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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).

AbstractAIMS:
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 microg x kg(-1) x min(-1)) or placebo were administered intravenously for 6h 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 24h (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 0.33-0.95];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).
CONCLUSION:
s Levosimendan at doses 0.1-0.2 microg x kg(-1) x 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.
AuthorsV S Moiseyev, P Põder, N Andrejevs, M Y Ruda, A P Golikov, L B Lazebnik, Z D Kobalava, L A Lehtonen, T Laine, M S Nieminen, K I Lie, RUSSLAN Study Investigators
JournalEuropean heart journal (Eur Heart J) Vol. 23 Issue 18 Pg. 1422-32 (Sep 2002) ISSN: 0195-668X [Print] England
PMID12208222 (Publication Type: Clinical Trial, Comparative Study, Evaluation Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.
Chemical References
  • Cardiotonic Agents
  • Hydrazones
  • Pyridazines
  • Simendan
Topics
  • Acute Disease
  • Aged
  • Analysis of Variance
  • Cardiotonic Agents (adverse effects, therapeutic use)
  • Double-Blind Method
  • Drug Evaluation
  • Endpoint Determination
  • Female
  • Heart Failure (drug therapy, etiology, mortality)
  • Humans
  • Hydrazones (adverse effects, therapeutic use)
  • Hypotension (etiology)
  • Male
  • Myocardial Infarction (complications, drug therapy, mortality)
  • Prospective Studies
  • Pyridazines (adverse effects, therapeutic use)
  • Risk Factors
  • Safety
  • Simendan
  • Survival Analysis
  • Treatment Outcome
  • Ventricular Dysfunction, Left (drug therapy, etiology, mortality)

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