TUESDAY, April 24, 2007 (HealthDay News) -- A major trial has dashed hopes that a new drug would reduce the incidence of death, heart attack and other major cardiac events in people with the persistent chest pain called angina.
The best that can be said is that the drug, called ranolazine, "takes its place as an effective anti-anginal," said Dr. David A. Morrow, an assistant professor of medicine at Harvard Medical School and lead author of a report on the trial, which is published in the April 25 issue of the Journal of the American Medical Association.
Even then, ranolazine will not be the first drug used for the treatment of angina, said Dr. L. Kristin Newby, an associate professor of medicine at Duke University, who wrote an accompanying editorial.
"Beta blockers are first-line," Newby said. "But every day in practice, we see patients who have side effects to beta blockers. Having this option could have a major effect on how we treat patients."
The results are important to the estimated 5 million to 6 million Americans who suffer from angina, chest pain caused by a reduction in blood supply to part of the heart muscle. The findings also follow the results of another major trial, which showed that angioplasty -- in which a balloon is threaded into a blocked artery and a thin metal tube called a stent inserted -- also does not reduce the incidence of death and major cardiac events for people with angina any more than drug therapy.
The net result of that trial was "to underscore the importance of medical [drug] therapy," including medicines such as beta blockers and ACE inhibitors that have been used for decades to control angina, said Dr. William Boden, leader of the angioplasty trial and chief of cardiology at Buffalo General Hospital.
In that respect, ranolazine remains important, because "it is the first new class of medications in the last 30 years" to prove effective in controlling angina pain, Boden said. "[It] gives us another arrow in our quiver."
The new trial may dispel lingering fears that ranolazine might be dangerous. "Small changes [noted] in heart rhythm raised safety fears," Morrow explained, but the drug "met all major safety endpoints."
The ranolazine trial involved more than 6,500 participants in 17 countries. It was funded by CV Therapeutics, which helped develop the medication.
While the drug did not reduce the incidence of major cardiac events, it did reduce patient angina by 23 percent in those who took it. It also allowed patients to cut back on about 17 percent of the other drugs that they had been taking, Morrow said.
Ranolazine "did not add significantly to our current standard of treatment for angina," Morrow said, but "it met all safety endpoints," with no increase in deaths or abnormal heart rhythms. The medication was also well-tolerated by those who took it, he added.
According to Boden, the results of the angioplasty and ranolazine trials "underscore medical therapy as the primary approach to angina" and "show the importance of treatment of patients to optimal targets."
The trials also provide more impetus for scientists to develop newer, better drugs for angina, Newby added.
"There is a lot of room and certainly an unmet need for other agents," she said.
There's more on treating angina at the American Heart Association.