For the first time since statins have been regularly used, a large study has found that another type of cholesterol-lowering drug can protect people from heart attacks and strokes.
The finding can help millions at high risk of heart attacks who cannot tolerate statins or do not respond to them sufficiently. And it helps clarify the role of LDL cholesterol, the dangerous form. Some had argued that statins reduced heart-attack risk not just by lowering LDL levels but also by reducing inflammation. The new study indicates that the crucial factor is LDL, and the lower, the better.
The six-year study, reported Monday at the annual meeting of the American Heart Association, involved 18,000 people who had had heart attacks or episodes of chest pain so severe they went to a hospital. They were randomly assigned to take a statin or a combination of a statin and the alternative drug to further reduce LDL levels.
Both groups ended up with very low LDL levels — those taking the statin, simvastatin, had an average LDL of 69, and those taking simvastatin and the other drug, ezetimibe, or Zetia, in a combination pill sold as Vytorin, had an average LDL of 54. No clinical trial had ever asked what happened when LDL levels get below 70 because, said Dr. Robert Califf, a Duke cardiologist and the study chairman, “many people were nervous about going this low and imagined a lot of possible toxicities.”
Statins lower LDL by preventing it from being made. Ezetimibe lowers LDL by preventing cholesterol from being absorbed in the gut.
The drugs were so effective that there were few cardiac events among the participants, but eventually a difference emerged: 6.4 percent fewer heart disease deaths, heart attacks, strokes, bypass surgery, stent insertion and severe chest pain leading to hospitalization in those assigned to take Vytorin.
The study found absolutely no side effects from ezetimibe — no excess cancer, no muscle aches no headaches, Califf said.
The study was sponsored by Merck, the maker of Vytorin, but the investigators had the right to publish what they wanted, with final say over what they wrote.
“Fantastic,” said Dr. Sekar Kathiresan of the Broad Institute and Massachusetts General Hospital who studies the genetics of heart disease but had no part in the study. “A truly spectacular result for patients.”
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