Shin Anna, Choi Se Rim, Han Minji, Ha You-Jung, Lee Yun Jong, Lee Eun Bong, Kang Eun Ha
Division of Rheumatology Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Health Science and Technology, Graduate School of Convergence Science and Technology, Seoul National University.
Semin Arthritis Rheum. 2022 Oct;56:152080. doi: 10.1016/j.semarthrit.2022.152080. Epub 2022 Aug 3.
To re-evaluate comparative cardiovascular (CV) safety of febuxostat versus allopurinol among patients with gout following recent accumulated use of febuxostat.
Using 2011-2019 Korea National Health Insurance database, we conducted a cohort study comparing gout patients initiating febuxostat versus allopurinol, 1:1 matched on a propensity-score (PS) for >60 covariates. The primary outcome was a composite endpoint of myocardial infarction, coronary revascularization, and stroke. Secondary outcomes were individual components of the primary outcome, hospitalized heart failure, and all-cause mortality. Subgroup analyses were done for those at high CV risk, long-term users (follow-up >3 years), and those without chronic kidney disease. We used Cox proportional hazard models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).
We included 160,930 PS-matched pairs of febuxostat and allopurinol users (mean age 59.3 years, 79.6% male). Incidence rates of the primary outcome were 2.06 and 2.27 per 100 person-years for febuxostat and allopurinol users, respectively, with a HR [95% CI] of 1.03 [0.95-1.12] comparing febuxostat versus allopurinol initiators. We also observed similar risks for secondary outcomes, except for reduced all-cause mortality among febuxostat users (HR [95% CI] of 0.84 [0.78-0.91]). Subgroup analyses also showed non-inferior CV safety of febuxostat.
In this population-based cohort study including the largest number of febuxostat users to date, we found non-inferior CV safety of febuxostat versus allopurinol. There was a 16% reduction in all-cause mortality among febuxostat users.
鉴于非布司他近期的累积使用情况，重新评估痛风患者中，非布司他与别嘌醇相比的心血管（CV）安全性。
利用2011 - 2019年韩国国民健康保险数据库，我们开展了一项队列研究，比较起始使用非布司他与别嘌醇的痛风患者，根据60多个协变量的倾向评分（PS）进行1:1匹配。主要结局是心肌梗死、冠状动脉血运重建和中风的复合终点。次要结局是主要结局的各个组成部分、住院心力衰竭和全因死亡率。对心血管风险高的患者、长期使用者（随访>3年）以及无慢性肾病的患者进行亚组分析。我们使用Cox比例风险模型来估计风险比（HRs）和95%置信区间（CIs）。
我们纳入了160,930对按PS匹配的非布司他和别嘌醇使用者（平均年龄59.3岁，79.6%为男性）。非布司他和别嘌醇使用者的主要结局发生率分别为每100人年2.06例和2.27例，比较起始使用非布司他与别嘌醇的患者，HR [95% CI]为1.03 [0.95 - 1.12]。我们还观察到次要结局的风险相似，但非布司他使用者的全因死亡率有所降低（HR [95% CI]为0.84 [0.78 - 0.91]）。亚组分析也显示非布司他的心血管安全性不劣。
在这项基于人群的队列研究中，纳入了迄今为止最多数量的非布司他使用者，我们发现非布司他与别嘌醇相比，心血管安全性不劣。非布司他使用者的全因死亡率降低了16%。
