Trial Results Demonstrate Testing BNP Levels May Improve Emergency Department Triage Decisions for CHF Patients September 24, 2003 4:29:00 PM ET
Data Presented as Late Breaker During Heart Failure Society of America National Meeting
LAS VEGAS, Sept. 24 /PRNewswire-FirstCall/ -- Data from an emergency department heart failure trial suggest that omitting measurements of b-type natriuretic peptide (BNP), when evaluating congestive heart failure patients, may result in inappropriate triage decisions. The data from the first phase of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT), sponsored by Biosite(R) Incorporated BSTE, was presented this morning in a late breaking clinical trial presentation at the Heart Failure Society of America 7th Annual Scientific Meeting.
"REDHOT is the first large clinical trial to examine BNP in relation to physician decision-making, patient disposition and critical outcomes in the emergency medicine setting," said Alan Maisel, M.D., director of the coronary care unit at the San Diego V.A. Healthcare System and a principle investigator for the study. "The data from phase one demonstrate that, in emergency departments, there is a strong disconnect between the perceived severity of congestive heart failure cases by physicians and severity as determined by BNP levels." Dr. Maisel is a consultant to Biosite.
Biosite's REDHOT study is a two-phase, multi-center trial aimed at demonstrating the utility of using BNP testing to manage heart failure patients in the emergency department. In phase one of the study, 464 patients visiting emergency departments with complaints of breathing difficulty had BNP measurements taken on arrival, then every three hours in the emergency department, as well as at the time of hospital admission or discharge. Physicians were told only whether the initial BNP level was greater or less than 100 pg/mL and were blinded to subsequent BNP levels. Patients were followed for 90 days after discharge.
REDHOT Study: Phase One Results * Patients who were discharged home from the emergency department actually had higher BNP levels than those admitted to the hospital. The median BNP level of discharged patients, 976 pg/mL, was 27 percent higher than the mean BNP levels of those patients admitted (766 pg/mL). * Approximately 90 percent of all patients were admitted to the hospital from the emergency department. Of these, 11 percent had BNP levels of less than 200 pg/mL, which is indicative of less severe cases of congestive heart failure that typically do not require hospitalization. Additionally, 30-day and 90-day mortalities for these patients were 0 percent and 2 percent, respectively. * In the trial, approximately 10 percent of all patients were ultimately discharged home. Of these, 78 percent had BNP levels greater than 400 pg/mL. While 30-day mortality for these patients was 0 percent, 90-day mortality was 9 percent. Published studies suggest that patients with BNP levels of 230-480 pg/mL could be at significant risk for mortality or readmission. The second phase of the REDHOT study is expected to commence in the fourth quarter of 2003. Enrollment is expected to be completed within 6 months. In this phase, physicians will not be blinded to BNP concentrations.
About the Triage(R) BNP Test
The Triage BNP Test is currently used in more than 2,000 U.S. hospitals to aid in the diagnosis of heart failure and the assessment of disease severity. In approximately 15 minutes, the test measures circulating levels of BNP, which are elevated during heart dysfunction in both symptomatic (late-stage) and asymptomatic (early-stage) heart failure patients.
Based on an innovative rapid testing platform, the Triage BNP Test is well suited for use at the point-of-care. Diagnostic results are available in approximately 15 minutes, ensuring that the test can be performed while a patient waits. The process involves placing a few drops of blood on a small diagnostic chip, which is subsequently inserted into the Triage MeterPlus, a portable device that scans the chip and utilizes fluorescence technology to measure the level of a targeted marker in a patient's sample.
The Triage BNP Test was the first commercially available test for measurement of BNP. A 1,586 patient study, sponsored in part by Biosite and published in the July 18, 2002 issue of the New England Journal of Medicine, validated the utility of using BNP as an aid in the diagnosis of heart failure.
Biosite Incorporated, developer of the Triage BNP Test, which is used in more than 2,000 U.S. hospitals to perform BNP measurements, is sponsoring the REDHOT study. Dr. Maisel and McCullough are consultants to Biosite, who sponsored the study.
About Heart Failure
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. Heart failure 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 patient's 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.
Congestive heart failure affects more than 15 million people worldwide and approximately five million cases in the United States alone. About 550,000 new cases are diagnosed each year, another two million Americans are hospitalized each year with heart failure as the secondary diagnosis, and the disease contributes to 287,000 deaths annually. It is estimated that the total healthcare cost for congestive heart failure will reach $24.3 billion in 2003.
About Biosite
A leader in the drive to advance diagnosis, Biosite Incorporated is a research-based company dedicated to the discovery and development of novel protein-based diagnostics that improve a physician's ability to diagnose debilitating and life-threatening diseases. Through combined expertise in diagnostic discovery and commercialization, Biosite is able to access potential markers of disease, identify proteins with high diagnostic utility, develop and commercialize products and educate the medical community on new diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of U.S. hospitals and in more than 50 international markets for toxicology screening and diagnosis of infectious and cardiovascular disease. Information on Biosite can be found at www.biosite.com .
Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including but not limited to statements that are preceded by, followed by, or that include the words "will"; "believes"; "should"; "intend"; "anticipates"; "plans"; "expects"; "estimates"; or similar statements are forward-looking statements. Risks and uncertainties include risks associated with Biosite's ability to initiate phase two of the REDHOT trial when expected, the ability of clinical investigators to enroll patients to participate in phase two of the REDHOT trial that meet the specified enrollment criteria, and other risks associated with clinical trials generally as more fully described in our most recent SEC filings. In addition, the results of phase two of the REDHOT trial may not support the thesis that BNP tests can aid physicians in making appropriate triage decisions on whether or not to admit or discharge patients in the emergency department setting. Other risks that should be considered include risks associated with Biosite's business such as changing market conditions, sales, profitability, and the extent to which our products and products under development are successfully developed and gain market acceptance, risks associated with the introduction of competitive products from companies with greater capital and resources, and risks and expenses associated with litigation, contract disputes, patent conflicts, product recalls, manufacturing constraints, backlog, delays or inefficiencies, shipment problems, seasonal customer demand, the timing of significant orders, uncertainties or delays, changes in reimbursement policies, regulatory changes, competitive pressures on average selling prices, changes in the mix of products sold, and the other risks detailed in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other SEC filings. The Company disclaims, however, any intent or obligation to update these forward- looking statements. Copies of the Company's public disclosure filings are available from the Investor Relations department.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered trademarks of Biosite Incorporated. The Company's logo is a trademark of Biosite Incorporated.
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