Lisbon, 27 May 2013: Ambulatory levosimendan improves event free survival by 50% compared to placebo, according to results from the LevoRep Study presented today during the late breaking trial session1 of the Heart Failure Congress 2013. In a second study, the third generation mineralocorticoid receptor antagonist (MRA) BAY 94-8862 showed improved potassium and kidney tolerance in heart failure patients with chronic kidney disease (CKD).
Heart Failure 2013 is the main annual meeting of the Heart Failure Association of the European Society of Cardiology and is being held 25-28 May in Lisbon, Portugal (1)
The prevalence of end-stage heart failure is increasing significantly and is associated with frequent hospital admissions and high costs. LevoRep is the largest trial of repetitive ambulatory administration of an inotrope in end-stage heart failure. The study focused on the safety and efficacy of levosimendan in an ambulatory setting.
LevoRep was a multicentre study in which 120 patients with end-stage heart failure were randomised to receive biweekly 0.2 mcg/kg/min levosimendan for 6 hours over 6 weeks or placebo. The study met its secondary endpoints and showed that ambulatory levosimendan was safe and improved event free survival by 50% compared with placebo. However, the study failed to show significant improvements in functional capacity and quality of life which were the primary endpoints.
Presenter Dr Gerhard Poelzl (Austria) said: "Future studies with more patients and higher dosing or higher repetition frequencies of levosimendan in an outpatient setting could show positive results for the primary endpoints. The improvement in event-free survival shown in this study may revive an old concept of ambulatory treatment of end-stage heart failure patients which has been largely dismissed because of the excessive mortality with in
|Contact: Jacqueline Partarrieu|
European Society of Cardiology