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Fixed Dose combination ppt


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Fixed Dose combination ppt

  1. 1. Achieving Target Blood pressure Fixed dose Combination
  2. 2. Hypertension • Worldwide hypertension remains the most common modifiable risk factor for cardiovascular disease, affecting 25-30% of adults, rising to 70-80% in the elderly. • Despite significant improvements in the treatment of hypertension over the last 30 years, high blood pressure is still a significant cause of mortality (responsible for approximately 6% of deaths world wide )
  3. 3. Relationship between HTN and CVD • The relationship between blood pressure and cardiovascular events is continuous, with each 20 mmHg increment in systolic blood pressure or 10 mmHg increment in diastolic blood pressure associated with at least a doubling of risk of death from stroke, ischaemic heart disease or other vascular causes.
  4. 4. HTN and CVD • Clinical trial suggests that by lowering blood pressure to agreed target levels the incidences of cardiovascular and Cerbovascular events are significantly reduced • Pooled results of many trial suggest that an overall reduction in SBP by only 2mmHg reduces the risk of cardiovascular events by 7- 10%
  5. 5. Target BP :Far beyond Reach • Despite advances in Pharmacotherapy, 45- 80% of Patients fail to achieve internationally agreed target • Recent Data shows that control rates are about 25% I western Europe • In BP-Care survey in nine central and eastern European countries , on average 27% of treated patients achieved the recommended target of <140 /90mmhg
  6. 6. BP-CARE survey
  7. 7. Target BP :Far beyond Reach • Taking into account that both treated and untreated patients were included in the Western European data , it was estimated that only about 17% of the hypertensive population in Europe are well controlled • Data from US National Health and Nutrition Examination survey ( NHANES ) showed that 52to 62% of treated patients were uncontrolled
  8. 8. Uncontrolled HTN and its consequences Consequences of uncontrolled blood pressure in treated patients is serious Such patients have 57% greater risk of all cause mortality and 74% greater risk of Cardiovascular mortality when compared to patients of controlled BP
  9. 9. Risk of all-cause and cardiovascular mortality in different patient groups in the NHANES III survey in US adults
  10. 10. Uncontrolled HTN and its consequences • The relationship between blood pressure and cardiovascular events is continuous, with each 20 mmHg increment in systolic blood pressure or 10 mmHg increment in diastolic blood pressure associated with at least a doubling of risk of death from stroke, ischaemic heart disease or other vascular causes.
  11. 11. High Blood pressure and Its consequences • Uncontrolled HTN has important consequences for increasing risk of • CVD • Kidney disease • Micro vascular disease • Dementia • Alzheimer’s Disease • Parkinson Disease
  12. 12. Reason for Poor control of BP • Physicians may be reluctant to take appropriate action possibly due to • Concern about the potential increased risk of side effect • The perceived complexity of the treatment regimen or treatment cost • Mis diagnosis , in Particular the problem of hypertension • Non –adherence with treatment is also one of the reason
  13. 13. Reason for Poor control of BP • Multifactorial aetiology of hypertension • Due to Involvement of a number of complex physiological responses in regulation of blood pressure , monotherapy is effective only in 25% of the patients • Simply up titrating the dose of treatment is unlikely to significantly improve response .
  14. 14. Reason for Poor control • The complexity of underlying causes of hypertension is a further important cause of poor blood pressure control • A retrospective study of patients with newly diagnosed hypertension suggested that excessive reliance on monotherapy was the most important factor contributing to poor control , with 40% of patients remaining on monotherapy at the end of the study
  15. 15. Reason for Poor control of BP • The limited efficacy of individuals therapies in controlling blood pressure and the time taken new treatments sequentially may lead to loss of motivation from both patient and Physicians
  16. 16. The Increasing Importance of Combination Therapy • Combination therapy is now considered to be critically important for improved blood pressure control
  17. 17. Advantage of Combination Therapy • Complementary mode of actions for optimal blood pressure lowering effect • Inhibits the counter regulatory responses that occur when physiological system is blocked by single agent • Effective in patients with moderate /severe hypertension ( 160/100mmHg) who account for some 10-15% of hypertensive populations and are at substantially greater risk of future CVD risk
  18. 18. Advantage of Combination Therapy • Decreases blood pressure variability when compared with Monotherapy . • Such variability is strong predictor of storke and another good reason for using combination therapy
  19. 19. Advantage of Combination Therapy • All Large prospective clinical trials like • ALLHAT • Life • ASCOT –BPLA Endorses Combination Therapy ALLHAT ( Antihypertensive and lipid lowering treatment to prevent Heart attack trial )
  20. 20. Advantage of Combination Therapy • Nearly 80% of patients in ASCOT-BPLA were two or more medications at the end of the study • Meta analysis of 42 trials in nearly 11000 hypertensive patients showed that combining two different anti-hypertensive classes provides approximately 5 times additional reduction in blood pressure compared with doubling the dose of single drug
  21. 21. Advantage of Combination Therapy • Another Meta analysis of 119 randomized double-blind placebo controlled trials of major classes of antihypertensive monotherapies showed that, an average first and second drugs given alone lower blood pressure by only 7.0/4.6mmHg, whereas when they are given together blood pressure reduction was 14.6/8.6mmHg
  22. 22. Guidelines Recommendations • Emphasize the need of combination therapy • Highlight the necessity of using multiple therapies with complimentary mode of Action to achieve blood pressure targets
  23. 23. Recommendations for Combination Therapy • The JNC 7 guidelines states that most hypertensive patients will require 2 or more drugs to achieve blood pressure control • The 2007 ESH/ESC hypertension guidelines emphasize the need for treatment with multiple antihypertensive agents to attain blood pressure goals .
  24. 24. ESH /ESC 2013 Recommendations • The recent ESH / ESC guidelines strengthens this approach with the statement that in “ In vast majority hypertensive patients , effective blood pressure control can only be achieved by combination Therapy of at least 2 anti-hypertensives drugs ( from different classes )
  25. 25. Possible combinations • The ESH/ESC guidelines recommend different combinations that have been found to be effective and well tolerated in randomized trial
  26. 26. Acceptable combinations of Anti- hypertensive drug classes • Acceptable dual combinations based on outcomes ,anti- hypertensive efficacy and tolerability, as recommended by international guidelines • These combinations are of drug with complimentary modes of action which allow patient to meet blood pressure targets
  27. 27. Problems of Combination therapy • Increased pill burden leading to poor compliance • Patients with HTN have many co-existing morbidities which also require multiple drugs . The resulting therapeutic complexities lead to poor compliance and increased Risk of CVD • Notably , one study demonstrated a 35% reduction in compliance with a four times a dy regimen when compared with a once daily dose
  28. 28. Increased PILL burden • The increased pill burden is significant contributory factor to poor compliance • Data from a retrospective US study of compliance with anti-hypertensive and Lipid lowering therapy show that taking fewer other medications for co-morbidities is associated with higher likelihood of compliance
  29. 29. Consequences of Poor compliance with therapy • Non compliance with therapy is associated with • Excess Morbidity and Mortality • Less Likely to achieve blood pressure Goals • Study of 840 patients from 13 US managed care organization showed that poorly complaint individual were 45% less likely to achieve blood pressure target of <140/90 mmHg
  30. 30. Consequences of Improved Compliance • Improved compliance with anti-hypertensive medications has been shown to have significant beneficial effects on cardiovascular outcomes and to decrease risk of hospitalizations • Good compliance with therapy has been associated with significant 38% reduction in Cardiovascular events
  31. 31. Need of an Hour • Compliance with therapy can be improved by simplification of drug regimens, both reducing frequency of dosing and overall pill burden • Most importantly Compliance are improved with FIXED DOSE COMBINATION
  32. 32. FDC • FDC of anti-hypertensives drug in a single once daily tab are an important strategy • To reduce pill burden • Improves level of compliance with therapy • Causes significant reductions in CVD events • Endorsed by various Meta analysis of cohort studies
  33. 33. Reappraisal of ESH /ESC guidelines • A Reappraisal of ESH /ESC guidelines 2007 strongly recommends the use of fixed dose combination therapy Stating : • “ Whenever possible , use of fixed dose combinations should be preferred because simplification of treatment carries advantages for compliance with treatment”
  34. 34. Benefits of FDC • A recent study compared compliance with therapy over 12 month in 14,449 patients receiving FDC or free combinations of the same anti-hypertensive drugs • Patients receiving FDC anti-hypertensive therapies showed a 22.5% increased rate of compliance and 43.4% increased rate of persistence with therapy when compared with those patients on free combinations of anti-hypertensive
  35. 35. Summary • Combination therapy with two anti- hypertensive’s drugs with complimentary mode of action is required for most hypertensive's patients in order of achieve internationally agreed Blood Pressure targets • A number of evidence based combinations are available to physicians and guidelines encourage the early use of combination therapy
  36. 36. Summary • Guidelines recommends various drugs and emphasize the importance of FDC . • Combining complimentary treatments in a single tablet recognizes the need to treat the multiple cause of hypertension while maximizing compliance with therapy . • Evidence shows that such an approach will improve blood pressure control and minimize adverse effect to reduce the risk of cardiac and cerbrovascular events