{"corpus_id":6351267,"paper_sha":"98e8da36096b71519ab9b47355dd415d61a43b21","doi":"10.1186/ar2978","arxiv_id":null,"pmid":20370912,"pmcid":"2888216","mag_id":2106983312,"dblp_id":null,"acl_id":null,"title":"The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial","year":2010,"publication_date":"2010-04-06","venue":"Arthritis Research & Therapy","journal":{"name":"Arthritis Research & Therapy","pages":"R63 - R63","volume":"12"},"journal_issn":null,"journal_title":null,"publication_types":["Study","JournalArticle"],"pubmed_pub_types":["Comparative Study","Journal Article","Multicenter Study","Randomized Controlled Trial","Research Support, Non-U.S. Gov't"],"s2_fields_of_study":["Medicine"],"reference_count":54,"citation_count":519,"influential_citation_count":25,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Adolescent","mj":false,"ui":"D000293"},{"d":"Adult","mj":false,"ui":"D000328"},{"d":"Aged","mj":false,"ui":"D000368"},{"d":"Aged, 80 and over","mj":false,"ui":"D000369"},{"d":"Allopurinol","mj":false,"qs":[{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D000493"},{"d":"Comorbidity","mj":false,"ui":"D015897"},{"d":"Dose-Response Relationship, Drug","mj":false,"ui":"D004305"},{"d":"Febuxostat","mj":false,"ui":"D000069465"},{"d":"Female","mj":false,"ui":"D005260"},{"d":"Gout","mj":false,"qs":[{"q":"blood","mj":false,"ui":"Q000097"},{"q":"drug therapy","mj":false,"ui":"Q000188"},{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D006073"},{"d":"Gout Suppressants","mj":false,"qs":[{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D006074"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Hyperlipidemias","mj":false,"qs":[{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D006949"},{"d":"Hypertension","mj":false,"qs":[{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D006973"},{"d":"Hyperuricemia","mj":false,"qs":[{"q":"blood","mj":false,"ui":"Q000097"},{"q":"drug therapy","mj":true,"ui":"Q000188"},{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D033461"},{"d":"Kidney Diseases","mj":false,"qs":[{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D007674"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Middle Aged","mj":false,"ui":"D008875"},{"d":"Obesity","mj":false,"qs":[{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D009765"},{"d":"Thiazoles","mj":false,"qs":[{"q":"therapeutic use","mj":true,"ui":"Q000627"}],"ui":"D013844"},{"d":"Treatment Outcome","mj":false,"ui":"D016896"},{"d":"United States","mj":false,"qs":[{"q":"epidemiology","mj":false,"ui":"Q000453"}],"ui":"D014481"},{"d":"Uric Acid","mj":false,"qs":[{"q":"blood","mj":true,"ui":"Q000097"}],"ui":"D014527"},{"d":"Young Adult","mj":false,"ui":"D055815"}],"chemicals":[{"n":"Gout Suppressants","ui":"D006074","reg":"0"},{"n":"Thiazoles","ui":"D013844","reg":"0"},{"n":"Febuxostat","ui":"D000069465","reg":"101V0R1N2E"},{"n":"Uric Acid","ui":"D014527","reg":"268B43MJ25"},{"n":"Allopurinol","ui":"D000493","reg":"63CZ7GJN5I"}],"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":"https://arthritis-research.biomedcentral.com/counter/pdf/10.1186/ar2978","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/98e8da36096b71519ab9b47355dd415d61a43b21","s2_open_access_license":"CCBY","s2_open_access_status":"GOLD","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"IntroductionThe purpose of this study was to compare urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate (sUA) ≥ 8.0 mg/dL in a six-month trial.MethodsSubjects (n = 2,269) were randomized to febuxostat 40 mg or 80 mg, or allopurinol 300 mg (200 mg in moderate renal impairment). Endpoints included the proportion of all subjects with sUA <6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA <6.0 mg/dL. Safety assessments included blinded adjudication of each cardiovascular (CV) adverse event (AE) and death.ResultsComorbidities included: renal impairment (65%); obesity (64%); hyperlipidemia (42%); and hypertension (53%). In febuxostat 40 mg, febuxostat 80 mg, and allopurinol groups, primary endpoint was achieved in 45%, 67%, and 42%, respectively. Febuxostat 40 mg UL was statistically non-inferior to allopurinol, but febuxostat 80 mg was superior to both (P < 0.001). Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg (72%; P < 0.001) compared with febuxostat 40 mg (50%) or allopurinol (42%), but febuxostat 40 mg showed greater efficacy than allopurinol (P = 0.021). Rates of AEs did not differ across treatment groups. Adjudicated (APTC) CV event rates were 0.0% for febuxostat 40 mg and 0.4% for both febuxostat 80 mg and allopurinol. One death occurred in each febuxostat group and three in the allopurinol group.ConclusionsUrate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol (300/200 mg), which were comparable. In subjects with mild/moderate renal impairment, both febuxostat doses were more efficacious than allopurinol and equally safe. At the doses tested, safety of febuxostat and allopurinol was comparable.Clinical Trial RegistrationNCT00430248","claims":[{"public_id":"cl_c9dd1ea4d9210cb4d05b482e138ada3f","status":"active","text":"Adverse event rates did not differ across treatment groups, and adjudicated cardiovascular event rates were similarly low.","confidence":0.93,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_c9dd1ea4d9210cb4d05b482e138ada3f"},{"public_id":"cl_2ec0e0c278687abf79d08773ee118252","status":"active","text":"Among subjects with mild or moderate renal impairment, both febuxostat doses were more efficacious than allopurinol for reaching serum urate <6.0 mg/dL.","confidence":0.96,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous 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