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D-sotalol increases the risk of sudden cardiac death in patients with recent myocardial infarction and a reduced ejection fraction.

Clinical Bottom Line

d-sotalol increases mortality in patients with previous myocardial infarction.

Citation

Pratt CM et al. Mortality in the Survival With ORal D-sotalol (SWORD) trial: why did patients die? Am-J-Cardiol 1998: 81:869-76.

AND

Waldo AL et al. Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. The SWORD Investigators. Survival With Oral d-Sotalol. Lancet 1996; 348:7-12.

Clinical Question

Does sotalol increase the risk of sudden cardiac death?

Search Terms

sotalol AND (mortality OR death*) - search done in the Cochrane Controlled Trials Registry

The Study

The study randomised 3121 patients with a recent myocardial infarction (6-42 days) and an ejection fraction of 40% or less to placebo or 100mg of d-sotalol (increasing to 200mg if tolerated).

The Evidence

There were 78 deaths (5%) among 1549 patients on sotalol compared to 48 deaths (3.1%) among 1572 patients on placebo.

Relative Risk of 1.65 (95% CI 1.15 to 2.36). Relative Risk for presumed arrhythmic deaths was 1.77. Absolute Risk Difference was 1.9%, giving a Number Needed to Kill of about 50.
Outcome	Time to Outcome	CER	EER	RRR	ARR	NNH
death		0.031	0.05	65%	0.019	53
death	95% Confidence Intervals			15% to 136%	0.006 to 0.034	29 to 167

Comments

D-sotalol is an isomer of sotalol, but there is no equivalent data for sotalol nor for patients who have not had a myocardial infarction. However, prudence would suggest avoided its use unless adequate safety data did appear.

Appraised By

Paul Glasziou

Expiry Date

never.

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Centre for Evidence-
Based Medicine