In their article “Carcinogenicity of lipid lowering drugs,” Newman and Hulley (1996) contend that “all members of the two most popular classes of lipidlowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animal exposure close to those prescribed to humans. [However,] evidence of carcinogenicity of lipid-lowering drugs from clinical trials in humans is inconclusive.” The results of clinical trials published by mid1996 indicated that the incidence of cancer (overall) was nearly identical after five years of follow-up in users of simvastatin and placebo (Scandinavian Simvastatin Survival Study Group, 1994) and in users of pravastatin and placebo (Shepherd et al., 1995), respectively. By “inconclusive,” Newman and Hulley no doubt were referring to the relatively small number of cancer cases identified in these studies (collectively, only about 200 in users of a statin), and especially to the much smaller number of cancers of individual sites. What do you believe was another important reason for their reluctance to accept the results of these well-done trials as assurance of no increased risk of cancer associated with long-term statin prophylaxis?
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