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钠-葡萄糖协同转运蛋白 2 抑制剂与 2 型糖尿病患者痛风风险:一项使用 IQVIA 医疗研究数据英国数据库的倾向评分匹配、新用户设计研究,采用活性对照药物。

Sodium-glucose cotransporter-2 inhibitors and the risk of gout in patients with type 2 diabetes mellitus: A propensity-score-matched, new-user design study with an active comparator using the IQVIA Medical Research Data UK database.

机构信息

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.

出版信息

Diabetes Obes Metab. 2023 Jan;25(1):156-165. doi: 10.1111/dom.14858. Epub 2022 Sep 20.

Abstract

AIM

To conduct a pharmacoepidemiological study to explore the association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and gout in patients with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS

A retrospective open cohort study using the IQVIA Medical Research Data UK database was performed between November 1, 2012 and December 31, 2018, estimating the risk of gout in patients with T2DM who were new users of SGLT2 inhibitors, compared to propensity-score-matched new users of dipeptidyl peptidase-4 (DPP-4) inhibitors.

RESULTS

A total of 85 incident cases of gout were recorded over 30 389 person-years of observation in 13 617 new users of SGLT2 inhibitors and 29 426 new users of DPP-4 inhibitors. Crude incidence rates (IRs) per 1000 person-years were 2.90 and 2.47 for new users of SGLT2 inhibitors and DPP-4 inhibitors, respectively. The unadjusted hazard ratio (HR) was 1.18 (95% confidence interval [CI] 0.76-1.83). The adjusted HR was 1.20 (95% CI 0.77-1.86). In the at-treatment analysis, crude IRs per 1000 person-years were found to be 2.68 and 2.53 for SGLT2 inhibitor and DPP-4 inhibitor users, respectively. In the adjusted model, the adjusted HR was 1.3 (95% CI 0.90-2.29). Sensitivity analyses did not change the findings.

CONCLUSIONS

In this nationwide study, no difference in the incidence of gout was documented in patients treated with SGLT2 inhibitors compared to DPP-4 inhibitor users. This neutral finding remained consistent in sensitivity analyses.

摘要

目的

开展一项药物流行病学研究,以探讨钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂与 2 型糖尿病(T2DM)患者痛风之间的关联。

材料和方法

采用 IQVIA 医疗研究数据英国数据库,进行了一项回顾性开放队列研究,该研究于 2012 年 11 月 1 日至 2018 年 12 月 31 日期间进行,评估了 SGLT2 抑制剂新使用者与二肽基肽酶-4(DPP-4)抑制剂新使用者相比,T2DM 患者痛风风险。

结果

在 13617 例 SGLT2 抑制剂新使用者和 29426 例 DPP-4 抑制剂新使用者中,共记录到 30389 人年观察期间的 85 例痛风事件。新使用者的 SGLT2 抑制剂和 DPP-4 抑制剂的粗发病率(IR)分别为每 1000 人年 2.90 和 2.47。未调整的风险比(HR)为 1.18(95%置信区间[CI]0.76-1.83)。调整后的 HR 为 1.20(95%CI0.77-1.86)。在治疗期间分析中,发现 SGLT2 抑制剂和 DPP-4 抑制剂使用者的每 1000 人年粗发病率分别为 2.68 和 2.53。在调整模型中,调整后的 HR 为 1.3(95%CI0.90-2.29)。敏感性分析并未改变这些发现。

结论

在这项全国性研究中,与 DPP-4 抑制剂使用者相比,接受 SGLT2 抑制剂治疗的患者痛风发病率没有差异。敏感性分析也保持了这一中性发现。

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