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Submitted on October 14, 2002
From Kardiologie, Herzzentrum Ludwigshafen (R.Z., S.S., B.F., K.S., J.S.), Kardiologie, Klinikum Detmold (U.T.); Innere Medizin I, Klinikum Dachau (M.W.); Kardiologie, Städtisches Klinikum Nürnberg (M.G.); Kardiologie, Städtisches Klinikum Dresden-Friedrichstadt (E.A.); Innere Medizin II, Klinikum Kempten (F.S.); Innere Medizin, Allgemeines Krankenhaus Hagen (J.R.); Institut für Mikrobiologie und Hygiene, Klinikum Ludwigshafen (U.H.); and Städtisches Klinikum, Kassel (K.-L.N.), Germany. * To whom correspondence should be addressed. E-mail: erzahn{at}aol.com.
Background--Infection with Chlamydia pneumoniae is suspected to contribute to the pathogenesis of human atherosclerosis. We investigated whether treatment with the macrolide antibiotic roxithromycin would reduce mortality or morbidity in patients with an acute myocardial infarction. Methods and Results--Eight hundred seventy-two patients with an acute myocardial infarction (AMI) were randomly assigned to receive double-blind treatment with either 300 mg roxithromycin or placebo daily for 6 weeks. Primary end point was total mortality during 12-month follow-up. Four hundred thirty-three patients were treated with roxithromycin and 439 with placebo. With the exception of a higher proportion of patients suffering an anterior wall AMI (48.1% in the roxithromycin group versus 40.2% in the placebo group; P=0.027) and a lower prevalence of chronic obstructive pulmonary disease in the roxithromycin group (3.5% versus 6.9%, P=0.028), baseline characteristics, reperfusion therapy, and medical treatment were well balanced between the two groups. More patients in the roxithromycin group interrupted their study medication before completion of at least 4 weeks of treatment (78 of 433 [18%] versus 48 of 439 [11%]; P=0.003; odds ratio, 1.8; 95% CI, 1.2 to 2.6). Follow-up at 12 months was achieved in 868 of 872 (99.5%) patients. Total mortality at 12 months was 6.5% (28 of 431) in the roxithromycin group compared with 6.0% (26 of 437) in the placebo group (odds ratio, 1.1; 95% CI, 0.6 to 1.9; P=0.739). There were also no differences in the secondary combined end points at 12 months. Conclusions--Treatment of AMI patients with roxithromycin did not reduce event rates during 12 months of follow-up. Therefore, our findings do not support the routine use of antibiotic treatment with a macrolide in patients with AMI.
Revised on December 5, 2002
Accepted on December 5, 2002
Antibiotic Therapy After Acute Myocardial Infarction. A Prospective Randomized Study
Ralf Zahn MD, FESC*,
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