药物组合而不是增加一种药物的剂量可以获得更大的疗效和更低的风险。因此，作为高强度他汀单药治疗的替代方案，中强度他汀联合依折麦布治疗可以有效降低LDL胆固醇浓度，同时减少不良反应。然而，需要来自随机试验的证据来比较长期临床结果。

共纳入3780例患者:1894例患者接受联合治疗组，1886例患者接受高强度他汀类药物单药治疗组。在联合治疗组73%、75%和72%的患者，以及高强度他汀单药治疗组55%、60%和58%的患者中，在1、2和3年的LDL胆固醇浓度低于70 mg/dL(均p＜0·0001)。观察到88例患者(4.8%)和150例患者(8.2%)因不耐受而停药或减少剂量(P＜ 0.0001)。

研究表明，在ASCVD患者中，在3年复合终点方面，中等强度他汀联合依折麦布治疗，不劣于高强度的他汀单药治疗，其低密度脂蛋白胆固醇浓度低于70mg/dL的患者比例较高，与不耐受相关的停药或减药的情况较少。

Abstract

Background: Drug combinations rather than increasing doses of one drug can achieve greater efficacy and lower risks. Thus, as an alternative to high-intensity statin monotherapy, moderate-intensity statin with ezetimibe combination therapy can lower LDL cholesterol concentrations effectively while reducing adverse effects. However, evidence from randomised trials to compare long-term clinical outcomes is needed.

Methods: In this randomised, open-label, non-inferiority trial, patients with atherosclerotic cardiovascular disease (ASCVD) at 26 clinical centres in South Korea were randomly assigned (1:1) to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint was the 3-year composite of cardiovascular death, major cardiovascular events, or non-fatal stroke, in the intention-to-treat population with a non-inferiority margin of 2·0%. This trial is registered with ClinicalTrials.gov, NCT03044665 and is complete.

Findings: Between Feb 14, 2017, and Dec 18, 2018, 3780 patients were enrolled: 1894 patients to the combination therapy group and 1886 to the high-intensity statin monotherapy group. The primary endpoint occurred in 172 patients (9·1%) in the combination therapy group and 186 patients (9·9%) in the high-intensity statin monotherapy group (absolute difference -0·78%; 90% CI -2·39 to 0·83). LDL cholesterol concentrations of less than 70 mg/dL at 1, 2, and 3 years were observed in 73%, 75%, and 72% of patients in the combination therapy group, and 55%, 60%, and 58% of patients in the high-intensity statin monotherapy group (all p<0·0001). Discontinuation or dose reduction of the study drug by intolerance was observed in 88 patients (4·8%) and 150 patients (8·2%), respectively (p<0·0001).

Interpretation: Among patients with ASCVD, moderate-intensity statin with ezetimibe combination therapy was non-inferior to high-intensity statin monotherapy for the 3-year composite outcomes with a higher proportion of patients with LDL cholesterol concentrations of less than 70 mg/dL and lower intolerance-related drug discontinuation or dose reduction.

Funding: Hanmi Pharmaceutical.

文章连接：https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00916-3/fulltext

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