WALTHAM, Mass., March 25, 2014 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq: BGMD ) announced today the publication of results, in the American Heart Journal, of an analysis of aggregated data from three large, multicenter clinical research trials in the United States and Europe. The trials included a total of 902 heart failure patients and demonstrated that elevations of galectin-3 levels in blood, as measured using the BGM Galectin-3® Test, were significantly predictive of rehospitalization for heart failure as early as within the first 30 days following discharge from an initial hospital stay. [1]
The authors reported that heart failure patients with elevations in their galectin-3 levels at the time of their hospitalization were re-admitted within 30 days at nearly three times the rate of patients without galectin-3 elevation (risk ratio of 2.80 at 30 days, P-value of 0.003). The increased risk conferred by elevations in galectin-3 was seen to persist at 60, 90 and 120 days in the study. Galectin-3 testing correctly identified markedly higher risk among between one-fifth to one-third of all patients who, based on conventional risk assessment, were placed into a low risk category at the time of their initial hospital discharge but who, nonetheless, went on to be rehospitalized or suffer a fatal event (net reclassification improvement statistic value of +42.6% at 30 days, P-value < 0.001).
In the United States, the annual cost to Medicare of hospital readmissions within 30 days of discharge has been estimated to exceed $17 billion. [2] The leading cause of hospital readmissions among Medicare beneficiaries is heart failure related complications. [2] The recently enacted Affordable Care Act required the Centers for Medicare and Medicaid to implement penalty-based reductions in payments to hospitals with excessive rates of readmissions within 30 days of hospital discharge. The Medicare Payment Advisory Commission has concluded that approximately three-quarters of these hospital readmissions are potentially preventable. [3]
"We believe that this analysis of data from three significant clinical research trials further affirms the previously reported utility of galectin-3 testing as an aid in assessing the prognosis of patients with heart failure when used in conjunction with clinical evaluation," said Dr. Paul R. Sohmer, President and CEO of BG Medicine, Inc. "The identification of heart failure patients who are at significantly elevated risk for unforeseen events may facilitate the care of heart failure patients and help control the cost burden of this disease on healthcare systems worldwide."
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.
The BGM Galectin-3® Test is CE Marked and is 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 an aid in assessing the risk of new onset heart failure.
About Galectin-3 and Heart Failure
Galectin-3 is a protein that is involved in fundamental disease processes including the development of fibrosis in organ tissues, and cardiac remodeling, which may lead to 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 hospitalization or death. 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 .
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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: our belief that this analysis further affirms the previously reported utility of galectin-3 testing; and our belief that the identification of heart failure patients who are at significantly elevated risk for unforeseen events may facilitate the care of heart failure patients and help control the cost burden on healthcare systems worldwide. 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. Meijers WC, Januzzi JL, deFilippi C, et al. Elevated Plasma Galectin-3 is Associated with Near-Term Rehospitalization in Heart Failure: A Pooled Analysis of 3 Clinical Trials. American Heart Journal (2014), doi:10.1016/j.ahj.2014.02.011.
2. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi:10.1056/NEJMsa0803563.
3. Medicare Payment Advisory Commission. A path to bundled payment around a rehospitalization. In: Report to the Congress: reforming the delivery system. Washington, DC:, June 2005:83-103.
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