Cardiome oxypurinol fails CHF trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Oxypurinol's failure to demonstrate a statistically significant benefit over placebo in congestive heart failure is an "unequivocal negative outcome," the Vancouver firm says Aug. 15. Oxypurinol showed no benefit (p=0.357) for a primary composite endpoint that included NYHA class, global heart failure status and hospitalizations/visits for worsening condition. "In addition, no benefits over placebo were observed in Minnesota CHF Quality of Life index and time to acute clinical events," Cardiome said. The firm plans to "review the data in greater detail prior to making any final decisions about the future of this program"...