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Executive Summary

LOPID ADVISORY COMMITTEE REVIEW WILL LOOK AT RELEVANCE OF CLOFIBRATE trial conducted by the World Health Organization (WHO). That study, published in 1978, found increased mortality with the previous generation lipid lowering agent. FDA will ask the committee at the Oct. 17 meeting to consider whether increased mortality might also be expected with Warner-Lambert's Lopid (gemfibrozil). Warner-Lambert's Helsinki Heart study, which is the basis for the company's NDA for the prevention of coronary heart disease, found that mortality in the Loppid group was not statistically different from the placebo group. Among FDA's list of questions to the committee, the agency asks: "Are the data from the Helsinke Heart Study adequate to conclude that the increases mortality observed in the WHO study [with clofibrate] might not also be observed with gemfibrozil if a large number of patients were treated . . . for prevention of coronary heart disease?" The FDA document indicates that the question of potential increased mortalilty is being raised, in part, because, part, because the Helsinki study "did not have the power to detect an increase in total mortality of the magnitude observed in the WHO study, which had 2.5 times as many patients in each group." Like the Lopid Helsinki study, the Who clofibrate (Ayerst's Atromid-S) study found a reduction in nonfatal coronary endpoints in the drug group. However, because of the increased mortality seen in the study, "it appeared that the risk of death outweighed the benefits of reduction in nonfatal coronary events, and, consequently, labeling for drugs of the fibrate class has emphasized reduction of triglycerides for prevention of pancreatitis," FDA notes. FDA points out that "gemfibrozil is a drug of the fibrate class, which shares many pharmacologic effects with clofibrate, including peroxisomal proliferation and carcinogencity in rodents,, similar effects on lipids in people, and probably increased lithogenicity of bile." The committee will also be asked to consider whether "the data from the Helsinki Heart Study [are] adequate to determine that the potential benefits are likely to out weigh the potential risks when gemfibrozil is used for prevention of coronary heart disease." FDA further is asking for advice on the patient population. The agency wants to know for which patients "gemfibrozil should be recommended." If approved for prevention of coronary heart disease, Lopid will receive a patent extension to Jan. 4, 1993. The Lopid extension, provided for under the recently enacted trade bill (The Pink Sheet" Aug. 22, "In Brief", is contingent upon FDA approving the new indication before July 4, 1989, when Loppid's patent expires.

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