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Analytical Results for Women from Large Scale Clinical Trial MEGA Study Employing the Hypercholesterolemia Drug Mevalotin(R) Published Print E-mail
01 Feb 2008

Mevalotin(R) Lowers the Risk of Cardiovascular Disease for Postmenopausal Women

TOKYO, Japan | February 1, 2008 | In the January 29, 2008 issue of AHA journal Circulation,DAIICHI SANKYO COMPANY, LIMITED published the findings of the large scale clinical trial MEGA Study, conducted in Japan which showed that Mevalotin(R) (generic name:pravastatin sodium) is equally effective for treating postmenopausal women with hypercholesterolemia and no history of cardiovascular disease as it is for men. Before the study, it had not been determined how hypercholesterolemia treatments for women could reduce the risk of initial cardiovascular events such as myocardial infarction,angina and cerebral infarction.

The MEGA Study (Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese) was initiated in 1994 as a contract research project sponsored by the Japanese Ministry of Health, Labour and Welfare (the Ministry of Health and Welfare at the time). The study targeted 8000 hyperlipidemia patients indicating total cholesterol levels of 220-270 mg/dL, randomly assigned to a diet therapy alone group and a diet therapy plus Mevalotin® combination group testing effectiveness in primary prevention against cardiovascular disease over an average observation period of more than five years. The study was Japan’s first large scale randomized, controlled trial to test effectiveness in primary prevention against cardiovascular disease by lowering cholesterol.

The results are the analysis of data from 5,356 postmenopausal women who were the main patient group in the MEGA Study. By comparing the control group (diet therapy alone group) against the diet therapy plus Mevalotin(R)combination group, the following results were obtained:

-- Showed possible lowered risk of incidence of coronary heart diseases (CHD) such as myocardial infarction, angina and the incidence of cardiovascular events (CHD and cerebrovascular damage) for women equal to the effectiveness showed for men.

-- Higher clinical effectiveness of Mevalotin® shown with age.

The MEGA Study chair, Haruo Nakamura M.D., Ph.D. (National Defense Medical College, emeritus professor/director of the Mitsukoshi Health and Welfare Foundation) stated: “Through the many large scale clinical trials we conducted, the effectiveness of statins in cholesterol-lowering therapy in primary and secondary prevention against cardiovascular events in men and the effectiveness in secondary prevention in women were shown.”

“There has been a trend of increased incidence of cardiovascular disease for women in recent years, and the rate of female hypercholesterolemia patients receiving regular treatment is increasing. The fact that Mevalotin(R) has shown effectiveness in primary prevention against cardiovascular disease for postmenopausal women is very significant.In our aging society, my hope is that postmenopausal women over the age of 55 diagnosed with hyperlipidemia consult a doctor and receive treatment, so that they may live full, healthy lives” he added.

SOURCE: DAIICHI SANKYO COMPANY, LIMITED





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