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Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary

Christian M Jespersen1, Bodil Als-Nielsen, Morten Damgaard

  • 1Bispebjerg Hospital, Copenhagen University Hospital, Department of Cardiology Y, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark. cmj01@bbh.hosp.dk

BMJ (Clinical Research Ed.)
|December 13, 2005
PubMed

Insights

Short-term clarithromycin treatment in patients with stable coronary heart disease did not significantly impact primary outcomes but led to increased cardiovascular mortality. Further research is needed to assess the long-term safety of clarithromycin in this patient population.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • Stable coronary heart disease (CHD) affects millions globally.
  • Macrolide antibiotics, like clarithromycin, are widely used.
  • The cardiovascular safety of clarithromycin in CHD patients is not well-established.

Purpose of the Study:

  • To investigate the effect of clarithromycin on mortality and cardiovascular morbidity in patients with stable coronary heart disease.
  • To evaluate the safety profile of short-term clarithromycin use in this vulnerable population.

Main Methods:

  • A centrally randomized, double-blind, multicenter trial.
  • 4373 patients with stable CHD were randomized to receive either two weeks of clarithromycin or placebo.
  • Outcomes were assessed over three years using Danish health registers.

Main Results:

  • Clarithromycin showed no significant effect on the primary composite outcome of all-cause mortality, myocardial infarction, or unstable angina.
  • However, all-cause mortality was significantly higher in the clarithromycin group (HR 1.27, P=0.03).
  • Cardiovascular mortality was also significantly elevated in the clarithromycin arm (HR 1.45, P=0.01).

Conclusions:

  • Short-term clarithromycin administration may increase cardiovascular mortality in patients with stable coronary heart disease.
  • The long-term safety of clarithromycin in patients with stable ischemic heart disease requires further investigation.
  • ClinicalTrials.gov identifier: NCT00121550.
Abstract

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