Diabetes and gout: efficacy and safety of febuxostat and allopurinol

M A Becker, P A MacDonald, B J Hunt, R L Jackson, M A Becker, P A MacDonald, B J Hunt, R L Jackson

Abstract

Aim: 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.

Trial registration: ClinicalTrials.gov NCT00430248.

Keywords: clinical trial; diabetes mellitus; drug utilisation.

© 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flow of diabetic gout patients randomized and receiving study drug in the CONFIRMS trial.
Figure 2
Figure 2
Achievement of sUA ap < 0.001 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in diabetic patients; bp < 0.001 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in non-diabetic patients; cp < 0.050 for comparison between diabetic and non-diabetic subjects receiving ALLO. (b) Patients with mild renal impairment: ap < 0.050 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in diabetic patients; bp < 0.001 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in non-diabetic patients; c2 patients with mild renal impairment received 200 mg ALLO. (c) Patients with moderate renal impairment: ap < 0.001 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in diabetic patients; bp < 0.050 for comparisons between FEB 80 mg and either FEB 40 mg or ALLO in non-diabetic patients; cp < 0.050 for comparison between diabetic and non-diabetic patients receiving FEB 40 mg; dp < 0.050 for comparison between diabetic and non-diabetic subjects receiving FEB 80 mg; e1 patient with moderate renal impairment received 300 mg ALLO.

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