A family of heart medicines, known as statins, muay prevent heart attack and stroke in many more people than previously thought. That is the conclusion of a very large study by British researchers that found the drugs might be safely given to people who are at risk for coronary events.
Researchers from the University of Oxford's Clinical Trial Service Unit wanted find out whether individuals at high risk of heart attack or stroke could be protected with statin drugs.
Researchers recruited 20,000 adults between the ages of 40 and 80 for the Heart Protection Study. Jane Armitage, the study's clinical coordinator, said "essentially, what we were interested in is whether, if you take a wide range of people, whether lowering cholesterol across the board is worthwhile. And this meant we took people even though they had average or below average levels (of cholesterol) if they were otherwise at risk."
Most of the participants suffered from diabetes, coronary artery disease or blocked blood vessels in their legs. Some had already suffered a stroke.
Dr. Armitage said the volunteers were randomly assigned to receive daily doses of simvastatin or dummy pills for five years. In the end, those who got the drug were one-third less likely to suffer either a heart attack or stroke, or require surgery to open blocked coronary arteries. The results of the study are published this week in "The Lancet."
Dr. Armitage thinks the findings will lead to more prescriptions being written for statin drugs. "We think it will probably triple the number of people who would be currently eligible for statins," she said. "I mean these things are not easy to estimate. But there are large numbers patients out there who are at risk who are not currently being treated."
These include women and the elderly, both of whom were included in large numbers in the Heart Protection Study, but whom Ms. Armitage said have been overlooked in other studies of statin drugs.
Doctors have long feared that cholesterol-lowering drugs increase the risk of a type of stroke known as hemorrhagic, or bleeding, stroke. Sidney Smith, a professor of cardiology at the University of North Carolina in Chapel Hill, said British researchers found otherwise. "There was no increase in hemorrhagic stroke, and an overall reduction in stroke. So, if you go to a country like China, where you have literally tens of millions of individuals at risk from stroke, and they have higher hemorrhagic stroke, we learn from this study that you can lower cholesterol and those patients are going to benefit from a reduction in stroke and not experience more hemorrhagic stroke."
Frank Sacks is a professor of medicine at Harvard Medical School in Boston and co-author of another landmark study on statins known as the CARE trial, which found them beneficial in diabetics with average cholesterol levels. Dr. Sacks said the British study extends the findings of previous studies, and demonstrates the safety of statin drugs. "I hope it will quell some of the fears that was generated among mostly patients but also some doctors about cerivastatin the Baycol problem," he said. "That was a particular statin drug that did have a safety problem where this study showed that simvastatin, like pravastatin, has a very, very safe profile for long term use."
Last month, the American College of Cardiology, the American Heart Association and the National Heart, Lung and Blood Institute issued a joint statement declaring statin drugs safe and urging doctors to continue to prescribe them. The action, along with the release of clinical guidelines, follows the reported death of a small number of patients taking Baycol.