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Efta Triastuti, M.Farm.Klin., Apt.
Study Program of Pharmacy, Faculty of Medicine, Brawijaya University
Malang-Indonesia
Clinical
   Heart        syndromes
 function
impairment


             Various
                                                      High
              heart                                   mortality
             diseases                     High
                                          morbidity

                             Quality of
                             life
                             reduction

  Heart Failure
CIBIS

                       COPER
                                                 BEST
                       NICUS
                               Previous
                                studies
              AHA                           MERIT
                          SENIORS
                                             -HF



Therapeutic
                SIGN
 Guideline
                                    Improve
                                     QOL

              NICE
                           Reduce            Reduce
                          Morbidity         Mortality
Available in Indonesia
              β blocker


                                 BISOPROLOL


     surge of β
adrenergic activity
  in heart failure           High β1 affinity
                          Low effect on bronchus
                                  No ISA
                                 No MSA
EF


QOL

Left ventricular
function

Systolic heart
failure
Cardiovascular           Stage C Systolic Heart           Bisoprolol
Ambulatory Clinic            Failure Patients
                                                        Added on

                                                       Checked
                                                       “baseline”
                                                       Ejection Fraction
                                           17          & Quality of Life
                              13                       Questionnaire
                          40-80 Years of Age (n=30)    score
 Dr Saiful Anwar       Receiving Combination of
 General Hospital     ACE Inhibitor & Furosemide
                                       3 months Followed up
                     Checked “endpoint” Ejection Fraction & Quality of
                     Life Questionnaire score


Quasi-experimental study used a one group pretest-posttest design
Stage C chronic & stable heart
               failure

Had Ejection Fraction reduction (EF
              < 50%)

 Receiving optimum dose of ACE
    inhibitor and furosemide


  Fulfill for Bisoprolol indication
Acute heart failure and needed
Already accepted Bisoprolol
                                    positive inotropic except
before recruitment
                                    digoxin


Comorbid condition which
affect to quality of life such as   Bradycardia (heart rate below
mitral regurgitation, atrial        60 times per minute)
fibrilation, & cardiogenic shock



Hypotension with systolic
                                    Severe asthma
pressure below 100 mmHg
Simpson method
                   of measurement
Measured by two    as a gold standard
experts in
operating
Echocardiography
21 questions  each
       Minessota
       Living with          contained 6 choice
      Heart Failure       answers based on the
      Questionnaire       symptom frequencies




The worse heart failure    The more frequent
condition & the higher    symptoms the higher
   impact on QOL           questionnaire score
Mean       Mean               Mean       Mean
                              Baseline   Endpoint
Baseline   Endpoint           MLHFQ      MLHFQ
  EF          EF               score       score




 Comparison method:
 Gaussian distribution  pair t-test analysis
 Non-Gaussian distribution  Wilcoxon analysis
Inclusion &
              February -
  Subjects                   exclusion
               October                    Eligible       30 subjects
recruitment                   criteria
                2011
                             screening




               Age

                           Comorbid
  Sex                                                Chi-Square
                            disease
                                                      Analysis

              EF & QOL
Percentage (%)   P value

Sex:
Male                                73.3        0.465
Female                              26,7



Age:                                                      P > 0.05  No
40 to 50 years old                  13.3                     significant
51 to 60 years old                   30         0.141       contribution
61 to 70 years old                   40                    between those
71 to 80 years old                  16,7                  factors to EF or
                                                                QOL


History of previous illness:
Hypertension                        26.7
                                                0.061
Ischemic heart disease + HT         53.3
Diabetes Mellitus + HT               20
Mean EF did not meet
Mean Ejection Fraction Percentage




                                    45
                                                                                            Gaussian Distribution
                                    40
                                    35
                                    30
                                                                                            Non-parametric test
                                    25
                                                                                               comparison
               (%)




                                    20                                       Baseline
                                     15
                                                                             3rd months
                                    10                                                       One group pretest-
                                      5                                                       posttest design
                                      0
                                            Baseline     3rd months
                                          Time of Measurements (before & after Bisoprolol     Wilcoxon analysis
                                                           Addition)

                                                                EF percentage (%)                  P value
Mean baseline                                                     35.20 ± 8.98
                                                                                                   0.000
Mean at 3rd months                                               42.80 ± 10.15
Mean QOL Questionnaire Score



                                                                                         Mean QOL questionnaire score
                               56
                                                                                          met Gaussian Distribution
                               54
                               52
                                                                                          Parametric test comparison
                               50
                                                                          Baseline
                               48
                                                                          3rd months
                               46                                                         One group pretest-posttest
                                                                                                   design
                               44
                                           Baseline   3rd months
                                      Time of Measurements (before & after                    Paired t test analysis
                                              Bisoprolol Addition)

                                                          Mean QOL Questionnaire Score               P value

Mean baseline                                                      54.93 ± 9.61
                                                                                                     0.000
Mean at                             3rd   months
Cardiac oxygen
                                                  ischemic-related           QOL
                              demand
                                                 symptoms relieve        improvement
                             reduction

             Decrease
             heart rate                              Increase cardiac output by
                                                      increasing stroke volume
                                                      though heart rate decline
                              Adequate
                              filling &
                            loading time            Increase Ejection Fraction by
Bisoprolol                                           reduce blood volume which
                                                         left in the ventricle


              Inhibit       Aldosterone
                                                Decrease water &        Cardiac load
               renin        antagonistic
                                                sodium retention         reduction
              release          effect
                   No ISA  high effect on HR
                           reduction                         Slow down HF-related
                   No MSA  minimum effect                cardiomyopathy progression
                    on cardiac conductance
Accp 12 presentation efta
Accp 12 presentation efta

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Accp 12 presentation efta

  • 1. Efta Triastuti, M.Farm.Klin., Apt. Study Program of Pharmacy, Faculty of Medicine, Brawijaya University Malang-Indonesia
  • 2. Clinical Heart syndromes function impairment Various High heart mortality diseases High morbidity Quality of life reduction Heart Failure
  • 3. CIBIS COPER BEST NICUS Previous studies AHA MERIT SENIORS -HF Therapeutic SIGN Guideline Improve QOL NICE Reduce Reduce Morbidity Mortality
  • 4. Available in Indonesia β blocker BISOPROLOL surge of β adrenergic activity in heart failure High β1 affinity Low effect on bronchus No ISA No MSA
  • 6. Cardiovascular Stage C Systolic Heart Bisoprolol Ambulatory Clinic Failure Patients Added on Checked “baseline” Ejection Fraction 17 & Quality of Life 13 Questionnaire 40-80 Years of Age (n=30) score Dr Saiful Anwar Receiving Combination of General Hospital ACE Inhibitor & Furosemide 3 months Followed up Checked “endpoint” Ejection Fraction & Quality of Life Questionnaire score Quasi-experimental study used a one group pretest-posttest design
  • 7. Stage C chronic & stable heart failure Had Ejection Fraction reduction (EF < 50%) Receiving optimum dose of ACE inhibitor and furosemide Fulfill for Bisoprolol indication
  • 8. Acute heart failure and needed Already accepted Bisoprolol positive inotropic except before recruitment digoxin Comorbid condition which affect to quality of life such as Bradycardia (heart rate below mitral regurgitation, atrial 60 times per minute) fibrilation, & cardiogenic shock Hypotension with systolic Severe asthma pressure below 100 mmHg
  • 9. Simpson method of measurement Measured by two as a gold standard experts in operating Echocardiography
  • 10. 21 questions  each Minessota Living with contained 6 choice Heart Failure answers based on the Questionnaire symptom frequencies The worse heart failure The more frequent condition & the higher symptoms the higher impact on QOL questionnaire score
  • 11. Mean Mean Mean Mean Baseline Endpoint Baseline Endpoint MLHFQ MLHFQ EF EF score score Comparison method: Gaussian distribution  pair t-test analysis Non-Gaussian distribution  Wilcoxon analysis
  • 12. Inclusion & February - Subjects exclusion October Eligible 30 subjects recruitment criteria 2011 screening Age Comorbid Sex Chi-Square disease Analysis EF & QOL
  • 13. Percentage (%) P value Sex: Male 73.3 0.465 Female 26,7 Age: P > 0.05  No 40 to 50 years old 13.3 significant 51 to 60 years old 30 0.141 contribution 61 to 70 years old 40 between those 71 to 80 years old 16,7 factors to EF or QOL History of previous illness: Hypertension 26.7 0.061 Ischemic heart disease + HT 53.3 Diabetes Mellitus + HT 20
  • 14. Mean EF did not meet Mean Ejection Fraction Percentage 45 Gaussian Distribution 40 35 30 Non-parametric test 25 comparison (%) 20 Baseline 15 3rd months 10 One group pretest- 5 posttest design 0 Baseline 3rd months Time of Measurements (before & after Bisoprolol Wilcoxon analysis Addition) EF percentage (%) P value Mean baseline 35.20 ± 8.98 0.000 Mean at 3rd months 42.80 ± 10.15
  • 15. Mean QOL Questionnaire Score Mean QOL questionnaire score 56 met Gaussian Distribution 54 52 Parametric test comparison 50 Baseline 48 3rd months 46 One group pretest-posttest design 44 Baseline 3rd months Time of Measurements (before & after Paired t test analysis Bisoprolol Addition) Mean QOL Questionnaire Score P value Mean baseline 54.93 ± 9.61 0.000 Mean at 3rd months
  • 16. Cardiac oxygen ischemic-related QOL demand symptoms relieve improvement reduction Decrease heart rate Increase cardiac output by increasing stroke volume though heart rate decline Adequate filling & loading time Increase Ejection Fraction by Bisoprolol reduce blood volume which left in the ventricle Inhibit Aldosterone Decrease water & Cardiac load renin antagonistic sodium retention reduction release effect No ISA  high effect on HR reduction Slow down HF-related No MSA  minimum effect cardiomyopathy progression on cardiac conductance

Editor's Notes

  1. Good afternoon ladies &amp; gentlemen..AssalamualaikumFor the first let me introduce my self. My name is EftaTriastuti, I am a lecturer in study program of pharmacy, faculty of medicine, Brawijaya university, Malang, Indonesia Secondly, I am very grateful to all of you for being here and listening to my research presentation entitled “role of bisoprolol addition on angiotensin converting enzyme inhibitor and furosemide combination on the left ventricular function in systolic HF patients”.
  2. HF can be defined as clinical syndromes which are caused by the impairment of heart function and related to various kind of heart diseases.HF syndrome may lead to the reduction of QOL with high morbidity and mortality rate
  3. Therapeutic guideline of heart failure from american heart association (AHA), Scottish Intercollegiate Guidelines Network (SIGN), and National Institute for Health and Clinical Excellence (NICE). Based on the result from several studies such as The Cardiac Insufficiency Bisoprolol Study (CIBIS),ß-Blocker Evaluation of Survival Trial (BEST), MetoprololRandomised Intervention Trial in congestive heart failure (MERIT-HF), Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure (SENIORS) and Carvedilol Prospective Randomized Cumulative Survival trial (COPERNICUS)  Recommend the routinely use of beta blocker for stable heart failure patients. Which found that beta blocker brought many benefits in QOL, morbidity and mortality if given to stable heart failure patients.Bisoprolol, carvedilol or nebivolol should be the beta blocker of first choice for the treatment of patients with chronic heart failure due to left ventricular systolic dysfunction.
  4. Beta blocker play role on the surge beta adrenergic activity in HF by block this activity will provide the reduction effect of excess beta adrenergic activity such as vasocontriction, sodium and water retention which lead to increase cardiac load and aggravate hypoperfusion due to inadequate ventricular ejectionOne of beta blocker which is recommended as the first choice therapy in stable HF is bisoprolol.This agent is available in IndonesiaThis agent has many benefits such as high affinity on beta one receptor that will bring lower risk of bronchospasm. This agent also does not have intrinsic sympathomimetic activity that will cause the more reduction in HR and provide the more adequate filling and loading time of left ventricle. Bisoprolol has no membrane stability activity that will provide the minimum effect on the cardiac conductance.
  5. The aim of this study is to analyze the addition effect of bisoprolol on the optimum combination of ACE inhibitor &amp; furosemide in systolic HF primarily in left ventricular function which affect to the QOL and the reduction of EF
  6. This was quasi-experimental study used a one group pretest-posttest design.Research was conducted in cardiovascular ambulatory clinic of Dr. Saiful Anwar General Hospital Malang, Indonesia between february 2011 to january 2012. 13 women and 17 men with stage C systolic heart failure who receiving an optimum combinatio of ACE inhibitor and furosemide were recruited Bisoprolol was added on after baseline EF by echocardiography &amp; QOL by Minessota Living with Heart Failure questionnaire measurementThen followed up for 3 monthsAnd checked end point EF &amp; QOL
  7. Inclusion criteria for patient recruitment were:Stage C chronic &amp; stable HFHad EF reductionReceiving optimum combination dose of ACE inhibitor &amp; furosmideFulfill for bisoprolol indication
  8. Whereas exclusion criteria were:already accepted bisoprolol before recruitmentAcute HF &amp; needed positive inotropic except digoxinComorbid condition which affect to QOL such as MR, AF &amp; cardiogenic shockBradycardia with HR below 60 x per minuteHypotension with systolic pressure below 100 milimeterof mercurySevere asthma
  9. Ejection fraction was measured by 2 expert in operating echocardiography with Simpson method as a gold standard.This method measures the ventricular volume in the end of diastolic phase and systolic phaseThe volume of end diastolic &amp; systolic phase are being used to calculate the EF with this formula
  10. While QOL measured by Minnesota Living with HF questionnaire which contain of 21 questions &amp; each question contained 6 choice answers based on the symptom frequenciesThe more frequent symptoms resulted in the higher questionnaire scoreIt’s mean the worse heart failure condition &amp; the higher impact on QOL
  11. Statistical analysis in this study is to compare mean baseline EF to mean endpoint EF and mean baseline MLHFQ score to mean endpoint MLHFQ score.If the data following Gaussian distribution then the comparison method used pair t test analysisWhile non-Gaussian distribution data were analyzed by Wilcoxon test
  12. Subjects recruitment was held on February to October 2011 &amp; then we conducted sample screening to meet the inclusion &amp; exclusion criteria, recruited subjects with a good adherence only found 30 patients.Comorbid disease, age, &amp; sex were confounding factors that might have contribution to EF &amp; QOLTherefore should be test the contribution by chi-square analysis
  13. Chi-square analysis resulted that between sex, age, &amp; history of previous illness had no significant contribution to EF &amp; QOL showed with the P value more than 0.05
  14. The bar charts between mean EF percentage versus time of measurements (before &amp; after Bisoprolol addition) showed the mean baseline EF with the red color &amp; mean endpoint EF with blue color.The mean EF did not meet Gaussian distribution, therefore we conducted non-parametric test comparison in one group pretest-posttest design using Wilcoxon analysisWilcoxon test for EF showed that there was significantly difference between baseline EF &amp; endpoint EF with P value lest than 0.000
  15. The bar charts between mean QOL questionnaire score versus time of measurements (before &amp; after Bisoprolol addition) showed the mean baseline QOL questionnaire score with the green color &amp; mean endpoint QOL questionnaire score with orange color.The mean QOL questionnaire score met Gaussian distribution, therefore we conducted parametric test comparison in one group pretest-posttest design using paired t test analysisPaired t test for QOL questionnaire score showed that there was significantly difference between baseline &amp; endpoint QOL questionnaire score with P value lest than 0.000
  16. From this results we discussed that the characteristic of bisoprolol in ISA provide the high effect on HR reduction and bisoprolol characteristic in MSA provide the minimum effect on cardiac conductance.Bisoprolol act to decrease HR which provide Cardiac oxygen demand reduction that relieve ischemic-related symptoms &amp; provide QOL improvement, besides the reduction of HR might provide Adequate filling &amp; loading time which resulted in Increase cardiac output by increasing stroke volume though heart rate decline &amp; Increase Ejection Fraction by reduce blood volume which left in the left ventricle.Bisoprolol also has a role to inhibit renin release which might provide Aldosterone antagonistic effect &amp; caused Decrease water &amp; sodium retention that brought to the Cardiac load reduction &amp; Slow down HF-related cardiomyopathy progression
  17. Based on the result we might conclude that This prospective study showed that the routine addition of Bisoprolol to ACE inhibitor and furosemide combination may significantly improve ejection fraction and quality of life in systolic heart failure patients (each by P = 0.000; 95% confidence of interval)
  18. This is the end of my presentation. Thank you very much