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Published on 5/9/2006 in the Prospect News Biotech Daily.

Scios data shows nesiritide favorably affects renal function following surgery

By Elaine Rigoli

Tampa, Fla., May 9 -Scios, Inc. released data from a pilot trial of the heart-failure drug nesiritide, which studied postoperative renal function and clinical outcomes in heart-failure patients who required coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass.

Nesiritide is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.

In this study, patients with reduced heart pumping function who were scheduled for CABG surgery using cardiopulmonary bypass were randomized to be treated with an infusion of nesiritide or a placebo after induction of anesthesia in addition to usual care for 24 to 96 hours, according to a news release.

The maximum mean increase in serum creatinine from baseline was 0.15+/-0.29 mg/dL in nesiritide patients compared to 0.34+/-0.48 mg/dL in placebo patients. This difference was even greater in patients who had some degree of renal dysfunction before surgery.

The maximum decrease in glomerular filtration rate from baseline was -10.8 mL/min/1.73 m2 in nesiritide patients compared to -17.2 mL/min/1.73 m2 in placebo patients.

Although the use of intravenous diuretic medications was similar between the two groups, urine output 24 hours after admission to an intensive care unit was greater in patients receiving nesiritide than a placebo. Nesiritide patients also had a shorter hospital length of stay compared to the placebo group.

Scios, a Johnson & Johnson company, is a biopharmaceutical company with headquarters in Fremont, Calif.


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