The study report has just been posted in PR News.
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Largest Study to Date Shows New Therapy Reduces Heart Attack, Stroke and Death Following Coronary Bypass Surgery
Worldwide Trials Involving 4,000 Bypass Patients at Leading International
Medical Centers Using Bioengineered Compound Acadesine Reduced Rates of Deathand Complications
Study Appears in Tomorrow's Journal of The American Medical Association
SAN FRANCISCO, Jan. 21 /PRNewswire/ -- A massive, worldwide study aimed
at reducing death and cardiovascular complications following cardiac surgery
shows that therapy using a new bioengineered compound, acadesine [GENSIA], reduces the
incidence of heart attack, stroke and death after coronary artery bypass
surgery.
Analysis of five trials that included more than 4,000 patients was
conducted by Dr. Dennis T. Mangano, Ph.D., M.D., and investigators of the
Ischemia Research and Education Foundation (IREF) in San Francisco. Research
data was gathered at 81 international medical centers which are members of
IREF's university consortium, the Multicenter Study of Perioperative Ischemia
(McSPI) Research Group. The study appears in tomorrow's Journal of the
American Medical Association.
The article, entitled "Effects of Acadesine on Myocardial Infarction,
Stroke, and Death Following Surgery," contains "definitive data indicating
that the use of acadesine prior to and during surgery can significantly reduce
cardiac death, stroke and other adverse complications following coronary
surgery," according to Dr. Mangano, an internationally recognized expert in
heart attack and stroke, Director of the McSPI Research Group and lead author
of the study. "Acadesine is a bioengineered compound that enhances the body's
natural defense against ischemic injury by stimulating production of
adenosine, one of the four building blocks of DNA," he added.
"In our meta-analysis of the five international clinical trials, we found
that acadesine-treated patients had significantly lower occurrences of
cardiac death and adverse complications. Acadesine decreased the incidence
of myocardial infarction by 27 percent and decreased the incidence of cardiac
death by 50 percent. The results of our analysis have important implications
for patients undergoing coronary artery bypass surgery, as well as the
nation's overall healthcare budget."
Mangano noted that the number of patients undergoing coronary artery
bypass graft (CABG) surgery worldwide has increased dramatically to more than
800,000 patients annually with associated health expenditures exceeding
$20 billion. Rates of death following CABG surgery ranges from less than
1 percent to more than 8 percent and rates of adverse complications range from
1 percent to 28 percent.
"These incidences are likely to worsen given the continued aging of the
population and the selection of higher risk patients for this procedure.
Likewise, the costs of such adverse cardiovascular outcomes, currently
estimated to be $4 billion annually, will continue to escalate," he added.
Pharmacological interventions aimed at mitigating adverse outcomes
associated with CABG surgery have been investigated in a series of smaller
trials, but none have been widely accepted because preliminary findings could
not be confirmed. The current findings, reported in the Journal of the
American Medical Association, represent the largest set of trials to date
aimed at reducing cardiovascular morbidity and mortality following cardiac
surgery.
The meta-analysis was based on five prospective, randomized, blinded
multicenter trials with a total of 4,043 patients at leading medical centers
in the United States, Canada and Europe. In the trials with 2,031 patients
receiving a placebo and 2,012 patients receiving high-dose acadesine prior to
and during surgery, the incidence of myocardial infarction, stroke and death
was lower in the acadesine group than in the placebo group. Acadesine reduced
the overall incidence of these serious complications by 25 to 50 percent.
In addition, the study found that the therapy significantly reduced the
number of deaths due to heart attacks. In the placebo group, 13 percent of
patients who experienced heart attacks died, whereas in the treatment group
only 1 percent of patients who had heart attacks died -- an 89 percent
reduction in the death rate following heart attack.
Treatment with acadesine would also prevent expensive cardiovascular
complications in 20 of every 1,000 patients undergoing heart surgery every
year; a rate that would result in 16,000 fewer patients per year requiring
expensive additional treatment and thereby ultimately reducing national
healthcare costs.
Founded more than a decade ago by Dr. Mangano, San Francisco-based
Ischemia Research and Education Foundation (IREF) is an independent nonprofit
medical research foundation dedicated to saving lives and reducing health care
costs through unbiased scientific research. The nonprofit foundation is
presently focusing on the prevention of ischemic injury such as heart attack,
stroke and renal failure in high-risk patients undergoing surgery. IREF has a
staff of 90 professionals and consultants that includes clinical researchers,
biometricians and engineers as well as professionals in diverse specialties in
the fields of medicine, health and economics.
The Multicenter Study of Perioperative Ischemia, also founded by Dr.
Mangano, is a research network of approximately 300 investigators and
160 academic centers in North and South America, Europe, Asia, Australia and
India. Its members, in affiliation with IREF, conduct unbiased, large-scale
clinical trials to find treatments which can prevent or reduce devastating
cardiovascular complications in the 60 million patients worldwide undergoing
surgery.
CONTACT: Jorge Sanchez/Administrative Analyst of Ischemia Research and Education Foundation, 415-715-2318 |
