Data has been presented by Johnson & Johnson unit Scios which shows that the controversial drug Natrecor, which has been linked to kidney damage and fatalities, was safe in a study of patients with severe, chronic heart failure but did not prolong life.
Data from the 920-patient, Phase II study, known as FUSION II, of Natrecor (nesiritide) were presented at the American College of Cardiology' meeting in New Orleans,USA which showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalisation at 12 weeks, but provided “important renal and mortality safety data” in patients with advanced chronic decompensated heart failure receiving serial outpatient infusions, Scios noted.
Although nesiritide did not show additional benefit compared to placebo when given serially in CDHF outpatients, Clyde Yancy, principal investigator of the randomised, placebo-controlled, double-blind FUSION II, said the safety findings from the trial, “and other recent clinical studies, should be reassuring for physicians who use nesiritide to treat patients according to its currently labelled indication and who are evaluating the drug in ongoing investigations." He added that "the relatively low clinical event rates observed in both treatment groups are consistent with previous investigations that have demonstrated the utility of rigorous disease management…this is an important message for practitioners."
Natrcor is the only US Food and Drug Administration-approved intravenous treatment for patients with acutely decompensated congestive heart failure who have dyspnea (shortness of breath) at rest or with minimal activity and J&J will now start the largest ever global trial in ADHF to assess the impact of nesiritide on health outcomes in the acute phase of the illness.
The data represents some good news at last for Natrecor, sales of which collapsed after questions were raised in the Journal of the American Medical Association in April 2005 about the drug’s effect on the kidneys and link to fatalities: a meta-analysis of three clinical studies suggested that Natrecor was linked to a higher rate of death than standard therapy after 30 days' treatment.
The news triggered a label change to include the mortality data and, in June 2005, an FDA panel recommended Natrecor's use should be limited to only the sickest patients while J&J conducted a large-scale study to prove the drug is safe. Earlier this month, J&J received subpoenas from attorneys in Boston, Philadelphia and San Francisco over allegations it marketed Natrecor and two other drugs for unapproved uses.