TIMI Study Group, Division of Cardiovascular Medicine, Harvard Medical School, Boston, MA, USA.
Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Lancet. 2020 Nov 21;396(10263):1637-1643. doi: 10.1016/S0140-6736(20)32332-1. Epub 2020 Nov 10.
The clinical benefit of LDL cholesterol lowering treatment in older patients remains debated. We aimed to summarise the evidence of LDL cholesterol lowering therapies in older patients.
In this systematic review and meta-analysis, we searched MEDLINE and Embase for articles published between March 1, 2015, and Aug 14, 2020, without any language restrictions. We included randomised controlled trials of cardiovascular outcomes of an LDL cholesterol-lowering drug recommended by the 2018 American College of Cardiology and American Heart Association guidelines, with a median follow-up of at least 2 years and data on older patients (aged ≥75 years). We excluded trials that exclusively enrolled participants with heart failure or on dialysis because guidelines do not recommend lipid-lowering therapy in such patients who do not have another indication. We extracted data for older patients using a standardised data form for aggregated study-level data. We meta-analysed the risk ratio (RR) for major vascular events (a composite of cardiovascular death, myocardial infarction or other acute coronary syndrome, stroke, or coronary revascularisation) per 1 mmol/L reduction in LDL cholesterol.
Data from six articles were included in the systematic review and meta-analysis, which included 24 trials from the Cholesterol Treatment Trialists' Collaboration meta-analysis plus five individual trials. Among 244 090 patients from 29 trials, 21 492 (8·8%) were aged at least 75 years, of whom 11 750 (54·7%) were from statin trials, 6209 (28·9%) from ezetimibe trials, and 3533 (16·4%) from PCSK9 inhibitor trials. Median follow-up ranged from 2·2 years to 6·0 years. LDL cholesterol lowering significantly reduced the risk of major vascular events (n=3519) in older patients by 26% per 1 mmol/L reduction in LDL cholesterol (RR 0·74 [95% CI 0·61-0·89]; p=0·0019), with no statistically significant difference with the risk reduction in patients younger than 75 years (0·85 [0·78-0·92]; p=0·37). Among older patients, RRs were not statistically different for statin (0·82 [0·73-0·91]) and non-statin treatment (0·67 [0·47-0·95]; p=0·64). The benefit of LDL cholesterol lowering in older patients was observed for each component of the composite, including cardiovascular death (0·85 [0·74-0·98]), myocardial infarction (0·80 [0·71-0·90]), stroke (0·73 [0·61-0·87]), and coronary revascularisation (0·80 [0·66-0·96]).
In patients aged 75 years and older, lipid lowering was as effective in reducing cardiovascular events as it was in patients younger than 75 years. These results should strengthen guideline recommendations for the use of lipid-lowering therapies, including non-statin treatment, in older patients.
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在老年患者中，降低 LDL 胆固醇治疗的临床获益仍存在争议。我们旨在总结 LDL 胆固醇降低疗法在老年患者中的证据。
在这项系统评价和荟萃分析中，我们检索了 MEDLINE 和 Embase 数据库，检索时间为 2015 年 3 月 1 日至 2020 年 8 月 14 日，无任何语言限制。我们纳入了心血管结局的随机对照试验，研究对象为推荐使用 LDL 胆固醇降低药物的患者，这些药物符合 2018 年美国心脏病学会和美国心脏协会指南，中位随访时间至少为 2 年，且有关于老年患者（年龄≥75 岁）的数据。我们排除了仅纳入心力衰竭或透析患者的试验，因为指南不建议在没有其他适应证的情况下对这些患者进行降脂治疗。我们使用标准化数据表单提取老年患者的数据。我们荟萃分析了 LDL 胆固醇每降低 1mmol/L 时主要血管事件（心血管死亡、心肌梗死或其他急性冠脉综合征、卒中和冠状动脉血运重建的复合事件）的风险比（RR）。
有 6 篇文章的数据纳入系统评价和荟萃分析，其中包括来自胆固醇治疗试验者协作荟萃分析的 24 项试验和另外 5 项单独的试验。在 29 项试验的 244090 例患者中，21492 例（8.8%）年龄至少为 75 岁，其中 11750 例（54.7%）来自他汀类药物试验，6209 例（28.9%）来自依折麦布试验，3533 例（16.4%）来自 PCSK9 抑制剂试验。中位随访时间从 2.2 年到 6.0 年不等。LDL 胆固醇降低显著降低了主要血管事件（n=3519）的风险，在 LDL 胆固醇每降低 1mmol/L 时，风险降低 26%（RR 0.74 [95%CI 0.61-0.89]；p=0.0019），与年龄小于 75 岁的患者相比，风险降低无统计学差异（0.85 [0.78-0.92]；p=0.37）。在老年患者中，他汀类药物（0.82 [0.73-0.91]）和非他汀类药物（0.67 [0.47-0.95]）治疗的 RR 均无统计学差异（p=0.64）。LDL 胆固醇降低对复合终点的每个组成部分都有获益，包括心血管死亡（0.85 [0.74-0.98]）、心肌梗死（0.80 [0.71-0.90]）、卒中和冠状动脉血运重建（0.80 [0.66-0.96]）。
在 75 岁及以上的患者中，降脂治疗在降低心血管事件方面与 75 岁以下的患者一样有效。这些结果应加强指南推荐，在老年患者中使用降脂治疗，包括非他汀类药物治疗。
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