Efta Triastuti, M.Farm.Klin., Apt.Study Program of Pharmacy, Faculty of Medicine, Brawijaya UniversityMalang-Indonesia
Clinical   Heart        syndromes functionimpairment             Various                                                  ...
CIBIS                       COPER                                                 BEST                       NICUS        ...
Available in Indonesia              β blocker                                 BISOPROLOL     surge of βadrenergic activity...
EFQOLLeft ventricularfunctionSystolic heartfailure
Cardiovascular           Stage C Systolic Heart           BisoprololAmbulatory Clinic            Failure Patients         ...
Stage C chronic & stable heart               failureHad Ejection Fraction reduction (EF              < 50%) Receiving opti...
Acute heart failure and neededAlready accepted Bisoprolol                                    positive inotropic exceptbefo...
Simpson method                   of measurementMeasured by two    as a gold standardexperts inoperatingEchocardiography
21 questions  each       Minessota       Living with          contained 6 choice      Heart Failure       answers based o...
Mean       Mean               Mean       Mean                              Baseline   EndpointBaseline   Endpoint         ...
Inclusion &              February -  Subjects                   exclusion               October                    Eligibl...
Percentage (%)   P valueSex:Male                                73.3        0.465Female                              26,7A...
Mean EF did not meetMean Ejection Fraction Percentage                                    45                               ...
Mean QOL Questionnaire Score                                                                                         Mean ...
Cardiac oxygen                                                  ischemic-related           QOL                            ...
Accp 12 presentation efta
Accp 12 presentation efta
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  • 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”.
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • This is the end of my presentation. Thank you very much
  • Accp 12 presentation efta

    1. 1. Efta Triastuti, M.Farm.Klin., Apt.Study Program of Pharmacy, Faculty of Medicine, Brawijaya UniversityMalang-Indonesia
    2. 2. Clinical Heart syndromes functionimpairment Various High heart mortality diseases High morbidity Quality of life reduction Heart Failure
    3. 3. CIBIS COPER BEST NICUS Previous studies AHA MERIT SENIORS -HFTherapeutic SIGN Guideline Improve QOL NICE Reduce Reduce Morbidity Mortality
    4. 4. Available in Indonesia β blocker BISOPROLOL surge of βadrenergic activity in heart failure High β1 affinity Low effect on bronchus No ISA No MSA
    5. 5. EFQOLLeft ventricularfunctionSystolic heartfailure
    6. 6. Cardiovascular Stage C Systolic Heart BisoprololAmbulatory 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 scoreQuasi-experimental study used a one group pretest-posttest design
    7. 7. Stage C chronic & stable heart failureHad Ejection Fraction reduction (EF < 50%) Receiving optimum dose of ACE inhibitor and furosemide Fulfill for Bisoprolol indication
    8. 8. Acute heart failure and neededAlready accepted Bisoprolol positive inotropic exceptbefore recruitment digoxinComorbid condition whichaffect to quality of life such as Bradycardia (heart rate belowmitral regurgitation, atrial 60 times per minute)fibrilation, & cardiogenic shockHypotension with systolic Severe asthmapressure below 100 mmHg
    9. 9. Simpson method of measurementMeasured by two as a gold standardexperts inoperatingEchocardiography
    10. 10. 21 questions  each Minessota Living with contained 6 choice Heart Failure answers based on the Questionnaire symptom frequenciesThe worse heart failure The more frequentcondition & the higher symptoms the higher impact on QOL questionnaire score
    11. 11. Mean Mean Mean Mean Baseline EndpointBaseline Endpoint MLHFQ MLHFQ EF EF score score Comparison method: Gaussian distribution  pair t-test analysis Non-Gaussian distribution  Wilcoxon analysis
    12. 12. Inclusion & February - Subjects exclusion October Eligible 30 subjectsrecruitment criteria 2011 screening Age Comorbid Sex Chi-Square disease Analysis EF & QOL
    13. 13. Percentage (%) P valueSex:Male 73.3 0.465Female 26,7Age: P > 0.05  No40 to 50 years old 13.3 significant51 to 60 years old 30 0.141 contribution61 to 70 years old 40 between those71 to 80 years old 16,7 factors to EF or QOLHistory of previous illness:Hypertension 26.7 0.061Ischemic heart disease + HT 53.3Diabetes Mellitus + HT 20
    14. 14. Mean EF did not meetMean 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 valueMean baseline 35.20 ± 8.98 0.000Mean at 3rd months 42.80 ± 10.15
    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 valueMean baseline 54.93 ± 9.61 0.000Mean at 3rd months
    16. 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 byBisoprolol 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

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