Can heart disease -- the nation's number-one killer -- be effectively treated with antibiotics? A national clinical trial directed by the University of Washington and funded through an $11 million grant from the National Institutes of Health (National Heart, Lung and Blood Institute) and Pfizer Corporation will examine the effectiveness of antibiotic treatment for patients with coronary artery disease.
The Azithromycin and Cardiac Events Study (ACES) focuses on the role of a common bacterium, Chlamydia pneumoniae, that has been associated with atherosclerosis in humans. The study will be led by principal investigator
Dr. J. Thomas Grayston, a pioneer in chlamydia research and professor of epidemiology at the University of Washington School of Public Health and Community Medicine. Approximately 27 clinical centers nationwide will participate in the study.
"The idea of giving antibiotics to treat a chronic disease like coronary artery disease is not as farfetched an idea as it once was," said Grayston. "This clinical trial should help prove whether the Chlamydia pneumoniae bacteria plays a role in the cause of complications of atherosclerosis."
Chlamydia pneumoniae is a common cause of respiratory infections, including pneumonia and bronchitis. Nearly every person is infected with the bacteria at some time in life. In the late 1980s, researchers, including Grayston, identified a possible relationship between Chlamydia pneumoniae and heart disease when the bacteria was identified in samples of diseased coronary artery tissue.
Two small trials evaluating the use of antibiotics for patients with coronary artery disease showed some positive indications.
"This large-scale clinical trial will provide substantial evidence about whether antibiotics should be used in the treatment of coronary artery disease," Grayston said.
Participating research centers will enroll approximately 4,000 volunteers for the study. Volunteers must have had a heart attack in the past or have evidence of heart disease by angiography. For one year, each participant will receive weekly treatment with azithromycin or a placebo. Patients will then be followed for about four years to monitor for any coronary events, including hospitalization for heart pain, coronary artery bypass grafting, angioplasty, heart attack or death due to complications of coronary artery disease.
Recruitment for the ACES study is expected to begin in February 1999.