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在经皮冠状动脉介入治疗的实际患者中,中等强度阿托伐他汀与依折麦布联合治疗对比高强度阿托伐他汀单药治疗:评估RACING研究的可推广性

Combination therapy with moderate-intensity atorvastatin and ezetimibe vs. high-intensity atorvastatin monotherapy in patients treated with percutaneous coronary intervention in practice: assessing RACING generalizability.

作者信息

Lee Seung-Jun, Joo Jae Hong, Park Sohee, Kim Choongki, Choi Dong-Woo, Lee Yong-Joon, Hong Sung-Jin, Ahn Chul-Min, Kim Jung-Sun, Kim Byeong-Keuk, Ko Young-Guk, Choi Donghoon, Jang Yangsoo, Nam Chung-Mo, Hong Myeong-Ki

机构信息

Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.

Department of Preventive Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2025 Jan 11;10(8):676-685. doi: 10.1093/ehjcvp/pvad083.

Abstract

AIMS

Using rosuvastatin, the RACING (randomized comparison of efficacy and safety of lipid-lowering with statin monotherapy versus statin/ezetimibe combination for high-risk cardiovascular diseases) trial showed the beneficial effects of combining moderate-intensity statin with ezetimibe compared with high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease. This study investigated whether the beneficial effects of combination lipid-lowering therapy extend to patients treated with atorvastatin, not rosuvastatin, in daily clinical practice.

METHODS AND RESULTS

Using stabilized inverse probability of treatment weighting, a total of 31 993 patients who were prescribed atorvastatin after drug-eluting stent (DES) implantation were identified from a nationwide cohort database: 6215 patients with atorvastatin 20 mg plus ezetimibe 10 mg (combination lipid-lowering therapy) and 25 778 patients with atorvastatin 40-80 mg monotherapy. The primary endpoint was the 3-year composite of cardiovascular death, myocardial infarction, coronary artery revascularization, hospitalization for heart failure treatment, or non-fatal stroke in accordance with the RACING trial design. Combination lipid-lowering therapy was associated with a lower incidence of the primary endpoint (12.9% vs. 15.1% in high-intensity atorvastatin monotherapy; hazard ratio [HR] 0.81, 95% confidence interval [CI] 0.74-0.88, P < 0.001). Compared with high-intensity atorvastatin monotherapy, combination lipid-lowering therapy was also significantly associated with lower rates of statin discontinuation (10.0% vs. 8.4%, HR 0.81, 95% CI 0.73-0.90, P < 0.001) and new-onset diabetes requiring medication (8.8% vs. 7.0%, HR 0.80, 95% CI 0.70-0.92, P = 0.002).

CONCLUSION

In clinical practice, a combined lipid-lowering approach utilizing ezetimibe and moderate-intensity atorvastatin was correlated with favourable clinical outcomes, drug compliance, and a reduced incidence of new-onset diabetes requiring medications in patients treated with DES implantation. Trial registration:  ClinicalTrial.gov (NCT04715594).

摘要

目的

使用瑞舒伐他汀的RACING(高危心血管疾病他汀类单药治疗与他汀类/依折麦布联合降脂疗效和安全性的随机比较)试验表明,在动脉粥样硬化性心血管疾病患者中,与高强度他汀类单药治疗相比,中等强度他汀类药物与依折麦布联合使用具有有益效果。本研究调查了在日常临床实践中,联合降脂治疗的有益效果是否适用于接受阿托伐他汀而非瑞舒伐他汀治疗的患者。

方法和结果

使用稳定的治疗权重逆概率法,从全国队列数据库中识别出31993例药物洗脱支架(DES)植入后服用阿托伐他汀的患者:6215例服用阿托伐他汀20毫克加依折麦布10毫克(联合降脂治疗),25778例接受阿托伐他汀40 - 80毫克单药治疗。根据RACING试验设计,主要终点是3年心血管死亡、心肌梗死、冠状动脉血运重建、因心力衰竭治疗住院或非致死性卒中的复合终点。联合降脂治疗与主要终点发生率较低相关(高强度阿托伐他汀单药治疗组为15.1%,联合治疗组为12.9%;风险比[HR]0.81,95%置信区间[CI]0.74 - 0.88,P < 0.001)。与高强度阿托伐他汀单药治疗相比,联合降脂治疗还与较低的他汀类药物停药率(10.0%对8.4%,HR 0.81,95% CI 0.73 - 0.90,P < 0.001)和需要药物治疗的新发糖尿病发生率较低相关(8.8%对7.0%,HR 0.80,95% CI 0.70 - 0.92,P = 0.002)。

结论

在临床实践中,使用依折麦布和中等强度阿托伐他汀的联合降脂方法与良好的临床结果、药物依从性以及DES植入患者中需要药物治疗的新发糖尿病发生率降低相关。试验注册:ClinicalTrial.gov(NCT04715594)。

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