NEW ORLEANS-- Just how do doctors figure out if a new drug for heart disease is effective? Most trials look at whether the drug reduces the number of deaths and heart attacks in group of patients taking it, compared to patients who don't.
But what if the drug turns a large heart attack, one that could potentially kill the patient, into a smaller heart attack that does less damage? Under the traditional way of testing medicines, the drug wouldn't be deemed effective, because it didn't reduce the number of heart attacks.
And that's far from an academic matter, say researchers at Duke University Medical Center, who argue that the way cardiology trials are conducted should be changed.
"Just counting the number of heart attacks may be the wrong way to measure a drug's effectiveness," says Dr. John Alexander, who prepared the results of his analysis for presentation Sunday at the annual scientific sessions of the American College of Cardiology.
"The fact that we may be able to reduce the size of myocardial infarction (MI) without necessarily reducing the incidence may be very important clinically," said Alexander, a cardiologist at the Duke Clinical Research Institute (DCRI).
Alexander based his findings on a close examination of data from the recently completed 10,948-patient PURSUIT trial of the drug eptifibatide (Integrilin), which was funded by the drug manufacturer, COR Therapeutics Inc., of San Francisco. He and his team found that while the drug slightly reduced the number of myocardial infarctions, it also reduced the size of MIs, possibly by converting larger ones into smaller ones.
Like many studies in heart disease, PURSUIT used the occurrence of an MI -- the death of heart muscle from the sudden loss of blood supply -- as a key part of the principal measurement of whether or not the patient benefited from the therapy. Since not all MIs are clear-cut, however, a committee of cardiologists not involved
Contact: Richard Merritt
Duke University Medical Center