Drug to Prevent First Heart Attack, Stroke Clears FDA Hurdle
May 1, 2000 (Washington) -- On Monday, an FDA advisory committee cleared the way for thousands of people at high risk of suffering a heart attack or stroke for the first time to take a drug that may help them beat the odds after experiencing such an event.
The drug, Altace, already is on pharmacy shelves, currently being used for the treatment of high blood pressure, heart failure, and to prevent repeat heart attacks in people who already have suffered one.
This important step was taken after the release of a study earlier this year, which found that Altace reduced the number of heart attacks, strokes, and deaths from heart disease by 25%. The study, which was paid for by the makers of the drug, was performed to look at the benefits of Altace or vitamin E in preventing heart attacks and strokes in people at high risk of suffering such events. It included more than 9,500 people over the age of 55. The study found no benefit of vitamin E.
"This is an outstanding trial," Robert M. Califf, MD, of Duke UniversityMedical Center in Durham, N.C., told WebMD following the vote.
As a testament to the robust results, the study was halted in March 1999, citing clear evidence that Altace reduced the overall risk of death by about 20%.
But some members of the advisory committee did question the results of the study and whether Altace had positive results for minorities. The question regarding minority populations was more difficult to answer. There were only 141 black participants and 155 Asian participants. It would be a considerable oversight not to mention this deficiency, committee members agreed.
The committee also questioned whether Altace prevented some of the adverse effects of diabetes like the manufacturer had claimed. For example, although the drug slowed kidney disease in diabetics, it clearly did not prevent it.
Safety, however, was not an issue. The most common treatment-related side effect was cough, which caused 7% of the group to withdraw from the trial.