Department of Epidemiology and Statistics, School of Public Health, Hebei Medical University, Shijiazhuang, China.
Hebei Key Laboratory of Environment and Human Health, Shijiazhuang, China.
Am J Cardiovasc Drugs. 2024 Jul;24(4):557-568. doi: 10.1007/s40256-024-00651-7. Epub 2024 May 23.
The objective of this investigation is to examine the benefits and potential risks of these drugs in individuals by varying baseline low-density lipoprotein cholesterol (LDL-C) values, utilizing the concept of the number needed to treat (NNT).
We extensively searched electronic databases, such as PubMed, EMBASE, Cochrane, and Web of Science, up to 6 August 2023. Baseline LDL-C values were stratified into four categories: < 100, 100-129, 130-159, and ≥ 160 mg/dL. Risk ratios (RRs) and NNT values were computed.
This analysis incorporated data from 46 randomized controlled trials (RCTs), encompassing a total of 237,870 participants. The meta-regression analysis demonstrated an incremental diminishing risk of major adverse cardiovascular events (MACE) with increasing baseline LDL-C values. Statins exhibited a significant reduction in MACE [number needed to treat to benefit (NNTB) 31, 95% confidence interval (CI) 25-37], but this effect was observed only in individuals with baseline LDL-C values of 100 mg/dL or higher. Ezetimibe and PCSK9 inhibitors also were effective in reducing MACE (NNTB 18, 95% CI 11-41, and NNTB 18, 95% CI 16-24). Notably, the safety outcomes of statins and ezetimibe did not reach statistical significance, while the incidence of injection-site reactions with PCSK9 inhibitors was statistically significant [number needed to treat to harm (NNTH) 41, 95% CI 80-26].
Statins, ezetimibe, and PCSK9 inhibitors demonstrated a substantial capacity to reduce MACE, particularly among individuals whose baseline LDL-C values were relatively higher. The NNT visually demonstrates the gradient between baseline LDL-C and cardiovascular disease (CVD) risk.
Registration: PROSPERO identifier number: CRD42023458630.
本研究旨在通过基线低密度脂蛋白胆固醇（LDL-C）值的变化，利用需要治疗的人数（NNT）的概念，来考察这些药物在个体中的获益和潜在风险。
我们广泛检索了电子数据库，如 PubMed、EMBASE、Cochrane 和 Web of Science，检索时间截至 2023 年 8 月 6 日。将基线 LDL-C 值分为四个类别：<100、100-129、130-159 和≥160mg/dL。计算风险比（RR）和 NNT 值。
本分析纳入了来自 46 项随机对照试验（RCT）的数据，共计 237870 名参与者。荟萃回归分析显示，随着基线 LDL-C 值的增加，主要不良心血管事件（MACE）的风险呈递减趋势。他汀类药物可显著降低 MACE[获益需要治疗的人数（NNTB）31，95%置信区间（CI）25-37]，但这种效果仅见于基线 LDL-C 值为 100mg/dL 或更高的患者。依折麦布和 PCSK9 抑制剂也能有效降低 MACE[NNTB 18，95%CI 11-41 和 NNTB 18，95%CI 16-24]。值得注意的是，他汀类药物和依折麦布的安全性结果未达到统计学意义，而 PCSK9 抑制剂的注射部位反应发生率具有统计学意义[需要治疗的人数以产生伤害（NNTH）41，95%CI 80-26]。
他汀类药物、依折麦布和 PCSK9 抑制剂在降低 MACE 方面具有显著的效果，尤其是在基线 LDL-C 值相对较高的患者中。NNT 直观地展示了基线 LDL-C 与心血管疾病（CVD）风险之间的梯度关系。
注册：PROSPERO 标识符号：CRD42023458630。
