Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
BMC Med. 2021 Jun 22;19(1):139. doi: 10.1186/s12916-021-02009-1.
Current evidence from randomized controlled trials on statins for primary prevention of cardiovascular disease (CVD) in older people, especially those aged > 75 years, is still lacking. We conducted a systematic review and meta-analysis of observational studies to extend the current evidence about the association of statin use in older people primary prevention group with risk of CVD and mortality.
PubMed, Scopus, and Embase were searched from inception until March 18, 2021. We included observational studies (cohort or nested case-control) that compared statin use vs non-use for primary prevention of CVD in older people aged ≥ 65 years; provided that each of them reported the risk estimate on at least one of the following primary outcomes: all cause-mortality, CVD death, myocardial infarction (MI), and stroke. Risk estimates of each relevant outcome were pooled as a hazard ratio (HR) with a 95% confidence interval (CI) using the random-effects meta-analysis model. The quality of the evidence was rated using the GRADE approach.
Ten observational studies (9 cohorts and one case-control study; n = 815,667) fulfilled our criteria. The overall combined estimate suggested that statin therapy was associated with a significantly lower risk of all-cause mortality (HR: 0.86 [95% CI 0.79 to 0.93]), CVD death (HR: 0.80 [95% CI 0.78 to 0.81]), and stroke (HR: 0.85 [95% CI 0.76 to 0.94]) and a non-significant association with risk of MI (HR 0.74 [95% CI 0.53 to 1.02]). The beneficial association of statins with the risk of all-cause mortality remained significant even at higher ages (> 75 years old; HR 0.88 [95% CI 0.81 to 0.96]) and in both men (HR: 0.75 [95% CI: 0.74 to 0.76]) and women (HR 0.85 [95% CI 0.72 to 0.99]). However, this association with the risk of all-cause mortality remained significant only in those with diabetes mellitus (DM) (HR 0.82 [95% CI 0.68 to 0.98]) but not in those without DM. The level of evidence of all the primary outcomes was rated as "very low."
Statin therapy in older people (aged ≥ 65 years) without CVD was associated with a 14%, 20%, and 15% lower risk of all-cause mortality, CVD death, and stroke, respectively. The beneficial association with the risk of all-cause mortality remained significant even at higher ages (> 75 years old), in both men and women, and in individuals with DM, but not in those without DM. These observational findings support the need for trials to test the benefits of statins in those above 75 years of age.
目前，关于他汀类药物在老年人（尤其是 > 75 岁人群）一级预防心血管疾病（CVD）的随机对照试验证据仍然缺乏。我们进行了一项系统评价和荟萃分析，以扩展目前关于他汀类药物在老年一级预防人群中使用与 CVD 和死亡率风险之间关联的证据。
从建库到 2021 年 3 月 18 日，我们在 PubMed、Scopus 和 Embase 中进行了检索。我们纳入了比较他汀类药物用于 > 65 岁老年人一级预防 CVD 的观察性研究（队列或巢式病例对照研究）；其中每个研究均报告了以下至少一项主要结局的风险估计值：全因死亡率、CVD 死亡、心肌梗死（MI）和卒中。使用随机效应荟萃分析模型，将每个相关结局的风险估计值汇总为风险比（HR）及其 95%置信区间（CI）。使用 GRADE 方法评价证据质量。
符合标准的有 10 项观察性研究（9 项队列研究和 1 项巢式病例对照研究；n = 815667）。总体合并估计表明，他汀类药物治疗与全因死亡率（HR：0.86 [95%CI 0.79 至 0.93]）、CVD 死亡率（HR：0.80 [95%CI 0.78 至 0.81]）和卒中（HR：0.85 [95%CI 0.76 至 0.94]）风险显著降低相关，但与 MI 风险无显著相关性（HR 0.74 [95%CI 0.53 至 1.02]）。即使在更高的年龄（> 75 岁；HR 0.88 [95%CI 0.81 至 0.96]）和男性（HR：0.75 [95%CI：0.74 至 0.76]）和女性（HR 0.85 [95%CI 0.72 至 0.99]）中，他汀类药物与全因死亡率风险的有益关联仍然显著。然而，这种与全因死亡率风险的关联仅在患有糖尿病（DM）的患者中（HR 0.82 [95%CI 0.68 至 0.98]）显著，但在无 DM 的患者中不显著。所有主要结局的证据质量均被评为“极低”。
对于无 CVD 的老年人（≥ 65 岁），他汀类药物治疗与全因死亡率、CVD 死亡和卒中风险分别降低 14%、20%和 15%相关。即使在更高的年龄（> 75 岁）、男性和女性以及患有 DM 的患者中，他汀类药物与全因死亡率风险的有益关联仍然显著，但在无 DM 的患者中不显著。这些观察性研究结果支持需要进行试验来检验他汀类药物在 75 岁以上人群中的获益。
