Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial
Objective To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function. Methods Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with n...
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| Veröffentlicht in: | Arthritis and rheumatism 2008-11, Vol.59 (11), p.1540-1548 |
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| creator | Schumacher, H. RALPH Becker, Michael A. Wortmann, Robert L. MacDonald, Patricia A. Hunt, Barbara Streit, Janet Lademacher, Christopher Joseph‐Ridge, Nancy |
| description | Objective
To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function.
Methods
Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once‐daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks.
Results
Significantly (P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels |
| doi_str_mv | 10.1002/art.24209 |
| format | Article |
| fullrecord | <record><control><sourceid>wiley_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1002_art_24209</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>ART24209</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3799-69d337f1f281c5cdf0a7be01d5920a96c199b00b1e67c7dd3ccec3e4891dcecf3</originalsourceid><addsrcrecordid>eNp1kc1uEzEUhS0EoqGw4AWQNyyQMq1_Mpkxu6gqEKkSEirrkX-uExfPeGSPCWHVR-gj8Sw8CW4SwYqVfa8_nXOvD0KvKbmghLBLGacLtmBEPEEzWjNREcrpUzQjhCwqXgt6hl6kdFdKxmv-HJ3RVjQ1X4oZ-nVtLegp4WCxBZV_hDTJCX-HmHLC0vsw5uiG4LEcDB691KACdgOOYLJ2wwYniLnHOcoJHvspq7uD4M5NW7zdj-U5Og29kweJTcjTe7zCrP19_7AD-DbH41YmwOv1eo5jQULvfoKZYxOy8lAo5d1Q6lHGMg_40tnEkEc8RSf9S_TMSp_g1ek8R18_XN9efapuPn9cX61uKs0bIaqlMJw3llrWUl1rY4lsFBBqasGIFEtNhVCEKArLRjfGcK1Bc1i0gppys_wcvTvq6hhSimC7Mbpexn1HSfeYQldS6A4pFPbNkR2z6sH8I0_fXoC3J0AmLb0ta2uX_nKMtAvaCFa4yyO3cx72_3fsVl9uj9Z_ACFKpbw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Schumacher, H. RALPH ; Becker, Michael A. ; Wortmann, Robert L. ; MacDonald, Patricia A. ; Hunt, Barbara ; Streit, Janet ; Lademacher, Christopher ; Joseph‐Ridge, Nancy</creator><creatorcontrib>Schumacher, H. RALPH ; Becker, Michael A. ; Wortmann, Robert L. ; MacDonald, Patricia A. ; Hunt, Barbara ; Streit, Janet ; Lademacher, Christopher ; Joseph‐Ridge, Nancy</creatorcontrib><description>Objective
To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function.
Methods
Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once‐daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks.
Results
Significantly (P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl compared with allopurinol (22%) and placebo (0%). A significantly (P < 0.05) higher percentage of subjects with impaired renal function treated with febuxostat 80 mg (4 [44%] of 9), 120 mg (5 [45%] of 11), and 240 mg (3 [60%] of 5) achieved the primary end point compared with those treated with 100 mg of allopurinol (0 [0%] of 10). Proportions of subjects experiencing any adverse event or serious adverse event were similar across groups, although diarrhea and dizziness were more frequent in the febuxostat 240 mg group. The primary reasons for withdrawal were similar across groups except for gout flares, which were more frequent with febuxostat than with allopurinol.
Conclusion
At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.</description><identifier>ISSN: 0004-3591</identifier><identifier>ISSN: 0893-7524</identifier><identifier>EISSN: 1529-0131</identifier><identifier>EISSN: 1529-0123</identifier><identifier>DOI: 10.1002/art.24209</identifier><identifier>PMID: 18975369</identifier><identifier>CODEN: ARCREG</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adult ; Aged ; Allopurinol - adverse effects ; Allopurinol - therapeutic use ; Biological and medical sciences ; Creatinine - blood ; Diseases of the osteoarticular system ; Dose-Response Relationship, Drug ; Double-Blind Method ; Febuxostat ; Female ; Gout - blood ; Gout - drug therapy ; Gout Suppressants - adverse effects ; Gout Suppressants - therapeutic use ; Humans ; Hyperuricemia - blood ; Hyperuricemia - drug therapy ; Inflammatory joint diseases ; Male ; Medical sciences ; Metabolic diseases ; Middle Aged ; Miscellaneous. Osteoarticular involvement in other diseases ; Other metabolic disorders ; Purines and pyrimidines (gout, hyperuricemia...) ; Thiazoles - adverse effects ; Thiazoles - therapeutic use ; Treatment Outcome ; Uric Acid - blood</subject><ispartof>Arthritis and rheumatism, 2008-11, Vol.59 (11), p.1540-1548</ispartof><rights>Copyright © 2008 by the American College of Rheumatology</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3799-69d337f1f281c5cdf0a7be01d5920a96c199b00b1e67c7dd3ccec3e4891dcecf3</citedby><cites>FETCH-LOGICAL-c3799-69d337f1f281c5cdf0a7be01d5920a96c199b00b1e67c7dd3ccec3e4891dcecf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.24209$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.24209$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20841792$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18975369$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schumacher, H. RALPH</creatorcontrib><creatorcontrib>Becker, Michael A.</creatorcontrib><creatorcontrib>Wortmann, Robert L.</creatorcontrib><creatorcontrib>MacDonald, Patricia A.</creatorcontrib><creatorcontrib>Hunt, Barbara</creatorcontrib><creatorcontrib>Streit, Janet</creatorcontrib><creatorcontrib>Lademacher, Christopher</creatorcontrib><creatorcontrib>Joseph‐Ridge, Nancy</creatorcontrib><title>Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial</title><title>Arthritis and rheumatism</title><addtitle>Arthritis Rheum</addtitle><description>Objective
To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function.
Methods
Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once‐daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks.
Results
Significantly (P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl compared with allopurinol (22%) and placebo (0%). A significantly (P < 0.05) higher percentage of subjects with impaired renal function treated with febuxostat 80 mg (4 [44%] of 9), 120 mg (5 [45%] of 11), and 240 mg (3 [60%] of 5) achieved the primary end point compared with those treated with 100 mg of allopurinol (0 [0%] of 10). Proportions of subjects experiencing any adverse event or serious adverse event were similar across groups, although diarrhea and dizziness were more frequent in the febuxostat 240 mg group. The primary reasons for withdrawal were similar across groups except for gout flares, which were more frequent with febuxostat than with allopurinol.
Conclusion
At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.</description><subject>Adult</subject><subject>Aged</subject><subject>Allopurinol - adverse effects</subject><subject>Allopurinol - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Creatinine - blood</subject><subject>Diseases of the osteoarticular system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Febuxostat</subject><subject>Female</subject><subject>Gout - blood</subject><subject>Gout - drug therapy</subject><subject>Gout Suppressants - adverse effects</subject><subject>Gout Suppressants - therapeutic use</subject><subject>Humans</subject><subject>Hyperuricemia - blood</subject><subject>Hyperuricemia - drug therapy</subject><subject>Inflammatory joint diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Middle Aged</subject><subject>Miscellaneous. Osteoarticular involvement in other diseases</subject><subject>Other metabolic disorders</subject><subject>Purines and pyrimidines (gout, hyperuricemia...)</subject><subject>Thiazoles - adverse effects</subject><subject>Thiazoles - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Uric Acid - blood</subject><issn>0004-3591</issn><issn>0893-7524</issn><issn>1529-0131</issn><issn>1529-0123</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1uEzEUhS0EoqGw4AWQNyyQMq1_Mpkxu6gqEKkSEirrkX-uExfPeGSPCWHVR-gj8Sw8CW4SwYqVfa8_nXOvD0KvKbmghLBLGacLtmBEPEEzWjNREcrpUzQjhCwqXgt6hl6kdFdKxmv-HJ3RVjQ1X4oZ-nVtLegp4WCxBZV_hDTJCX-HmHLC0vsw5uiG4LEcDB691KACdgOOYLJ2wwYniLnHOcoJHvspq7uD4M5NW7zdj-U5Og29kweJTcjTe7zCrP19_7AD-DbH41YmwOv1eo5jQULvfoKZYxOy8lAo5d1Q6lHGMg_40tnEkEc8RSf9S_TMSp_g1ek8R18_XN9efapuPn9cX61uKs0bIaqlMJw3llrWUl1rY4lsFBBqasGIFEtNhVCEKArLRjfGcK1Bc1i0gppys_wcvTvq6hhSimC7Mbpexn1HSfeYQldS6A4pFPbNkR2z6sH8I0_fXoC3J0AmLb0ta2uX_nKMtAvaCFa4yyO3cx72_3fsVl9uj9Z_ACFKpbw</recordid><startdate>20081115</startdate><enddate>20081115</enddate><creator>Schumacher, H. RALPH</creator><creator>Becker, Michael A.</creator><creator>Wortmann, Robert L.</creator><creator>MacDonald, Patricia A.</creator><creator>Hunt, Barbara</creator><creator>Streit, Janet</creator><creator>Lademacher, Christopher</creator><creator>Joseph‐Ridge, Nancy</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20081115</creationdate><title>Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial</title><author>Schumacher, H. RALPH ; Becker, Michael A. ; Wortmann, Robert L. ; MacDonald, Patricia A. ; Hunt, Barbara ; Streit, Janet ; Lademacher, Christopher ; Joseph‐Ridge, Nancy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3799-69d337f1f281c5cdf0a7be01d5920a96c199b00b1e67c7dd3ccec3e4891dcecf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Allopurinol - adverse effects</topic><topic>Allopurinol - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Creatinine - blood</topic><topic>Diseases of the osteoarticular system</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Febuxostat</topic><topic>Female</topic><topic>Gout - blood</topic><topic>Gout - drug therapy</topic><topic>Gout Suppressants - adverse effects</topic><topic>Gout Suppressants - therapeutic use</topic><topic>Humans</topic><topic>Hyperuricemia - blood</topic><topic>Hyperuricemia - drug therapy</topic><topic>Inflammatory joint diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic diseases</topic><topic>Middle Aged</topic><topic>Miscellaneous. Osteoarticular involvement in other diseases</topic><topic>Other metabolic disorders</topic><topic>Purines and pyrimidines (gout, hyperuricemia...)</topic><topic>Thiazoles - adverse effects</topic><topic>Thiazoles - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Uric Acid - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schumacher, H. RALPH</creatorcontrib><creatorcontrib>Becker, Michael A.</creatorcontrib><creatorcontrib>Wortmann, Robert L.</creatorcontrib><creatorcontrib>MacDonald, Patricia A.</creatorcontrib><creatorcontrib>Hunt, Barbara</creatorcontrib><creatorcontrib>Streit, Janet</creatorcontrib><creatorcontrib>Lademacher, Christopher</creatorcontrib><creatorcontrib>Joseph‐Ridge, Nancy</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Arthritis and rheumatism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schumacher, H. RALPH</au><au>Becker, Michael A.</au><au>Wortmann, Robert L.</au><au>MacDonald, Patricia A.</au><au>Hunt, Barbara</au><au>Streit, Janet</au><au>Lademacher, Christopher</au><au>Joseph‐Ridge, Nancy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial</atitle><jtitle>Arthritis and rheumatism</jtitle><addtitle>Arthritis Rheum</addtitle><date>2008-11-15</date><risdate>2008</risdate><volume>59</volume><issue>11</issue><spage>1540</spage><epage>1548</epage><pages>1540-1548</pages><issn>0004-3591</issn><issn>0893-7524</issn><eissn>1529-0131</eissn><eissn>1529-0123</eissn><coden>ARCREG</coden><abstract>Objective
To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function.
Methods
Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once‐daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks.
Results
Significantly (P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl compared with allopurinol (22%) and placebo (0%). A significantly (P < 0.05) higher percentage of subjects with impaired renal function treated with febuxostat 80 mg (4 [44%] of 9), 120 mg (5 [45%] of 11), and 240 mg (3 [60%] of 5) achieved the primary end point compared with those treated with 100 mg of allopurinol (0 [0%] of 10). Proportions of subjects experiencing any adverse event or serious adverse event were similar across groups, although diarrhea and dizziness were more frequent in the febuxostat 240 mg group. The primary reasons for withdrawal were similar across groups except for gout flares, which were more frequent with febuxostat than with allopurinol.
Conclusion
At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>18975369</pmid><doi>10.1002/art.24209</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0004-3591 |
| ispartof | Arthritis and rheumatism, 2008-11, Vol.59 (11), p.1540-1548 |
| issn | 0004-3591 0893-7524 1529-0131 1529-0123 |
| language | eng |
| recordid | cdi_crossref_primary_10_1002_art_24209 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adult Aged Allopurinol - adverse effects Allopurinol - therapeutic use Biological and medical sciences Creatinine - blood Diseases of the osteoarticular system Dose-Response Relationship, Drug Double-Blind Method Febuxostat Female Gout - blood Gout - drug therapy Gout Suppressants - adverse effects Gout Suppressants - therapeutic use Humans Hyperuricemia - blood Hyperuricemia - drug therapy Inflammatory joint diseases Male Medical sciences Metabolic diseases Middle Aged Miscellaneous. Osteoarticular involvement in other diseases Other metabolic disorders Purines and pyrimidines (gout, hyperuricemia...) Thiazoles - adverse effects Thiazoles - therapeutic use Treatment Outcome Uric Acid - blood |
| title | Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial |
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