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.wisepoqder Sotalol
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.
SWORD is one of 15 studies in progress evaluating d-sotalol in the prevention of ventricular tachyarrhythmia. The other prevention trials are studying different patient populations than in the SWORD trial. B-MS said that study of the compound will continue. However, all trials of d-sotalol with SWORD-like patient and protocol profiles will be discontinued and enrollment in the supra-ventricular arrhythmia trial has been halted pending protocol revision.
...And Withdraws Questran Tablets Bristol-Myers Squibb is also withdrawing Questran (cholestyramine) tablets in the USA and Canada, following seven reports of patients experiencing swallowing difficulties with the tablets including two reports of choking episodes. The 1gm tablets were launched in May last year at a 10% discount to the oral suspension formulation. Neither of the powder forms are affected by the withdrawal.