title: Comparative effectiveness of urate lowering with febuxostat versus allopurinol in gout: analyses from large U.S. managed care cohort.
abstract: BACKGROUND
  To assess the comparative effectiveness of febuxostat and allopurinol in reducing serum urate (sUA) levels in a real-world U.S. managed care setting.
  
  
  METHODS
  This retrospective study utilized 2009 to 2012 medical and pharmacy claims and laboratory data from a large U.S. commercial and Medicare Advantage health plan. Study patients had at least one medical claim with a diagnosis of gout, at least one filled prescription for febuxostat or allopurinol and at least one sUA measurement post-index prescription. Reduction in sUA was examined using propensity score-matched cohorts, matched on patient demographics (gender, age), baseline sUA, comorbidities, geographic region and insurance type.
  
  
  RESULTS
  The study sample included 2,015 patients taking febuxostat and 14,025 taking allopurinol. At baseline, febuxostat users had a higher Quan-Charlson comorbidity score (0.78 vs. 0.53; P <0.001), but similar age and gender distribution. Mean (standard deviation (SD)) sUA level following propensity score matching among treatment-naïve febuxostat vs. allopurinol users (n = 873 each) were: pre-index sUA, 8.86 (SD, 1.79) vs. 8.72 (SD, 1.63; P = 0.20); and post-index sUA, 6.53 (SD, 2.01) vs. 6.71 (SD, 1.70; P = 0.04), respectively. A higher proportion of febuxostat users attained sUA goals of <6.0 mg/dl (56.9% vs. 44.8%; P <0.001) and <5.0 mg/dl (35.5% vs. 19.2%; P <0.001), respectively. Time to achieve sUA goals of <6.0 mg/dl (346 vs. 397 days; P <0.001) and <5.0 mg/dl was shorter in febuxostat vs. allopurinol users (431 vs. 478 days; P <0.001), respectively. Similar observations were made for overall propensity score-matched cohorts that included both treatment-naïve and current users (n = 1,932 each).
  
  
  CONCLUSIONS
  Febuxostat was more effective than allopurinol at the currently used doses (40 mg/day for febuxostat in 83% users and 300 mg/day or lower for allopurinol in 97% users) in lowering sUA in gout patients as demonstrated by post-index mean sUA level, the likelihood of and the time to achieving sUA goals.
authors.affiliation: Medicine Service and Center for Surgical Medical Acute care Research and Transitions (C-SMART), Birmingham VA Medical Center, 700 South 19th Street, Birmingham, AL, 35233, USA. jassingh@uab.edu.|Department of Medicine at School of Medicine, University of Alabama, 1670 University Boulevard, Birmingham, AL, 35233, USA. jassingh@uab.edu.|Division of Epidemiology at School of Public Health, University of Alabama, 1665 University Boulevard, Birmingham, AL, 35233, USA. jassingh@uab.edu.|Department of Orthopedic Surgery, Mayo Clinic College of Medicine, 200 1st St SW, Rochester, MN, 55905, USA. jassingh@uab.edu.|University of Alabama, Faculty Office Tower 805B, 510 20th Street S, Birmingham, AL, 35294, USA. jassingh@uab.edu.
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Takeda Pharmaceuticals International, Inc., One Takeda Parkway, Deerfield, IL, 60015, USA. kasem08a@msn.com.
authors.forename: Kasem S
authors.initials: KS
authors.lastname: Akhras
authors.affiliation: Takeda Pharmaceuticals International, Inc., One Takeda Parkway, Deerfield, IL, 60015, USA. aki.shiozawa@takeda.com.
authors.forename: Aki
authors.initials: A
authors.lastname: Shiozawa
mesh_terms: D000368:Aged; D000493:Allopurinol / Q000627:therapeutic use*; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D003404:Creatinine / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000069465:Febuxostat / Q000627:therapeutic use*; D005260:Female; D006073:Gout / Q000175:diagnosis / Q000188:drug therapy*; D006074:Gout Suppressants / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics; D006278:Medicare / Q000191:economics; D012016:Reference Values; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States; D014527:Uric Acid / Q000097:blood
chemical_list: D006074:Gout Suppressants; D000069465:Febuxostat; D014527:Uric Acid; D000493:Allopurinol; D003404:Creatinine