Natrecor nesiritide: Phase III data

JNJ's Scios Inc. subsidiary reported data from the double-blind, international Phase III ASCEND-HF trial in 7,141 patients showing that Natrecor plus standard of care (SOC) for up to 7 days missed the co-primary endpoints of significantly reducing the composite of heart failure re-hospitalization or all-cause mortality during the first 30 days post-treatment (9.4% vs. 10.1%, p=0.313) and of significantly reducing heart failure symptoms as measured by subject self-assessed dyspnea scale scores at 6 (p=0.03) and 24 hours (p=0.007) after initiating treatment vs. placebo plus SOC. The pre-specified requirement for significance in dyspnea scale scores was p<0.005.

Rates of mortality were similar between treatment groups (3.6% vs. 4%), and there was no evidence of kidney function impairment in Natrecor-treated patients during the first 30 days based on a 25% reduction in glomerular filtration rate (GFR) vs. placebo (31.4% vs. 29.5%). Natrecor did significantly increase hypotension vs. placebo (26.6% vs. 15.3%, p<0.0001). SOC consisted of various diuretics and vasodilators. The data, which were presented at the American Heart Association meeting in Chicago, will be submitted to FDA as part of the standard collection of post-marketing drug experience. ...