Randomized secondary prevention trial of azithromycin in patients with coronary artery disease and serological evidence for Chlamydia pneumoniae infection: The Azithromycin in Coronary Artery Disease: Elimination of Myocardial Infection with Chlamydia (ACADEMIC) study

Circulation. 1999 Mar 30;99(12):1540-7. doi: 10.1161/01.cir.99.12.1540.

Abstract

Background: Chlamydia pneumoniae commonly causes respiratory infection, is vasotropic, causes atherosclerosis in animal models, and has been found in human atheromas. Whether it plays a causal role in clinical coronary artery disease (CAD) and is amenable to antibiotic therapy is uncertain.

Methods and results: CAD patients (n=302) who had a seropositive reaction to C pneumoniae (IgG titers >/=1:16) were randomized to receive placebo or azithromycin, 500 mg/d for 3 days, then 500 mg/wk for 3 months. Circulating markers of inflammation (C-reactive protein [CRP], interleukin [IL]-1, IL-6, and tumor necrosis factor [TNF]-alpha), C pneumoniae antibody titers, and cardiovascular events were assessed at 3 and 6 months. Treatment groups were balanced, with age averaging 64 (SD=10) years; 89% of the patients were male. Azithromycin reduced a global rank sum score of the 4 inflammatory markers at 6 (but not 3) months (P=0. 011) as well as the mean global rank sum change score: 531 (SD=201) for active drug and 587 (SD=190) for placebo (P=0.027). Specifically, change-score ranks were significantly lower for CRP (P=0.011) and IL-6 (P=0.043). Antibody titers were unchanged, and number of clinical cardiovascular events at 6 months did not differ by therapy (9 for active drug, 7 for placebo). Azithromycin decreased infections requiring antibiotics (1 versus 12 at 3 months, P=0.002) but caused more mild, primarily gastrointestinal, adverse effects (36 versus 17, P=0.003).

Conclusions: In CAD patients positive for C pneumoniae antibodies, global tests of 4 markers of inflammation improved at 6 months with azithromycin. However, unlike another smaller study, no differences in antibody titers and clinical events were observed. Longer-term and larger studies of antichlamydial therapy are indicated.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Antibodies, Bacterial / blood
  • Azithromycin / administration & dosage
  • Azithromycin / adverse effects
  • Azithromycin / therapeutic use*
  • C-Reactive Protein / analysis
  • Chlamydia Infections / drug therapy*
  • Chlamydophila pneumoniae* / immunology
  • Coronary Disease / drug therapy*
  • Coronary Disease / prevention & control
  • Double-Blind Method
  • Drug Tolerance
  • Female
  • Humans
  • Interleukin-1 / analysis
  • Interleukin-6 / analysis
  • Leukocyte Count
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care
  • Tumor Necrosis Factor-alpha / analysis

Substances

  • Anti-Bacterial Agents
  • Antibodies, Bacterial
  • Interleukin-1
  • Interleukin-6
  • Tumor Necrosis Factor-alpha
  • Azithromycin
  • C-Reactive Protein