The cholesterol-lowering drug trials published in 2008-2009 were either negative (ENHANCE, SEAS, GISSI-HF, AURORA) or obviously biased and therefore not credible (JUPITER). How can we explain this wave of negative cholesterol-lowering drug trials? In this article, authors review and comment the results of these recent trials. It is also noteworthy that most cholesterol-lowering drug trials published between 2005 (the year of the Vioxx affair and of enforcement of new clinical trial regulations) and 2007 were also negative or ambiguous. Taken together, these recent trials, including those of 2008-2009, strongly suggest that the results of previous, highly positive trials with statins - particularly in the secondary prevention of coronary heart disease - published between 1994 and 2004 and that were used to issue guidelines for medical practitioners should be carefully re-examined by experts independent from the pharmaceutical industry. The next question would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality.
2010 Japan Society for Lipid Nutrition