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

Volumn 23, Issue 18, 2002, Pages 1422-1432

  Moiseyev, V S ^a   Poder P ^b   Andrejevs, N ^c   Ruda, M Y ^d   Golikov, A P ^e   Lazebnik, L B ^f   Kobalava, Z D ^a   Lehtonen, L A ^g   Laine, T ^b   Nieminen, Markku S ^h   Lie, K I ⁱ  

^a PEOPLES FRIENDSHIP UNIVERSITY OF RUSSIA   (Russian Federation)

^b ORION CORPORATION   (Finland)

^c PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL   (Latvia)

^d INSTITUTE OF EXPERIMENTAL CARDIOLOGY   (Russian Federation)

^e N V SKLIFOSOVSKY RESEARCH INSTITUTE FOR EMERGENCY MEDICINE   (Russian Federation)

^f Russian Academy of Postgraduate Medical Training   (Russian Federation)

^g UNIVERSITY OF HELSINKI   (Finland)

^h HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

ⁱ UNIVERSITY OF AMSTERDAM   (Netherlands)

Author keywords

Hypotension; Ischaemia; Left ventricular failure; Levosimendan; Mortality; Myocardial infarction

Indexed keywords

ACETYLSALICYLIC ACID; ANALGESIC AGENT; ANTIARRHYTHMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CALCIUM SENSITIZER; CARDIAC GLYCOSIDE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; DOPAMINE; FIBRINOLYTIC AGENT; HEPARIN; HEPARIN DERIVATIVE; INOTROPIC AGENT; LEVOSIMENDAN; NITRIC ACID DERIVATIVE;

ACUTE HEART INFARCTION; ADULT; AGED; ANGINA PECTORIS; ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INFUSION; DRUG SAFETY; FEMALE; FOLLOW UP; HEADACHE; HEART ATRIUM ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART LEFT VENTRICLE FAILURE; HEART MUSCLE ISCHEMIA; HEART RUPTURE; HEART VENTRICLE EXTRASYSTOLE; HUMAN; HYPERTENSION; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SINUS TACHYCARDIA; ST SEGMENT DEPRESSION; ST SEGMENT ELEVATION;

ACUTE DISEASE; AGED; ANALYSIS OF VARIANCE; CARDIOTONIC AGENTS; DOUBLE-BLIND METHOD; DRUG EVALUATION; ENDPOINT DETERMINATION; FEMALE; HEART FAILURE, CONGESTIVE; HUMANS; HYDRAZONES; HYPOTENSION; MALE; MYOCARDIAL INFARCTION; PROSPECTIVE STUDIES; PYRIDAZINES; RISK FACTORS; SAFETY; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VENTRICULAR DYSFUNCTION, LEFT;

EID: 0036764821     PISSN: 0195668X     EISSN: None     Source Type: Journal    
DOI: 10.1053/euhj.2001.3158     Document Type: Article

References (38)

1. Dwyer EM, Greenberg HM, Steinberg G and The Multicenter Postinfarction Research Group. Clinical characteristics and natural history of survivors of pulmonary congestion during acute myocardial infarction. Am J Cardiol 1989; 63: 1423-8.
2. The Acute Infarction Ramipril Efficacy (AIRE) Study investigators. Effect of ramipril on mortality and morbidity in survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet 1993; 342: 821-8.
3. Mahon NG, O'Rorke CO, Codd MB, McCann HA, McGarry K, Sugrue DD. Hospital mortality of acute myocardial infarction in the thrombolytic era. Heart 1999; 81: 478-82.
4. Gillespie TA, Ambos HD, Sobel BE, Roberts R. Effects of dobutamine in patients with acute myocardial infarction. Am J Cardiol 1977; 39: 588-94.
5. Caldicott LD, Hawley K, Heppell R, Woodmansey PA, Channer KS. Intravenous enoximone or dobutamine for severe heart failure after acute myocardial infarction: a randomized double-blind trial. Eur Heart J 1993; 14: 696-700.
6. Karlsberg RP, DeWood MA, DeMaria AN, Berk MR, Lasher KP for The Milrinone-Dobutamine Study Group. Comparative efficacy of short-term intravenous infusions of milrinone and dobutamine in acute congestive heart failure following acute myocardial infarction. Clin Cardiol 1996; 19: 21-30.
7. Krell MJ, Kline EM, Bates ER et al. Intermittent, ambulatory dobutamine infusions in patients with severe congestive heart failure. Am Heart J 1986; 112: 787-91.
8. Packer M, Carver JR, Rodeheffer RJ, Ivanhoe RJ, DiBianco R, Zeldis SM for the PROMISE Study Research Group. Effect of oral milrinone on mortality in severe chronic heart failure. N Engl J Med 1991; 325: 1468-75.
9. Cohn JN, Goldstein SO, Greenberg BH et al. A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. N Engl J Med 1998; 339: 1810-6.
10. O'Connor CM, Gattis WA, Uretsky BF, Kirkwood FA, McNulty SE, Grossman SH for the FIRST Investigators. Continuous intravenous dobutamine is associated with an increased risk of death in patients with advanced heart failure: Insights from the Flolan International Randomized Survival Trial (FIRST). Am Heart J 1999; 138: 78-86.
11. Haikala H, Nissinen E, Etemadzadeh E, Levijoki J, Linden I-B. Troponin C-mediated calcium sensitization induced by levosimendan does not impair relaxation. J Cardiovasc Pharmacol 1995; 25: 794-801.
12. i in guinea-pig isolated ventricular myocytes. Eur J Pharmacol 1997; 339: 97-100.
13. Kristof E, Szigeti G, Papp Z et al. Cardiac responses to calcium sensitizers and isoproterenol in intact guinea pig hearts. Effects on cyclic AMP levels, protein phosphorylation, myoplasmic calcium concentration and left ventricular function. Ann N Y Acad Sci 1998; 853: 316-9.
14. Singh BN, Lilleberg J, Sandell E-P, Ylönen V, Lehtonen L, Toivonen L. Effects of levosimendan on cardiac arrhythmias: electrophysiologic and ambulatory electrocardiographic findings in Phase II and Phase III clinical studies in cardiac failure. Am J Cardiol 1999; 83 (Suppl I): (I)16-(I)20.
15. Ukkonen H, Saraste M, Akkila J et al. Myocardial efficiency during calcium sensitization with levosimendan: a noninvasive study with positron emission tomography and echocardiography in healthy volunteers. J Clin Pharmacol Ther 1997; 61: 596-607.
16. Ukkonen H, Saraste M, Akkila J et al. Myocardial efficiency during levosimendan infusion in congestive heart failure. J Clin Pharmacol Ther 2000; 68: 522-31.
17. + channel in rat ventricular cells. J Pharmacol Expt Ther 1997; 283: 375-83.
18. + channel in rat arterial myocytes. Eur J Pharmacol 1997; 333: 249-59.
19. Pataricza J, Hohn J, Petri A, Balogh A, Papp JG. Comparison of the vasorelaxing effect of cromakallim and the new inodilator, levosimendan, in human isolated portal vein. J Pharm Pharmacol 2000; 52: 213-17.
20. Kersten JR, Montgomery MW, Pagel PS, Warltier DC. Levosimendan, a new positive inotropic drug, decreases myocardial infarct size via activation of K (ATP) channels. Anesth Analg 2000; 90: 5-11.
21. Nieminen MS, Akkila J, Hasenfuss G, Kleber FX, Lehtonen LA, Mitrovic V on behalf of the Study Group. Haemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure. J Am Coll Cardiol 2000; 36: 1903-12.
22. Slawsky MT, Colucci WS, Gottlieb SS, Greenberg BH, Haeusslein E, Hare J on behalf of the Study Investigators. Acute hemodynamic and clinical effects of levosimendan in patients with severe heart failure. Circulation 2000; 102: 2222-7.
23. Follath F, Hinkka S, Jäger D et al. Dose-ranging and safety with intravenous levosimendan in low-output heart failure: experience in 3 pilot studies and outline of the LIDO trial. Am J Cardiol 1999; 83 (Suppl I): (I)21-(I)25.
24. Luotolahti M, Lammintausta O, Ukkonen H et al. Levosimendan, a calcium sensitizer and potassium channel opener, is safe and improves left ventricular function in acute myocardial infarction. Circulation 1998; 98 (Suppl I): (I)105-(I)106.
25. European Secondary Prevention Group. Translation of clinical trials into practice: a European population-based study of the use of thrombolysis for acute myocardial infarction. Lancet 1996; 347: 1203-7.
26. Chen J, Radford MJ, Wang Y, Marcinak TA, Krumholz HM. Do 'America's best hospitals' perform better for acute myocardial infarction? N Engl J Med 1999; 340: 286-92.
27. Michaels AD, Maynard C, Every NR, Barron HV for the National Registry of Myocardial Infarction 2 participants. Early use of ACE inhibitors in the treatment of acute myocardial infarction in the United States: Experience from National Registry of Myocardial Infarction 2. Am J Cardiol 1999; 84: 1176-81.
28. Zion MM, Balkin J, Rosenmann D et al. Use of pulmonary artery catheters in patients with acute myocardial infarction. Analysis of experience in 5841 patients in the SPRINT Registry. Chest 1990; 98: 1331-5.
29. Gill JB, Cairns JA, Roberts RS et al. Prognostic importance of myocardial ischemia early after acute myocardial infarction. N Engl J Med 1996; 334: 65-70.
30. Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail 2001; 7: 176-82.
31. ISIS-1 (First International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous atenolol among 16027 cases of suspected acute myocardial infarction: ISIS 1. Lancet 1986; ii: 57-65.
32. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Long-term effects of intravenous thrombolysis in acute myocardial infarction: Final Report of the GISSI study. Lancet 1987; ii: 871-4.
33. ISIS-2. Randomised trial of intravenous streptokinase, oral aspirin, both or neither among 17187 cases of suspected acute myocardial infarction. Lancet 1988; ii: 349-60.
34. Levijoki J, Pollesello P, Kaheinen P, Haikala H. Improved survival with simendan after experimental myocardial infarction in rats. Eur J Pharmacol 2001; 419: 243-8.
35. Binkley PF, Nunziata E, Hatton PS, Leier CV. The positive inotropic agent levosimendan mediates increased cardiac output without progression of sympathovagal imbalance in patients with heart failure. Circulation 2000; 102 (Suppl II): (II)720-(II)721.
36. Lehtonen LA. Levosimendan: a parenteral calcium-sensitising drug with additional vasodilatory properties. Exp Opin Invest Drugs 2001; 10: 945-60.
37. Karlson BW, Herlitz J, Hjalmarson Å. Prognosis of acute myocardial infarction in diabetic and non-diabetic patients. Diabet Med 1993; 10: 449-54.
38. McGuire DK, Emanuelsson H, Granger CB et al. for GUSTO-IIb Investigators. Influence of diabetes mellitus on clinical outcomes across the spectrum of acute coronary syndromes. Findings from the GUSTO-IIb Study. Eur Heart J 2000; 21: 1750-8.