Tachycardia: sotalol decreased implantable-defibrillator first shocks.

Clinical bottom line (level 1b)

  1. Patients with ventricular tachycardia and an implantable-defibrillator who were given sotalol, were less likely to have a first shock from the defibrillator than those given placebo (NNT = 5 at 12 months) .
  2. Patients given sotalol had no clear difference in death than those given placebo.
Pacifico et al: New England Journal of Medicine 1999; 340 (24): 1855-1862
Expires January 2004

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 41 US centres and 3 Europe

302 patients (aged mean 62 years, 83% male) history of life-threatening ventricular tachyarrhythmias that were not due to a reversible cause and had received their first or a replacement implantable cardioverter-defibrillator within three months of enrolment. The defibrillator had to provide tiered therapy with electrogram storage and separate logging of shocks and antitachycardia pacing episodes.

Excluded if
  • candidates for heart transplantation
  • other condition that is likely to fatal in < 2 years
  • unsuccessful defibrillation at time of implantation
  • no informed consent
  • incessant ventricular tachycardia
  • received class I and III antiarrhythmic drug therapy fewer than five half lives of the drug before randomisation, and amiodarone less than three months before
  • QT interval >450 msec in absence of drug therapy
  • long QT syndrome, including prolongation of QT interval in response to specific drugs
  • unstable coronary artery syndromes or acute MI < 2weeks before screening
  • intractable heart failure (New York Heart Association class IV)
  • <18 years


    • Note:
  • Patients were stratified according to ejection fraction and site.


    • Control Group: (n = 151, 151 analysed): placebo
    Experimental Group: (n = 151, 151 analysed): sotalol 120 mg twice daily for at least four days
    Investigators were allowed to adjust the dose of placebo or sotalol to a minimum of 80 mg and a maximum of 160 mg twice daily to optimise efficacy and avoid toxicity.
    100% followed for 12 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    delivery of first shock for any reason 12 months 73
    (48.3%)    		 45
    (29.8%)    		 38.0%
    (17.0% to 54.0%)    		 18.5%
    (7.74% to 29.4%)    		 5
    (3 to 13)
    death from any cause 12 months 7
    (4.64%)    		 4
    (2.65%)    		 43.0%
    (-91.0% to 83.0%)    		 1.99%
    (-2.23% to 6.21%)    		 50
    (NNT = 16 to infinity;
    NNH = 45 to infinity)

    Comments

    1. Treatment lasted less than 12 months in 34% assigned to sotalol and 35% assigned to placebo.

    Citation

    1. Pacifico A, Hohnloser SH, Williams JH, et al: Prevention of implantable-defibrillator shocks by treatment with sotalol. New England Journal of Medicine 1999; 340 (24): 1855-1862
    Contributor: Clare Wotton and Bob Phillips, January 2000
    Reviewer:

    Clinical Question.
    Patient irreversible ventricular tachycardia
    Intervention or Exposure sotalol
    Comparison placebo
    Outcome death