BACKGROUND New National Institute for Health and Care Excellence (NICE) guidance endorses the prescription of statins in larger population groups for the prevention of cardiovascular and cerebrovascular morbidity and mortality, especially in people with severe mental illness. However, the evidence base for their safety and risk/benefit balance in depression is not established. OBJECTIVES This study aims to assess the real-world mortality and adverse events of statins in depressive disorders. METHODS Population-based, nationwide (England), between-subject, cohort study. We used electronic health records (QResearch database) of people aged 18-100 years with first-episode depression, registered with English primary care practices over January 1998-August 2020 for 12(+) months, divided into statin users versus non-users.Primary safety outcomes included all-cause mortality and any adverse event measured at 2, 6 and 12 months. Multivariable logistic regression was employed to control for several potential confounders and calculate adjusted ORs (aORs) with 99% CIs. FINDINGS From over 1 050 105 patients with depression (42.64% males, mean age 43.23±18.32 years), 21 384 (2.04%) died, while 707 111 (67.34%) experienced at least one adverse event during the 12-month follow-up. Statin use was associated with lower mortality over 12 months (range aOR2-12months 0.66-0.67, range 99% CI 0.60 to 0.73) and with lower adverse events over 6 months (range aOR2-6months 0.90-0.96, range 99% CI 0.91 to 0.99), but not at 1 year (aOR12months 0.99, 99% CI 0.96 to 1.03). No association with any other individual outcome measure (ie, any other neuropsychiatric symptoms) was identified. CONCLUSIONS We found no evidence that statin use among people with depression increases mortality or other adverse events. CLINICAL IMPLICATIONS Our findings support the safety of updated NICE guidelines for prescribing statins in people with depressive disorders.

中文翻译：

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初级保健抑郁症患者与他汀类药物使用相关的死亡率和不良事件：一项基于现实世界的人群队列研究。


背景 新的国家健康与护理卓越研究所 (NICE) 指南支持在较大人群中使用他汀类药物来预防心脑血管发病和死亡，特别是患有严重精神疾病的人群。然而，其治疗抑郁症的安全性和风险/效益平衡的证据基础尚未建立。目的 本研究旨在评估他汀类药物治疗抑郁症的现实死亡率和不良事件。方法 基于人群的全国性（英格兰）受试者间队列研究。我们使用了 18-100 岁首发抑郁症患者的电子健康记录（QResearch 数据库），这些患者在 1998 年 1 月至 2020 年 8 月期间在英国初级保健实践中注册了 12（+）个月，分为他汀类药物使用者和非使用者。主要安全性结局包括全因死亡率以及 2、6 和 12 个月时测量的任何不良事件。采用多变量逻辑回归来控制几个潜在的混杂因素，并计算调整后的 OR (aOR)，置信区间为 99%。结果 超过 1 050 105 名抑郁症患者（42.64% 为男性，平均年龄 43.23±18.32 岁）中，有 21 384 名患者（2.04%）死亡，而 707 111 名患者（67.34%）在 12 个月的随访期间经历了至少一种不良事件。向上。他汀类药物的使用与 12 个月内较低的死亡率相关（范围 aOR2-12 个月 0.66-0.67，范围 99% CI 0.60 至 0.73），并且与 6 个月内较低的不良事件相关（范围 aOR2-6 个月 0.90-0.96，范围 99% CI 0.91 至0.99），但 1 年时则不然（aOR12 个月 0.99，99% CI 0.96 至 1.03）。未发现与任何其他个体结果测量（即任何其他神经精神症状）相关。 结论 我们没有发现证据表明抑郁症患者使用他汀类药物会增加死亡率或其他不良事件。临床意义 我们的研究结果支持更新的 NICE 指南为抑郁症患者开他汀类药物的安全性。