Dofetilide in Patients with Congestive Heart Failure and Left Ventricular Dysfunction

doi:10.1056/NEJM199909163411201

Volume 341:857-865		September 16, 1999		Number 12

Dofetilide in Patients with Congestive Heart Failure and Left Ventricular Dysfunction

Christian Torp-Pedersen, M.D., Mogens Møller, M.D., Poul Erik Bloch-Thomsen, M.D., Lars Køber, M.D., Erik Sandøe, M.D., Kenneth Egstrup, M.D., Erik Agner, M.D., Jan Carlsen, M.D., Jørgen Videbæk, M.D., Bradley Marchant, M.D., A. John Camm, M.D., for The Danish Investigations of Arrhythmia and Mortality on Dofetilide Study Group

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by Stevenson, W. G.

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ABSTRACT

Background Atrial fibrillation occurs frequently in patientswith congestive heart failure and commonly results in clinicaldeterioration and hospitalization. Sinus rhythm may be maintainedwith antiarrhythmic drugs, but some of these drugs increasethe risk of death.

Methods We studied 1518 patients with symptomatic congestiveheart failure and severe left ventricular dysfunction at 34Danish hospitals. We randomly assigned 762 patients to receivedofetilide, a novel class III antiarrhythmic agent, and 756to receive placebo in a double-blind study. Treatment was initiatedin the hospital and included three days of cardiac monitoringand dose adjustment. The primary end point was death from anycause.

Results During a median follow-up of 18 months, 311 patientsin the dofetilide group (41 percent) and 317 patients in theplacebo group (42 percent) died (hazard ratio, 0.95; 95 percentconfidence interval, 0.81 to 1.11). Treatment with dofetilidesignificantly reduced the risk of hospitalization for worseningcongestive heart failure (risk ratio, 0.75; 95 percent confidenceinterval, 0.63 to 0.89). Dofetilide was effective in convertingatrial fibrillation to sinus rhythm. After one month, 22 of190 patients with atrial fibrillation at base line (12 percent)had sinus rhythm restored with dofetilide, as compared withonly 3 of 201 patients (1 percent) given placebo. Once sinusrhythm was restored, dofetilide was significantly more effectivethan placebo in maintaining sinus rhythm (hazard ratio for therecurrence of atrial fibrillation, 0.35; 95 percent confidenceinterval, 0.22 to 0.57; P<0.001). There were 25 cases oftorsade de pointes in the dofetilide group (3.3 percent) ascompared with none in the placebo group.

Conclusions In patients with congestive heart failure and reducedleft ventricular function, dofetilide was effective in convertingatrial fibrillation, preventing its recurrence, and reducingthe risk of hospitalization for worsening heart failure. Dofetilidehad no effect on mortality.

Source Information

From the Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark (C.T.-P., P.E.B.-T., L.K.); the Department of Cardiology, Odense University Hospital, Odense, Denmark (M.M.); the Department of Cardiology, Haderslev Hospital, Haderslev, Denmark (E.S., K.E.); the Department of Cardiology, Helsingor Hospital, Helsingor, Denmark (E.A.); the Department of Cardiology, Bispebjerg University Hospital, Bispebjerg, Denmark (J.C., J.V.); Pfizer Central Research, Sandwich, Kent, United Kingdom (B.M.); and the Department of Cardiology, St. George's Hospital, London (A.J.C.).

Address reprint requests to Dr. Møller at the Department of Cardiology B, Odense University Hospital, DK-5000 Odense, Denmark, or at moller{at}pacemaker.dk.

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