Media Release

03 November 2011

NT-proBNP–guided therapy reduces cardiovascular event rates and improved quality of life in heart failure patients

Positive study results promote a new paradigm in the management of heart failure

In the recently published PROTECT (Pro-BNP Outpatient Tailored Chronic HF Therapy) trial1, a strategy of NT-proBNP guided heart failure care was independently associated with a significant reduction in total cardiovascular events, the primary composite endpoint of the study, which included worsening heart failure, heart failure hospitalization and cardiovascular related death.

Patients with chronic systolic heart failure (left ventricular ejection fraction <40%) were randomized to one of two treatment approaches: a standard-of-care arm, where patients received aggressive guideline-compliant heart failure care, or an NT-proBNP arm, where patients were treated with similar aggressive clinical care, but with a simultaneous goal to decrease and maintaining NT-proBNP concentrations to a level below 1,000 pg/mL, a value which previous studies have shown the cardiovascular event risk in heart failure to be considerably lower.2

Alan Maisel, Director, Coronary Care Unit and Heart Failure Program, Veterans Affairs San Diego Healthcare System, commented in the Journal of the American College of Cardiology (JACC): “The investigators are to be congratulated for strong adherence to study protocol with consistent biomonitoring of amino-terminal pro-BNP (NT-proBNP) levels, allowing aggressive therapeutic efforts at NT-proBNP lowering.”3 Moreover he pointed out: “The validation of some biomarkers as physiologic or biochemical surrogate markers that can be used to both guide therapy and monitor the effects of that therapy may lead to a better segmentation of the HF syndrome into individual phenotypes (so-called pharmaco-phenomics) on the basis of the likelihood of response to specific therapies.”3

Heart failure – a global burden

Estimates from 51 countries represented by the European Society of Cardiology talk about 15 million heart failure patients, whilst as many as 5.7 million Americans have heart failure, with 600,000 - 700,000 new cases per year. The diagnosis carries a mortality rate that exceeds many cancers. Heart failure ranks among the most costly chronic conditions in developed countries, with the burden being greatest among the elderly. Heart failure hospitalization represents a major burden on the healthcare system both in the U.S. and the rest of the world.4,5

Given this rapidly increasing incidence of heart failure and relative shortage of novel therapies for diagnosis, a new strategy of care utilizing existing therapies, including the intention to not only address symptoms, but also to lower NT-proBNP concentrations with the goal of reducing risk in parallel, would not only contribute to better patient outcomes, but also likely reduce healthcare costs.

About the PROTECT study

PROTECT, a prospective randomized trial comparing a strategy of aggressive heart failure therapy guided by levels of a cardiac hormone—amino-terminal pro-B type natriuretic peptide (NT-proBNP)—versus standard heart failure treatment without NT-proBNP guidance has been enrolling subjects in the Heart Center at the Massachusetts General Hospital since 2006.

Besides the primary endpoint of total cardiovascular events over a one year period, other endpoints in PROTECT include effects of NT-proBNP guidance on quality of life, and of NT-proBNP guided care on cardiac structure and function. The principal investigator James L. Januzzi is planning to publish sub-studies of the PROTECT in the near future with the analysis of the age groups, the detailed echocardiography findings and the health economy aspects of the differences in the two treatment arms.

About NT-proBNP

Tests for NT-proBNP, a cardiac hormone that is released into the blood when the heart wall is stretched, are developed and marketed by Roche. NT-proBNP is an objective marker for the aid in diagnosis in individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure and aid in assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.6

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more

1) Januzzi JL, Rehman SU. Use of Amino-terminal Pro-B Type Natriuretic Peptide to Guide Outpatient Therapy of Patients with Chronic Left Ventricular Systolic Dysfunction, JACC 2011; 58: 1881-9
2) Masson S, Latini R. Prognostic Value of Changes in N-Terminal Pro-Brain Natriuretic Peptide in Val-HeFT (Valsartan Heart Failure Trial) JACC 2008;52:997–1003
3) Maisel A. Biomonitoring and Biomarker-Guided Therapy, JACC 2011; 58:1890–2
4) Dickstein, K., Cohen-Solal, A., Filippatos, G., et al. (2008). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. European Journal of Heart Failure, S. 935 doi:10.1016/j.ejheart.2008.08.005.
5) Véronique L. Roger, Alan S. Go, Donald M. Lloyd-Jones et al. Heart Disease and Stroke Statistics 2011 Update: A Report From the American Heart Association. Circulation, 2011;123:e18-e209, published online before print December 15 2010, doi:10.1161/CIR.0b013e3182009701
6) Roche Diagnostics. NT-pro BNP, US Package Insert. 2008