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 10 mgof atorvastatin per day; 52 patients received 20mgof atorvastatin per day; and the remaining 53 patients received 40mgof 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-MantelHaenszel 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 endpointda low-density lipoprotein-cholesterol (LDL-C) response of > 100 mg/dL at Week 12dwas achieved in a dose-dependent manner. The percentage of patients improving to this level was higher in the 20 mg/day group (82%) and 40 mg/day group (82%) than in the 10 mg/day group (56%; p=0.002). The percentage of patients achieving the more aggressive LDL-C goal of > 70 mg/dL was 9.6%, 31.4%, and 47.1% in the 10 mg/day, 20 mg/day, and 40 mg/day groups, respectively (p < 0.001 in 10 mg/day vs. 20 mg/day; p < 0.001 in 10 mg/day vs. 40 mg/day). The co-primary endpointethe percent change from the baseline LDL-C levelealso increased in a dose-dependent manner: by 36.5% in the 10 mg/day group; by 44.7% in the 20 mg/day group, and by 49.3% in the 40 mg/day group. For every 10 mg 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. Copyright (C) 2013, Buddhist Compassion Relief Tzu Chi Foundation. Published by Elsevier Taiwan LLC. All rights reserved.