12 February 2018
February 2018 post
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, randomized, parallel-group, placebo-controlled trials in this area of medicine.
The 69 patients in LION-HEART were recruited at 12 centers in Spain: they had chronic AdHF (NYHA grade III or IV) and low mean ejection fraction (~26%). They were randomized 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 hospitalization compared with placebo (hazard ratio 0.25; 95% CI 0.11–0.56; P =0.001) and were less to experience a clinically significant decline in HF-related quality of life in follow-up to 25 weeks (P =0.022).