Effectiveness and safety of levosimendan in clinical practice [13]

Background: In previous randomized studies levosimendan improved hemodynamics and clinical course, with a still unclear effect on prognosis. There are, however, few data regarding its effects when used in daily practice. Aims: We evaluated the clinical effectiveness and safety of levosimendan in the treatment of acute systolic heart failure (SHF) in daily practice conditions. Methods: In this prospective, multicenter, nonrandomized trial, a continuous infusion of levosimendan (0.05 μg/kg/min-0.2 μg/kg/min) was administered for 24 hours. An optional loading dose of 12 μg/kg over 10 minutes was used. The primary combined endpoint of clinical effectiveness (as defined by a eight- variable clinical score) and safety (defined by the absence of serious adverse events) was assessed at 24 hours after the beginning of treatment; a second similar primary combined endpoint was assessed at 5 days. Results: One hundred and twenty-nine consecutive patients requiring inotropes despite optimal oral background heart failure therapy were recruited. The primary end point was reached in 80.6% at 24 hours and in 79.7% at 5 days. During the six months before levosimendan the number of patient days of hospitalization for heart failure was 14.9±14.6 versus 3.1±7.6 during the six months following levosimendan (p<0.001). Conclusions: In daily practice, levosimendan was clinically effective and safe in 80.6% and 79.7% of patients with acute SHF at 24 hours and 5 days respectively after the beginning of treatment. A marked reduction in the number of days of hospitalization for heart failure was also seen during the subsequent six months.