Jafari Mahtab, Ebrahimi Ramin, Ahmadi-Kashani Mastaneh, Balian Harry, Bashir Mohammad
University of California, Irvine, UCI Medical Center--Division of Cardiology, Building 53, Route 81, Room 100, Orange, California 92868-4080, USA.
J Cardiovasc Pharmacol Ther. 2003 Jun;8(2):123-6. doi: 10.1177/107424840300800205.
Atorvastatin is a synthetic inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. In placebo-controlled trials, it has been shown to achieve significant dose-dependent reductions in low-density lipoprotein cholesterol, total cholesterol, and triglycerides. This trial compared the efficacy of daily atorvastatin administration with that of alternate-day dosing.
This was a randomized, prospective, nonblinded, controlled clinical trial. Fifty-four patients with low-density lipoprotein cholesterol of 100 to 200 mg/dL were enrolled. Baseline fasting lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), liver function tests (aspartate transaminase and alanine aminotransferase), and creatine kinase were drawn. Patients were randomized to three atorvastatin dose groups. Group I received 10 mg of atorvastatin every day, Group II received 10 mg every other day, and Group III received 20 mg every other day. After 6 weeks of treatment with atorvastatin, fasting lipid profiles, liver function tests, and creatine kinase concentrations were redrawn. Compliance to treatment was assessed at each visit.
Of the 54 patients enrolled, 46 completed the study. All three regimens significantly reduced total cholesterol and low-density lipoprotein cholesterol compared to baseline. No statistically significant differences existed between the three groups in regards to total, or a percentage, decrease in total cholesterol and low-density lipoprotein cholesterol at 6 weeks compared to baseline. All regimens were well tolerated and none of the patients had a significant elevation of liver enzymes or creatine kinase during the course of the study.
Alternate-day dosing of atorvastatin is an efficacious and safe alternative to daily dosing.
阿托伐他汀是3-羟基-3-甲基戊二酰辅酶A(HMG-CoA)还原酶的合成抑制剂。在安慰剂对照试验中,已证明其能显著降低低密度脂蛋白胆固醇、总胆固醇和甘油三酯,且呈剂量依赖性。本试验比较了阿托伐他汀每日给药与隔日给药的疗效。
这是一项随机、前瞻性、非盲法对照临床试验。纳入了54名低密度脂蛋白胆固醇水平在100至200mg/dL之间的患者。检测了基线空腹血脂谱(总胆固醇、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇和甘油三酯)、肝功能检查(天冬氨酸转氨酶和丙氨酸转氨酶)以及肌酸激酶。患者被随机分为三个阿托伐他汀剂量组。第一组每天服用10mg阿托伐他汀,第二组每隔一天服用10mg,第三组每隔一天服用20mg。用阿托伐他汀治疗6周后,再次检测空腹血脂谱、肝功能检查和肌酸激酶浓度。每次就诊时评估治疗依从性。
在纳入的54名患者中,46名完成了研究。与基线相比,所有三种治疗方案均显著降低了总胆固醇和低密度脂蛋白胆固醇。在6周时,与基线相比,三组在总胆固醇和低密度脂蛋白胆固醇的降低总量或降低百分比方面无统计学显著差异。所有治疗方案耐受性良好,在研究过程中没有患者出现肝酶或肌酸激酶的显著升高。
阿托伐他汀隔日给药是每日给药的一种有效且安全的替代方案。