{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T22:43:27Z","timestamp":1790981007357,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,12,27]],"date-time":"2018-12-27T00:00:00Z","timestamp":1545868800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Takeda Pharmaceuticals International, Inc."}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2019,1]]},"abstract":"\n Objective<\/jats:title>\n \n To assess the efficacy and safety of febuxostat extended release (\n XR<\/jats:styled-content>\n ) and immediate release (\n IR<\/jats:styled-content>\n ) in patients with gout and normal or impaired renal function.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This was a 3\u2010month, phase\n III<\/jats:styled-content>\n , multicenter, double\u2010blind, placebo\u2010controlled study. Patients (n = 1,790) with a history of gout and normal or impaired (mild\u2010to\u2010severe) renal function were randomized to receive placebo, febuxostat\n IR<\/jats:styled-content>\n 40\u00a0or 80 mg, or febuxostat\n XR<\/jats:styled-content>\n 40 or 80 mg once daily (1:1:1:1:1 ratio). End points included proportions of patients with a serum urate (\n UA<\/jats:styled-content>\n ) level of <5.0\u00a0mg\/dl at month 3 (primary end point), a serum\n UA<\/jats:styled-content>\n level of <6.0\u00a0mg\/dl at month 3, and \u22651 gout flare requiring treatment over 3 months (secondary end points).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Both febuxostat formulations led to significantly greater proportions of patients achieving a serum\n UA<\/jats:styled-content>\n level of <5.0 mg\/dl or <6.0 mg\/dl at month 3 (\n P<\/jats:italic>\n < 0.001 for all comparisons versus placebo). Equivalent doses of febuxostat\n XR<\/jats:styled-content>\n and\n IR<\/jats:styled-content>\n had similar treatment effects on serum\n UA<\/jats:styled-content>\n level end points; however, a significantly greater proportion of patients achieved a serum\n UA<\/jats:styled-content>\n level of <5.0 mg\/dl with\n XR<\/jats:styled-content>\n 40 mg versus\n IR<\/jats:styled-content>\n 40 mg. Similar proportions of patients experienced \u22651 gout flare across treatment groups. Rates of treatment\u2010emergent adverse events were low and evenly distributed between treatment arms. A preplanned subgroup analysis demonstrated that febuxostat formulations were well tolerated and generally effective on serum\n UA<\/jats:styled-content>\n level end points (versus placebo) across all renal function subgroups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Both formulations of febuxostat (\n XR<\/jats:styled-content>\n and\n IR<\/jats:styled-content>\n ) were well tolerated and effective in patients with gout and normal or impaired renal function, including patients with severe renal impairment.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40685","type":"journal-article","created":{"date-parts":[[2018,8,7]],"date-time":"2018-08-07T00:42:09Z","timestamp":1533602529000},"page":"143-153","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase\n III<\/scp>\n Placebo\u2010Controlled Study"],"prefix":"10.1002","volume":"71","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6189-8078","authenticated-orcid":false,"given":"Kenneth G.","family":"Saag","sequence":"first","affiliation":[{"name":"Birmingham VA Medical Center, Birmingham, Alabama, and University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Becker","sequence":"additional","affiliation":[{"name":"University of Chicago Pritzker School of Medicine Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Whelton","sequence":"additional","affiliation":[{"name":"Johns Hopkins University Baltimore Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Hunt","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals Deerfield Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Majin","family":"Castillo","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals Deerfield Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina","family":"Kisfalvi","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals Deerfield Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2232-8931","authenticated-orcid":false,"given":"Lhanoo","family":"Gunawardhana","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals Deerfield Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,12,27]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.30520"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2008.605"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1291\/hypres.24.691"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semnephrol.2004.10.001"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2008010080"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1159\/000326848"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2011.09.033"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0050046"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-015-0610-9"},{"key":"e_1_2_8_11_1","volume-title":"Zyloprim (allopurinol) product monograph","year":"2010"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.21772"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39654"},{"key":"e_1_2_8_14_1","volume-title":"Uloric (febuxostat) prescribing information","year":"2013"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9343(84)90743-5"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028013504740"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210872"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.20935"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050373"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.080814"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar2978"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.24209"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ken457"},{"key":"e_1_2_8_24_1","unstructured":"Febuxostat: study number. 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