Atrial fibrillation, atrial flutter: paroxysmal: sotalol 120 mg twice daily reduced recurrent symptomatic episodes.

Clinical bottom line (level 1b)

  1. Patients who took 80 mg sotalol twice daily were not clearly less likely to have recurrent attacks than patients on placebo.
  2. Patients with paroxysmal atrial fibrillation or flutter who took 160 mg of sotalol or 120 mg of sotalol twice daily were less likely to have recurrent symptomatic attacks (NNT = 5 at 12 months) .
  3. Patients on sotalol compared with placebo were not clearly more likely to discontinue medication early.
Benditt et al: American Journal of Cardiology 1999; 84: 270-277
Expires January 2004

The study

Double-blinded concealed randomised trial without intention-to-treat
Setting: 29 acute hospitals, USA

253 patients (aged 24 to 86; mean 62, 64% male) with a symptomatic atrial fibrillation and/or flutter documented within previous three months, and in sinus rhythm at randomisation.

Excluded if
  • oral amiodarone therapy for one month or more within the past 12 weeks, or iv amiodarone within the previous month
  • use of class I antiarrhythmic drugs that prolong QT interval, congenital or acquired long QT intervals, QT > 450 ms, history of torsade de pointes, Wolff-Parkinson-White syndrome
  • electrolyte imbalance
  • acute myocardial infarction within previous two months, unstable angina
  • previous use of d,l-sotalol
  • asymptomatic AF and/or flutter
  • contraindications to beta-blocker therapy
  • congestive heart failure, renal failure (creatinine clearance < 40 ml/min), syncope, embolic cerebrovascular event, transient ischaemic attack, thyrotoxicosis, perioperative cardiothoracic surgery, acute pulmonary failure, pulmonary embolism or pneumonia
  • bradycardia-tachycardia syndrome in the absence of an implanted pacemaker, or sinus rate < 50 beats/min during waking hours


    • Note:
  • Patients with impaired renal function (creatinine clearance 40 to 60 ml/min) received half the daily dose.


    • Control Group: (n = 69, 69 analysed): placebo
    Experimental Group: (n = 59, 59 analysed): d,l-sotalol 80 mg twice daily
    Experimental Group: (n = 63, 63 analysed): d,l-sotalol 120 mg twice daily
    Experimental Group: (n = 62, 62 analysed): sotalol 160 mg twice daily

    94% followed for 12 months
    Outcome notes:
    • discontinued medication early : sotalol 160 mg
    • symptomatic AF or flutter : documented on ECG: sotalol 160 mg
    • discontinued medication early : sotalol 120 mg
    • symptomatic AF or flutter : documented on ECG: sotalol 120 mg
    • discontinued medication early : sotalol 80 mg
    • symptomatic AF or flutter : documented on ECG: sotalol 80 mg

    The evidence

    sotalol 160 mg v. placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    discontinued medication early 12 months 53
    (76.8%)    		 48
    (77.4%)    		 -1%
    (-21% to 16%)    		 -0.61%
    (-15.0% to 13.8%)    		 -170
    (NNT = 7 to infinity;
    NNH = 7 to infinity)
    symptomatic AF or flutter 12 months 46
    (66.7%)    		 26
    (41.9%)    		 37%
    (12% to 55%)    		 24.7%
    (8.16% to 41.3%)    		 4
    (2 to 12)

    sotalol 120 mg v. placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    discontinued medication early 12 months 53
    (76.8%)    		 45
    (71.4%)    		 7%
    (-14% to 24%)    		 5.38%
    (-9.57% to 20.3%)    		 19
    (NNT = 5 to infinity;
    NNH = 10 to infinity)
    symptomatic AF or flutter 12 months 46
    (66.7%)    		 31
    (49.2%)    		 26%
    (0% to 45%)    		 17.5%
    (0.84% to 34.1%)    		 6
    (3 to 120)

    sotalol 80 mg v. placebo
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    discontinued medication early 12 months 53
    (76.8%)    		 46
    (78.0%)    		 -2%
    (-22% to 16%)    		 -1.15%
    (-15.7% to 13.4%)    		 -87
    (NNT = 7 to infinity;
    NNH = 6 to infinity)
    symptomatic AF or flutter 12 months 46
    (66.7%)    		 34
    (57.6%)    		 14%
    (-14% to 34%)    		 9.04%
    (-7.77% to 25.9%)    		 11
    (NNT = 4 to infinity;
    NNH = 13 to infinity)

    Comments

    1. Using 160 mg of sotalol was not clearly more likely to prevent recurrent symptomatic arrhythmias than using 120 mg sotalol.
    2. No patients died during the study.

    Citation

    1. Benditt DG, Williams JH, Jin J, et al: maintenance of sinus rhythm with oral d,l-sotalol therapy in patients with symptomatic atrial fibrillation and/or atrial flutter. American Journal of Cardiology 1999; 84: 270-277
    Search Terms: from 'other articles noted' in ACP Journal Club Nov-Dec 1999
    Contributor: Chris Ball and Clare Wotton, January 2000
    Reviewer:

    Clinical Question.
    Patient paroxysmal symptomatic atrial fibrillation or flutter
    Intervention or Exposure sotalol
    Comparison placebo
    Outcome recurrent symptomatic AF or flutter