Effectiveness and safety of levosimendan in clinical practice

• Author(s): Silva-Cardoso, J ; Ferreira, J ; Oliveira-Soares, A ; Martins-de-Campos, J ; Fonseca, C ; Lousada, N ; Ilídio-Moreira, J ; Rabaçal, C ; Damasceno, A ; Amorim, S ; Seabra-Gomes, R ; Ferreira, R ; Abreu-Lima, C
• Date: 2009
• Persistent ID: http://hdl.handle.net/10400.10/656
• Origin: Repositório do Hospital Prof. Doutor Fernando Fonseca
• Subject(s): Insuficiência cardíaca; Levosimendam; Heart failure; Levosimendan
• Document Type: Article
• Language: English

Description

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 microg/kg/min-0.2 microg/kg/min) was administered for 24 hours. An optional loading dose of 12 microg/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 endpoint 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.