Roche Diagnostics Release: New Study Demonstrates Significant Economic and Clinical Value of NT-proBNP Testing for the Management of Heart Failure

ROTKREUZ, Switzerland, June 19 /PRNewswire-FirstCall/ -- A study published today in Circulation demonstrates the effective use of NT-proBNP, Roche Diagnostics' breakthrough marker for suspected heart failure (HF), for use in both point of care and laboratory testing. The multi-center, randomized-controlled trial conducted on 500 patients in seven hospitals, shows that NT-proBNP (N-terminal proB-type natriuretic peptide) guided strategy in the management of suspected acute HF in the emergency department (ED) reduced the duration of emergency department (ED) visits by 21 percent (6.3 to 5.6 hours, p =0.031), numbers of patients re-hospitalized over 60 days by 35 percent (51 to 33, p=0.046) and direct medical costs of all ED visits, hospitalisations and subsequent outpatient services by 15 percent (USD6,129 to USD5,180 per patient, p=0.023) over 60 days from enrolment. With the total annual cost of managing HF estimated to be between USD1.4 and USD2.3 billion(1),(2), this can be calculated as potential annual savings to the Canadian healthcare system of between USD210 and USD345 million.

Cardiovascular diseases are currently responsible for one-third of all deaths globally(3). The incidence and prevalence of heart failure (HF) is rising, with heart disease and stroke predicted to become the leading cause of death and disability worldwide by 2020 according to the World Health Organization (WHO). The number of fatalities is projected to increase to over 24 million a year by 2030(3). Early and accurate diagnosis of HF is crucial for better quality of care and cost-effective patient management. NT-proBNP and B-type natriuretic peptide (BNP) have been shown to provide incremental value in the rapid diagnosis of HF in the emergency room. Due to its greater stability, NT-proBNP may represent a more useful diagnostic marker than BNP for cardiovascular disorders including HF.

Dr. Gordon W. Moe, a cardiologist and director of the heart failure programme and biomarker laboratory at St. Michael's Hospital in Toronto, Canada who chaired the study stated: "In a universal-access publicly-funded healthcare system like we have in Canada, we have to mandate judicious resource allocation. An approach using NT-proBNP in conjunction with clinical assessment improves the overall management of patients presenting to the emergency department with suspected acute HF through the facilitation of diagnosis, and provides health cost savings that are accompanied by an improvement in selected clinical outcomes. The use of the NT-proBNP test will improve the overall management of patients with suspected acute HF, and this biomarker should be part of the routine management of these patients."

About the Study

The multi-centre, randomised-controlled trial was conducted in 500 patients who arrived at the hospitals' emergency with shortness of breath, a classic symptom of HF. Shortness of breath is also a common symptom of other conditions such as worsening chronic obstructive pulmonary (lung) disease, pneumonia and some heart attacks, forcing emergency physicians to spend a significant amount of time trying to reach a diagnosis. NT-proBNP facilitates differentiation of those conditions.

In this study, physicians immediately committed to a diagnosis for each patient based on their clinical judgment. Those diagnoses were later judged by cardiologists blinded to each patient's NT-proBNP results, which were measured upon admission and again at 72 hours. The patients were then randomised to receive either usual care or care guided by the NT-proBNP test results. The median level of NT-proBNP in the 230 patients with final diagnoses of acute HF was 3,097 picograms per milliliter (pg/ml), compared to 212 pg/ml in those without acute decompensate HF. In establishing a diagnosis, adding NT-proBNP to clinical judgment enhanced accuracy, the area under the receiver-operating characteristic curve increased from 0.83 to 0.90 (p<0.00001).

About the Roche NT-proBNP Diagnostic Test

The Roche NT-proBNP test is a quick and simple blood test that allows the identification and exclusion of HF by measuring the level of NT-proBNP in a patient's blood(4). In addition, monitoring levels of NT-proBNP can be used to guide drug treatment and in turn reduce the total number of cardiovascular events with clinically guided treatment(5). NT-proBNP is approved by the FDA and recommended by the European Society of Cardiology (ESC), for instance, as an aid in the diagnosis of congestive heart failure (CHF) and assessing its severity and the detection of mild forms of cardiac dysfunction(6).

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our website www.roche.com.

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Circulation

For more information about the publication please visit the following website: http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.666255?ijkey= YkajnBHIzCzzUUw&keytype=ref

References:

(1) Shibata MC, Nilsson C, Hervas-Malo M, Jacobs P, Tsuyuki RT. Economic implications of treatment guidelines for congestive heart failure. Can J Cardiol. 2005; 21:1301-1306.

(2) Bentkover JD, Stewart EJ, Ignaszewski A, Lepage S, Liu P, Cooper J. New technologies and potential cost savings related to morbidity and mortality.

(3) Dr Judith Mackay and Dr George A Mensah, The Atlas of Heart Disease and Stroke. Published by the World Health Organisation, 2004.

(4) Roche's NT-proBNP Test Proves Its Worth in Two Clinical Studies - Nearly $600 Million Savings to US Healthcare System. www.probnp.com. Accessed June 2007.

(5) Troughton, R.W., et al., Treatment of heart failure guided by plasma aminoterminal brain natriuretic peptide (N-BNP) concentrations. Lancet, 2000. 355(9210): p. 1126-30

(6) GP Brochure - Cobas and Life needs answers. Roche Diagnostics 2006. Document on file.

CONTACT: Roche Diagnostics Contact: Thomas Klein, Roche Professionaldiagnostics, Tel: +41-41-7987135, Email: thomas.kleint.k1@roche.com; AgencyContact: Eve Cohen, Biosector 2, Tel: +44-(0)207-632-1964, Email:ecohen@biosector2.co.uk