Effectiveness of Therapy with Levosimendan Versus Dobutamine in Acute Heart Failure: A Randomized Controlled Trial
Background: Acute heart failure (AHF) is defined as the rapid onset of symptoms and signs secondary to cardiac dysfunction. Dobutamine is an established positive inotropic drug used in AHF with prompt action, most useful in heart failure complicated with hypotension. Levosimendan, another inotropic agent, has been shown to increase calcium sensitivity of Troponin C (TropC) of myofilaments by a novel mechanism and to inhibit phosphodiesterase III activity in myocardium. The present study was attempted to know the effectiveness of levosimendan with dobutamine in the management of AHF, as add-on to standard treatment.
Methods: In present study, 40 AHF patients were randomly selected those who were admitted to intensive coronary care unit (ICCU). A head-to-head comparison was carried out between levosimendan and dobutamine administered to AHF patients in addition to other existing drugs as a parallel group, open label, randomized controlled trial. Dosing was as per standard recommendation with infusion of each drug being continued for up to 48hrs. Subjects were assessed at baseline, and then at 24hrs, 1 week and 4 weeks. The primary outcome measures were change of heart rate, blood pressure, cardinal clinical features (dyspnea, orthopnea and crepitations), and 24hrs urine output. The secondary outcomes were changes in left ventricular ejection fraction (LVEF), LV end diastolic volume (LVEDV) and plasma NT-ProBNP. Treatment emergent adverse events were captured.
Results: Among 40 patients recruited 35 could complete the study. Both Dobutamine and Levosimendan provided symptom relief within 24hrs; heart rate declined, blood pressure and urine output improved along with improvement of echocardiographic parameters. NT-Pro BNP also declined in both groups. Although statistically significant differences were observed at some time points, and symptom relief was better in Levosimendan arm, no clear differences in LVEF and NT-pro BNP were observed. LVEDV reduction was arguably better in the Levosimendan arm.
Conclusion: In conclusion, Levosimendan can be considered as a therapeutic option in AHF but cannot be considered as a substitute for Dobutamine.
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