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Coronary heart disease patients may experience higher mortality when treated with clarithromycin
Short-term clarithromycin in patients with stable coronary heart disease may cause higher cardiovascular mortality.
Researchers in Denmark conducted a study "to determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease."
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C.M. Jespersen and colleagues at Copenhagen University Hospital explained, [The design was a] centrally randomized multicenter trial. All parties at all stages were blinded. Analyses were by intention to treat. [The setting included] 5 Copenhagen University cardiology departments and a coordinating center. Thirteen thousand seven hundred two (13 702) patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and [were] alive in August 1999 were invited by letter; 4373 were randomized."
They continued, "Interventions [were] two weeks' treatment with clarithromycin 500 mg/day or matching placebo. Primary outcome [was a] composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome [was a] 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 randomized to clarithromycin and 2201 to placebo."
The researchers reported, "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)."
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"Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischemic heart disease should be examined," concluded the researchers.
Jespersen and colleagues published their study in the British Medical Journal (Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial. BRIT MED J, 2006;332(7532):22-24).
For additional information, contact C.M. Jespersen, Copenhagen University Hospital, Dept. of Cardiology Y, Bispebjerg Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark.
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