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EMBARGOED FOR RELEASE UNTIL WED., July 26, 2000, 5:00 p.m. EST
NEW ENGLAND JOURNAL OF MEDICINE ARTICLE REPORTS NEW DRUG MAY BE USEFUL FOR PATIENTS HOSPITALIZED WITH ACUTE CONGESTIVE HEART FAILURE
Boston, Mass., July 26, 2000 - There is new hope for the more than one million patients hospitalized in the United States each year with acute congestive heart failure (CHF) according to an article published in this week's issue of The New England Journal of Medicine.
The results of two separate studies indicate that a new experimental drug, nesiritide, significantly improves hemodynamic function (i.e., blood circulation forces) and clinical status of patients hospitalized with decompensated CHF and may provide a potent new treatment option for these very sick patients. Nesiritide (Scios Inc., Sunnyvale, Calif.) is a recombinant form of human BNP (B-type natriuretic peptide), part of the body's natural response to a failing heart.
The standard treatments currently used for acute CHF are not ideal according to Wilson S. Colucci, M.D., Professor of Medicine and Physiology and Cardiovascular Medicine, Boston University School of Medicine, and the lead author of the article. The use of dobutamine and milrinone can be limited by the dose-dependent adverse effects they have on heart rate and arrythmias. Patients taking nitroglycerin are susceptible to developing a tolerance of the drug. Although sodium nitroprusside is a potent vasodilator, its use is often limited by the need for close monitoring and by concern about the toxic side effects of cyanide or thiocyanide.
"Nesiritide would be a valuable addition to the initial treatment of patients admitted to the hospital for acute decompensated CHF," said Colucci. "The drug's salutary clinical and hemodynamic profile and the relative absence of adverse side effects circumvent several of the limitations we have with currently available treatments."
In one double-blind, placebo-controlled trial with 127 patients conducted at 23 U.S. medical centers, investigators determined the short-term efficacy of two different doses of nesiritide with regard to hemodynamic measures and symptoms. Both doses of nesiritide caused statistically significant improvements in global clinical status and symptoms of decompensated CHF (e.g., severe shortness of breath, or "air hunger," and fatigue) compared to placebo.
In a separate randomized, open-label, active-controlled study of 305 patients conducted at 46 U.S. medical centers, investigators compared two different doses of nesiritide with standard intravenous agents. Again, both doses of nesiritide produced statistically significant improvements in global clinical status and specific symptoms of decompensated CHF. Patients treated with nesiritide had a reduced need for diuretics. There was no significant difference between treatment groups in length of therapy, length of hospitalization, readmissions, medical interventions or mortality. In both trials, the most common adverse event in the patients treated with nesiritide was dose-related hypotension, which was usually asymptomatic.
Congestive Heart Failure (CHF)
A potentially life-threatening disorder that has no cure, heart failure is a chronic pathophysiologic condition in which 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/or rapid weight gain. CHF may result from an acute event (e.g., heart attack) or may develop gradually over time.
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 patients' condition. A sudden increase in dietary sodium (salt), failure to take 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, however, only half are diagnosed with the condition, which may go undetected because the body often compensates for many of the symptoms. There are approximately one million hospitalizations in the U.S. each year with CHF as the primary diagnosis. 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, Boston University Medical Center is a nationally-recognized leader in cardiovascular medicine, cancer, trauma, Parkinson's disease, arthritis, infectious diseases including AIDS, and spinal cord injuries.
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