PMID- 22052584 OWN - NLM STAT- MEDLINE DCOM- 20120313 LR - 20151119 IS - 2151-4658 (Electronic) IS - 2151-464X (Linking) VI - 64 IP - 2 DP - 2012 Feb TI - Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. PG - 256-61 LID - 10.1002/acr.20680 [doi] AB - 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 <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 <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 < 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. CI - Copyright (c) 2012 by the American College of Rheumatology. FAU - Chohan, Saima AU - Chohan S AD - University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA. schohan@medicine.bsd.uchicago.edu FAU - Becker, Michael A AU - Becker MA FAU - MacDonald, Patricia A AU - MacDonald PA FAU - Chefo, Solomon AU - Chefo S FAU - Jackson, Robert L AU - Jackson RL LA - eng SI - ClinicalTrials.gov/NCT00102440 SI - ClinicalTrials.gov/NCT00174915 SI - ClinicalTrials.gov/NCT00430248 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - 0 (Gout Suppressants) RN - 0 (Thiazoles) RN - 101V0R1N2E (Febuxostat) RN - 268B43MJ25 (Uric Acid) RN - 63CZ7GJN5I (Allopurinol) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Allopurinol/*therapeutic use MH - Cardiovascular Diseases/epidemiology MH - Comorbidity MH - Febuxostat MH - Female MH - Gout/blood/*drug therapy/epidemiology MH - Gout Suppressants/*therapeutic use MH - Humans MH - Hyperuricemia/blood/*drug therapy MH - Illinois/epidemiology MH - Male MH - Metabolic Diseases/epidemiology MH - Middle Aged MH - Obesity/epidemiology MH - Retrospective Studies MH - Sex Factors MH - Thiazoles/*therapeutic use MH - Treatment Outcome MH - Uric Acid/blood MH - Young Adult EDAT- 2011/11/05 06:00 MHDA- 2012/03/14 06:00 CRDT- 2011/11/05 06:00 PHST- 2011/11/05 06:00 [entrez] PHST- 2011/11/05 06:00 [pubmed] PHST- 2012/03/14 06:00 [medline] AID - 10.1002/acr.20680 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.