Promising New Treatment For Acute Congestive Heart Failure Reviewed In Journal Of Cardiac Failurestudies Involving Over 1,700 Patients Demonstrate Nesiritide Rapidly Improves Blood Circulation, Relieves Patient Symptoms

in Health & Medicine, News Releases, School of Medicine
March 22nd, 2001

Contact: Gina M. Digravio, 617-638-8491 | gina.digravio@bmc.org

(Boston, Mass.) — A promising investigational drug called nesiritide may become a useful new treatment for the one million Americans hospitalized each year with acute congestive heart failure (CHF), according to a comprehensive review article published in this week’s issue of the Journal of Cardiac Failure.

The article reviews results of clinical trials involving more than 1,700 acute CHF patients and concludes that nesiritide (NatrecorÒ, Scios, Inc. (Nasdaq: SCIO), Sunnyvale, Calif.) rapidly improves blood circulation and alleviates symptoms associated with acute CHF, such as shortness of breath and fatigue. Nesiritide is a recombinant form of B-type natriuretic peptide (BNP), a naturally occurring hormone in the body that aids healthy functioning of the heart. It causes arteries and veins to dilate, alleviating symptoms by improving blood movement around the heart without a change in heart rate. Nesiritide is administered intravenously in a standard fixed dose regimen, and does not require titration (i.e., dose adjustments).

“The impressive amount of data collected, analyzed and presented to date indicate that nesiritide improves symptoms, is well-tolerated and would be a valuable addition to the initial treatment of patients admitted to the hospital for acute decompensated CHF,” said the article’s author, Wilson S. Colucci, M.D., Professor of Medicine and Physiology and Cardiovascular Medicine, Boston University School of Medicine. “The drug’s salutary clinical and hemodynamic profile, rapid onset of action, ease of administration and favorable safety profile circumvent several of the limitations we have with currently available treatments.” Nesiritide is currently being reviewed by the U.S. Food and Drug Administration and, if approved, would be the first new treatment for acute CHF in more than a decade.

The article examines several studies, including the recently completed 498-patient VMAC (Vasodilation in the Management of Acute Congestive heart failure) trial, which demonstrated that nesiritide, added to standard care, had a statistically significant effect on the primary endpoint, reducing pulmonary capillary wedge pressure (PCWP), a measure of the pulmonary congestion resulting from acute CHF, in as little as 15 minutes. This effect was sustained for at least 48 hours. At three hours, nesiritide plus standard care significantly improved PCWP, compared to either the placebo plus standard care or intravenous (IV) nitroglycerin plus standard care regimens. Nesiritide also significantly improved patient breathing compared to the placebo plus standard care regimen, and produced a more rapid improvement in patient hemodynamics and caused significantly fewer side effects than the IV nitroglycerin regimen.

In the first three hours of the VMAC trial, 5% of the Natrecor patients reported headache, vs. 12% for IV nitroglycerin. In the first 24 hours of the trial, 9% of the Natrecor patients reported headache, vs. 20% for nitroglycerin. Symptomatic hypotension was reported in 4% of the Natrecor patients and 5% of the nitroglycerin patients.

Another recent study discussed in the article is the PRECEDENT (Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Nesiritide Therapy) trial, which showed that nesiritide produced fewer arrhythmias (irregular heart beats) and improved overall mortality rates compared to dobutamine, a commonly administered inotropic agent. The other studies reviewed in the article were published in the July 27th issue of The New England Journal of Medicine. In those studies, infusion of nesiritide in acute CHF patients resulted in significant improvements in hemodynamic function (i.e., blood circulation forces), including an increase in the cardiac index, and rapid and sustained improvements in clinical status. Congestive Heart Failure – An Epidemic

A potentially life-threatening disorder that has no cure, heart failure usually develops gradually over time, and is becoming more prevalent as the population ages. In heart failure, the heart functions inefficiently and circulation is reduced to the body’s organs. In congestive heart failure, fluid accumulates in the tissues, including lung tissue, causing such symptoms as difficulty breathing, swelling of the hands and feet, difficulty sleeping, dry cough, fatigue and rapid weight gain. CHF may result from an acute event (e.g., heart attack), where a patient survives but with a weakened heart.

During an acute episode of CHF, the heart’s inability to adequately circulate blood throughout the body worsens beyond its already compromised state, causing symptoms to become so pronounced that hospital treatment is required to stabilize the patient’s condition. A sudden increase in dietary sodium (salt), failure to take chronic oral medications for managing CHF, or the development of a new heart arrhythmia can precipitate an acute attack.

Roughly five million Americans suffer from heart failure, and there are approximately one million hospitalizations each year in the U.S. for CHF which cost the healthcare system $23 billion. Another two million Americans are hospitalized each year with CHF as the secondary diagnosis. In the U.S., CHF accounts for the largest cause of hospitalizations for patients over age 65. Virtually all CHF patients will have at least one acute episode, where the symptoms are so severe that often only intravenous (IV) medications administered in the hospital can improve patients’ health.

Boston University Medical Center is composed of the Boston University Schools of Medicine, Public Health, and Dental Medicine and Boston Medical Center. With more than 2,000 physicians and researchers on its staff,

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