B-MS Discontinues d-Sotalol Trial

Bristol-Myers Squibb has discontinued its oral d-sotalol SWORD (survival with oral d-sotalol) trial due to a monitoring committee report of excess mortality in the treated group compared to placebo. The Phase III trial was intended to study the effect of the drug in preventing sudden cardiac death in myocardial infarction patients at risk of life-threatening ventricular arrhythmia. Originally, the compound was intended as a single isomer follow-up to B-MS' Betapace (sotalol) drug.

The excess mortality came to light after the SWORD 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.

The SWORD trial was touted by B-MS as the largest of its kind and had enrolled 3,000 of the planned 6,400 patients. Because of problems with Class I (sodium channel blockers) and Class II (beta blocking) drugs, focus has now shifted to the Class III potassium-blocking agents, said B-MS. Sotalol has both Class II and III activity, but the single d-isomer is purely Class III in action.