Abstract | AIMS: 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:
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Authors | V 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 |
Journal | European heart journal
(Eur Heart J)
Vol. 23
Issue 18
Pg. 1422-32
(Sep 2002)
ISSN: 0195-668X [Print] England |
PMID | 12208222
(Publication Type: Clinical Trial, Comparative Study, Evaluation Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved. |
Chemical References |
- Cardiotonic Agents
- Hydrazones
- Pyridazines
- Simendan
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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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