Randomized secondary prevention trial of azithromycin in patients with coronary artery disease - Primary clinical results of the ACADEMIC study

Citation
Jb. Muhlestein et al., Randomized secondary prevention trial of azithromycin in patients with coronary artery disease - Primary clinical results of the ACADEMIC study, CIRCULATION, 102(15), 2000, pp. 1755-1760
Citations number
35
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Journal title
CIRCULATION
ISSN journal
0009-7322 → ACNP
Volume
102
Issue
15
Year of publication
2000
Pages
1755 - 1760
Database
ISI
SICI code
0009-7322(20001010)102:15<1755:RSPTOA>2.0.ZU;2-R
Abstract
Background-Chlamydia pneumoniae is associated with coronary artery disease (CAD), although its causal role is uncertain. A small preliminary study rep orted a >50% reduction in ischemic events by azithromycin, an antibiotic ef fective against C pneumoniae, in seropositive CAD patients. We tested this prospectively in a larger, randomized, double-blind study. Methods and Results-CAD patients (n=302) seropositive to C pneumoniae (IgG titers greater than or equal to 1:16) were randomized to placebo or azithro mycin 500 mg/d for 3 days and then 500 mg/wk for 3 months. The primary clin ical end point included cardiovascular death, resuscitated cardiac arrest, nonfatal myocardial infarction (MI), stroke, unstable angina, and unplanned coronary revascularization at 2 years. Treatment groups were balanced, and azithromycin was generally well tolerated. During the trial, 47 first prim ary events occurred (cardiovascular death, 9; resuscitated cardiac arrest, 1; MI, 11; stroke, 3; unstable angina, 4; and unplanned coronary revascular ization, 19), with 22 events in the azithromycin group and 25 in the placeb o group. There was no significant difference in the 1 primary end point bet ween the 2 groups (hazard ratio for azithromycin, 0.89; 95% CI, 0.51 to 1.6 1; P=0.74). Events included 9 versus 7 occurring within 6 months and 13 ver sus 18 between 6 and 24 months in the azithromycin and placebo groups, resp ectively. Conclusions-This study suggests that antibiotic therapy with azithromycin i s not associated with marked early reductions (greater than or equal to 50% ) in ischemic events as suggested by an initial published report. However, a clinically worthwhile benefit (ie, 20% to 30%) is still possible, althoug h it may be delayed. Larger (several thousand patient), longer-term (greate r than or equal to 3 to 5 years) antibiotic studies are therefore indicated .