BRISTOL DISCONTINUES ORAL d-SOTALOL SWORD TRIAL

BRISTOL DISCONTINUES ORAL d-SOTALOL SWORD TRIAL on Nov. 1 because of increased mortality compared to placebo in patients taking the investigational class III (potassium channel blocking) anti-arrhythmic drug. The SWORD (Survival with Oral d-Sotalol) Data Safety Monitoring Committee examined interim data from 2,762 patients and determined that "the overall mortality in the d- sotalol group was 3.9% compared to 2% in the placebo group;" Bristol-Myers Squibb reported Nov. 4.

The SWORD trial, which BMS announced as "the largest study of its kind," had enrolled 3,000 of a proposed 6,400 study subjects in approximately 500 centers worldwide ("The Pink Sheet," Oct. 31, T&G-7). SWORD was one of 15 studies of d-sotalol to prevent ventricular tachyarrhythmia. Study of the follow-on compound to Betapace (sotalol) will continue, BMS said.

The other ventricular arrhythmia prevention trials are studying different patient populations than SWORD, which enrolled patients "considered at risk for developing potentially life- threatening ventricular arrhythmias" but excluded those with "life-threatening" ventricular arrhythmias.

Other d-sotalol trials have enrolled patients with malignant ventricular arrhythmia, BMS said, who could see benefit from d- sotalol. The company pointed to studies of patients with life- threatening ventricular arrhythmia and supra-ventricular arrhythmia as examples of continuing trials.

All trials of d-sotalol will discontinue patients with SWORD- like profiles (left ventricular ejection fraction of less than or equal to 40% and an acute myocardial infarction within six to 42 days of enrollment or a remote MI and overt heart failure more than 42 days before enrollment). Enrollment in the supra- ventricular arrhythmia trial has been halted pending protocol revision, the company added.