A multicentre, double-blind randomized crossover comparative study on the efficacy and safety of dofetilide vs sotalol in patients with inducible sustained ventricular tachycardia and ischaemic heart disease
Key result
Oral dofetilide was as efficacious as sotalol in suppressing inducible ventricular tachycardia (35.9% vs 33.6%; P=ns) and had significantly fewer treatment-related adverse events in the acute phase.
Why the study?
Does dofetilide improve suppression of inducible sustained ventricular tachycardia compared to sotalol in patients with ischaemic heart disease?
Population
135 patients with ischaemic heart disease and inducible sustained ventricular tachycardia
Comparison
Oral dofetilide 500 microg twice daily for 3 to… vs Oral sotalol 160 mg twice daily for 3 to 5 days…
Design
RCT, randomized crossover design, double-blind
Follow-up
3 to 5 days per drug and unspecified long-term phase
Authors
Discussion
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Implication
Dofetilide matches sotalol efficacy with fewer acute adverse events; extends antiarrhythmic options for inducible VT in ischaemic heart disease.
Study Design
Type
RCT (n=135)
Blinding
Double-blind
Randomization
Crossover
Multicenter
Yes
Structured PICO
Does dofetilide improve suppression of inducible sustained ventricular tachycardia compared to sotalol in patients with ischaemic heart disease?
P
Population
135 patients with ischaemic heart disease and inducible sustained ventricular tachycardia
I
Intervention
Oral dofetilide 500 microg twice daily for 3 to 5 days (acute phase), followed by long-term treatment based on response
C
Comparator
Oral sotalol 160 mg twice daily for 3 to 5 days (acute phase), followed by long-term treatment based on response
O
Outcome
Suppression of inducible ventricular tachycardia assessed by programmed electrophysiological stimulationsurrogate
Main Result
Absolute Event Rate: 35.9% vs 33.6%
p-value: p=ns
Dofetilide and sotalol showed similar efficacy in suppressing inducible sustained ventricular tachycardia, though dofetilide was better tolerated in the acute phase.
Cite This Study
Giuseppe Boriani (2001) conducted an RCT in Ischaemic heart disease and inducible sustained ventricular tachycardia (n=135). Dofetilide vs. Sotalol 160 mg twice daily was evaluated on Suppression of inducible ventricular tachycardia (p=ns). Oral dofetilide was as efficacious as sotalol in suppressing inducible ventricular tachycardia (35.9% vs 33.6%; P=ns) and had significantly fewer treatment-related adverse events in the acute phase.