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Xueya Cai, Dept. of Social and Preventive Medicine, State University of New York at Buffalo, 265 Farber Hall, Building 26, Buffalo, NY 14260, 585-260-8196, xueyacai@buffalo.edu, Yue Li, Department of Community and Preventive Medicine, University of Rochester, Medical Center, 601 Elmwood Avenue, Box 644, rochester, NY 14642, and Juanhong Gu, Deputy Manager of Medical Affairs, Fujisawa Hong Kong Ltd., Unit E-H, 16/F Century Bashi Building, 398 Huaihai Zhong Road, Shanghai, 200020, China.
[Background]: Simvastatin has a well-documented long-term efficacy and safety records for CHD patients of western population. Little such data, however, have been obtained in mainland China, and the common prescription dose there (5mg/day) is lower than the American's (20mg/day).
[Hypothesis]: In urban mainland China, simvastatin 20mg/day will reduce the low density lipoprotein-cholesterol (LDL-C) level for CHD patients with hyperlipidemia greater than simvastatin 5mg/day at the one-tailed 0.05 significance level.
[Methods]: CHD patients with hyperlipidemia aged 21-70 were recruited. Eligible patients were randomly assigned to one of the two simvastatin dose groups: the high dose group (20 mg/day) and the low dose group (5mg/day) after a washout period. Simvastatin was administered orally once a day in the evening in both groups. LDL-C level was collected at baseline and after 6 weeks' treatment for all patients. Bivariate test and multivariate modeling were performed for analysis.
[Results]: The mean percent decrease of LDL-C in the high dose group (n=79) was significantly greater than in the low dose group (n=84) in the bivariate analysis (38.91%±17.09% vs. 27.51%±17.16%, P=0.0001). After controlling baseline LDL-C, age, sex, bone mass density (BMI), baseline serum blood pressure (SBP) and the random center effect in the generalized linear model, the effect was still significant (F=13.90, P=0.0003). In addition, no clinically significant adverse event was found in the high dose group.
[Conclusions]: Higher dose of simvastatin(from 5mg/day to 20mg/day) is more efficacious, while as safe as before, in lowering LDL-C level for CHD patients with hyperlipidemia for mainland China population.
Learning Objectives: The participant will learn to
Keywords: Clinical Trails, Cholesterol
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.