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Intensive Serum Urate Lowering With Oral Urate‐Lowering Therapy for Erosive Gout: A Randomized Double‐Blind Controlled Trial

医学 双盲 痛风 尿酸 内科学 随机对照试验 高尿酸血症 病理 安慰剂 替代医学
作者
Nicola Dalbeth,Anthony Doyle,Karen Billington,Greg Gamble,Paul Tan,Kieran Latto,Thrishila Parshu Ram,Ravi Narang,Rachel Murdoch,David Bursill,Borislav Mihov,Lisa K. Stamp,Anne Horne
出处
期刊:Arthritis & rheumatology [Wiley]
卷期号:74 (6): 1059-1069 被引量:24
标识
DOI:10.1002/art.42055
摘要

Objective To determine whether a therapeutic approach of intensive serum urate lowering results in improved bone erosion scores in patients with erosive gout. Methods We undertook a 2‐year, double‐blind randomized controlled trial of 104 participants with erosive gout who were receiving serum urate–lowering therapy orally and who had serum urate levels of ≥0.30 mmoles/liter at baseline. Participants were randomly assigned to either an intensive serum urate target of <0.20 mmoles/liter or a standard target of <0.30 mmoles/liter (considered the standard according to rheumatology guidelines). Oral serum urate–lowering therapy was titrated to target using a standardized protocol (with the maximum approved doses of allopurinol, probenecid, febuxostat, and benzbromarone). The primary end point was the total computed tomography (CT) bone erosion score. Outcome Measures in Rheumatology (OMERACT) gout core outcome domains were secondary end points. Results Although the serum urate levels were significantly lower in the intensive target group compared to the standard target group over the study period ( P = 0.002), fewer participants in the intensive target group achieved the randomized serum urate target level by year 2 (62% versus 83% of patients in the standard target group; P < 0.05). The intensive target group required higher doses of allopurinol (mean ± SD 746 ± 210 mg/day versus 497 ± 186 mg/day; P < 0.001) and received more combination therapy ( P = 0.0004) compared to the standard target group. We observed small increases in CT bone erosion scores in both serum urate target groups over 2 years, with no between‐group difference ( P = 0.20). OMERACT core outcome domains (gout flares, tophi, pain, patient's global assessment of disease activity, health‐related quality of life, and activity limitation) improved in both groups over 2 years, with no between‐group differences. Adverse event and serious adverse event rates were similar between the groups. Conclusion Compared to a serum urate target of <0.30 mmoles/liter, more intensive serum urate lowering is difficult to achieve with an oral urate‐lowering therapy. Intensive serum urate lowering leads to a high medication burden and does not improve bone erosion scores in patients with erosive gout.
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