Ferreira JP et al.Diabetes Obes Metab. 2022 Jan;24(1):135-141.
尿酸(UA)水平升高在2型糖尿病(T2D)患者中较常见,并与心血管风险增加有关。此外,尿酸水平升高会引发痛风性关节炎、肾结石等并发症。在EMPA-REG OUTCOME试验中主要评估依帕列净对糖尿病患者尿酸(UA)水平、抗痛风药物和痛风发作的影响,
该项研究纳入7020例患者,随机分为依帕列净组(10/20mg)或安慰剂组。与安慰剂相比依帕列净降低了血清UA水平,6607例未服用抗痛风药物的患者中,5.2%痛风发作或开始抗痛风治疗,依帕列净组为3.6%:风险比0.67 (95% CI 0.53, 0.85;P = 0.001)。
依帕列净减少了糖尿病患者UA水平和痛风发作。这些具有临床意义的发现扩大了依帕列净作为T2D患者潜在的抗痛风治疗方法的效用,超越了其公认的心肾功能益处。
Aim: To evaluate the effect of empagliflozin on uric acid (UA) levels, antigout medication and gout episodes in the EMPA-REG OUTCOME trial (NCT01131676).
Materials and methods: A total of 7020 patients with type 2 diabetes (T2D) were randomized to either empagliflozin (10 or 25 mg) or placebo. The effects of empagliflozin versus placebo on UA concentration were assessed using mixed linear models. A composite outcome of new prescription of antigout medication or gout episode was studied with Cox proportional hazards models.
Results: Empagliflozin reduced serum UA levels versus placebo: week 52 adjusted mean treatment difference = -0.37 (95% confidence interval [CI] -0.42, -0.31) mg/dL; this was more pronounced in patients with baseline UA ≥ 7.0 mg/dL versus <7.0 mg/dL: week 52 adjusted mean treatment difference = -0.56 (95% CI -0.68, -0.43) and -0.30 (95% CI -0.37, -0.24) mg/dL, respectively. Among 6607 patients not taking antigout medications at baseline, 5.2% had a gout episode or initiated antigout treatment versus 3.6% in the placebo and empagliflozin groups, respectively: hazard ratio 0.67 (95% CI 0.53, 0.85; P = 0.001). Both components of the composite outcome contributed to the reduction with empagliflozin in the composite. Risk reduction was similar with both empagliflozin doses.
Conclusions: Empagliflozin reduced UA levels and the composite of gout episodes or prescription of antigout medication. These clinically important findings expand the utility of empagliflozin as a potential antigout treatment in patients with T2D, beyond its well-established cardio-renal benefits
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