Efficacy of Dyslipidemia Control by Combination Therapy with Rosuvastatin 10 Mg and Ezetimibe 10 Mg Compared with Rosuvastatin 20 Mg Monotherapy in Patients with Chronic Coronary Syndromes: A Randomized, Single-blind Controlled Trial.

An Viet Tran, Bao Lam Thai Tran, Nghia Minh Bui, Anh To Tan Le, Diem Thi Nguyen, Son Kim Tran, Toan Hoang Ngo
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Abstract

Background: Studies have shown the combination treatment effectiveness of using rosuvastatin and ezetimibe in patients with chronic coronary artery disease. Our study aim to evaluate the effectiveness of dyslipidemia treatment with the combination of rosuvastatin and ezetimibe 10mg in patients with chronic coronary artery disease compared with 20 mg rosuvastatin.

Objectives: To evaluate the effectiveness of dyslipidemia treatment with the target of LDL-c < 1.4 mmol/L between combination therapy with rosuvastatin 10 mg and ezetimibe 10 mg in patients with chronic coronary artery disease compared with monotherapy increasing the dose of rosuvastatin 20 mg in Vietnam.

Methods: A randomized controlled clinical trial, single-blind, parallel-group with a 1:1 randomized ratio in 103 outpatients with chronic coronary syndromes treated with rosuvastatin 10mg daily. Group A received the combination therapy with rosuvastatin 10 mg plus ezetimibe 10 mg daily, and group B received rosuvastatin 20 mg daily. The primary outcome was to assess the efficacy of low-density lipoprotein - cholesterol (LDL-c) control between rosuvastatin 10 mg plus ezetimibe 10 mg versus rosuvastatin 20 mg after 4 weeks and 8 weeks.

Results: After 8 weeks of intervention, the proportion of archived treatment target patients with LDL-c < 1.4 mmol/L in groups A and B was 69.2% and 44.2%, respectively (Risk ratio (RR) = 1.57, p < 0.01), 50% LDL reduction was 27.9% and 55.8%, respectively (RR = 2.00, p < 0.01), and archived both targets were 51.9% and 25.6% (RR = 2.03, p < 0.01).

Conclusion: Group A's LDL-c reduction effect and target achievement proportion (Rosuvastatin 10mg + Ezetimibe 10 mg) were significantly higher than Group B's (Rosuvastatin 20 mg). Both medication therapies were safe in patients, and the increased dose of monotherapy showed more side effects than the combination therapy.

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与瑞舒伐他汀 20 毫克单药治疗相比,瑞舒伐他汀 10 毫克和依折麦布 10 毫克联合治疗对慢性冠状动脉综合征患者控制血脂异常的疗效:一项随机、单盲对照试验。
背景:研究表明,慢性冠心病患者使用罗伐他汀和依折麦布联合治疗效果显著。我们的研究旨在评估罗伐他汀和依折麦布 10 毫克联合治疗慢性冠心病患者血脂异常的疗效,并与罗伐他汀 20 毫克进行比较:评估越南慢性冠心病患者使用罗伐他汀10毫克和依折麦布10毫克联合疗法与增加罗伐他汀20毫克剂量的单一疗法治疗以LDL-c<1.4毫摩尔/升为目标的血脂异常的有效性:随机对照临床试验,单盲,平行组,随机比例为1:1,103名慢性冠状动脉综合征门诊患者每天接受罗伐他汀10毫克治疗。A 组每天服用罗伐他汀 10 毫克加依折麦布 10 毫克的联合疗法,B 组每天服用罗伐他汀 20 毫克。主要结果是评估罗伐他汀10毫克加依折麦布10毫克与罗伐他汀20毫克在4周和8周后控制低密度脂蛋白胆固醇(LDL-c)的疗效:干预8周后,A组和B组LDL-c<1.4 mmol/L的存档治疗目标患者比例分别为69.2%和44.2%(风险比(RR)=1.57,P<0.01),LDL降低50%的患者比例分别为27.9%和55.8%(RR=2.00,P<0.01),存档治疗目标患者比例分别为51.9%和25.6%(RR=2.03,P<0.01):结论:A组(瑞舒伐他汀10毫克+依折麦布10毫克)的低密度脂蛋白胆固醇降低效果和达标率明显高于B组(瑞舒伐他汀20毫克)。两种药物疗法对患者都是安全的,增加剂量的单一疗法比联合疗法的副作用更大。
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