Hypertension and dyslipidemia are important risk factors for cardiovascular disease. However, the clinical outcomes of fixed-dose combination (FDC) versus free-equivalent combination (FEC) of amlodipine and atorvastatin in the treatment of concurrent hypertension and dyslipidemia remain unknown. In this study, we included patients with newly diagnosed hypertension and dyslipidemia, without previously established cardiovascular disease, and treated with either FDC or FEC of amlodipine and atorvastatin were identified from the National Health Insurance Research Database of Taiwan and follow-up for 5 years. By using 1:1 propensity score matching, a total of 1756 patients were enrolled in this study. The composite of major adverse cardiovascular events, including all-cause mortality, myocardial infarction (MI), stroke, and coronary revascularization, occurred more frequently in the FEC group than in the FDC group (hazard ratio, 1.88; 95% confidence interval [CI], 1.42 to 2.5). Although the all-cause mortality did not differ (hazard ratio, 0.46; 95% CI, 0.36 to 1.59), the FEC group developed increased MI, stroke, and coronary revascularization (hazard ratio, 2.87; 95% CI, 1.07 to 7.68; hazard ratio, 1.97; 95% CI, 1.41 to 2.74; and hazard ratio, 2.44; 95% CI, 1.26 to 4.69, respectively). Furthermore, as an unexpected result, a higher risk to develop new-onset diabetes mellitus was observed with FEC regimens (hazard ratio, 2.19; 95% CI, 1.6 to 3.0). In conclusion, although the all-cause mortality did not differ between the two groups, the FDC regimen of amlodipine and atorvastatin improved clinical outcomes when compared to FEC in patients with newly diagnosed hypertension and dyslipidemia.

译文

高血压和血脂异常是心血管疾病的重要危险因素。然而,氨氯地平和阿托伐他汀的固定剂量组合 (FDC) 与自由等效组合 (FEC) 治疗并发高血压和血脂异常的临床结果仍然未知。在这项研究中,我们从台湾国家健康保险研究数据库中确定了新诊断的高血压和血脂异常,没有先前确定的心血管疾病,并接受了FDC或氨氯地平和阿托伐他汀的FEC治疗,并进行了5年的随访。通过使用1:1倾向评分匹配,本研究共招募了1756名患者。与FDC组相比,FEC组的主要不良心血管事件 (包括全因死亡率,心肌梗死 (MI),卒中和冠状动脉血运重建) 的发生率更高 (风险比,1.88; 95% 置信区间 [CI],1.42至2.5)。尽管全因死亡率没有差异 (风险比,0.46; 95% CI,0.36至1.59),但FEC组出现了MI,中风和冠状动脉血运重建 (风险比,2.87; 95% CI,1.07至7.68; 风险比,1.97; 95% CI,1.41至2.74; 和危险比,2.44; 95% CI,分别为1.26至4.69)。此外,作为意外的结果,使用FEC方案观察到发生新发糖尿病的较高风险 (风险比,2.19; 95% CI,1.6至3.0)。总之,尽管两组的全因死亡率没有差异,但与FEC相比,氨氯地平和阿托伐他汀的FDC方案在新诊断的高血压和血脂异常患者中改善了临床结局。

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