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Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol

Objective To compare the characteristics of female versus male gout patients and assess urate‐lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. Methods This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects en...

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Published in:Arthritis care & research (2010) 2012-02, Vol.64 (2), p.256-261
Main Authors: Chohan, Saima, Becker, Michael A., MacDonald, Patricia A., Chefo, Solomon, Jackson, Robert L.
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description Objective To compare the characteristics of female versus male gout patients and assess urate‐lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. Methods This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate‐lowering efficacy, which was defined as the proportion of subjects with sUA levels
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Methods This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate‐lowering efficacy, which was defined as the proportion of subjects with sUA levels &lt;6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function. Results Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels &lt;6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate‐lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P &lt; 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea. Conclusion These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.</description><identifier>ISSN: 2151-464X</identifier><identifier>EISSN: 2151-4658</identifier><identifier>DOI: 10.1002/acr.20680</identifier><identifier>PMID: 22052584</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley &amp; Sons, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Allopurinol - therapeutic use ; Cardiovascular Diseases - epidemiology ; Comorbidity ; Febuxostat ; Female ; Gout - blood ; Gout - drug therapy ; Gout - epidemiology ; Gout Suppressants - therapeutic use ; Humans ; Hyperuricemia - blood ; Hyperuricemia - drug therapy ; Illinois - epidemiology ; Male ; Metabolic Diseases - epidemiology ; Middle Aged ; Obesity - epidemiology ; Retrospective Studies ; Sex Factors ; Thiazoles - therapeutic use ; Treatment Outcome ; Uric Acid - blood ; Young Adult</subject><ispartof>Arthritis care &amp; research (2010), 2012-02, Vol.64 (2), p.256-261</ispartof><rights>Copyright © 2012 by the American College of Rheumatology</rights><rights>Copyright © 2012 by the American College of Rheumatology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3500-231df97162e11e7191e5b69ea6fe4a43ce527c12c6efeec8de07c719e6ca21073</citedby><cites>FETCH-LOGICAL-c3500-231df97162e11e7191e5b69ea6fe4a43ce527c12c6efeec8de07c719e6ca21073</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22052584$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chohan, Saima</creatorcontrib><creatorcontrib>Becker, Michael A.</creatorcontrib><creatorcontrib>MacDonald, Patricia A.</creatorcontrib><creatorcontrib>Chefo, Solomon</creatorcontrib><creatorcontrib>Jackson, Robert L.</creatorcontrib><title>Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol</title><title>Arthritis care &amp; research (2010)</title><addtitle>Arthritis Care Res (Hoboken)</addtitle><description>Objective To compare the characteristics of female versus male gout patients and assess urate‐lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. Methods This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate‐lowering efficacy, which was defined as the proportion of subjects with sUA levels &lt;6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function. Results Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels &lt;6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate‐lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P &lt; 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea. Conclusion These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Allopurinol - therapeutic use</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Comorbidity</subject><subject>Febuxostat</subject><subject>Female</subject><subject>Gout - blood</subject><subject>Gout - drug therapy</subject><subject>Gout - epidemiology</subject><subject>Gout Suppressants - therapeutic use</subject><subject>Humans</subject><subject>Hyperuricemia - blood</subject><subject>Hyperuricemia - drug therapy</subject><subject>Illinois - epidemiology</subject><subject>Male</subject><subject>Metabolic Diseases - epidemiology</subject><subject>Middle Aged</subject><subject>Obesity - epidemiology</subject><subject>Retrospective Studies</subject><subject>Sex Factors</subject><subject>Thiazoles - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Uric Acid - blood</subject><subject>Young Adult</subject><issn>2151-464X</issn><issn>2151-4658</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNp1kLtOwzAUQC0EolXpwA-gbIghre3ETsJWVeUhVUJCILpZrnNdgpy62IlKNj6Bb-RLCE3phpdr6Z57hoPQOcEjgjEdS-VGFPMUH6E-JYyEMWfp8eEfL3po6P0bbl9E0zTKTlGPUswoS-M-WrzYEtbBtqheg5Wtq-tgpnWhpGoCuc4DLzVUTWB1UDtZwffnl7FbcMV61Z1oWNYf1ley2uHSGLup27U1Z-hES-NhuJ8D9Hwze5rehfOH2_vpZB6qiGEc0ojkOksIp0AIJCQjwJY8A8k1xDKOFDCaKEIVBw2g0hxwoloMuJKU4CQaoMvOu3H2vQZfibLwCoyRa7C1FxlJWRIljLfkVUcqZ713oMXGFaV0jSBY_KYUbUqxS9myF3trvSwhP5B_4Vpg3AHbwkDzv0lMpo-d8gc-1n7I</recordid><startdate>201202</startdate><enddate>201202</enddate><creator>Chohan, Saima</creator><creator>Becker, Michael A.</creator><creator>MacDonald, Patricia A.</creator><creator>Chefo, Solomon</creator><creator>Jackson, Robert L.</creator><general>John Wiley &amp; Sons, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201202</creationdate><title>Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol</title><author>Chohan, Saima ; Becker, Michael A. ; MacDonald, Patricia A. ; Chefo, Solomon ; Jackson, Robert L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3500-231df97162e11e7191e5b69ea6fe4a43ce527c12c6efeec8de07c719e6ca21073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Allopurinol - therapeutic use</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Comorbidity</topic><topic>Febuxostat</topic><topic>Female</topic><topic>Gout - blood</topic><topic>Gout - drug therapy</topic><topic>Gout - epidemiology</topic><topic>Gout Suppressants - therapeutic use</topic><topic>Humans</topic><topic>Hyperuricemia - blood</topic><topic>Hyperuricemia - drug therapy</topic><topic>Illinois - epidemiology</topic><topic>Male</topic><topic>Metabolic Diseases - epidemiology</topic><topic>Middle Aged</topic><topic>Obesity - epidemiology</topic><topic>Retrospective Studies</topic><topic>Sex Factors</topic><topic>Thiazoles - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Uric Acid - blood</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chohan, Saima</creatorcontrib><creatorcontrib>Becker, Michael A.</creatorcontrib><creatorcontrib>MacDonald, Patricia A.</creatorcontrib><creatorcontrib>Chefo, Solomon</creatorcontrib><creatorcontrib>Jackson, Robert L.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Arthritis care &amp; research (2010)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chohan, Saima</au><au>Becker, Michael A.</au><au>MacDonald, Patricia A.</au><au>Chefo, Solomon</au><au>Jackson, Robert L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol</atitle><jtitle>Arthritis care &amp; research (2010)</jtitle><addtitle>Arthritis Care Res (Hoboken)</addtitle><date>2012-02</date><risdate>2012</risdate><volume>64</volume><issue>2</issue><spage>256</spage><epage>261</epage><pages>256-261</pages><issn>2151-464X</issn><eissn>2151-4658</eissn><abstract>Objective To compare the characteristics of female versus male gout patients and assess urate‐lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. Methods This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate‐lowering efficacy, which was defined as the proportion of subjects with sUA levels &lt;6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function. Results Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels &lt;6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate‐lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P &lt; 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea. Conclusion These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.</abstract><cop>Hoboken, USA</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>22052584</pmid><doi>10.1002/acr.20680</doi><tpages>6</tpages></addata></record>
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subjects Adolescent
Adult
Aged
Aged, 80 and over
Allopurinol - therapeutic use
Cardiovascular Diseases - epidemiology
Comorbidity
Febuxostat
Female
Gout - blood
Gout - drug therapy
Gout - epidemiology
Gout Suppressants - therapeutic use
Humans
Hyperuricemia - blood
Hyperuricemia - drug therapy
Illinois - epidemiology
Male
Metabolic Diseases - epidemiology
Middle Aged
Obesity - epidemiology
Retrospective Studies
Sex Factors
Thiazoles - therapeutic use
Treatment Outcome
Uric Acid - blood
Young Adult
title Women with gout: Efficacy and safety of urate‐lowering with febuxostat and allopurinol
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