Research Conducted at The University Hospital Leads to

First New Drug Treatment for Congestive Heart Failure in 14 Years. FDA Grants Approval of Heart Drug

Contact: Pat Samson (513) 585-7200
Date: 08/23/2001

Cincinnati--Based on research conducted at The University Hospital and other medical institutions nationwide, the U.S. Food and Drug Administration (FDA) recently approved the use of Natrecor™ (nesiritide) for the intravenous treatment of patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.

Natrecor™ is the first new drug approved to treat these patients in 14 years. In this population, the use of Natrecor™ reduced pulmonary capillary wedge pressure, an important measure of heart function, and improved breathing. Natrecor™ is the first product to receive FDA approval for acutely decompensated congestive heart failure showing an improvement in breathing in these patients.

Lynne Wagoner, M.D., director of the Heart Failure and Transplant Program at The University Hospital, was involved in the clinical trials for nesiritide, and co-authored an article for the July 27, 2000 New England Journal of Medicine that defined its efficacy in heart failure patients. "Nesiritide or Natrecor™ is a landmark therapy for the inpatient treatment of heart failure patients," says Wagoner. "It can be administered in the emergency room for severe shortness of breath or in the hospital setting for patients being treated for heart failure. It is much safer than conventional therapies such as dobutamine and milrinone."

Roughly five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute congestive heart failure, which cost the health care system $15 billion annually. Another two million Americans are hospitalized each year with acute congestive heart failure as a secondary diagnosis. In the U.S., congestive heart failure accounts for the largest cause of hospitalizations for patients over the age of 65. The impact of Natrecor™ on these costs is not known.

The University Hospital is part of the Health Alliance, an integrated health care delivery system that also includes The Christ Hospital, The St. Luke Hospitals, The Jewish Hospital, The Fort Hamilton Hospital and the physicians of Alliance Primary Care.

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