Mortality spike stops ANDROMEDA trial
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Mortality spike stops ANDROMEDA trial Investigators prematurely terminated the multinational ANDROMEDA* trial after the data and safety monitoring board identified an early increase in mortality among dronedarone recipients. The trial aimed to evaluate the efficacy of dronedarone versus placebo in patients hospitalised with symptomatic heart failure (HF) and severe left ventricular systolic dysfunction. Around 7 months after starting the trial, and after inclusion of 627 participants (310 assigned to the dronedarone group), the trial was stopped. Analysis at this point revealed that 25 dronedarone recipients had died during a median follow-up period of 2 months, compared with 12 placebo recipients, resulting in a hazard ratio (HR) of 2.13 (95% CI 1.07, 4.25). While the number of deaths attributable to arrhythmia or sudden death was not significantly different for the two groups, 10 patients in the dronedarone group had worsening HF when they died, compared with 2 placebo recipients. During 6 months’ follow-up post-termination, 42 dronedarone recipients died versus 39 placebo recipients (HR 1.13; 0.73, 1.74). Notably, the primary endpoint of death or hospitalisation for HF did not differ significantly between the two groups at the time of termination (1.38; 0.92, 2.09) or 6 months post-termination (1.09; 0.79, 1.51).
A chance finding? These findings may indicate that "dronedarone directly or indirectly causes worsening heart failure", explain the investigators. However, they urge caution as their findings are based on a post hoc subgroup analysis and may be due to chance, given the difference of only 13 deaths in total between the study groups. The question that remains to be answered is "whether dronedarone is safe in populations that are at lower risk than the patients in this trial". * Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease Køber L, et al. Increased mortality after dronedarone therapy for severe heart failure. New England Journal of Medicine 358: 2678-2687, No. 25, 19 Jun 801052629 2008
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Reactions 28 Jun 2008 No. 1208
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