Heart Protection Study

Use of Simvastatin in “High Risk” Individuals

Overall Study Question

These investigators evaluated the benefit of treating “high risk” patients with simvastatin.

Patients

20,536 “high risk” patients (76% males, 29% at least 70 years of age). High risk was defined as patients with previous MI (41%) or CHD (24%), occlusive disease of non-coronary arteries (22%), diabetes (20%), treated hypertension (41%), PLUS a total cholesterol greater than 3.5 mmol/L. Patients could have a combination of these risk factors.

Treatment

Simvastatin 40 mg PO daily or placebo.

Duration

5 years.

Results

All deaths (%) Any major vascular event (%) Coronary events (%) Strokes (%)
Simvastatin 12.9 19.8 8.7 4.3
Placebo 14.7 25.2 11.8 5.7
Relative Risk Reduction 12 21 26 25
Absolute Risk Reduction 1.8 5.4 3.1 1.4
NNT/NNH over 5 years 56 19 32 71

Other results

Total cholesterol was lowered by 1.0 mmol/L on average.

Relative reductions in the primary endpoint were similar for patients regardless of sex, age, total/LDL/HDL levels, or whether or not they had had a previous MI, other CHD, CVD, PVD, or diabetes.

No differences were detected between groups for elevated liver enzymes, cancers, myopathies, fractures, or neuropsychiatric disorders.

How does this study contribute to the drug therapy of cardiovascular protection?

This study shows that simvastatin given to “high risk” patients, regardless of age or sex, or baseline cholesterol levels lowers the chance of cardiovascular events.

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