Roche: Analysis Supports Early Closure Of Heart Failure Trial
December 11 2009 - 2:43AM
Dow Jones News
Swiss pharmacuetical company Roche Holding AG (ROG.VX) said
Friday active enrollment into a heart failure therapy study has
been stopped early based on a positive interim analysis.
MAIN FACTS:
- 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-versus
standard heart failure treatment without NT-proBNP guidance has
been enrolling subjects in the Heart Center at the Massachusetts
General Hospital since 2006.
- The positive interim analysis suggests a strategy of NT-proBNP
guided heart failure care was independently associated with a
significant reduction in total cardiovascular events, the primary
endpoint of the study, which included relevant cardiac outcomes,
such as worsening heart failure, heart failure hospitalization, and
cardiovascular death.
- 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 was approved by the US Food and Drug
Administration as an objective marker for the diagnosis and
prognosis of heart failure as well as the risk assessment in
patients with acute coronary syndrome.
- The trial is now closed. Final patient visits will be carried
out and final data will be collected to allow a full analysis.
Final results of the study will be presented and published in 2010,
once the analysis is complete.
Company Web site: http://www.roche.com
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