Effectiveness and safety of levosimendan in clinical practice.
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.


OBJECTIVE
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.
Silva-Cardoso
José
J
Heart Failure and Transplant Clinic, Department of Cardiology, Porto Medical School, Hospital de S. João, Porto, Portugal. silvacardoso30@hotmail.com
Ferreira
Jorge
J
Oliveira-Soares
Ana
A
Martins-de-Campos
José
J
Fonseca
Candida
C
Lousada
Nuno
N
Ilídio-Moreira
José
J
Rabaçal
Carlos
C
Damasceno
Albertino
A
Amorim
Sandra
S
Seabra-Gomes
Ricardo
R
Ferreira
Rafael
R
Abreu-Lima
Cassiano
C
D000208:Acute Disease; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D006835:Hydrazones / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011724:Pyridazines / Q000009:adverse effects / Q000627:therapeutic use*; D000077464:Simendan; D013599:Systole; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D006835:Hydrazones; D011724:Pyridazines; D014665:Vasodilator Agents; D000077464:Simendan