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. 2013 Jun 30;6(1):864. doi: 10.4022/jafib.864

Table 5. Summary of Randomized Trials of Dofetilide in Atrial Fibrillation.

Study No. of patients Onset of AF Endpoint Comparison Results
Nørgaard BL et al, 1999 [75] 96 1-180 days Conversion to SR I.V. dofetilide 8 mcg/kg vs. placebo 30.3% vs. 3.3%, P<0.006. AFl>AF, 64% vs. 24%, P<0.012
Frost L et al, 1997 [76] 98 1-6 days Conversion to SR I.V. dofetilide 8 mcg/kg, 4mcg/kg vs. placebo After 3 hr: 44% vs. 36% vs. 24%, P=insignificant.
Falk RH et al, 1997 [77] 91 Sustained AF/AFl Conversion to SR I.V. dofetilide 8 mcg/kg, 4mcg/kg vs. placebo 31% vs. 12.5% vs 0%. AFl>AF: (54% versus 12.5%)
Bianconi L et al, 2000 [78] 150 2 hr-6 Mn I.V. dofetilide vs. I.V. amiodarone vs. placebo 3 hr: 35%, 4%, and 4%, P<0.001. AFl > AF (75% vs. 22%, P=0.004)
Lindeboom JE et al, 2000 [79]
Singh S et al, (SAFIRE-D) 2000 [80] 325 Persistent AF/AFl Conversion to SR. SR at 1 yr. dofetilide (1250mcg, 250 mcg, 500 mcg) vs. placebo (6.1%, 9.8%, and 29.9%) vs. 1.2%, P=0.015 and P<0.001. SR at 1 yr (0.40, 0.37, 0.58) vs. 0.25, (500 mcg vs. placebo, P < 0.001).
Greenbaum RE et al (EMERALD) 1998 [81] 546 Persistent AF/AFl Conversion to SR. SR at 1 yr dofetilide (1250mcg, 250 mcg, 500 mcg) BID vs. Sotalol 80 BID vs. placebo (5.9%, 10.5%, and 29.5%) vs. 5.1% vs. 1.5%. SR at 1 yr: (30%, 45%, and 51%) vs. 38% vs. 16%.
Pedersen OD et al, (DIAMOND AF) 2001 [82] 506 Persistent AF/AFl Conversion to SR. SR at 1 yr dofetilide vs. placebo 59% vs. 34%. SR at 1 year: 79% vs. 42%, P<0.001. Reduced hospitalizations for worsening of heart failure (29% vs. 40%)
Torp-Pedersen CT et al (DIAMOND-CHF), 2000 [83] 1518 NA SR at 1 yr dofetilide vs. placebo At 1 yr: 61% vs. 33%, P<0.001. No effect on mortality. Reduced hospitalizations for worsening of heart failure HR 0.75 (0.63-0.89).
DIAMOND-MI, 1997 [84] 1510 NA SR at 1 yr dofetilide vs. placebo At 1 yr: survival 79% vs 77%. Hospitalizations for worsening of heart failure 27% for each.