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Executive Summary

Helsinki Heart Study patients taking Warner-Lambert's Lopid (gemfibrozil) experienced a heart attack rate approximately 14 percentage points lower than patients in the placebo group, according to results published in the Nov. 12 edition of The New England Journal of Medicine. "The total rate of cardiac end points [primarily fatal and nonfatal myocardial infarction and cardiac death] during the five-year study was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group," Frick, et al. noted. "The number of definite cardiac end points was 56 in the gemfibrozil group and 84 in the placebo group. Despite the fewer incidents of heart attacks, the Lopid group had a mortality rate higher than the placebo group -- 45 v. 42 deaths. "There were fewer deaths due to ischemic heart disease and more deaths due to violence, accidents and intracranial hemorrhage in the gemfibrozil group, but the differences were not statistically significant," the article states. The recently completed five-year, double-blind trial tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein (HDL) cholesterol and lowering levels non-HDL cholesterol with gemfibrozil in reducing the risk of coronary heart disease in 4,081 asymptomatic men aged 40-55. The study, the design of which was approved by FDA, was conducted at 37 centers. Participants, selected from an initial group of nearly 19,000, all had abnormal concentrations of blood lipids (non-HDL cholesterol at 200 mg/dl and above). Subjects were randomized into two groups -- one consisting of 2,051 received 600 mg of gemfibrozil twice daily and the remainder received placebo. Approximately 70% or 2,859 continued the trial through completion. "Gemfibrozil rapidly increased the HDL cholesterol level by more than 10%; this was followed by a small decline with time," the researchers noted. "The total cholesterol level was initially reduced by 11%, the level of LDL cholesterol by 10%, that of non-HDL cholesterol by 14%, and that of triglycerides by 43%; these changes were followed by a consistent level of total and of LDL cholesterol and a small increase in the triglyceride level during the last years of the trial." The rate of adverse effects were not significantly different between the two treatment groups, study results show. During the first year 11.3% of the subjects in the gemfibrozil group reported various moderate to severe upper gastrointestinal symptoms, compared to 7% in the placebo group. In subsequent years, the rates decreased to 2.4% and 1.2%, respectively. While noting that the difference in the number of surgical operations between the two groups was not significant, the researchers said that gemfibrozil "increases biliary cholesterol saturation in healthy persons and this may cause more gallstones and necessitate more cholecystectomies." The long-awaited Helsinki results are the key to Warner-Lambert's effort to expand Lopid's labeling. Lopid was originally approved in 1981 with the understanding that Warner-Lambert would undertake the epidemiological study. The firm has provided $37 mil. for the Phase IV study. At an Oct. 8 House hearing, Warner-Lambert Chairman Joseph Williams told the Judiciary/Courts Subcommittee that the company plans to submit all necessary documentation for a cholesterol-lowering, heart-disease prevention indication for Lopid 30-60 days following publication of the Helsinki results. At the same time, the company is trying to get Lopid's patent expiration extended from 1989 to 1994 ("The Pink Sheet" Oct. 12, p. 6).

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