EMBARGOED FOR RELEASE: 3 p.m. (CT) TUESDAY, JANUARY 21,
Media Advisory:
To contact Dennis T. Mangano, Ph.D., M.D., call 415/750 2069.
DRUG REDUCES ILLNESS AND DEATH AFTER HEART BYPASS SURGERY Acadesine treatment offers promising results for bypass patients
Treating heart bypass patients before and during surgery with a drug called acadesine can reduce heart attack, early cardiac death and other adverse cardiovascular outcomes such as stroke, according to an article in this week's issue of The Journal of the American Medical Association (JAMA).
Dennis T. Mangano, Ph.D., M.D., from San Francisco, Calif., and colleagues from The Multicenter Study of Perioperative Ischemia (McSPI) Research Group looked at the effects of acadesine on 4,043 patients who underwent coronary artery bypass graft (CABG) surgery at 81 medical centers in the United States, Canada and Europe. The patients participated in five separate clinical trials. A total of 2,012 patients received acadesine for seven continuous hours. The other 2,031 patients received a placebo.
When the results of all five clinical trial were combined, the researchers found that acadesine decreased the incidence of perioperative myocardial infarction (MI), or heart attack, by 27 percent. It also decreased the incidence of cardiac death through the first four days after surgery by 50 percent.
Dr. Mangano writes: "Patients in the acadesine group had increased survival throughout the observation period." This is especially significant because the number of patients undergoing CABG surgery has increased dramatically over two decades to more than 800,000 each year around the world, with associated health care expenditures exceeding $20 billion, according to statistics cited in the article.
The death rate among CABG patients currently ranges from 0.5 percent to 11 percent, but Dr. Mangano says that is "likely to worsen given the continued aging of the population and the selection of higher risk patients for this procedure."
Among the other findings of the combined randomized studies:
-- Acadesine decreased the incidence of one or more adverse cardiovascular outcomes (MI, cardiac death, stroke) by 26 percent.
-- The number of patients suffering strokes was lower in the acadesine group.
-- Acadesine reduced the use of ventricular assistance devices for serious postoperative heart failure by one third.
-- Regarding safety, the incidence of adverse events was similar in the acadesine and placebo groups, except for a transient increase in serum uric acid in the acadesine group.
The true magnitude of acadesine's effect in CABG patients was difficult to assess in any one of the five trials because they were powered to detect effects of 50 percent or more.
Dr. Mangano concludes: "The results of this meta analysis of more than 4,000 patients indicate that treatment with acadesine can reduce perioperative MI, cardiac death, and combined adverse cardiovascular outcomes. Continued study ... is necessary to define those subgroups of patients ... who may specially benefit from these therapies."
Editor's Note: Grant support for this meta analysis and the associated publications was provided by the Ischemia Research and Education Foundation (IREF) and Gensia Pharmaceuticals, Inc. There were no other financial relationships between the investigators, the central analysis group (IREF), and Gensia Pharmaceuticals, Inc.
Editor's Note: The McSPI Research group is a consortium of investigators from approximately 150 worldwide medical centers focusing on the problems of perioperative MI, stroke and renal dysfunction, as well as other organ dysfunction and the implications of such diseases for health economics. IREF is a nonprofit foundation dedicated to multicenter research in these areas and is closely affiliated with the McSPI investigators and their institutions.
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contact the AMA's Science News Department at 312/464 5374.
AMA web site: http://www.ama assn.org
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