Excess Sudden Cardiac Deaths after Short-Term Clarithromycin Administration in the CLARICOR Trial: Why Is This So, and Why Are Statins Protective?Winkel P.a · Hilden J.b · Fischer Hansen J.c · Hildebrandt P.e · Kastrup J.d · Kolmos H.J.f · Kjøller E.g · Jespersen C.M.a, c · Gluud C.a · Jensen G.B.h · the CLARICOR Trial Group
aRigshospitalet, Copenhagen University Hospital and Institute of Preventive Medicine, The Copenhagen Trial Unit, Center for Clinical Intervention Research, bDepartment of Biostatistics, Institute of Public Health Research, Faculty of Health Sciences, University of Copenhagen, cDepartment of Cardiology Y, Bispebjerg Hospital, Copenhagen University Hospital, dDepartment of Medicine B, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, eDepartment of Cardiology E, Frederiksberg Hospital, Copenhagen University Hospital, Frederiksberg, fDepartment of Clinical Microbiology, Odense University Hospital, Odense, gDepartment of Cardiology S, Herlev Hospital, Copenhagen University Hospital, Herlev, hDepartment of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark
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Article / Publication Details
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.
© 2011 S. Karger AG, Basel
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