Objectives This study compared survival between patients taking dofetilide
and patients taking placebo in a pooled analysis of randomized clinical tri
als of patients with supraventricular arrhythmias.
Background Clinical trials of antiarrhythmic drugs used to treat supraventr
icular arrhythmias rarely include enough patients to assess whether the dru
g being tested has an effect on survival. Pooling data from many trials pro
vides useful information on safety.
Methods Data from randomized clinical trials of antiarrhythmic drug therapy
of supraventricular arrhythmias were pooled to assess the effect on surviv
al of dofetilide (n = 1346) compared with placebo (n = 677) in this patient
population.
Results The unadjusted hazard ratio for risk of death (dofetilide/placebo)
was 1.4 with 95% confidence interval 0.4-5.1. After adjusting for effects o
f arrhythmia diagnosis, age, sex, and structural heart disease, the hazard
ratio was 1.1 (confidence interval 0.3-4.3).
Conclusions The pooled survival analysis provided reassurance regarding the
safety of dofetilide in patients with supraventricular arrhythmias.