SB's Carvedilol Effective In Congestive Heart Failure

SmithKline Beecham has discontinued two clinical trials of its antihypertensive drug carvedilol in patients with congestive heart failure because of an unexpectedly strong effect in reducing mortality. The Data and Safety Monitoring Board in the USA, consisting of independent medical authorities who oversee the safety of clinical trials, told the company to discontinue the two studies because to continue administering placebo would be unethical.

SB's congestive heart failure trials program has included a total of 1,000 patients in the USA. Two earlier trials involving 600 patients have already been completed on schedule. The latter two trials, involving 400 patients, are the ones which have been stopped early. All patients in the studies received either carvedilol or placebo, as well as standard drug therapy for congestive heart failure, including agents such as angiotensin converting enzyme inhibitors, diuretics and digoxin.

Following the recommendation of the advisory board, SB will terminate the trials and carvedilol will be offered to patients who have received placebo, while patients who were already on the drug will be offered the opportunity to continue with their medication. The results of the trials will be presented later in the year in an appropriate scientific forum. A spokesman for SB said no data was available for release as yet. Additional analysis of data is ongoing, including results from symptom and exercise tolerance measures and patient subgroup assessment.