University of British Columbia, Vancouver, BC, Canada.
Can J Cardiol. 2010 Feb;26(2):80-6. doi: 10.1016/s0828-282x(10)70003-9.
Despite an increasing body of evidence on the benefit of lowering elevated levels of low-density lipoprotein cholesterol (LDL-C), there is still considerable concern that patients are not achieving target LDL-C levels.
The CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) trial tested whether an algorithm-based statin dosing approach would enable patients to achieve LDL-C and total cholesterol/high-density lipoprotein cholesterol (TC/HDL-C) ratio targets quickly.
Subjects requiring statin therapy, but with an LDL-C level of 5.7 mmol/L or lower, and triglycerides of 6.8 mmol/L or lower at screening participated in the 12-week study, which had two open-label, six-week phases: a treatment period during which patients received 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin based on an algorithm incorporating baseline LDL-C value and cardiovascular risk; and patients who achieved both LDL-C and TC/HDL-C ratio targets at six weeks continued on the same atorvastatin dose. Patients who did not achieve both targets received dose uptitration using a single-step titration regimen. The primary efficacy outcome was the proportion of patients achieving target LDL-C levels after 12 weeks.
Of 2016 subjects screened at 88 Canadian sites, 1258 were assigned to a study drug (1101 were statin-free and 157 were statin-treated at baseline). The proportion of subjects who achieved LDL-C targets after 12 weeks of treatment was 86% (95% CI 84% to 88%) for statin-free patients and 54% (95% CI 46% to 61%) for statin-treated patients. Overall, 1003 subjects (80%; 95% CI 78% to 82%) achieved both lipid targets.
Algorithm-based statin dosing enables patients to achieve LDL-C and TC/HDL-C ratio targets quickly, with either no titration or a single titration.
尽管越来越多的证据表明降低升高的低密度脂蛋白胆固醇(LDL-C)水平有益,但仍有相当多的患者担心无法达到 LDL-C 目标水平。
CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration(CanACTFAST)试验旨在测试基于算法的他汀类药物剂量调整方法是否能够使患者快速达到 LDL-C 和总胆固醇/高密度脂蛋白胆固醇(TC/HDL-C)比值目标。
在筛查时,需要接受他汀类药物治疗但 LDL-C 水平为 5.7mmol/L 或更低且甘油三酯为 6.8mmol/L 或更低的患者参加了这项为期 12 周的研究,该研究分为两个开放标签的 6 周阶段:治疗期,在此期间,患者根据纳入基线 LDL-C 值和心血管风险的算法接受 10mg、20mg、40mg 或 80mg 的阿托伐他汀治疗;在 6 周时达到 LDL-C 和 TC/HDL-C 比值目标的患者继续使用相同剂量的阿托伐他汀。未达到两个目标的患者使用单一递增方案进行剂量递增。主要疗效结局是 12 周后达到 LDL-C 目标水平的患者比例。
在 88 个加拿大地点筛选的 2016 名患者中,1258 名患者被分配到研究药物组(1101 名患者在基线时未接受他汀类药物治疗,157 名患者在基线时接受他汀类药物治疗)。在他汀类药物治疗的患者中,12 周后达到 LDL-C 目标的患者比例为 86%(95%CI 84%至 88%),而在未接受他汀类药物治疗的患者中为 54%(95%CI 46%至 61%)。总体而言,1003 名患者(80%;95%CI 78%至 82%)达到了两个血脂目标。
基于算法的他汀类药物剂量调整方法可使患者快速达到 LDL-C 和 TC/HDL-C 比值目标,无论是不调整剂量还是仅进行一次调整。