2014

Pilot Study Demonstrates Home BNP Testing Is Feasible & Suggests Home Monitoring May Have Value in Guiding Therapy for High-Risk Patients

WALTHAM, Mass., April 23, 2013 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a leading provider of near-patient diagnostics and health information solutions, is pleased to announce the final results of the HABIT pilot study, which were recently published in the Journal of the American College of Cardiology.  Led by Dr. Alan Maisel, Professor of Medicine at the University of California, San Diego, the study is the first to capture serial data from patients at high risk for recurrent acute clinical heart failure decompensation (ADHF), who performed a fingerstick BNP self-test from home for a period of 60 days.  Results not only demonstrate that home BNP testing is safe and feasible for heart failure patients, but also indicate that BNP patterns following treatment for ADHF provide a wealth of information that may facilitate more personalized treatment leading to significant outcomes benefits.

In the United States, nearly one out of every four patients hospitalized for ADHF is rehospitalized within 30 days of discharge from the hospital, and the bulk of the costs associated with managing these patients derives from rehospitalization.  Consensus among clinical experts is that more than 50% of hospital readmissions can be prevented through increased attention to modifiable factors that affect pulmonary congestion.  But, while shortness of breath, edema, and weight gain can often signal pulmonary congestion, these symptoms may not appear in up to one-third of all heart failure patients.  Changes in natriuretic peptide (NP) levels, along with monitoring for symptoms, signs, and weight changes, have been shown to improve the certainty of predicting heart failure decompensation.  Up until now, however, NP measurements have been excluded from home heart failure monitoring programs because of the need for phlebotomy.

The HABIT study, a multi-center, single-arm, double-blinded observational prospective clinical trial, was designed to monitor daily concentrations of B-type natriuretic peptide (BNP) and determine the extent to which they correlate with ADHF and related adverse outcomes.  A total of 163 patients with ADHF who were discharged from the hospital or being treated in an outpatient setting measured their weight and BNP levels daily for a period of 60 days using a fingerstick test run on the Alere Heart Check.  Adverse outcomes for ADHF were measured as a composite of events that included cardiovascular death, admission for decompensated heart failure, or clinical heart failure decompensation requiring either parenteral therapy or adjustments to oral medications.

A total of 6,934 daily BNP values were recorded, with a median of 46 measures per patient over the course of the monitoring period.  40 patients had 56 events.  Correlations between BNP measures weakened over time, and the dispersion between measures grew.  When the monitoring period for each subject was broken into intervals based on ADHF events, there were 39 (18.4%) intervals of upward-trending BNP corresponding to a risk increase of 59.8% and 64 (30.2%) downward-trending intervals corresponding to a risk decline of 39.0%.  There were also 94 (44.3%) intervals with one or more days of weight gain corresponding to an increased risk of 26.1%.  Investigators concluded that daily weight monitoring is complementary to BNP measurement, but changes in BNP levels ultimately signaled larger shifts in risk, both upward and downward.

"Our results demonstrate that it is feasible and safe for heart failure patients to measure their results at home on a daily basis," said Alan Maisel.  "The incremental data from serial home measurements following an episode of ADHF appear to provide a novel means with which to identify those patients who are at highest risk of recurrent decompensation.  The pattern or trend in BNP values may be used to identify when to correlate with a face-to-face clinical assessment or therapeutic intervention, or to guide therapy with specific medication changes without additional office visits."

Investigators have determined that the results of the HABIT pilot study warrant an interventional trial to measure the extent to which home BNP testing impacts formal outcomes measures that include hospital readmissions. A study comparing today's standard of care, which involves monitoring symptoms of heart failure and body weight changes following hospital discharge under the management of hospital-based outpatient heart failure clinics, to an algorithm that incorporates routine, home BNP measurements is set to commence before the end of 2013.

More information about the utility of natriuretic peptide testing and Alere's diagnostics for heart failure management can be found at www.alereheartfailure.com.

About Alere
By developing new capabilities in near-patient diagnosis, monitoring and health information technology, Alere enables individuals to take charge of improving their health and quality of life at home. Alere's global leading products and services, as well as its new product development efforts, focus on cardiology, infectious disease, toxicology and diabetes. Alere is headquartered in Waltham, Massachusetts.  For more information regarding Alere, please visit www.alere.com.  

SOURCE Alere Inc.



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