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Abstract：
BACKGROUND: Hypertension and hypercholesterolemia are important risk factors for cardiovascular disease, and treatment with fixed-dose combination (FDC) regimens is recommended by current guidelines. However, the clinical outcomes of different FDC dosages remain unknown. This study aimed to examine the clinical outcomes of FDC regimens and the free combination of amlodipine and atorvastatin at different dosages.
RESULTS: Patients with concurrent hypertension and hypercholesterolemia treated daily with an FDC of 5 mg amlodipine and 10 mg atorvastatin (5/10 fixed group), and FDC of 5 mg amlodipine and 20 mg atorvastatin (5/20 fixed group), or free combination of 5 mg amlodipine and 20 mg atorvastatin (5/20 free group) were identified from the National Health Insurance Research Database of Taiwan. The primary outcome was the composite cardiovascular outcomes, including cardiovascular death, acute myocardial infarction, stroke, and coronary intervention. A total of 9095 patients were eligible for inclusion. The incidence of primary outcome per 1000 person-years was 16.6 in the 5/10 fixed group, 12.6 in the 5/20 fixed group, and 16.5 in the 5/20 free group (5/20 fixed versus 5/20 free: hazard ratio [HR], 0.76 [95% CI, 0.64-0.91]; 5/20 fixed versus 5/10 fixed: HR, 0.76 [95% CI, 0.63-0.90]).
CONCLUSIONS: Among patients with concomitant hypertension and hypercholesterolemia, treatment with an FDC of amlodipine and high-dose atorvastatin led to a lower risk of a composite of cardiovascular outcomes than treatment with the free combination or a similar FDC with a lower dose of atorvastatin.
RESULTS: Patients with concurrent hypertension and hypercholesterolemia treated daily with an FDC of 5 mg amlodipine and 10 mg atorvastatin (5/10 fixed group), and FDC of 5 mg amlodipine and 20 mg atorvastatin (5/20 fixed group), or free combination of 5 mg amlodipine and 20 mg atorvastatin (5/20 free group) were identified from the National Health Insurance Research Database of Taiwan. The primary outcome was the composite cardiovascular outcomes, including cardiovascular death, acute myocardial infarction, stroke, and coronary intervention. A total of 9095 patients were eligible for inclusion. The incidence of primary outcome per 1000 person-years was 16.6 in the 5/10 fixed group, 12.6 in the 5/20 fixed group, and 16.5 in the 5/20 free group (5/20 fixed versus 5/20 free: hazard ratio [HR], 0.76 [95% CI, 0.64-0.91]; 5/20 fixed versus 5/10 fixed: HR, 0.76 [95% CI, 0.63-0.90]).
CONCLUSIONS: Among patients with concomitant hypertension and hypercholesterolemia, treatment with an FDC of amlodipine and high-dose atorvastatin led to a lower risk of a composite of cardiovascular outcomes than treatment with the free combination or a similar FDC with a lower dose of atorvastatin.
摘要：
背景：高血压和高胆固醇血症是心血管疾病的重要危险因素，目前的指南建议采用固定剂量联合用药(FDC)方案进行治疗.然而,不同FDC剂量的临床结局尚不清楚.这项研究旨在检查FDC方案的临床结果以及氨氯地平和阿托伐他汀在不同剂量的自由组合。
结果：合并高血压和高胆固醇血症的患者每天使用5mg氨氯地平和10mg阿托伐他汀的FDC治疗（5/10固定组），和FDC的5毫克氨氯地平和20毫克阿托伐他汀（5/20固定组），或5mg氨氯地平和20mg阿托伐他汀的自由组合（5/20游离组）从台湾国家健康保险研究数据库中确定。主要结局是复合心血管结局，包括心血管死亡,急性心肌梗死,中风,冠状动脉介入治疗。共有9095名患者符合纳入条件。在5/10固定组中，每1000人年的主要结局发生率为16.6，5/20固定组中的12.6，在5/20自由组中为16.5（5/20固定与5/20自由：危险比[HR]，0.76[95%CI，0.64-0.91]；5/20固定与5/10固定：HR，0.76[95%CI，0.63-0.90]）。
结论：在合并高血压和高胆固醇血症的患者中，氨氯地平和高剂量阿托伐他汀的FDC治疗导致复合心血管结局的风险低于与较低剂量阿托伐他汀的自由组合或类似FDC治疗.
结果：合并高血压和高胆固醇血症的患者每天使用5mg氨氯地平和10mg阿托伐他汀的FDC治疗（5/10固定组），和FDC的5毫克氨氯地平和20毫克阿托伐他汀（5/20固定组），或5mg氨氯地平和20mg阿托伐他汀的自由组合（5/20游离组）从台湾国家健康保险研究数据库中确定。主要结局是复合心血管结局，包括心血管死亡,急性心肌梗死,中风,冠状动脉介入治疗。共有9095名患者符合纳入条件。在5/10固定组中，每1000人年的主要结局发生率为16.6，5/20固定组中的12.6，在5/20自由组中为16.5（5/20固定与5/20自由：危险比[HR]，0.76[95%CI，0.64-0.91]；5/20固定与5/10固定：HR，0.76[95%CI，0.63-0.90]）。
结论：在合并高血压和高胆固醇血症的患者中，氨氯地平和高剂量阿托伐他汀的FDC治疗导致复合心血管结局的风险低于与较低剂量阿托伐他汀的自由组合或类似FDC治疗.
