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Executive Summary

LOPID MAY REDUCE RISK OF CORONARY HEART DISEASE BY 25% in initially healthy, middle-aged men with elevated serum cholesterol, according to estimates, based on the Helsinki Heart Study, appearing in the Aug. 5 Journal of the American Medical Association. The study, by Manninen et al., assessed both lipid responses and the reduction of coronary heart disease (CHD) incidents in the recently completed Helsinki Heart Study. "Increase of high-density lipoprotein (HDL) and decrease of low-density lipoprotein (LDL) cholesterol were statistically significantly related to decrease of CHD incidence," the article states. "The lipid changes contributed jointly to a 25% mean reduction of CHD risk. The reduction in CHD risk was associated with an increase in serum HDL cholesterol during the study in the gemfibrozil-treated group." An earlier analysis of the five-year, 4,081-patient Helsinki study found that Warner-Lambert's Lopid (gemfibrozil) increased HDL by more than 10% while reducing LDL and triglycerides by 10% and 43%, respectively. Results of that study were published in the Nov. 12 edition of The New England Journal of Medicine. However, the researchers found that decreasing triglyceride levels did not appear to have much of an effect on CHD risk. "Despite a substantial change in serum triglyceride levels, the association of this lipid fraction with the risk of CHD was weak and not statistically significant in the gemfibrozil group," the article notes. The study evaluated CHD in terms of specific cardiovascular endpoints, defined as either fatal or non-fatal myocardial infarction. A total of 140 endpoints were reported in the Helsinki Heart Study -- 84 in the placebo group and 56 in the gemfibrozil group. The Cox proportional hazards model was used to predict the estimated reduction in risk of CHD. "The estimated effects are not, however, very precise due to the relatively small number of endpoints in the gemfibrozil-treated group," the researchers cautioned. "Also, the changes in HDL values may reflect alterations in other factors related to atherosclerosis like intermediate-density lipoprotein. These changes also include platelet reactivity, plasma kallikrein metabolism and plasma kininogen levels." The company's changes of getting a 3-1/2 year patent extension for Lopid from the date of the cholesterol claim approval now appear certain due to the revival of the Trade Bill. After initially vetoing trade legislation that contained the patent extension provision, President Reagan recently announced plans to sign the bill on the second go-around. The bill has passed both houses of Congress. Lopid, which has worldwide sales of over $ 100 mil. in 1987, is scheduled to go off patent in 1989. Warner-Lambert submitted a supplemental NDA for Lopid in April seeking a heart attack prevention claim. The expanded indication is based primarily on results at the Helsinki Heart Study.

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