Effects of high-dose Statin Versus low-dose statin plus Ezetimibe on Statin-Associated Muscle Symptoms & on reaching target LDL-C levels among elderly patients with atherosclerotic cardiovascular disease
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 582
研究概览
简要总结
High-intensity statin therapy reduces the risk of mortality and cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD). However, despite its benefits, recent guidelines suggest that moderate-intensity statins may be preferable to high-intensity statins for elderly patients owing to a higher risk of intolerance in this population. To investigated the incidence of statin-associated muscle symptoms (SAMS) and the effects on low-density lipoprotein cholesterol (LDL-C) levels in elderly patients with ASCVD receiving high-intensity statin monotherapy or moderate-intensity statin with ezetimibe single-pill combination therapy. In this prospective, multicenter, open-label trial in South Korea, we randomly assigned 561 patients (=70 years) with ASCVD. Enrollment occurred between June 2021, and September 2022, with final follow-up on March 2023. Participants were randomized in a 1:1 ratio to receive either moderate-intensity statin with ezetimibe single-pill combination therapy (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg) for six months The primary safety endpoint was the incidence of positive SAMS defined using the proposed statin myalgia clinical index scoring system within six months. The primary efficacy endpoint was achievement of target LDL-C (<70 mg/dL) level within six months. 561 patients (mean age 76.9 ± 4.8 years) were randomized to receive the single-pill combination therapy (n=279) or high-intensity statin monotherapy (n=282). The primary safety endpoint occurred in two patients (0.7%) in the single-pill combination therapy group and in 16 patients (5.7%) in the high-intensity statin monotherapy group (odds ratio [OR], 0.12; 95% confidence interval [CI], 0.03–0.53; p=0.005). Achievement of target LDL-C (primary efficacy endpoint) was similar in both groups (75.4% for single-pill combination therapy and 68.7% for high-intensity statin monotherapy; OR, 1.40; 95% CI, 0.93–2.12; p=0.110). Among elderly patients with ASCVD, moderate-intensity statin therapy with ezetimibe single-pill combination therapy resulted in lower risk of SAMS and similar reduction in LDL-C compared to high-intensity statin monotherapy.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 70(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) A person who is 70 years of age or older as of the date of consent
- •2) Arteriosclerotic cardiovascular disease (coronary artery disease, cerebrovascular disease, or peripheral vascular disease)
- •3) Subjects whose patients have agreed to the study plan and follow-up observation, and who have agreed in writing to the informed consent forms approved by the IRB/EC of the institution.
排除标准
- •1) Take statin or ezetemib within the last 4 weeks
- •2) In case of terminal kidney disease (eGFR<30 ml/min/1.73 m2)
- •3) If a heart operation or major surgery is planned within the next six months
- •4) Patients with chronic diseases such as severe lung disease and stroke with difficult activity
- •5) Patients with chronic inflammatory diseases requiring oral, intravenous, or intra-articular steroid treatment (Use of ointment, inhalants, or intra nasal steroids is permitted)
- •6) Cancer has been diagnosed within the past year or is currently undergoing chemotherapy
- •7) In the case of clinically significant abnormal findings that may infringe the safety of the study by determining the investigator identified in Screening visit, physical examination, blood test, or electrocardiogram test
- •8) Liver disease, bile obstruction, or liver enzyme level (ALT/AST) is more than three times the normal level
- •9) Subject has a disease with a life expectancy of not more than one year
- •10) If the procedures described in the study plan are not desired or compliance is not possible