不同瑞舒伐他汀治疗方案强化降脂在心血管疾病高危患者中的有效性和安全性：一项非盲、随机、对照试验
The Effectiveness and Safety of Intensive Lipid-Lowering with Different Rosuvastatin-Based Regimens in Patients at High Cardiovascular Disease Risk: A Nonblind, Randomized, Controlled Trial.
作者信息
Lin Lili, Luo Sihua, Cai Kuan, Huang Huanliang, Liang Hao, Zhong Liqin, Xu Yunhong
机构信息
Fever Clinic, The Third Affiliated Hospital of Guangzhou Medical University, 510150 Guangzhou, Guangdong, China.
Department of Cardiology, The Third Affiliated Hospital of Guangzhou Medical University, 510150 Guangzhou, Guangdong, China.
出版信息
Rev Cardiovasc Med. 2023 Aug 1;24(8):222. doi: 10.31083/j.rcm2408222. eCollection 2023 Aug.
BACKGROUND
A statin alone or non-statins as add-ons have been introduced to intensive low-density lipoprotein cholesterol (LDL-C) -lowering therapy in patients at risk for high cardiovascular disease (CVD). The purpose of this study was to evaluate the effectiveness and safety of different rosuvastatin-based regimens for patients at high risk.
METHODS
Three hundred patients at high CVD risk were randomly assigned to the statin group (rosuvastatin, 20 mg/d), statin_EZ group (statin 10 mg/d + ezetimibe 10 mg/d), statin_pcsk group (statin 10 mg/d + alirocumab 75 mg/2 weeks) or combine3 group (statin 10 mg/d + ezetimibe 10 mg/d + alirocumab 75 mg/2 weeks). The primary outcome measure was cholesterol levels after 24 weeks of follow-up. Secondary outcomes included safety markers and the proportion of patients achieving the 70 mg/dL (1.8 mmol/L) target for LDL-C. A logistic regression model was performed to explore the factors affecting lipid target achievement.
RESULTS
The total cholesterol (TC) and LDL-C levels in the four groups after treatment were significantly lower than those before treatment. TC and LDL-C levels after treatment were significantly different among the four groups ( 0.05). The levels in both the combine3 and statin_pcsk9 groups were significantly lower than those in the statin and statin_EZ groups ( 0.05), but there was no significant difference between the combine3 and statin_pcsk9 groups. Fifty-one participants (69%) in the statin_pcsk9 group and 56 participants (78%) in the combine3 group achieved the target. Body mass index (BMI) and hypertensive status were related to LDL-C target achievement. The incidence of adverse events in the four groups was low.
CONCLUSIONS
The combination of a statin and a PCSK9 inhibitor was safe and more effective for the treatment of high-risk CVD patients, while the addition of ezetimibe was unable to significantly lower lipid levels any further. The rate of achieving the target was higher in patients with hypertension and a low BMI.
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trial Registry, Identifier: ChiCTR2200058389, Date of Registration: 2022-04-08.
背景
对于心血管疾病（CVD）高危患者，已采用单独使用他汀类药物或加用非他汀类药物进行强化低密度脂蛋白胆固醇（LDL-C）降低治疗。本研究旨在评估不同的基于瑞舒伐他汀的治疗方案对高危患者的有效性和安全性。
方法
300例CVD高危患者被随机分配至他汀类药物组（瑞舒伐他汀，20mg/d）、他汀类药物_EZ组（他汀类药物10mg/d +依折麦布10mg/d）、他汀类药物_pcsk组（他汀类药物10mg/d +阿利西尤单抗75mg/2周）或联合3组（他汀类药物10mg/d +依折麦布10mg/d +阿利西尤单抗75mg/2周）。主要结局指标为随访24周后的胆固醇水平。次要结局包括安全性指标以及达到LDL-C目标值70mg/dL（1.8mmol/L）的患者比例。采用逻辑回归模型探讨影响血脂目标达成的因素。
结果
治疗后四组的总胆固醇（TC）和LDL-C水平均显著低于治疗前。四组治疗后的TC和LDL-C水平存在显著差异（P<0.05）。联合3组和他汀类药物_pcsk9组的水平均显著低于他汀类药物组和他汀类药物_EZ组（P<0.05），但联合3组和他汀类药物_pcsk9组之间无显著差异。他汀类药物_pcsk9组的51名参与者（69%）和联合3组的56名参与者（78%）达到了目标。体重指数（BMI）和高血压状态与LDL-C目标达成有关。四组不良事件的发生率较低。
结论
他汀类药物与PCSK9抑制剂联合应用对高危CVD患者的治疗安全且更有效，而加用依折麦布并不能进一步显著降低血脂水平。高血压和低BMI患者的目标达成率更高。
临床试验注册
中国临床试验注册中心，标识符：ChiCTR2200058389，注册日期：2022年4月8日。
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