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Statins Benefit Patients at Risk for Coronary Disease, Even When Cholesterol Levels Are Normal

Statin therapy provided protection against coronary disease-associated death in a large group of patients aged 40 to 80.

In the partly industry-funded Heart Protection Study, 20,536 British patients (75% male; age range, 40 to 80) with total cholesterol levels of at least 135 mg/dL (3.5 mmol/L) were randomized to receive simvastatin (40 mg daily) or placebo for 5 years. Enrollment criteria were histories of coronary disease, other occlusive arterial diseases, diabetes, or (in men aged 65 or older) treated hypertension.

Five-year all-cause mortality was significantly lower in the simvastatin group than in the placebo group (12.9% vs. 14.7%) -- a difference attributable mainly to a significantly lower coronary death rate. The simvastatin group also experienced significant reductions in nonfatal myocardial infarction (3.5% vs. 5.6%) and nonfatal stroke (3.6% vs. 4.9%). Simvastatin appeared to be effective regardless of age, sex, or initial cholesterol level. Because 17% of placebo patients also received nonstudy statins, the reductions may underestimate the true benefits.

In addition, all patients were randomized to receive daily vitamin E (600 mg), vitamin C (250 mg), and ß-carotene (20 mg), or matching placebos. Vitamin supplementation did not significantly reduce 5-year rates of fatal heart attack, stroke, cancer, or other major vascular events.

Comment: These findings expand the universe of patients for whom statin therapy should be considered. An editorialist notes that, in high-risk patients, aspirin, ß-blockers, angiotensin-converting-enzyme inhibitors, and lipid-lowering therapies each have been shown to lower risk for vascular events by about a quarter; together, these therapies might yield risk reductions approaching 75%. If smoking cessation and treatment for hypertension are added, then even larger risk reductions are possible. At the time of publication, the full text of the vitamin study and the editorial were available at http://www.thelancet.com/journal/vol360/iss9326/full/llan.360.9326.original_research.21714.1 and http://www.thelancet.com/journal/vol360/iss9326/full/llan.360.9326.editorial_and_review.21679.1 free of charge.

— Sir Brian Jarman, PhD, FRCP, FRCGP, FFPHM, FMedSci

Published in Journal Watch General Medicine July 30, 2002

Citation(s):

Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: A randomised placebo-controlled trial. Lancet 2002 Jul 6; 360:7-22.

• Medline abstract (Free)

Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20 536 high-risk individuals: A randomised placebo-controlled trial. Lancet 2002 Jul 6; 360:23-33.

• Medline abstract (Free)

Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002 Jul 6; 360:2-3.

• Medline abstract (Free)