Objectives: This study compared survival between patients taking dofetilide and patients taking placebo in a pooled analysis of randomized clinical trials of patients with supraventricular arrhythmias.
Background: Clinical trials of antiarrhythmic drugs used to treat supraventricular arrhythmias rarely include enough patients to assess whether the drug being tested has an effect on survival. Pooling data from many trials provides useful information on safety.
Methods: Data from randomized clinical trials of antiarrhythmic drug therapy of supraventricular arrhythmias were pooled to assess the effect on survival 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 of 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.