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SIMDAX in Operating Theater

 

COMPARED TO TRADITIONAL INOTROPES...

Current data suggest that SIMDAX is superior to traditional inotropes when used in operative settings:

  • Sustained hemodynamic improvement1
  • Less myocardial injury2,3
  • Less renal impairment4
  • Lower need for IABP5
  • Safe and efficacious even on patients with preoperative low ejection fraction6

In case of hypotension, vasopressors should be used concomitantly.

References: 1. De Hert SG et al. Anesth Analg. 2007;104:766–773. 2. Zangrillo A et al. J Cardiothorac Vasc Anesth. 2009;23:474–478. 3. Eriksson H et al. Ann Thor Surg. 2009;87:448. 4. Landoni G et al. J Cardiothorac Vasc Anesth. 2010;24:51–57. 5. Laitinen P et al. Crit Care Med 2011;39:1–8. 6. Sanfilippo F et al. Critical Care. 2017;21:252-62.

 

SIMDAX IS SAFE AND EFFECTIVE IN CARDIAC SURGERY

Taking all the available data into consideration, including the experience of three recent larger clinical trials1-3, a panel of experts reached the consensus that SIMDAX is a safe and effective agent for the treatment of patients undergoing cardiac surgery and in need of inotropic support.4

In a recent meta-analysis (including the most recent data) the effects of SIMDAX on mortality were confirmed.5 SIMDAX reduces mortality in patients with preoperative severely reduced ejection fraction (<35%).6

Long term mortality in isolated CABG patients treated with levosimendan before operation 

The effect of levosimendan therapy on postoperative mortality in patients undergoing cardiac surgery.5

References: 1. Mehta RH et al. N Engl J Med. 2017;376(21):2032–42; 2. Cholley B et al. JAMA. 2017;318(6):548–56; 3. Landoni G et al. N Engl J Med. 2017;376(21):2021–31; 4. Guarracino F et al. J Cardiovasc Pharmacol. 2018 ;71(1):1-9; 5. Chen Q-H et al. Critical Care 2017;21(1):253; 6. Sanfilippo F et al. Critical Care. 2017;21:252-62.

 

THE HEMODYNAMIC BENEFITS OF SIMDAX ARE SUSTAINED

After operation, in a comparative study vs milrinone, the positive hemodynamic effects of 19 hours treatment with SIMDAX lasted much longer than those from 83 hours treatment with milrinone.1

Sustained effects of levosimendan when used in cardiac surgery 

Reference: 1. De Hert SG et al. Anesth Analg. 2007;104:766–773.

 

…WITHOUT AN INCREASE IN OXYGEN CONSUMPTION

The positive inotropic effects of SIMDAX are achieved without an increase in oxygen consumption either in healthy volunteers1, heart failure patients2, or in cardiac surgery settings.3

No significant increase in oxygen consumption 

References: 1. Ukkonen H et al. Clin Pharmacol Ther. 2000;68(5):522-31. 2. Ukkonen H et al. Clin Pharmacol Ther. 1997;61(5):596-607. 3. Lilleberg J et al. Eur Heart J. 1998;19(4):660-8

 

SIMDAX DOES NOT DISTURB RELAXATION

In a study by Jörgenssen et al. SIMDAX not only improved contractility, but also decreased isovolumic relaxation time.1

SIMDAX has beneficial acute systolic and diastolic functional effects in experimental chronic pulmonary hypertension and right ventricle afterload compared to dobutamine and milrinone.2

Effects of levosimendan on relaxation time 

References: 1. Jörgensen K et al. Circulation. 2008;117(8):1075–1081. 2. Tavares-Silva M et al J Cardiovasc Pharmacol Therap 2017 22(5) 485-95.

 

...AND REDUCES MYOCARDIAL INJURY

Current data suggest that SIMDAX also diminished myocardial injury.1,2

Effects of levosimendan on release of troponin T during cardiac surgery 

References: 1. Zangrillo A et al. J Cardiothorac Vasc Anesth. 2009;23:474–478. 2. Eriksson H et al. Ann Thor Surg. 2009;87:448.

 

SIMDAX REDUCES LCOS

In the recent Phase III trial (LEVO-CTS1) SIMDAX, despite not meeting the primary endpoint, decreased significantly post-surgical low cardiac output syndrome (LCOS). This was accompanied with increased cardiac index and lower need for secondary inotropes.

Incidence of LCOS and secondary inotrope use in the LEVO-CTS trial (N=882)1 

References: 1. Mehta RH et al. N Engl J Med. 2017;376(21):2032-2042.

 

...AND HELPS WEANING FROM CARDIAC PULMONARY BYPASS

SIMDAX helps patients to be successfully weaned from cardiopulmonary bypass.1

Effects of levosimendan on weaning after cardiac surgery 

Reference: 1. Eriksson HI et al. Ann Thorac Surg. 2009;87:448–454.

 

THE BENEFITS OF SIMDAX FOR RENAL FUNCTION

SIMDAX preserves GFR during operation1 and reduces the risk of renal replacement therapy.2

Effects of levosimendan on glomerular filtration rate 

References: 1. Baysal A et al. J Cardiothoracic and Vascular Anesth. 2014;28(3):586–594. 2. Bove T et al. Heart Lung Vessels. 2015;7(1):35-46.

 

…ARE MEDIATED BY A DIRECT EFFECT ON RENAL CIRCULATION

SIMDAX selectively vasodilates the afferent renal arterioles1 thus inducing pre-glomerular vasodilation and leading to improved renal blood flow and glomerular filtration rate.2 The renal oxygen demand/supply relationship is not affected by SIMDAX.2

Effects of levosimendan versus placebo on cardiac index (CI), renal blood flow (RBF), glomerular filtration rate (GFR), and renal vascular resistance (RVR). *p < 0.05 ***p < 0.001 

References: 1. Yilmaz MB et al. Cardiovasc Drugs Ther. 2013;27(6):581-90; 2. Bragadottir G et al. Crit Care Med. 2013;41(10):2328-35.

 

EASING THE CHALLENGE OF TREATING THE FAILING HEART WITH A SUSTAINED HEMODYNAMIC STABILIZATION

SIMDAX GIVES YOU TIME BY PROVIDING:

  • Hemodynamic benefits1,2
  • Symptomatic benefits1,2
  • Sustained effects1
  • Protective effects on heart and other organs3,4
  • Stabilizing the patient for operation1

References: 1. De Hert SG et al. Anesth Analg. 2007;104:766–773. 2. Jörgensen K et al. Circulation. 2008;117(8):1075–1081. 3. Zangrillo A et al. J Cardiothorac Vasc Anesth. 2009;23:474–478. 4. Eriksson H et al. Ann Thor Surg. 2009;87:448.