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Clarithromycin use increased risk for cardiac death
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Use of clarithromycin was associated with an increased risk for cardiac death, researchers from Statens Serum Institut in Copenhagen, Denmark, have found. There was no risk associated with roxithromycin.
“The observed association for clarithromycin seemed to be largely attributable to women,” the researchers wrote in the British Medical Journal. “Before these results are used to guide clinical decision making, confirmation in independent populations is an urgent priority given the widespread use of macrolide antibiotics.”
The researchers conducted a prospective cohort study to evaluate cardiac deaths among patients prescribed macrolides or penicillin V from 1997 to 2011. In subgroup analyses, they also assessed cardiac death by age, sex, risk score for cardiac death and the use of cytochrome P450 3A inhibiting drugs. The final cohort included 588,988 courses of roxithromycin, 160,297 courses of clarithromycin and 4,355,309 courses of penicillin V.
There were 285 cardiac deaths during the study period: 18 among those receiving clarithromycin, 32 among patients receiving roxithromycin and 235 among patients receiving penicillin V. For clarithromycin, the incidence rate of cardiac deaths was 5.3 per 1,000 person years. For both roxithromycin and penicillin V, the incidence rate was 2.5 per 1,000 person years.
In an unadjusted analysis, current use of clarithromycin was associated with an increased risk for cardiac death, with a rate ratio of 2.07 (95% CI, 1.28-3.35). The adjusted absolute risk difference compared with current penicillin V use was 37 cardiac deaths per 1 million treatment courses. The relative risk was higher in women than in men, but this was not statistically significant. Age, cardiac risk score and concomitant use of cytochrome P450 3A inhibiting drugs had no effect. Past use of clarithromycin was not associated with an increased risk for cardiac death.
“The absolute risk is small, so this finding should probably have limited, if any, effect on prescribing practice in individual patients,” the researchers wrote. “On the other hand, clarithromycin is one of the more commonly used antibiotics in many countries and many millions of people are prescribed this drug each year; thus, the total number of excess cardiac deaths may not be negligible.”
Disclosure: The researchers report no relevant financial disclosures.
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