Tachycardia: sotalol had no clear difference in rhythm conversion.

Clinical bottom line (level 1b-)

  1. Patients who had atrial fibrillation or flutter and were given 1.0 mg/kg sotalol, had no clear difference in conversion to sinus rhythm than those given placebo.
  2. Patients with atrial fibrillation or flutter who were given 1.5 mg/kg sotalol had no clear difference in conversion to sinus rhythm.
Sung et al: American Heart Journal 1995; 129: 739-748
Expires October 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 12 study centres, USA

48 patients (aged range 28 to 83 years, mean 63, 71% male) atrial fibrillation or flutter

Excluded if
  • <5 minutes duration
  • >7 days duration
  • ventricular rate <120 beats per minute
  • clinically significant congestive heart failure
  • asthma or chronic obstructive lung disease
  • sick sinus syndrome
  • history of second- and third-degree atrioventricular block
  • unstable angina, myocardial infarction or coronary artery bypass surgery within preceding 2 months
  • severe hypertension (diastolic blood pressure >115 mmHg) or hypotension (systolic blood pressure <100 mmHg)
  • serum creatinine >2.5 mg per dl, significant liver dysfunction
  • administration of drugs that prolong QT interval, beta-adrenergic receptor blocking agents or verapamil, diltiazem or other antiarrhythmic agents within the preceding 24 hours
  • amiodarone therapy within the preceding 3 months
  • history of drug-induced torsade de pointes
  • electrolyte imbalance
  • pregnancy


    • Control Group: (n = 14, 14 analysed): placebo
    Experimental Group: (n = 18, 18 analysed): 1.0 mg per kg sotalol
    Experimental Group: (n = 16, 16 analysed): 1.5 mg per kg sotalol

    100% followed for 30 minutes

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    conversion to sinus rhythm (with 1.0 mg per kg sotalol) 30 minutes 2
    (14.3%)    		 2
    (11.1%)    		 -4%
    (-36% to 21%)    		 -3.17%
    (-26.56% to 20.21%)    		 32
    (NNT = 5 to infinity;
    NNH = 4 to infinity)
    conversion to sinus rhythm (with 1.5 mg per kg sotalol) 30 minutes 2
    (14.3%)    		 2
    (12.5%)    		 -2%
    (-35% to 23%)    		 -1.79%
    (-26.25% to 22.68%)    		 56
    (NNT = 4 to infinity;
    NNH = 4 to infinity)

    Comments

    1. The study is too small to show any clear difference in conversion to sinus rhythm between the groups.
    2. Adverse events included hypotension and dyspnoea, but no patients died.

    Citation

    1. Sung RJ, Tan HL, Karagounis L, et al: Intravenous sotalol for the termination of supraventricular tachycardia and atrial fibrillation and flutter: A multicenter, randomized, double-blind, placebo-controlled study. American Heart Journal 1995; 129: 739-748
    Contributor: Clare Wotton and Musab Hayatli, October 1999
    Reviewer:

    Clinical Question.
    Patient atrial fibrillation or flutter
    Intervention or Exposure sotalol
    Comparison placebo
    Outcome conversion to sinus rhythm