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.
OBJECTIVE: 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).
CONCLUSIONS: 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.
OBJECTIVE: 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).
CONCLUSIONS: 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.
摘要：
背景：研究表明，瑞舒伐他汀和依泽替米贝联合治疗慢性冠状动脉疾病的有效性。我们的研究旨在评估瑞舒伐他汀和依折麦布10mg联合治疗慢性冠心病患者血脂异常的有效性，与20mg瑞舒伐他汀相比。
目的：评估瑞舒伐他汀10mg和依泽替米贝10mg联合治疗慢性冠心病患者的LDL-c<1.4mmol/L目标血脂异常治疗的有效性与在越南增加瑞舒伐他汀20mg剂量的单药治疗相比。
方法：一项随机对照临床试验，单盲,在接受瑞舒伐他汀10mg/天治疗的103例门诊慢性冠脉综合征患者中,随机比例为1:1的平行组。A组接受瑞舒伐他汀10mg加依泽替米贝10mg/天联合治疗，B组接受瑞舒伐他汀20mg/d。主要结果是评估4周和8周后，瑞舒伐他汀10mg加依泽替米贝10mg与瑞舒伐他汀20mg之间低密度脂蛋白-胆固醇（LDL-c）控制的疗效。
结果：干预8周后，A组和B组中LDL-c<1.4mmol/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)，低密度脂蛋白减少50%，分别为27.9%和55.8%，分别为(RR=2.00，p<0.01)，存档的目标分别为51.9%和25.6%(RR=2.03，p<0.01)。
结论：A组的LDL-c降低效果和目标达成比例(瑞舒伐他汀10mg+依折麦布10mg)显著高于B组(瑞舒伐他汀20mg)。两种药物治疗对患者都是安全的，增加剂量的单一疗法比联合疗法显示出更多的副作用。
目的：评估瑞舒伐他汀10mg和依泽替米贝10mg联合治疗慢性冠心病患者的LDL-c<1.4mmol/L目标血脂异常治疗的有效性与在越南增加瑞舒伐他汀20mg剂量的单药治疗相比。
方法：一项随机对照临床试验，单盲,在接受瑞舒伐他汀10mg/天治疗的103例门诊慢性冠脉综合征患者中,随机比例为1:1的平行组。A组接受瑞舒伐他汀10mg加依泽替米贝10mg/天联合治疗，B组接受瑞舒伐他汀20mg/d。主要结果是评估4周和8周后，瑞舒伐他汀10mg加依泽替米贝10mg与瑞舒伐他汀20mg之间低密度脂蛋白-胆固醇（LDL-c）控制的疗效。
结果：干预8周后，A组和B组中LDL-c<1.4mmol/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)，低密度脂蛋白减少50%，分别为27.9%和55.8%，分别为(RR=2.00，p<0.01)，存档的目标分别为51.9%和25.6%(RR=2.03，p<0.01)。
结论：A组的LDL-c降低效果和目标达成比例(瑞舒伐他汀10mg+依折麦布10mg)显著高于B组(瑞舒伐他汀20mg)。两种药物治疗对患者都是安全的，增加剂量的单一疗法比联合疗法显示出更多的副作用。
