Clinical experience with dofetilide in the treatment of patients with atrial fibrillation.

UNLABELLED: Dofetilide for Treatment of AF. INTRODUCTION: Dofetilide is the newest drug approved by the United States Food and Drug Administration for the treatment of patients with atrial fibrillation (AF). Few data on the efficacy and safety of dofetilide in a diverse group of patients are available. The aim of this study was to evaluate the results of dofetilide in a consecutive series of 69 patients with AF. METHODS AND RESULTS: Sixty-nine patients with persistent (n = 53) or paroxysmal (n = 16) AF were administered dofetilide in-hospital. Prior to starting dofetilide, all patients had been adequately anticoagulated, and concomitant agents contraindicated in the presence of dofetilide were discontinued. Heart rhythms were monitored continuously by telemetry in all patients. The initial dose, which was determined using the Cockroft-Gault calculated creatinine clearance, was 500 microg bid, 250 microg bid, and 125 microg bid in 51, 13, and 5 patients, respectively. Reductions in subsequent dosage occurred in 12 patients, 4 for QT prolongation. Dofetilide was discontinued in-hospital in 7 patients, 2 for adverse arrhythmic events and 3 for unacceptable QT prolongation. Twenty-seven (63%) of 43 patients in AF converted spontaneously to sinus rhythm. Fifty-eight patients were discharged receiving dofetilide treatment and were followed as outpatients for 21 +/- 7 months. One third of patients continued to take dofetilide at 1 year. One patient had a cardiac arrest 1 day after hospital discharge. CONCLUSION: Dofetilide is a well-tolerated antiarrhythmic drug with a high conversion rate of AF to sinus rhythm. One third of patients maintained sinus rhythm at 1 year. Proarrhythmia can occur and initiation of therapy must be performed in-hospital.

Initiation and monitoring of class III antiarrhythmic agents.

Initiation and Monitoring of Class III Agents. Dofetilide is a Class III antiarrhythmic agent that is approved by the United States Food and Drug Administration (FDA) for use in the conversion of atrial fibrillation, as well as in the maintenance of normal sinus rhythm. Because of the risk of torsades de pointes associated with dofetilide, the FDA mandated in-hospital initiation of therapy and initially restricted dofetilide's availability to institutions and prescribers who completed appropriate educational forums. The use of dofetilide within health care systems requires specific procedures for prescribing, dispensing, and monitoring, as well as a format for educating personnel who will be involved in the care of these patients. Several models have demonstrated success in initiating dofetilide and are also used for sotalol, which also can cause torsades de pointes. The utilization of nonphysician personnel, such as nurse practitioners and clinical pharmacists, in conjunction with a team approach were essential components for the success of these models. Preprinted order forms or procedural guidelines, as well as computer-assisted dosing programs, can be utilized to prevent inappropriate or miscalculated dosing of these agents, which potentially can cause life-threatening ventricular arrhythmias.