Clarithromycin for 2 weeks for stable coronary heart disease: 6-year follow-up of the CLARICOR randomized trial and updated meta-analysis of antibiotics for coronary heart disease.

Abstract

OBJECTIVES:

We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses.

METHODS:

Centrally randomized, placebo controlled multicenter trial. All parties were blinded. Analyses were by intention to treat. Meta-analyses followed the Cochrane Collaboration methodology.

RESULTS:

We randomized 4,372 patients with stable coronary heart disease to clarithromycin 500 mg (n = 2,172) or placebo (n = 2,200) once daily for 2 weeks. Mortality was followed through public register. Nine hundred and twenty-three patients (21.1%) died. Six-year mortality was significantly higher in the clarithromycin group (hazard ratio 1.21, 95% confidence interval 1.06-1.38). Adjustment for entry characteristics (sex, age, prior myocardial infarction, center, and smoking) did not change the results (1.18, 1.04-1.35). Addition of our data to that of other randomized trials on antibiotics for patients with coronary heart disease versus placebo/no intervention (17 trials, 25,271 patients, 1,877 deaths) showed a significantly increased relative risk of death from antibiotics of 1.10 (1.01-1.20) without heterogeneity.

CONCLUSIONS:

Our results stress the necessity to consider carefully the strength of the indication before administering antibiotics to patients with coronary heart disease.

• 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, CLARICOR Trial Group
• Journal: Cardiology (Cardiology) Vol. 111 Issue 4 Pg. 280-7 ( 2008) ISSN: 1421-9751 [Electronic] Switzerland
• PMID: 18451646 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2008 S. Karger AG, Basel.

Chemical References

• Anti-Bacterial Agents
• Clarithromycin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Clarithromycin (administration & dosage, adverse effects)
• Confidence Intervals
• Coronary Disease (drug therapy, mortality)
• Denmark
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Male
• Meta-Analysis as Topic
• Middle Aged
• Odds Ratio
• Risk
• Survival Analysis