BACKGROUND: Epidemiologic, laboratory, animal, and clinical studies suggest that there is an association between Chlamydia pneumoniae infection and atherogenesis. We evaluated the efficacy of one year of azithromycin treatment for the secondary prevention of coronary events. METHODS: In this randomized, prospective trial, we assigned 4012 patients with documented stable coronary artery disease to receive either 600 mg ofazithromycin or placeboweekly for one year. The participants were followed for a mean of 3.9 years at 28 clinical centers throughout the United States. RESULTS: The primary end point, a composite of death due to coronary heart disease, nonfatal myocardial infarction, coronary revascularization, or hospitalization for unstable angina, occurred in 446 of the participants who had been randomly assigned to receive azithromycin and 449 of those who had been randomly assigned to receive placebo. There was no significant risk reduction in the azithromycin group as compared with the placebo group with regard to the primary end point (risk reduction, 1 percent [95 percent confidence interval, -13 to 13 percent]). There were also no significant risk reductions with regard to any of the components of the primary end point, death from any cause, or stroke. The results did not differ when the participants were stratified according to sex, age, smoking status, presence or absence of diabetes mellitus, or C. pneumoniae serologic status at baseline. CONCLUSIONS: A one-year course of weekly azithromycin did not alter the risk of cardiac events among patients with stable coronary artery disease. Copyright 2005 Massachusetts Medical Society.
RCT Entities:
BACKGROUND: Epidemiologic, laboratory, animal, and clinical studies suggest that there is an association between Chlamydia pneumoniae infection and atherogenesis. We evaluated the efficacy of one year of azithromycin treatment for the secondary prevention of coronary events. METHODS: In this randomized, prospective trial, we assigned 4012 patients with documented stable coronary artery disease to receive either 600 mg of azithromycin or placebo weekly for one year. The participants were followed for a mean of 3.9 years at 28 clinical centers throughout the United States. RESULTS: The primary end point, a composite of death due to coronary heart disease, nonfatal myocardial infarction, coronary revascularization, or hospitalization for unstable angina, occurred in 446 of the participants who had been randomly assigned to receive azithromycin and 449 of those who had been randomly assigned to receive placebo. There was no significant risk reduction in the azithromycin group as compared with the placebo group with regard to the primary end point (risk reduction, 1 percent [95 percent confidence interval, -13 to 13 percent]). There were also no significant risk reductions with regard to any of the components of the primary end point, death from any cause, or stroke. The results did not differ when the participants were stratified according to sex, age, smoking status, presence or absence of diabetes mellitus, or C. pneumoniae serologic status at baseline. CONCLUSIONS: A one-year course of weekly azithromycin did not alter the risk of cardiac events among patients with stable coronary artery disease. Copyright 2005 Massachusetts Medical Society.
Authors: Zhiqiang Kevin Lu; Jing Yuan; Minghui Li; S Scott Sutton; Gowtham A Rao; Sony Jacob; Charles L Bennett Journal: Expert Opin Drug Saf Date: 2014-12-10 Impact factor: 4.250
Authors: Christian Gluud; Bodil Als-Nielsen; Morten Damgaard; Jørgen Fischer Hansen; Stig Hansen; Olav H Helø; Per Hildebrandt; Jørgen Hilden; Gorm Boje Jensen; Jens Kastrup; Hans Jørn Kolmos; Erik Kjøller; Inga Lind; Henrik Nielsen; Lars Petersen; Christian M Jespersen Journal: Cardiology Date: 2008-05-02 Impact factor: 1.869
Authors: Mitchell S V Elkind; Pankajavalli Ramakrishnan; Yeseon P Moon; Bernadette Boden-Albala; Khin M Liu; Steve L Spitalnik; Tanja Rundek; Ralph L Sacco; Myunghee C Paik Journal: Arch Neurol Date: 2009-11-09