WALTHAM, Mass., Nov. 19, 2013 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD) announced today the publication of results of an independent multicenter clinical research trial in Europe that enrolled 419 heart failure patients and demonstrated that elevated levels of galectin-3 in blood, as measured using the BGM Galectin-3® Test, were significantly predictive of unplanned hospital readmissions and fatal events during the 12 month follow-up period of the trial. [1]
The physicians who led the study reported that the inclusion of galectin-3 testing into the observational trial's hospital discharge risk planning model significantly improved the accuracy with which patient risk upon discharge could be assigned. Galectin-3 testing correctly identified markedly elevated risk among nearly one-quarter (24.3%) of all patients who, without galectin-3 testing, were otherwise inappropriately placed into the lowest risk category at the time of their initial hospital discharge but who went on to be unexpectedly readmitted to hospital or suffer a fatal event (P-value < 0.001 for the net reclassification improvement statistic).
"This independent clinical research study, conducted with a real world cohort of heart failure patients, further demonstrates the utility of galectin-3 as a sentinel marker for adverse outcomes in heart failure patients after hospital discharge," said Dr. Paul R. Sohmer, President and CEO of BG Medicine, Inc.
In the trial, the results of which were reported in the November 5, 2013 issue of the International Journal of Cardiology, the authors, from four hospitals and university clinics across Spain, further reported that heart failure patients with elevated galectin-3 levels had rates of hospital readmission and fatal events that were 84% higher than those of patients with lower galectin-3 levels (P-value < 0.0001). The higher risk conferred by elevated galectin-3 levels was independent of, and additive to, other clinical risk variables considered for these patients, including impaired kidney function, age, diabetes, anemia, heart failure disease severity, and blood levels of the natriuretic peptide NT-proBNP, sodium and urea (P-value = 0.015 for galectin-3 upon full statistical adjustment). Subjects enrolled in the trial were acute heart failure patients, with commonly associated comorbidities and medication usage patterns, who were consecutively admitted to participating hospital centers. This real world cohort of patients spanned both mildly depressed and preserved left ventricular ejection fraction as well as a broad range of disease severity.
"The accurate identification of those heart failure patients who may outwardly appear to be at low risk for near-term events based on clinical assessment, but who are in reality at significantly elevated risk for unforeseen events, is a fundamental prerequisite for improving heart failure patient care and controlling the cost burden of this disease on healthcare systems worldwide," stated Dr. Sohmer. "The results of galectin-3 testing in this important trial demonstrate that this blood test may indeed be exceptionally useful, when used in conjunction with clinical evaluation, in identifying elevated risk in heart failure patients, which we believe will help physicians, hospitals and the healthcare community better match increasingly scarce resources with individual patient needs."
The BGM Galectin-3® Test is CE Marked and available in Europe as an aid in assessing the prognosis of patients diagnosed with acute and chronic heart failure when used in conjunction with clinical evaluation. It is also CE Marked for adults as aid in assessing the risk of new onset heart failure. The BGM Galectin-3® Test is cleared by the U.S. FDA as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.
About Galectin-3 and Heart Failure
Galectin-3 has been implicated in a variety of biological processes important in the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of death or hospitalization, including 30-day readmission. The BGM Galectin-3® Test is to be used as an aid in assessing the prognosis of patients with chronic heart failure, in conjunction with clinical evaluation. For more information please visit www.BG-Medicine.com.
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.BG-Medicine.com. The BG Medicine Inc. logo is available for download here.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the potential utility of galectin-3 as a sentinel marker for adverse outcomes in heart failure patients after hospital discharge; the utility of galectin-3 testing in uncovering hidden risk in heart failure patients; our belief that galectin-3 testing will help physicians, hospitals and the healthcare community better match increasingly scarce resources with individual patient needs; our belief that the results of the research study further support a large body of evidence regarding the utility of galectin-3 as a predictor of adverse outcomes in heart failure, and our understanding that the results of the study provide further evidence that galectin-3 testing may help to identify and facilitate triage of those heart failure patients who are at elevated risk of adverse events. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading "Risk Factors" contained in BG Medicine's annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.
Publication References
1. Carrasco-Sánchez FJ, Aramburu-Bodas O, Salamanca-Bautista P, Morales-Rull JL, Galisteo-Almeda L, Páez-Rubio MI, Arias-Jiménez JL, Aguayo-Canela M, Pérez-Calvo JI. Predictive value of serum galectin-3 levels in patients with acute heart failure with preserved ejection fraction. Int J Cardiol. 2013 Nov 5;169(3):177-82.