{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T18:33:11Z","timestamp":1788201191584,"version":"build-2803163510"},"reference-count":41,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,4,6]],"date-time":"2022-04-06T00:00:00Z","timestamp":1649203200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019720","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019720","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ther Apher Dial"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Daprodustat is an approved treatment for anemia of chronic kidney disease (CKD) in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This post hoc analysis evaluated pooled safety data for daprodustat from 3 phase 3 Japanese studies in dialysis\u2010dependent and nondialysis patients with anemia of CKD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Median drug exposure duration was 365\u2009days for both daprodustat (<jats:italic>N<\/jats:italic>\u00a0=\u00a0369) and injectable erythropoiesis\u2010stimulating agent (ESA, <jats:italic>N<\/jats:italic>\u00a0=\u00a0285). The incidence per 100 patient\u2010years of on\u2010therapy adverse events (AEs) was 363.1 and 306.4 in the daprodustat and ESA groups, respectively. The incidence per 100 patient\u2010years of thromboembolic and retinal events were 5.55 and 6.91 (daprodustat) and 6.28 and 7.46 (ESA), respectively. Cardiovascular and malignancy events were similar between groups, although analysis of these were limited by sample size and study duration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The safety of daprodustat was comparable to ESA in this pooled analysis, although further large\u2010scale research is needed to evaluate long\u2010term risks including cardiovascular and malignancy events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1744-9987.13839","type":"journal-article","created":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T12:50:41Z","timestamp":1647867041000},"page":"1065-1078","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety of daprodustat in patients with anemia of chronic kidney disease: A pooled analysis of phase 3 studies in Japan"],"prefix":"10.1111","volume":"26","author":[{"given":"Masaomi","family":"Nangaku","sequence":"first","affiliation":[{"name":"Division of Nephrology and Endocrinology The University of Tokyo Graduate School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6150-9201","authenticated-orcid":false,"given":"Tadao","family":"Akizawa","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine Showa University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Nagakubo","sequence":"additional","affiliation":[{"name":"Biostatistics GlaxoSmithKline  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taeko","family":"Yonekawa","sequence":"additional","affiliation":[{"name":"Medicines Development GlaxoSmithKline  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8831-7659","authenticated-orcid":false,"given":"Toshifumi","family":"Kimura","sequence":"additional","affiliation":[{"name":"Medical Affairs GlaxoSmithKline  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihiro","family":"Endo","sequence":"additional","affiliation":[{"name":"Medicines Development GlaxoSmithKline  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Cobitz","sequence":"additional","affiliation":[{"name":"Clinical Sciences GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,4,6]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2017.09.026"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10040839"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics11081518"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41100-017-0114-y"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000455166"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0907845"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa065485"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1005109"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2008.295"},{"key":"e_1_2_13_11_1","unstructured":"GlaxoSmithKline.GSK announces positive headline results from five Phase 3 studes of daprodustat for patients with anemia due to chronic kidney disease. 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