Heart failure treatment Entresto (LCZ696) shown to reduce the risk of cardiovascular death and hospitalisation approved by Health Canada

6 October 2015 - Entresto (sacubitril/valsartan), previously known as LCZ696 has been approved by Health Canada for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalization. The approval of the Novartis treatment is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it showed Entresto significantly reduced the incidence of cardiovascular death versus ACE-inhibitor enalapril, a standard of care treatment.

According to the Heart and Stroke Foundation, heart failure is a very serious health problem that is on the rise. More than 600,000 Canadians are living with heart failure, and each year 50,000 new patients are diagnosed. "Currently half of people diagnosed with heart failure will die within five years," says Dr. Gavin Arthur, Senior Manager for Promote Recovery at the Heart and Stroke Foundation. "There is no cure for heart failure and the cost of managing moderate and severe heart failure patients in Canada amounts to $2.89 billion annually. Progression of symptoms can be slowed with appropriate medical therapy and lifestyle modifications, both of which can prolong and improve quality of life, however there is a critical need for better ways to treat and support these patients."

Entresto was granted a Priority Review by Health Canada due to the positive nature of the results demonstrated by the PARADIGM-HF study. In the study, the benefit of Entresto was seen early, and patients with reduced ejection fraction who were given the treatment were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. A new treatment qualifies for Priority Review when it appears to have the potential to offer significant clinical benefit, defined as "outcomes that have an overall positive impact on the treatment" of diseases that are "serious, life-threatening or severely debilitating."

For more details, go to: http://www.newswire.ca/news-releases/heart-failure-treatment-prentrestotm-lcz696-shown-to-reduce-the-risk-of-cardiovascular-death-and-hospitalization1-approved-by-health-canada-530816641.html

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Canada