Thursday, March 8, 2012

EU regulators approve Ivabradine for heart failure

The EMA approved ivabradine (Procoralan™) for the treatment of chronic heart failure. The approval is for ivabradine use as a treatment for

• long-term heart failure with symptoms (NYHA II to IV)
• heart failure involving systolic dysfunction
• a regular rhythm and a heart rate of 75 beats a minute or more

The approval is based on SHIFT trial (a randomised controlled,  6,558 patients, moderate to severe heart failure associated with left ventricular systolic dysfunction)

Results of the SHIFT study - http://www.nelm.nhs.uk/en/NeLM-Area/News/2010---August/31/Ivabradine-reduces-deaths-hospitalisation-in-heart-failure/?query=ivabradine&rank=42