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)

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. © 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.

Moiseyev V.S. 1 , Põder P.2 , Andrejevs N.3 , Ruda M.Y.4 , Golikov A.P.5 , Lazebnik L.B.6 , Kobalava Z.D. 1 , Lehtonen L.A.7 , Laine T.2 , Nieminen M.S.8, 10 , Lie K.I.9
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  • 1 Hospital No. 64, Russian Univ. of People's Friendship, Moscow, Russian Federation
  • 2 Orion Pharma, Research Center, Espoo, Finland
  • 3 P. Stradin's Res./Teaching Hospital, Latvian Medical Academy, Riga, Latvia
  • 4 A.L. Myasnikov Inst. of Cardiology, Cardiology Research Center, Moscow, Russian Federation
  • 5 Cardiology Clinic, Sklifosovsky Res. Inst. Emerg. Med., Moscow, Russian Federation
  • 6 Department of Gerontology, Russian Med. Acad. Postgrad. Train., Moscow, Russian Federation
  • 7 Department of Clinical Pharmacology, University of Helsinki, Helsinki, Finland
  • 8 Helsinki University Central Hospital, Cardiology Division, Helsinki, Finland
  • 9 Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
  • 10 Helsinki University Central Hospital, Department of Internal Medicine, Cardiology Division, 00029, Haartmaninkatu, 4 Helsinki, Finland
Ключевые слова
Hypotension; Ischaemia; Left ventricular failure; Levosimendan; Mortality; Myocardial infarction
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