Brown A S, Bakker-Arkema R G, Yellen L, Henley R W, Guthrie R, Campbell C F, Koren M, Woo W, McLain R, Black D M
Midwest Heart Research Foundation, Naperville, Illinois, USA.
J Am Coll Cardiol. 1998 Sep;32(3):665-72. doi: 10.1016/s0735-1097(98)00300-3.
This study compared the efficacy and safety of atorvastatin, fluvastatin, lovastatin, and simvastatin in patients with documented atherosclerosis treated to U.S. National Cholesterol Education Program (NCEP) recommended low-density-lipoprotein (LDL) cholesterol concentration (< or = 100 mg/dl [2.59 mmol/liter]).
For patients with advanced atherosclerosis, NCEP recommends lipid-lowering drug therapy if LDL cholesterol remains > or = 130 mg/dl (3.36 mmol/liter).
A total of 318 men or women with documented atherosclerosis and LDL cholesterol > or = 130 mg/dl (3.36 mmol/liter) and < or = 250 mg/dl (6.5 mmol/liter), and triglycerides < or = 400 mg/dl (4.5 mmol/liter) participated in this 54-week, multicenter, open-label, randomized, parallel-group, active-controlled, treat-to-target study. Patients were titrated at 12-week intervals until the LDL cholesterol goal was reached. Number of patients reaching target LDL cholesterol levels and dose to reach target were evaluated.
At the starting doses, atorvastatin 10 mg produced significantly greater decreases (p < 0.05) in plasma LDL cholesterol than the other treatments. Subsequently, the percentage of patients reaching goal at the starting dose was 32% for atorvastatin, 1% for fluvastatin, 10% for lovastatin and 22% for simvastatin. Atorvastatin-treated patients required a lower median dose than other treatments. Median doses at week 54 with the last available visit carried forward were atorvastatin 20 mg/day, fluvastatin 40 mg/day + colestipol 20 g/day, lovastatin 80 mg/day, simvastatin 40 mg/day.
A significantly greater number (p < 0.05) of patients with confirmed atherosclerosis treated with atorvastatin reached the target LDL cholesterol concentration at the starting dose than patients treated with fluvastatin or lovastatin, and significantly fewer (p < 0.05) patients treated with atorvastatin required combination therapy with colestipol to achieve target LDL cholesterol concentrations than all other statins tested.
本研究比较了阿托伐他汀、氟伐他汀、洛伐他汀和辛伐他汀在已确诊动脉粥样硬化且接受治疗以达到美国国家胆固醇教育计划（NCEP）推荐的低密度脂蛋白（LDL）胆固醇浓度（≤100mg/dl[2.59mmol/L]）的患者中的疗效和安全性。
对于晚期动脉粥样硬化患者，如果LDL胆固醇仍≥130mg/dl（3.36mmol/L），NCEP建议进行降脂药物治疗。
共有318名已确诊动脉粥样硬化且LDL胆固醇≥130mg/dl（3.36mmol/L）且≤250mg/dl（6.5mmol/L）、甘油三酯≤400mg/dl（4.5mmol/L）的男性或女性参与了这项为期54周的多中心、开放标签、随机、平行组、活性对照、达标治疗研究。患者每隔12周进行一次滴定，直至达到LDL胆固醇目标。评估达到目标LDL胆固醇水平的患者数量以及达到目标所需的剂量。
在起始剂量时，阿托伐他汀10mg使血浆LDL胆固醇降低的幅度显著大于其他治疗（p<0.05）。随后，起始剂量时达到目标的患者百分比，阿托伐他汀为32%，氟伐他汀为1%，洛伐他汀为10%，辛伐他汀为22%。阿托伐他汀治疗的患者所需的中位剂量低于其他治疗。在第54周最后一次可获得访视数据时的中位剂量分别为：阿托伐他汀20mg/天，氟伐他汀40mg/天+考来替泊20g/天，洛伐他汀80mg/天，辛伐他汀40mg/天。
与接受氟伐他汀或洛伐他汀治疗的患者相比，接受阿托伐他汀治疗的已确诊动脉粥样硬化患者在起始剂量时达到目标LDL胆固醇浓度的人数显著更多（p<0.05），并且与所有其他测试的他汀类药物相比，接受阿托伐他汀治疗的患者需要与考来替泊联合治疗以达到目标LDL胆固醇浓度的人数显著更少（p<0.05）。
