Statin therapy primary prevention trials

RCTs supporting the benefits of fibrate therapy is not consistent. Gemfibrozil was used in the Helsinki Heart Study, a primary prevention trial in men with raised non-HDL-cholesterol [55], and the Veterans Administration HDL Intervention Trial, VAHIT, a secondary CVD prevention trial in men with low HDL-cholesterol and relatively normal LDL [56], These studies showed significant positive benefit for the drug overall and in diabetic subgroups. However, the populations studied in these trials also respond well to statin therapy [43], In the Bezafibrate Infarction Prevention Trial, a CVD secondary prevention trial [57], there was a trend... 

Because the above trials showed a >50% relative reduction in total mortality with ICD therapy, MADIT II used broader entry criteria for primary prevention of SCD, removing the criteria for NSVT and EPS 1,232 patients with a history of MI > 30 days prior and an EF < 30% were randomized to conventional therapy or ICD implantation [10]. Conventional therapy was comparable in both arms and included a high rate of use of beta blockers, angiotensin-converting enzyme inhibitors, and statins (over two thirds for all medications in both arms). The trial was stopped early at 20 months because the relative reduction in total mortality... 

Elevated serum cholesterol levels and in particular LDL-cholesterol levels are strongly associated with cardiovascular mortality across the spectrum of epidemiologic studies and pharmacologic intervention studies in primary and secondary prevention trials (Ligure 4.4). In the Cholesterol Treatment Trialists Collaborators meta-analysis of >90,000 patients studied in 14 randomized trials of statin therapy, a reduction in LDL cholesterol of 1 mmol/L (39 mg/dL) was associated with a 12% proportional reduction in all-cause mortality, predominantly driven by a 19% proportional reduction in cardiovascular mortality (45). Among patients with pre-existing heart disease there were 14 fewer deaths per 1000 participants per mmol LDL cholesterol reduction, as well as an approximately 25% reduction in major adverse cardiac events. 

Note that a number of the large-scale trials of the use of lipid-regulating drugs in primary or secondary prevention of cardiovascular events included patients with diabetes. A review of these subgroups concluded that statins were the drug of choice for lipid-lowering therapy in patients with type 2 diabetes and known coronary artery disease or other cardiovascular risk factors. There was no evidence to recommend one statin over another. ... 

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