AB1034 The urate-lowering effect of febuxostat 80 mg and 40 mg (80 MG FILM-COATED TABLETS SPLIT IN HALF) in gout patients in daily clinical practice. (12th June 2018)

• Record Type: Journal Article
• Authors: Flendrie, M.; van den Bemt, B.; Huiskes, V.; Hoefnagels, M.; van den Hoogen, F.
• Is Part Of: Annals of the rheumatic diseases. Volume 77(2018)Supplement 2
• Page Start: 1633
• Page End: 1633
• Publication Date: 2018-06-12
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2018-eular.5321
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: In Europe, the urate-lowering drug febuxostat for gout is registered in two strenghts, 80 mg and 120 mg, but not 40 mg. Starting 40 mg can sometimes be considered desirable, for instance for safety reasons. Splitting an 80 mg film-coated tablet in half is an option, but is off-label and might violate coating function and influence effectiveness and safety. Objectives: To investigate the urate-lowering effect and safety of starting febuxostat at 40 mg once daily (80 mg film-coated tablet split in half) in gout patients compared to 80 mg once daily. Methods: Single-centre retrospective study on all gout patients starting febuxostat 80 mg or 40 mg (80 mg film-coated tablets split in half). Patients characteristics were collected, as well as starting dose and starting date of febuxostat, follow-up time, adverse events (AEs), stop date and reason, serum urate (sU) and creatinin (sCreat) over time and relevant comorbidity. Patient characteristics were compared by Chi-square or T-test. Mean sU, percentual change from baseline and percentage of patients reaching targets (sU <0.36 or 0.30 mmol/L) were tested using the appropriate t-test. Results: 36 gout patients started febuxostat between April 1st 2012 and July 1st 2017. Twenty-three started on 80 mg and 13 on 40 mg once daily. Patient characteristics are shown in table 1. Table 2 shows mean sU at baseline and after start, percentage change in sU and percentage of patients reaching targets. Median follow-up time was 1.6 years (range 0–6.7); 1.4 y (0–6.7) resp. 1.9 (0.4–5.5) for 80 mg resp. 40 mg group. Figure 3 shows mean sU per group in the first year. 5 of 36 (14%) stopped during follow-up, all within 8 weeks after start and all because of AEs: diarrhoea (n=2, 40 mg and 80 mg), coronary syndrome (n=1, 80 mg), erectile dysfunction (n=1, 40 mg) and gout attacks (n=1, 40 mg). Other possible related AEs were dry mouth (n=1, 80 mg), elevated liver enzymes (n=1, 40 mg) and flushing (n=1, 40 mg). Conclusions: Both daily dosages febuxostat of 80 and 40 mg (80 mg film-coated tablets split in half) result in significant decline in sU levels within 12 weeks. A starting dose of 80 mg febuxostat appears more effective in reducing sU levels. Selection bias may be a problem. Disclosure of Interest: None declared