At the American Heart Association Scientific Sessions in Anaheim in November, 2001, results were reported from the Heart Protection Study (HPS) the largest cholesterol-lowering study yet conducted. HPS shows unequivocally that statins greatly benefit people who have a high risk of coronary artery disease - even if their original cholesterol levels are normal or low.
HPS enrolled 20,000 patients between the ages of 40 and 80 whose risk of heart disease was statistically high, but for whom there was little direct evidence that statins would be beneficial. Such patients included those without elevated cholesterol levels, women, the elderly, and diabetics. Patients were randomized to receive 40 mg of simvastatin daily (considered a high dose,) or placebo.
Summary of results:
After 5 1/2 years of treatment with either the statin or the placebo, the risk of heart attack and stroke had been reduced by one third in patients who received the statin.
Statins also significantly reduced the risk of developing angina, and the need for angioplasty, bypass surgery, and amputations.
HPS showed that statins benefit women, patients over 70 years of age, and diabetics.
All 20,000 patients were monitored carefully for signs of muscle toxicity or liver toxicity, and no differences were found between those receiving statins and those receiving placebo - despite the high doses used.
There was no evidence that patients suffered from cholesterol levels that were rendered "too low" by statins (a concern raised by prior, much smaller studies.)
The sheer size of this study renders these results highly significant from a statistical perspective, and justifies the authors' contention that HPS ought to change the worldwide practice of medicine regarding the use of statins. These drugs should probably be used in all patients with a high risk of coronary artery disease, regardless of whether their baseline cholesterol levels are elevated. Patients who fall into this category should make it a point to press their doctors on this issue.
