLW Ordinance No. 171 issued on December 20, 2004. As the study is a non-interventional in accordance with GPSP, informed consent to patients and approval of ethical committees in healthcare institutions were not mandatory.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}}]}}