The lipid-lowering effect of atorvastatin in Taiwanese diabetic patients with hyperlipidemia

Objective: Patients with diabetes mellitus have an increased risk of coronary heart disease; however, many patients with diabetes remain untreated or undertreated for coronary heart disease risk factors. The incidence of type 2 diabetes is rapidly increasing in Taiwan. The aim of this study was to assess the lipid-lowering effects of atorvastatin in Taiwanese diabetic patients with hyperlipidemia. Materials and Methods: This 12-week open-label study, conducted at six hospitals in Taiwan, included 157 outpatients (aged 18-80 years old) with type 2 diabetes and concomitant hyperlipidemia. Individuals were randomized (1:1:1) to three dosage groups, as follows: 52 patients received 10mg of atorvastatin per day; 52 patients received 20mg of atorvastatin per day; and the remaining 53 patients received 40mg of atorvastatin per day. Treatment targets were established according to the recommendations of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III. The response was evaluated by Cochran-Mantel-Haenszel tests. The change from the baseline level of all lipid parameters and high-sensitivity C-reactive protein (hs-CRP) was determined through analysis of covariance and was assessed at each time point. Results: The primary endpoint-a low-density lipoprotein-cholesterol (LDL-C) response of >100mg/dL at Week 12-was achieved in a dose-dependent manner. The percentage of patients improving to this level was higher in the 20mg/day group (82%) and 40mg/day group (82%) than in the 10mg/day group (56%; p=0.002). The percentage of patients achieving the more aggressive LDL-C goal of >70mg/dL was 9.6%, 31.4%, and 47.1% in the 10mg/day, 20mg/day, and 40mg/day groups, respectively (p<0.001 in 10mg/day vs. 20mg/day; p<0.001 in 10mg/day vs. 40mg/day). The co-primary endpoint-the percent change from the baseline LDL-C level-also increased in a dose-dependent manner: by 36.5% in the 10mg/day group; by 44.7% in the 20mg/day group, and by 49.3% in the 40mg/day group. For every 10mg increase in dose, an estimated 4.0% reduction in LDL-C and 3.5% reduction in total cholesterol could be achieved. Triglyceride levels were also lowered, but there were no clinically meaningful changes in the level of high-density lipoprotein-cholesterol or in hs-CRP. Fasting glucose and glycosylated hemoglobin levels were not affected. Treatment-related adverse events were infrequent and mostly mild. Conclusion: Atorvastatin is an effective and safe treatment for hyperlipidemia in Taiwanese diabetic patients. Most patients taking the drug are able to achieve NCEP ATP III-recommended treatment targets without any measurable effects on glycemic control.