Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial: why is this so, and why are statins protective?

TY - JOUR

T1 - Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial

T2 - why is this so, and why are statins protective?

AU - Winkel, Per

AU - Hilden, J

AU - Hansen, Jørgen Fischer

AU - Hildebrandt, Per

AU - Kastrup, Jens

AU - Kolmos, Hans Jørn

AU - Kjøller, Erik

AU - Jespersen, Christian M.

AU - Gluud, Christian

AU - Jensen, GB

AU - CLARICOR Trial, Group

PY - 2011/4

Y1 - 2011/4

N2 - Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital (nonsudden) death. Result: In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69–4.05, p < 0.0005). Other categories of deaths showed no marked drug-placebo difference. Conclusions: Short-term clarithromycin administration was significantly associated with increased risk of sudden CV death in stable coronary heart disease patients not using statins.

AB - Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital (nonsudden) death. Result: In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69–4.05, p < 0.0005). Other categories of deaths showed no marked drug-placebo difference. Conclusions: Short-term clarithromycin administration was significantly associated with increased risk of sudden CV death in stable coronary heart disease patients not using statins.

U2 - 10.1159/000324533

DO - 10.1159/000324533

M3 - Journal article

SN - 0008-6312

VL - 118

SP - 63

EP - 67

JO - Cardiologia

JF - Cardiologia

IS - 1

ER -