AB0920 APPLICATION OF THE EULAR 2016 GUIDELINES FOR URATE-LOWERING THERAPY IN CLINICAL PRACTICE (DATA OF A SIX-MONTH PROSPECTIVE STUDY)

Abstract

Background:The EULAR 2016 guidelines on gout management provide for a consecutive regimen of urate-lowering medications; however, the possibility of reaching the target uric acid level when using the regimen has not been studied in clinical practice.Objectives:To assess the possibility of reaching the target uric acid level when following the EULAR 2016 guidelines on gout management with use of different xanthine oxidase inhibitors available in Russia.Methods:This monocentric prospective study included 83 gout patients (79 (95%) male and 4 (5%) female patients) with the mean age of 51.3±10.9 years old. The inclusion criterion was indications for urate-lowering therapy in accordance with the EULAR 2016 guidelines. The exclusion criteria were the following: absolute contraindications to all of the study drugs, GFR <30ml/min/1.73m2, and NYHA class III-IV heart failure.At urate-lowering therapy initiation, the patients were prescribed allopurinol with the starting dose of 100mg/day; the dose was titrated until the target uric acid level was reached (maximum up to 900mg/day), and in the patients with GFR between 30 and 60ml/min/1.73m2 – up to 300mg/day. In case of insufficient efficacy of allopurinol (unachieved target uric acid level of <360µmol/L, for the patients with severe gout of <300µmol/L) or development of adverse reactions, allopurinol was replaced with febuxostat with the starting dose of 80mg/day and dose titration up to 120mg/day if necessary. The laboratory tests included serum creatinine level, uric acid level, AST, ALT, creatine phosphokinase, glucose; clinical blood test. The following parameters were assessed: possibility of reaching the target uric acid level when following the suggested regimen, and frequency of development of adverse reactions when using allopurinol and febuxostat.Results:37 (45%) patients had the target uric acid level of <360µmol/L and 46 (55%) pts – of <300µmol/L. The recommended therapy regimen allowed 77 (93%) patients under study to reach their target uric acid level.The target uric acid level was achieved by 44 (53%) out of 79 patients on allopurinol, of whom 36 (82%) received 100-600mg/day, and 8 (18%) – 700-900mg/day. Of the patients with GFR of >60ml/min/1.73m2, 32 (73%) patients achieved their target uric acid level and of those with GFR <60ml/min/1.73m2 – so did 12 (27%).Then the patients on allopurinol with unachieved target uric acid level were prescribed febuxostat (in 30 (77%) cases because of inefficacy of the allopurinol therapy, in 9 (33%) patients because of their development of adverse reactions where 5 pts had a more than doubled level of transaminase (ALT, AST), 2 pts had skin itch and 2 pts had hives).In total, 39 patients received febuxostat, of whom 4 pts were with initial intolerance for allopurinol in past history, and 35 pts after therapy with maximum dose of allopurinol. A febuxostat dose of 80mg/day was associated with achievement of the target uric acid level in 14 (42%) patients and that of 120mg/day – in 19 (58%) patients, therefore, total 33 (85%) patients reached their target uric acid level. Four patients on febuxostat developed adverse reactions: 3 patients had a more than doubled serum transaminase level (ALT, AST) and 1 patient had hives. Also, an insignificant increase in the mean GFR was registered from 73±21.4ml/min/1.73m2 to 78.4±22.5ml/min/1.73m2 which did not differ between the two drugs.Conclusion:The recommended regimen of xanthine oxidase inhibitors in their maximal doses secures reaching the target uric acid level in 93% patients. In 47% patients, allopurinol in maximal doses (up to 900mg/day) does not significantly increase the possibility of reaching the target uric acid level, even though it demonstrates high tolerance.Disclosure of Interests:Maria Chikina: None declared, Maxim Elisеev Speakers bureau: Novartis, Menarini Group, Alium, Olga Sheliabina: None declared