( d followed studyparticipants for a min...)Scios Announces Results From Exploratory Nesiritide Study Providing,Important New Renal and Mortality Safety Data with a Neutral Effect,on the Primary Endpoint,Health

This Phase 2 trial was designed to further assess the safety, outcomes and optimal dosing frequency of nesiritide in an outpatient setting compared to placebo as a post-hospitalization treatment strategy in patients with advanced CDHF. The primary endpoint was a composite of all-cause mortality and/or cardiorenal hospitalization at 12 weeks. The study also measured numerous safety parameters, including effect on renal function and mortality.

    Primary Composite Endpoint


                      Nesiritide         Placebo           *P-value

                      Combined           Combined

                      (n=605)            (n=306)

    All cause

     mortality and

     CV/renal

     hospitalization+   36.7 %             36.8 %             0.79

    All cause

     mortality           9.5 %              9.6 %             0.98

    CV/renal

     hospitalization    32.9 %             33.9 %             0.95



    *P-value:  Nesiritide vs. placebo stratified by dose group

    +Modified intent-to-treat (ITT): all treated ITT patients

The intensive disease management provided in this study is not the current standard of care for patients with advanced CDHF. Patients saw a health care provider once or twice weekly for four to six hours per visit, allowing opportunity for optimization of evidence-based therapies for heart failure.

"This trial provides another important element in the evidence base about chronic decompensated heart failure," said Robert M. Califf, M.D., Vice Chancellor for Clinical Research and Professor of Medicine in the Division of Cardiology at Duke University Medical Center. "Although nesiritide did not show additional benefit compared to placebo when given serially in CDHF outpatients, these data are reassuring with regard to previous concerns about renal toxicity and mortality outcomes. Now that we have this important safety information from FU
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