ARTICLE | Clinical News

Natrecor safe but not efficacious in heart failure study

November 16, 2010 1:14 AM UTC

Johnson & Johnson (NYSE:JNJ) said Natrecor nesiritide did not impair kidney function or increase mortality rates vs. placebo; however, the drug also missed the co-primary efficacy endpoints in the Phase III ASCEND-HF trial to treat acute decompensated heart failure (ADHF). Natrecor plus standard of care (SOC) did not significantly reduce the composite of heart failure re-hospitalization or all-cause mortality during the first 30 days post-treatment vs. placebo plus SOC (p=0.313). The recombinant B-type natriuretic peptide (BNP) vasodilator also did not significantly reduce 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. The double-blind, international trial enrolled 7,141 patients.

Rates of mortality were similar between treatment groups, and there was no evidence of kidney function impairment in Natrecor patients during the first 30 days. 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. Natrecor is marketed to treat ADHF in patients who experience dyspnea at rest or with minimal activity. ...