Effectiveness and safety of levosimendan in clinical practice [13]

José Silva-Cardoso, Jorge Ferreira, Ana Oliveira-Soares, José Martins-de-Campos, Cândida Fonseca, Nuno Lousada, José Ilídio-Moreira, Carlos Rabaçal, Albertino Damasceno, Sandra Amorim, Ricardo Seabra-Gomes, Rafael Ferreira, Cassiano Abreu-Lima

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)143-154
Number of pages12
JournalRevista Portuguesa de Cardiologia
Volume28
Issue number2
Publication statusPublished - 1 Feb 2009

Fingerprint

Safety
Systolic Heart Failure
Heart Failure
Hospitalization
Therapeutics
Multicenter Studies
simendan
Hemodynamics

Keywords

  • Acute heart failure
  • Levosimendan
  • notropes

Cite this

Silva-Cardoso, J., Ferreira, J., Oliveira-Soares, A., Martins-de-Campos, J., Fonseca, C., Lousada, N., ... Abreu-Lima, C. (2009). Effectiveness and safety of levosimendan in clinical practice [13]. Revista Portuguesa de Cardiologia, 28(2), 143-154.
Silva-Cardoso, José ; Ferreira, Jorge ; Oliveira-Soares, Ana ; Martins-de-Campos, José ; Fonseca, Cândida ; Lousada, Nuno ; Ilídio-Moreira, José ; Rabaçal, Carlos ; Damasceno, Albertino ; Amorim, Sandra ; Seabra-Gomes, Ricardo ; Ferreira, Rafael ; Abreu-Lima, Cassiano. / Effectiveness and safety of levosimendan in clinical practice [13]. In: Revista Portuguesa de Cardiologia. 2009 ; Vol. 28, No. 2. pp. 143-154.
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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 2009, 'Effectiveness and safety of levosimendan in clinical practice [13]', Revista Portuguesa de Cardiologia, vol. 28, no. 2, pp. 143-154.

Effectiveness and safety of levosimendan in clinical practice [13]. / Silva-Cardoso, José; Ferreira, Jorge; Oliveira-Soares, Ana; Martins-de-Campos, José; Fonseca, Cândida; Lousada, Nuno; Ilídio-Moreira, José; Rabaçal, Carlos; Damasceno, Albertino; Amorim, Sandra; Seabra-Gomes, Ricardo; Ferreira, Rafael; Abreu-Lima, Cassiano.

In: Revista Portuguesa de Cardiologia, Vol. 28, No. 2, 01.02.2009, p. 143-154.

Research output: Contribution to journalArticle

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T1 - Effectiveness and safety of levosimendan in clinical practice [13]

AU - Silva-Cardoso, José

AU - Ferreira, Jorge

AU - Oliveira-Soares, Ana

AU - Martins-de-Campos, José

AU - Fonseca, Cândida

AU - Lousada, Nuno

AU - Ilídio-Moreira, José

AU - Rabaçal, Carlos

AU - Damasceno, Albertino

AU - Amorim, Sandra

AU - Seabra-Gomes, Ricardo

AU - Ferreira, Rafael

AU - Abreu-Lima, Cassiano

PY - 2009/2/1

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N2 - 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.

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Silva-Cardoso J, Ferreira J, Oliveira-Soares A, Martins-de-Campos J, Fonseca C, Lousada N et al. Effectiveness and safety of levosimendan in clinical practice [13]. Revista Portuguesa de Cardiologia. 2009 Feb 1;28(2):143-154.