title: Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol.
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 <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.
  
  
  CONCLUSIONS
  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.
authors: University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA. schohan@medicine.bsd.uchicago.edu
authors: Saima
authors: S
authors: Chohan
authors: Michael A
authors: MA
authors: Becker
authors: Patricia A
authors: PA
authors: MacDonald
authors: Solomon
authors: S
authors: Chefo
authors: Robert L
authors: RL
authors: Jackson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000493:Allopurinol / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology; D015897:Comorbidity; D000069465:Febuxostat; D005260:Female; D006073:Gout / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D006074:Gout Suppressants / Q000627:therapeutic use*; D006801:Humans; D033461:Hyperuricemia / Q000097:blood / Q000188:drug therapy*; D007087:Illinois / Q000453:epidemiology; D008297:Male; D008659:Metabolic Diseases / Q000453:epidemiology; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology; D012189:Retrospective Studies; D012737:Sex Factors; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood; D055815:Young Adult
chemical_list: D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat; D014527:Uric Acid; D000493:Allopurinol