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SIMDAX in Advanced Heart Failure

 

SIMDAX IN ADVANCED HEART FAILURE

Advanced heart failure (AdHF)1 is characterized by:

  • repeated episodes of cardiac decompensation2
  • severely compromised patient quality of life3
  • frequent and prolonged hospitalizations4
  • more pronounced decrease in cardiac function at each successive admission4
  • increased risk of death3
  • increased burden of hospital and social costs3

Repetitive SIMDAX therapy represents a safe and effective treatment option for stabilizing these patients.5

 Functional capacity during the progression of heart failure

References: 1. Ponikowski P et al. Eur Heart J. 2016;37:2129-2200 2. Roger VL Circ Res. 2013;113:646–659. 3. Braunschweig F. J Am Coll Cardiol. 2011;58:738-9 4. Gheorghiade M et al. Am J Cardiol. 2005;96[suppl]:11G–17G. 5. Nieminen MS et al. Int J Cardiol. 2014;174(2):360–367.

 

SIMDAX MAINTAINS PATIENT STABILITY IN ADVANCED HEART FAILURE

The benefits of the repetitive use of SIMDAX in advanced heart failure have been assessed in several independent randomized trials including, in total, more than 500 patients.1

The use of SIMDAX is associated with improvements in hemodynamics, symptoms, rehospitalization rates, and biomarkers (see chart).1,2

The current data and clinical experience suggest that in selected patients, intermittent/repetitive SIMDAX can be used in advanced heart failure to maintain patient stability.1

 Effects of levosimendan in advanced heart failure

References: 1. Nieminen MS et al. Int J Cardiol. 2014;174(2):360–367. 2. Parissis JT et al. Heart. 2006;92:1768−1772.

 

IN HOSPITALIZATION FOR AHF, THE EFFECTS OF SIMDAX ALLOW A SHORTER HOSPITAL STAY

SIMDAX, on top of standard of care, shortens hospital stay in acute heart failure.  These data have been shown in a phase III study (vs placebo).1,2

Hospital stay is reduced by 1.92 DAYS 

References: 1. De Lissovoy G et al. Eur J Health Econ. 2010;11:185–193. 2. Packer M et al. JACC Heart Fail. 2013;1(2):103-11.

 

SHORTER HOSPITAL STAYS ARE CONFIRMED BY META-ANALYSIS

These results are corroborated by a meta-analysis of 8 studies in which SIMDAX was used in cardiology settings:

Length of stay in hospital was decreased by 1.59 days in SIMDAX treated patients in addition to a significant reduction in mortality.1

Meta-analysis of the levosimendan effects on length of stay in hospital1 

Reference: 1. Landoni G et al. Crit Care Med. 2012;40:634–646 (electronic supplementary material).

 

REPEATED TREATMENT WITH SIMDAX REDUCES RE-HOSPITALIZATION…

In the LION-HEART Study,1 the treatment with 6 cycles of intermittent infusions of levosimendan every 2 weeks at a dose of 0.2 μg/kg/min in outpatients with advanced heart failure significantly reduced the risk of heart failure hospitalization and the risk of the combined endpoint of all-cause death or heart failure hospitalization, showing a lesser decline in their healthrelated QoL over time.

HF Hospitalization & All-Cause death or HF Hospitalization 

Reference: 1. Comin-Colet J et al Eur J Heart Fail 2017 [ePub Dec 30]

 

…AS CONFIRMED BY A META-ANALYSIS

Repetitive or intermittent administration of SIMDAX for patients with advanced heart failure is associated with a reduction in the re-hospitalization rate at 3 months1

Meta-analysis of repetitive use of levosimendan in advanced heart failure 

References: 1. Silvetti S et al. ESC Heart Failure 2017;4:595-604

 

SIMDAX AND QUALITY OF LIFE

Advanced heart failure is characterized by poor quality of life (QoL) and frequent hospitalizations.1 The efficacy of SIMDAX in advanced heart failure was not only assessed by parameters such as clinical status, hemodynamics, neurohormonal status, and echo indices, but also by QoL–related parameters, such as functional capacity, exercise  performance, psychological status, and frequency of rehospitalizations, which are more relevant from the patient perspective.2

References: 1. Jaarsma T et al. Eur. J Heart Fail. 2009;11:433–443. 2. Nieminen MS et al. Int J Cardiol. 2015;191:256–264.

 

SIMDAX AND QUALITY OF LIFE IN ADVANCED HEART FAILURE

Levosimendan appears more favourable in quality of life related variables than other vasoactive agents 

Reference: 1. Nieminen MS et al. Int J Cardiol. 2014;174(2):360–367.

 

THE BENEFITS OF SIMDAX FOR RENAL FUNCTION

GFR improved in SIMDAX compared to dobutamine-treated patients with heart failure who required inotropic therapy.1

A placebo-controlled study in patients hospitalized for decompensated heart failure and renal dysfunction, showed a statistically significant improvement of GFR in SIMDAX-treated patients.2

The peak effect was seen at three days after a 24 hour infusion and the effects persisted up to 14 days.2

GFR improved in SIMDAX® compared to dobutamine-treated patients with heart failure who required inotropic therapy.1 

Reference: 1. Yilmaz et al. Cardiovasc Drugs Ther. 2007;21:431–435. 2. Hou Z-Q et al. Cardiovasc Ther. 2013;31:108–114.

 

NO COMPROMISE ON SURVIVAL IN ADVANCED HEART FAILURE

Moreover, recent metaanalysis on the mortality of repetitive use of SIMDAX shows encouraging results.1,2

Meta-analysis of mortality in advanced heart failure studies of repetitive levosimendan therapy1 

References: 1. Nieminen MS et al. Int J Cardiol. 2014;174(2):360–367. 2. Silvetti S & Nieminen MS Int J Cardiol. 2016;202:138–143.

 

RECOMMENDED PATIENT PROFILE AND DOSING IN ADVANCED HEART FAILURE

A panel of experts from 15 European countries convened to review and discuss the existing data on the repetitive use of SIMDAX.1

The panel reached a consensus in potential indications for SIMDAX in advanced heart failure1 (see Table I).

The panel also gave recommendations for the optimal dosing (see Table II) which should be considered when administering SIMDAX to such patients.1

Expert consensus on indication and dosing of levosimendan in advanced heart failure 

Reference: 1. Nieminen MS et al. Int J Cardiol. 2014;174(2):360–367.