A Comparison of Haemodynamic Effects and Safety between Domestic Levosimendan versus Dobutamine for Hospitalized Patients with Acute Decompensated Heart Failure

Tianyi Gan, Xuemei Zhao, Yan Huang, Yuhui Zhang, Enming Qing, Hui li, Yingxian Sun, Lin Zhang, Xiaojuan Bai, Wenxian Liu, Yinong Jiang, Peng Qu, Bingqi Wei, Qiong Zhou, Shiming Ji and Jian Zhang

Aims: This study was a phase II trial of efficacy and safety of intravenous treatment with domestic levosimendan versus dobutamine in hospitalized patients with acute decompensated heart failure (ADHF). Methods and results: This was a multicentre, positive-controlled, prospective randomized open-label blinded study. A total of 228 ADHF patients from 8 medical centres were received 24 h intravenous domestic levosimendan (n=114) or dobutamine (n=114) therapy. SWAN-GANZ catheter was applied for patients with Pulmonary Capillary Wedge Pressure (PCWP) ≥ 15 mmHg and Cardiac Index (CI) ≤ 2.5 L/min/m2 (n=39 each). Compared with baseline level, left ventricular ejection fraction (LVEF) increased at 24 h in both groups (31.56% versus 28.44%, P<0.01). The change rate of LVEF at 24 h was similar between two groups (10.9% versus 12.7%, P>0.05). The change rate of PCWP at 24 h was remarkably greater in levosimendan group than in dobutamine group (-38.7% versus -23.9%, P<0.05). The change rate of NT-proBNP level at 3 days was also more remarkable in levosimendan group than in dubotamine group (-22.4% versus -8.6%, P<0.01). The incidences of adverse reactions and events were similar between two groups. Conclusion: In patients with ADHF, domestic levosimendan improved haemodynamic performance and NT-proBNP effectively than dobutamine. LVEF improvement was similar between domestic levosimendan and dobutamine. Tolerability and safety were similar between domestic levosimendan and dobutamine.