(RxWiki News) An experimental medication designed to protect the heart from injury during coronary artery bypass surgery does not appear to reduce serious complications including stroke or dying.
Though the large Merck-funded prospective study did not find experimental drug acadesine to be beneficial, the research did reveal that fewer bypass patients are suffering complications.
"Follow your cardiologist's instructions after bypass surgery."
Mark F. Newman, MD, chairman of the Department of Anesthesiology at Duke University Medical Center and lead author of the study, said researchers had expected that about 10 percent of patients were at high risk of complications following bypass surgery. However, they found the actual risk was 5 percent.
Despite the finding that fewer patients experience bypass complications, the phase III trial did not determine that the medication reduced the rate of complications.
Previous small studies had suggested that acadesine given before, during and after surgery could reduce inflammation that causes cell death following oxygen deprivation. Most of those studies occurred before 1997 when the complication rate associated with bypass surgery was higher.
During the current trial researchers enrolled 3,080 bypass patients from 300 medical centers in seven countries. Participants were randomly assigned to receive either acadesine or an inactive drug. They were followed for one month.
Patients taking acadesine did not fare better than patients taking a placebo, with 5 percent of patients from both groups experiencing a severe event such as a stroke or death within the first month after treatment. The study was halted early based on the preliminary findings.
Dr. Newman expressed disappointment that the drug did not benefit patients, but noted that tremendous strides have been made in other areas, allowing older and sicker individuals to safely undergo heart surgery with good outcomes.
Some of the study's authors, including Newman, received grant funds, consulting fees or travel reimbursement from Schering-Plough/Merck, manufacturer of the drug.
The study was published in the July 11 issue of the Journal of the American Medical Association.