An open-label, uncontrolled, prospective study of the effects of atorvastatin 10 mg on low-density lipoprotein cholesterol levels in chinese adults with coronary artery disease and hypercholesterolemia

Abstract

Background: A high level of low-density lipoprotein cholesterol (LDL-C) is a major risk factor for coronary artery disease (CAD). Evidence shows that lowering LDL-C improves the outcomes of patients with CAD. Atorvastatin is an established drug for the treatment of hypercholesterolemia. Objective: The purpose of this open-label, uncontrolled, prospective study was to assess the effectiveness of treatment with atorvastatin 10 mg/d for 18 weeks in achieving the target level of LDL-C (<2.6 mmol/L [<100 mg/dL]) established by the National Cholesterol Education Program (NCEP) (United States) for patients with established CAD and hypercholesterolemia. Methods: Chinese patients with CAD, hypercholesterolemia (defined as a baseline LDL-C level between 3.4 and 5.2 mmol/L [131–201 mg/dL]), and body mass index <30 kg/m 2 were eligible. Atorvastatin 10 mg/d was given to each patient for 18 weeks. Lipid profiles were checked at 6, 12, and 18 weeks. To assess the extent of the achievement of NCEP LDL-C target levels, patients were categorized into 3 groups retrospectively according to baseline LDL-C level: group 1, 3.4 to 4.0 mmol/L (131–154 mg/dL); group 2, 4.01 to 4.6 mmol/L (155–178 mg/dL); and group 3, 4.61 to 5.2 mmol/L (179–201 mg/dL). Results: A total of 63 patients (50 men, 13 women; mean age, 64.3 years) were enrolled. Significant decreases in total cholesterol (31.3% at week 18), LDL-C (42.9% at week 18), and triglycerides (21.8% at week 18) from baseline levels were found at 6, 12, and 18 weeks of treatment ( P < 0.001 for all). The changes in high-density lipoprotein cholesterol levels were nonsignificant. In group 1, 83.3% of patients met the target level of LDL-C; group 2, 87.5%; group 3, 37.5%; groups 1 and 2 combined, 85.2%. Atorvastatin 10 mg/d was well tolerated. Clinical adverse events were mild and transient; no severe adverse events were reported. One patient (1.6%) developed an elevated alanine aminotransferase level and withdrew. Sixty-two of 63 patients (98.4%) completed the study. Conclusions: In this group of Chinese patients with CAD and hypercholesterolemia treated with atorvastatin 10 mg/d for 18 weeks, 85.2% of patients with a baseline LDL-C level of 3.4 to 4.6 mmol/L achieved the NCEP target LDL-C level of <2.6 mmol/L, suggesting that atorvastatin 10 mg/d is efficacious in preventing secondary CAD.