Candesartan CHF Trial Stopped On Mortality Concerns

Results of the RESOLVD study of Takeda/Astra's angioensin II receptorantagonist candesartan cilexetil in patients with heart failure were presented at the American Heart Association meeting. The trial was stopped prematurely when an excess mortality appeared to be emerging for the candesartan group.

RESOLVD compared three doses of candesartan (4mg, 8mg or 16mg/day) to enalapril (10mg twice-daily) and a combination of candesartan at two doses (4mg and 8mg) with enalapril. A total of 769 patients were enrolled from 60 centers in five countries, and received treatment for 10 months. The primary endpoints were left ventricular function, exercise capacity, neurohormonal effects and quality of life - it was not powered to show an effect on mortality or other clinical events. Analyses were performed at 18 and 43 weeks.

Non-Significant Difference Principle investigator Salim Yusuf of McMaster University in Canada told the meeting that despite the early halt, by the time the data had all come in, the difference in the death rate between the groups was not significant. The overall mortality rates were 6.1% for candesartan alone, 8.7% for the combination and 3.7% for enalapril alone. There was also no difference between the groups in hospitalization rates for heart failure, hospitalization for any cause, or the combination of death and hospitalization.