Levosimendan in decompensated heart failure patients: efficacy in a Brazilian cohort. Results of the BELIEF study.
BACKGROUND
Levosimendan is a new inodilatory agent that enhances cardiac contractility via Ca(2+) sensitization and induces vasodilation through the activation of KATP/BKCa.


OBJECTIVE
To study the efficacy and safety of levosimendan in a decompensated heart failure (DHF) Brazilian cohort, and in b-adrenergic agonist resistant patients.


METHODS
The Brazilian Evaluation of Levosimendan Infusion Efficacy (BELIEF) study was prospective, multicenter, observational and included 182 high-risk DHF patients, all of which received open-label levosimendan. Primary end point was hospital discharge without additional inotropic therapy (responder). Secondary end points were changes in hemodynamics, clinical parameters, and brain natriuretic peptide (BNP).


RESULTS
Mortality rate was 14.8%, and 139 of 182 patients were responders. In non responders it was 62.8%. Systolic blood pressure was a predictor of response. In b-adrenergic agonist resistant group, 55.8% were responders. Overall, 54 patients experienced at least one adverse event; most of them resolved either spontaneously or after levosimendan dose reduction. A significant improvement in quality of life was verified at 2-6 months of follow-up (p<0.0001).


CONCLUSIONS
Our results suggest levosimendan infusion as an alternative therapy in the short term management of DHF patients. HF severity can influence the response to levosimendan treatment. Prospective studies are warranted in a Brazilian cohort including Chagas heart disease.
Bocchi
Edimar Alcides
EA
Heart Institute (InCor) of São Paulo University Medical School, São Paulo, SP, Brazil. edimarbocchi@cardiol.br
Vilas-Boas
Fábio
F
Moreira
Maria da Consolação
Mda C
Barretto
Antonio Carlos Pereira
AC
Lage
Silvia
S
Albuquerque
Denilson
D
Baima
Jader
J
Rassi
Salvador
S
Ribeiro
Jorge Pinto
JP
D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D001938:Brazil / Q000453:epidemiology; D002316:Cardiotonic Agents / Q000008:administration & dosage*; D004417:Dyspnea / Q000150:complications; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D006835:Hydrazones / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011724:Pyridazines / Q000008:administration & dosage*; D011788:Quality of Life; D000077464:Simendan; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*; D055815:Young Adult
D000318:Adrenergic beta-Agonists; D002316:Cardiotonic Agents; D006835:Hydrazones; D011724:Pyridazines; D014665:Vasodilator Agents; D000077464:Simendan