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基于需要治疗的人数,不同 LDL 胆固醇水平的成年人使用降脂药物的获益和风险。

Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.

机构信息

Department of Epidemiology and Statistics, School of Public Health, Hebei Medical University, Shijiazhuang, China.

Hebei Key Laboratory of Environment and Human Health, Shijiazhuang, China.

出版信息

Am J Cardiovasc Drugs. 2024 Jul;24(4):557-568. doi: 10.1007/s40256-024-00651-7. Epub 2024 May 23.

Abstract

PURPOSE

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).

METHODS

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.

RESULTS

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].

CONCLUSION

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.

SYSTEMATIC REVIEW REGISTRATION

Registration: PROSPERO identifier number: CRD42023458630.

摘要

目的

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。

方法

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。

结果

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]。

结论

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。

系统评价注册

注册:PROSPERO 标识符号:CRD42023458630。

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