ABSTRACT: To compare the efficacy and safety of domestic levosimendan versus dobutamine for patients with acute decompensated heart failure (ADHF).
ADHF patients from 8 medical centers were recruited in this multicenter, blind, positive-controlled, randomized study and received 24 h intravenous levosimendan (n = 114) or dobutamine (n = 114) therapy. SWAN-GANZ catheter was performed in patients with pulmonary capillary wedge pressure (PCWP) ≥ 15 mm Hg (1 mm Hg = 0.133 kPa) and cardiac index (CI) ≤ 2.5 L·min(-1)×m(-2) (n = 39 each).
Compared with baseline level, LVEF increased [(31.56 ± 9.69)% vs. (28.44 ± 7.08)%, P < 0.01] at 24 h in both groups. LVEF increase at 24 h was similar between two groups [(3.11 ± 6.90)% vs. (3.00 ± 6.63)%, P > 0.05]. The PCWP decrease at 24 h was significantly greater in levosimendan group than in dobutamine group [(-8.90 ± 7.14) mm Hg vs. (-5.64 ± 6.83) mm Hg, P = 0.04]. Decrease in NT-proBNP at 3 days was also more significant in levosimendan group than in dobutamine group [the percentage change compared to baseline: (-22.36 ± 38.98)% vs. (-8.56 ± 42.42)%, P < 0.01]. Dyspnea improvement at 24 h was more significant in levosimendan group than in dobutamine group. The incidences of adverse reactions and events were similar between two groups.
LVEF improvement is similar between dobutamine and domestic levosimendan while greater decreases in PCWP and NT-proBNP are achieved with domestic levosimendan in patients with ADHF.
Zhonghua xin xue guan bing za zhi [Chinese journal of cardiovascular diseases] 02/2012; 40(2):153-6.