Chwen-Tzuei Changa, Jenn-Kuen Leeb, Jen-Der Linc, Yi-Jen Hungd, Rue-Tsuan Liue, Wen-Yi Shauf, Wayne Huey-Herng Sheug, h
a Division of Endocrinology and Metabolism, China Medical University Hospital, Taichung, Taiwan
b Division of Endocrinology and Metabolism, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
c Division of Endocrinology and Metabolism, Chang Gung University, Taoyuan, Taiwan
d Division of Endocrinology and Metabolism, Tri-Service General Hospital, Taipei, Taiwan
e Division of Endocrinology and Metabolism, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
f Medical Affairs Division, Pfizer Limited, New Taipei, Taiwan
g Division of Endocrinology and Metabolism, Taichung Veterans General Hospital, Taichung, Taiwan
h College of Medicine, National Yang Ming University, Taipei, Taiwan
Abstract
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 mg of atorvastatin per day; 52 patients received 20 mg of atorvastatin per day; and the remaining 53 patients received 40 mg 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 >100 mg/dL at Week 12—was 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 endpoint–the percent change from the baseline LDL-C level–also 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.
Keywords
Atorvastatin; Diabetes; Dyslipidemia; Hyperlipidemia; Treat to target
