Please use this identifier to cite or link to this item:
10.1053/euhj.2001.3158
Title: | Safety and efficacy of a novel calcium sensitizer, levosimendan, in patients with left ventricular failure due to an acute myocardial infarction : A randomized, placebo-controlled, double-blind study (RUSSLAN) |
Authors: | Moiseyev, V. S. Põder, P. Andrejevs, N. Ruda, M. Y. Golikov, A. P. Lazebnik, L. B. Kobalava, Z. D. Lehtonen, L. A. Laine, T. Nieminen, Markku S. Lie, K. I. |
Keywords: | Hypotension;Ischaemia;Left ventricular failure;Levosimendan;Mortality;Myocardial infarction;3.2 Clinical medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database;Cardiology and Cardiovascular Medicine |
Issue Date: | Sep-2002 |
Citation: | Moiseyev , V S , Põder , P , Andrejevs , N , Ruda , M Y , Golikov , A P , Lazebnik , L B , Kobalava , Z D , Lehtonen , L A , Laine , T , Nieminen , M S & Lie , K I 2002 , ' Safety and efficacy of a novel calcium sensitizer, levosimendan, in patients with left ventricular failure due to an acute myocardial infarction : A randomized, placebo-controlled, double-blind study (RUSSLAN) ' , European Heart Journal , vol. 23 , no. 18 , pp. 1422-1432 . https://doi.org/10.1053/euhj.2001.3158 |
Abstract: | Aims: To evaluate the safety and efficacy of levosimendan in patients with left ventricular failure complicating acute myocardial infarction. Methods and Results: Levosimendan at different doses (0·1-0·4 μg . kg-1 . min-1) or placebo were administered intravenously for 6 h to 504 patients in a randomised, placebo-controlled, double-blind study. The primary end-point was hypotension or myocardial ischaemia of clinical significance adjudicated by an independent Safety Committee. Secondary end-points included risk of death and worsening heart failure, symptoms of heart failure and all-cause mortality. The incidence of ischaemia and/or hypotension was similar in all treatment groups (P=0·319). A higher frequency of ischaemia and/or hypotension was only seen in the highest levosimendan dose group. Levosimendan-treated patients experienced lower risk of death and worsening heart failure than patients receiving placebo, during both the 6h infusion (2·0% vs 5·9%; P=0·033) and over 24 h (4·0% vs 8·8%; P=0·044). Mortality was lower with levosimendan compared with placebo at 14 days (11·7% vs 19·6%; hazard ratio 0·56 [95% CI 0·33-0·951; P=0·031) and the reduction was maintained at the 180-day retrospective follow-up (22·6% vs 31·4%; 0·67 [0·45-1·00], P=0·053). Conclusions: Levosimendan at doses 0·1-0·2 μg . kg-1 . min-1 did not induce hypotension or ischaemia and reduced the risk of worsening heart failure and death in patients with left ventricular failure complicating acute myocardial infarction. |
DOI: | 10.1053/euhj.2001.3158 |
ISSN: | 0195-668X |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Safety.pdf | 168.99 kB | Adobe PDF | View/Open |
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