Cholesterol-Lowering Therapy: Evaluation of Clinical Trial by Scott M. Grundy

By Scott M. Grundy

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Subgroup analysis of recent statin trials provide strong support for benefit from intensive cholesterol-lowering therapy in diabetic patients (89,104,105). The decision to employ statin therapy in high-risk, primary prevention goes beyond absolute risk estimates. Both safety and costs of statin therapy must be taken into account. WOSCOPS and AFCAPS/TexCAPS (98,99) revealed a high level of safety of statins over the duration of the trials. This fact helps to justify their use in high-risk patients.

Drug trials were found to be more effective for reducing CHD incidence presumably because of a greater cholesterol lowering. 5%. lO). Effect of cholesterol intervention was not 18 Grundy uniform in all categories. For example, a trend toward a decrease in total mortality appeared to be greater in secondary than in primary prevention trials. Other meta-analyses were subsequently carried out. In 1992, Ravnskov (55) reported a combined analysis of all clinical trials of cholesterol-lowering therapy.

The study is based in the Netherlands, and will last 5 years. Three questions are being addressed: (1) whether hormone replacement therapy is more effective than placebo in preventing vascular events in postmenopausal women with established CHD; (2) whether simvastatin is more effective than placebo in reducing new vascular events; and (3) whether the combination of hormone replacement therapy + simvastatin is more effective than monotherapy . Primary endpoints will be major coronary events and coronary procedures.

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