Zocor

[simvastatin]

Clinical Pharmacology
CLINICAL PHARMACOLOGY

The involvement of low-density lipoprotein cholesterol (LDL-C) in atherogenesis has been well-documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological studies have established that elevated plasma levels of total cholesterol (total-C), LDL-C, and apolipoprotein B (Apo B) promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of high-density lipoprotein cholesterol (HDL-C) and its transport complex, Apo A-I, are associated with decreased cardiovascular risk.

High plasma triglycerides (TG) and cholesterol-enriched TG-rich lipoproteins, including very-low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis. Elevated plasma TG are frequently found in a triad with low HDL-C and small LDL particles, as well as in association with non-lipid metabolic risk factors for CHD. As such, total plasma TG has not consistently been shown to be an independent risk factor for CHD. Furthermore, the independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.

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In the Scandinavian Simvastatin Survival Study (4S), the effect of improving lipoprotein levels with ZOCOR on total mortality was assessed in 4,444 patients with CHD and baseline total cholesterol (total-C) 212-309 mg/ dL (5. 5-8. 0 mmol/ L). The patients were followed for a median of 5.4 years. In this multicenter, randomized, double-blind, placebo-controlled study, ZOCOR significantly reduced the risk of mortality by 30% (11.5% vs 8.2%, placebo vs ZOCOR); of CHD mortality by 42% (8.5% vs 5.0%); and of having a hospital-verified non-fatal myocardial infarction by 37% (19.6% vs 12.9%). Furthermore, ZOCOR significantly reduced the risk for undergoing myocardial revascularization procedures (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty) by 37% (17.2% vs 11.4%) [see CLINICAL PHARMACOLOGY, Clinical Studies].

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