The study, which is being presented at the European Society of Cardiology (ESC) 2012 Annual Congress, was designed to show whether LCZ696 could be used to treat heart failure with preserved ejection fraction*. There is currently no effective drug treatment available for this type of heart failure, though it accounts for up to half of all heart failure cases.
While the researchers did not examine patient outcomes, they tested whether patients who were given LCZ696 showed reduced levels of a protein called NT-proBNP, a marker that increases as heart failure worsens. Reductions in NT-proBNP levels have previously been associated with improved outcomes for heart failure patients.
The group, led by Dr Scott Solomon of the Brigham and Women's Hospital, USA, found that heart failure patients who were treated with LCZ696 showed considerably reduced levels of NT-proBNP after 12 weeks of treatment compared to patients who were treated with valsartan, a drug which reduces blood pressure and is used in the treatment of heart failure.
LCZ696 also appeared to have a beneficial physiological effect on patients, with this group experiencing a reduction in the volume of the left atrium of the heart, which has again been previously associated with improved outcomes for heart failure patients.
According to Dr Solomon, "LCZ696 might have beneficial effects in patients with heart failure with preserved ejection fraction and further testing of this compound could be warranted in patients with this disorder. However, it should be noted that the results of this study are based on biomarkers and surrogate endpoints; whether the observed effects will translate into improved clinical outcomes needs prospective testing in an appropriately sized outcomes study."
In a linked Comment, Professor John Cleland of Castle Hill Hospital, Kingston-upon-Hull, UK, states: "The positive results from this work will surely trigger a definitive trial. But what will the comparator be? Given that there are no known effective treatments for this type of heart failure, researchers will need to choose very carefully how they assess the efficacy of LCZ696 in treating heart failure with preserved ejection fraction."**
NOTES TO EDITORS:
*Ejection fraction is a measure of the percentage of blood that leaves the left ventricle of the heart when it contracts. Ejection fraction for a healthy heart is typically around 55% - 70%; in heart failure with preserved ejection fraction, the patient experiences all of the symptoms and signs of heart failure but with an ejection fraction greater than 40%.
**Quote direct from author and cannot be found in text of Comment.
Dr Scott Solomon, Cardiovascular Division, Brigham and Women's Hospital, Boston, USA
E) ssolomon@rics.bwh.harvard.edu
Professor John Cleland, Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hull, UK
T) +44 (0) 1482 461 780 E) j.g.cleland@hull.ac.uk
Journal
The Lancet