Long-Awaited Natrecor Trial Starts To Enroll Patients In June 2007

Scios Inc. Finally Going To Assess Benefit / Risk Profile Of Natrecor In Large Trial Of Patients With Acutely Decompensated Heart Failure

On June 8, 2007 Scios, Inc. let the public know that it has started enrolling patients in a 7,000-patient trial designed to "assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF)".

According to this June 8 announcement by Scios on the Johnson & Johnson (J&J) web site, Natrecor has previously only been studied in "16 prospective clinical trials involving 2,012 patients", while it has been used to treat "more than 800,000" patients with ADHF since it was approved in 2001.

As background, in June 2005 asked a prominent cardiologist, Eugene Braunwald of Harvard, to convene an advisory panel of heart doctors in order to assess analyses published by two leading medical journals that raised new safety questions regarding Natrecor. Those analyses pooled data from selected tests of Natrecor and estimated the drug may increase the risk of compromised kidney failure by 50%, and of death within 30 days by 74% or more, compared with other therapies.  Soon thereafter, Dr. Braunwald's panel urged J&J and Scios to proceed with a follow-up study to investigate the safety profile of Natrecor.

About a year later, in May 2006 one of the members of that Braunwald panel, Dr. Milton Packer, criticized J&J and Scios for their delay in doing the definitive study that the panel recommended in the summer of 2005.

Now, in the summer of 2007, we learn from J&J and Scios that they are starting to enroll the first patients in this long-awaited Natrecor safety trial.

The June 2007 announcement by J&J and Scios provides these details about this new trial, called Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure, or ASCEND-HF:

In this randomized, double-blind, placebo-controlled, parallel-group, multi-center outcomes trial, approximately 7,000 patients with ADHF will be randomized to receive placebo or NATRECOR® for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.

The primary objective of the trial is to assess whether treatment with NATRECOR® in addition to standard care, compared with placebo plus standard care, improves patient outcomes, as measured by reduction in the composite of heart failure rehospitalization and all-cause mortality through 30 days; or improves heart failure symptoms, as measured by a patient self-assessed dyspnea, or shortness of breath, scale at six and 24 hours after NATRECOR® initiation.

The ASCEND-HF Natrecor trial is being conducted by the Duke Clinical Research Institute (DCRI), which is working in collaboration with the Cleveland Clinic Cardiovascular Coordinating Center (C5).

There was no mention in the June 2007 announcement about when this Natrecor safety trial would be completed nor when its results can be expected.