Clinical Question:
In patients with stable coronary heart disease, does treatment with
clarithromycin decrease bad outcomes?
Bottom Line:
The theory of a bacterial cause of heart disease is rapidly deflating. Using
the antibiotic clarithromycin in patients with coronary heart disease (CHD)
is not beneficial and may be harmful, with 1 additional death for every 50
patients who receive clarithromycin. Two other studies have also shown a
slight increase in mortality with antibiotic therapy; taken together, these
3 studies show a 28% increase in mortality with clarithromycin (odds ratio =
1.28; 95% CI, 1.05 - 1.57).
Reference:
Jespersen CM, Als-Nielsen B, Damgaard M, et al, for the CLARICOR Trial
Group. Randomised placebo controlled multicentre trial to assess short term
clarithromycin for patients with stable coronary heart disease: CLARICOR
trial. BMJ 2006;332:22-24.
Study Design:
Randomized controlled trial (double-blinded)
Synopsis:
To determine if the macrolide clarithromycin affects mortality and
cardiovascular morbidity in patients with stable coronary heart disease.
Centrally randomised multicentre trial. All parties at all stages were
blinded. Analyses were by intention to treat. Five Copenhagen University
cardiology departments and a coordinating centre. 13,702 patients aged 18 to
85 years who had a discharge diagnosis of myocardial infarction or angina
pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373
were randomised. Two weeks' treatment with clarithromycin 500 mg/day or
matching placebo. Primary outcome: composite of all cause mortality,
myocardial infarction, or unstable angina pectoris during three years'
follow-up. Secondary outcome: composite of cardiovascular mortality,
myocardial infarction, or unstable angina pectoris. The outcomes were
obtained from Danish registers and were blindly assessed by the event
committee. 2172 participants were randomised to clarithromycin and 2201 to
placebo. We found no significant effects of clarithromycin on the primary
outcome (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or
secondary outcome (1.17, 0.98 to 1.40). Mortality was significantly higher
in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of
significantly higher cardiovascular mortality (1.45, 1.09 to 1.92; P =
0.01). |