Roche (SIX: RO, ROG; OTCQX: RHHBY) and study investigators from Harvard University and Massachusetts General Hospital announced today that in the PROTECT (Pro-BNP Outpatient Tailored Chronic HF Therapy) trial, 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.
"The data of the study indicates a significant difference between the treatment arms in favor of the NT-proBNP group", the principal investigator Dr James Januzzi, associate professor of medicine at Harvard Medical School and director of the Cardiac Intensive Care Unit at the Massachusetts General Hospital, said in his talk. "We are excited to see that following the interim results, the full results of the trial support the concept of biomarker-guided heart failure care."
In the PROTECT study, 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 maintain NT-proBNP concentrations below 1,000 pg/mL, a value which previous studies have shown the cardiovascular event risk in heart failure to be considerably lower.
"While previous studies have returned mixed results with respect to the approach of "guided therapy" with natriuretic peptide testing, the reduction in total cardiovascular events in the NT-proBNP arm suggests the important role of this cardiac hormone in the management of heart failure," Dr. Januzzi said.
Heart failure – a global burden
It is estimated that as many as five million Americans have heart failure, with 400,000-500,000 new cases/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.
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.
SOURCE Roche Diagnostics