A-HeFT EXTENSION

BiDil® was approved in June 2005, and was commercially launched in July of that year.  All patients who participated in A-HeFT were offered the option to participate in X-A-HeFT, and approximately 200 patients enrolled.  The purpose of this study was to assess BiDil’s continued safety and tolerability, and patient compliance with treatment regimen.     

All participating patients received BiDil in X-A-HeFT, regardless of which group (drug or placebo) they were in during A-HeFT.  Each patient was started on one BiDil tablet three times per day.  Over time, the dose was increased (titrated upwards) to a target dose two BiDil tablets three times per day.  All patients were treated and followed for up to twelve months. Every three months, patients underwent a physical assessment, were monitored for adverse events and concomitant medications, and NYHA class.  The trial was completed in December 2005, and X-A-HeFT results are expected to be presented at a major cardiovascular medical meeting during 2006.