Levosimendan roars ahead as LION-HEART results published
Important new support for the use of levosimendan in the management of advanced heart failure (AdHF) has emerged from the LION-HEART study, primary results of which have recently been published in the European Journal of Heart Failure (10.1002/ejhf.1145).
The unique pharmacodynamic and pharmacokinetic qualities of levosimendan have already made it a drug of interest for treating AdHF through intermittent i.v. infusions. LION-HEART is one of the multicenter, double-blind, randomised, parallel-group, placebo-controlled trials in this area of medicine.
The 69 patients in LION-HEART were recruited at 12 centres in Spain: they had chronic AdHF (NYHA grade III or IV) and low mean ejection fraction (~26%). They were randomised in a 1:2 ratio to placebo or to levosimendan (0.2 mcg/kg/min, with no loading dose) administered for 6h in each of 6 treatment cycles at 2 week intervals.
Potent effects of levosimendan were observed on the study primary endpoint of serum concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6-month follow-up. The proportion of patients exhibiting a reduction in NT-proBNP levels >25% from baseline was higher in the levosimendan group (48% vs. 9%; P=0.002) and the difference in average percentage change from baseline in NT-pro BNP strongly favored levosimendan (-20% vs. +50%; P<0.001).
Among secondary endpoints, patients treated with levosimendan experienced a reduction in the rate of HF-related hospitalisation compared with placebo (hazard ratio 0.25; 95% CI 0.11–0.56; P=0.001) and were less likely to experience a clinically significant decline in HF-related quality of life in follow-up to 25 weeks (P=0.022).
Professor Gerhard Pölzl highlights Hospitalisation for the management of acute decompensation being a critical moment in the trajectory of heart failure (HF) and one that has gloomy prognostic implications for many patients.
There have been some recent achievements in the LEODOR trial including a new website to facilitate administration and communication and submission of a formal study protocol synopsis to the European Journal of Heart Failure.
Professor Cynthia M Dougherty and colleagues outline an array of options for the treatment of advanced heart failure (HF) that create – quite reasonably – the impression that we are in a golden age of therapeutic possibilities for this difficult condition.
If we had a way to reduce the risk of life-threatening complications after cardiac surgery would we use it? Of course we would. It is for reason that this blog post highlights the recent work of Dr. Qiang and colleagues. See the details here.