Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Am J Cardiol. 2011 Mar 15;107(6):898-905. doi: 10.1016/j.amjcard.2010.11.009. Epub 2011 Jan 19.
The combination of fibrate and statin therapies may be a treatment option for women with multiple lipid abnormalities. We, therefore, initiated the present safety and efficacy analysis to address the paucity of such data in women with mixed dyslipidemia. A total of 1,393 women with mixed dyslipidemia (low-density lipoprotein [LDL] cholesterol ≥ 130 mg/dl, triglycerides [TG] ≥ 150 mg/dl, high-density lipoprotein [HDL] cholesterol <50 mg/dl), who had enrolled in any 1 of 3 randomized clinical trials, were evaluated. The eligible women were randomized to receive fenofibric acid plus a low- or moderate-dose statin (combination treatment); or low-, moderate-, or high-dose statin monotherapy; or fenofibric acid monotherapy. With low-dose combination treatment, the baseline HDL cholesterol level increased 20% and TG decreased 46% compared to an 8% HDL cholesterol increase and 20% TG decrease with low-dose statins alone. With the moderate-dose combination, the baseline HDL cholesterol increased 21% and TG decreased 44% compared to an 8% HDL cholesterol increase and 26% TG decrease with moderate-dose statins alone. The reduction in baseline LDL cholesterol with low-dose and moderate-dose combinations (37% and 39%, respectively) was comparable to the reduction with corresponding-dose statins (36% and 43%, respectively). High-dose statins decreased the baseline LDL cholesterol 47%; however, the increase in HDL cholesterol (9%) and decrease in TG (25%) were similar to the changes observed with lower doses of statins. The safety profiles of the combinations were comparable to those of the component therapies. In conclusion, these data suggest that a combination of fenofibric acid and a statin could be considered safe and efficacious for treating women with mixed dyslipidemia.
贝特类药物与他汀类药物联合治疗可能是多种血脂异常女性的治疗选择。因此，我们启动了本项安全性和疗效分析，以解决混合性血脂异常女性中此类数据不足的问题。共有 1393 名患有混合性血脂异常（低密度脂蛋白胆固醇 [LDL-C] ≥ 130mg/dl，甘油三酯 [TG] ≥ 150mg/dl，高密度脂蛋白胆固醇 [HDL-C] <50mg/dl）的女性入组了我们的 3 项随机临床试验中的任意 1 项，对其进行了评估。合格的女性被随机分为接受非诺贝特联合低或中剂量他汀（联合治疗）；或低、中或高剂量他汀单药治疗；或非诺贝特单药治疗。与低剂量联合治疗相比，低剂量组合治疗时基线 HDL-C 水平升高 20%，TG 降低 46%，而低剂量他汀单药治疗时 HDL-C 仅升高 8%，TG 降低 20%。与中剂量联合治疗相比，中剂量组合治疗时基线 HDL-C 升高 21%，TG 降低 44%，而中剂量他汀单药治疗时 HDL-C 仅升高 8%，TG 降低 26%。低剂量和中剂量联合治疗降低 LDL-C 的幅度（分别为 37%和 39%）与相应剂量他汀治疗降低 LDL-C 的幅度（分别为 36%和 43%）相当。高剂量他汀降低 LDL-C 幅度为 47%；然而，HDL-C 升高（9%）和 TG 降低（25%）与低剂量他汀治疗时观察到的变化相似。联合治疗的安全性与各组成部分的治疗相似。总之，这些数据表明，非诺贝特联合他汀类药物治疗混合性血脂异常的女性可能是安全有效的。
