title: Diabetes and gout: efficacy and safety of febuxostat and allopurinol.
abstract: OBJECTIVE
  Assess influences of demographics and co-morbidities of gout patients with or without diabetes on safety and efficacy of urate-lowering agents.
  
  
  METHODS
  Post-hoc analysis of 312 diabetic and 1957 non-diabetic gout patients [baseline serum urate levels (sUA) ≥8.0 mg/dl] enrolled in a 6-month randomized controlled trial comparing urate-lowering efficacy (ULE) and safety of daily xanthine oxidase inhibitors (XOIs) febuxostat (40 mg or 80 mg) and allopurinol (200 mg or 300 mg). We compared baseline demographic, gout and co-morbid characteristics, ULE, and safety of XOI treatment in diabetic and non-diabetic gout patients. ULE was measured by the proportion of diabetic and non-diabetic patients in each treatment group achieving final visit sUA < 6.0 mg/dl. Safety was monitored throughout the trial.
  
  
  RESULTS
  Diabetic gout patients were older, more frequently female, and had longer gout duration. Co-morbidities were more frequent among diabetic patients: cardiovascular disease; impaired renal function; hyperlipidemia; and obesity (body mass index >30 kg/m²) (p < 0.001 for all comparisons). Febuxostat 80 mg ULE exceeded that of febuxostat 40 mg or allopurinol (p < 0.050) at all levels of renal function, achieving sUA goal range in the majority of diabetic and non-diabetic patients. Diabetics and non-diabetics reported self-limiting diarrhoea and URIs as the most common adverse events.
  
  
  CONCLUSIONS
  Despite higher co-morbidity rates in diabetic patients, febuxostat and allopurinol were safe in both groups at the doses tested. Febuxostat 80 mg achieved sUA <6.0 mg/dl more often than febuxostat 40 mg or allopurinol at commonly prescribed doses.
authors.affiliation: Pritzker School of Medicine, The University of Chicago, Chicago, IL, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Becker
authors.forename: P A
authors.initials: PA
authors.lastname: MacDonald
authors.forename: B J
authors.initials: BJ
authors.lastname: Hunt
authors.forename: R L
authors.initials: RL
authors.lastname: Jackson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000493:Allopurinol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D015331:Cohort Studies; D015897:Comorbidity; D048909:Diabetes Complications / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069465:Febuxostat; D005260:Female; D006073:Gout / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D006074:Gout Suppressants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D057194:Intention to Treat Analysis; D007668:Kidney / Q000503:physiopathology; D059012:Lost to Follow-Up; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology; D010352:Patient Dropouts; D051437:Renal Insufficiency / Q000453:epidemiology / Q000503:physiopathology; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014969:Xanthine Oxidase / Q000037:antagonists & inhibitors* / Q000378:metabolism; D055815:Young Adult
chemical_list: D004791:Enzyme Inhibitors; D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat; D000493:Allopurinol; D014969:Xanthine Oxidase
keywords: clinical trial; diabetes mellitus; drug utilisation