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Zocor

Clinical Pharmacology
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Clinical Pharmacology

In the Multicenter Anti-Atheroma Study, the effect of simvastatin on atherosclerosis was assessed by quantitative coronary angiography in hypercholesterolemic patients with coronary heart disease. In this randomized, double-blind, controlled study, patients were treated with simvastatin 20 mg/day or placebo. Angiograms were evaluated at baseline, two and four years. The co-primary study endpoints were mean change per-patient in minimum and mean lumen diameters, indicating focal and diffuse disease, respectively. Simvastatin significantly slowed the progression of lesions as measured in the Year 4 angiogram by both parameters, as well as by change in percent diameter stenosis. In addition, simvastatin significantly decreased the proportion of patients with new lesions and with new total occlusions.

Modifications of Lipid Profiles

Primary Hypercholesterolemia (Fredrickson type lla and llb)

ZOCOR has been shown to be highly effective in reducing total-C and LDL-C in heterozygous familial and non-familial forms of hypercholesterolemia and in mixed hyperlipidemia. A marked response was seen within 2 weeks, and the maximum therapeutic response occurred within 4-6 weeks. The response was maintained during chronic therapy. ZOCOR consistently and significantly decreased total-C, LDL-C, total-C/HDL-C ratio, and LDL-C/HDL-C ratio; ZOCOR also decreased TG and increased HDL-C (see Table 2).

TABLE 2
Mean Response in Patients with Primary Hypercholesterolemia and Combined (mixed) Hyperlipidemia
(Mean Percent Change from Baseline After 6 to 24 Weeks)


TREATMENT N TOTAL-C LDL-C HDL-C TG
Lower Dose Comparative Study
(Mean % Chanqe at Week 6)
ZOCOR 5 mg q.p.m. 109 -19 -26 10 -12
ZOCOR 10 mg q.p.m. 110 -23 -30 12 -15
Scandinavian Simvastatin Survival Study §
(Mean % Change at Week 6)
Placebo 2223 -1 -1 0 -2
ZOCOR 20 mg q.p.m. 2221 -28 -38 8 -19
Upper Dose Comparative Study ||
(Mean % Change Averaged at
Weeks 18 and 24)
ZOCOR 40 mg q.p.m. 433 -31 -41 9 -18
ZOCOR 80 mg q.p.m. 664 -36 -47 8 -24
Multi-Center Combined Hyperlipidemia Study
(Mean % Change at Week 6)
Placebo 125 1 2 3 -4
ZOCOR 40 mg q.p.m. 123 -25 -29 13 -28
ZOCOR 80 mg q.p.m. 124 -31 -36 16 -33
median percent change
mean baseline LDL-C 244 mg/dL and median baseline TG 168 mg/dL
§ mean baseline LDL-C 188 mg/dL and median baseline TG 128 mg/dL
|| mean baseline LDL-C 226 mg/dL and median baseline TG 156 mg/dL
mean baseline LDL-C 156 mg/dL and median baseline TG 391 mg/dL.
Brand Name: Zocor
Generic Name: Simvastatin
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