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UPDATES IN PHARMACOTHERAPY OF THE ELDERLY

UPDATES IN PHARMACOTHERAPY OF THE ELDERLY. Miran F. Kenda Slovenian Society of Cardiology Slovenian Heart House Ljubljana, Slovenia 20 % of population in North America and Europe is over 65 years old Cardiovascular diseases are growing in this age group

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UPDATES IN PHARMACOTHERAPY OF THE ELDERLY

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  1. UPDATES IN PHARMACOTHERAPY OF THE ELDERLY Miran F. Kenda Slovenian Society of Cardiology Slovenian Heart House Ljubljana, Slovenia 20 % of population in North America and Europe is over 65 years old Cardiovascular diseases are growing in this age group Many patients over 65 are still very fit and active We move this age limit to 75 years

  2. Aging World Populations 300 World Population Aged >75 Years (Millions) 200 100 0 1950 1960 1970 1980 1990 2000 2010 2020 2030 Year www.census.gov/prod/2001/p95-01-1.pdf

  3. Cardiovascular diseases in the elderly • 2nd most common disease in elderly • 1st most common are depression and dementia • aging process itself • many comorbidites • complex approach to diagnostic procedures and treatment • important to improve quality of life

  4. Trial Drug N Mean age US Carvedilol Carvedilol 1094 58 Merit HF Metoprolol CR/XL 3991 64 CIBIS-II Bisoprolol 2647 60 4S Simvastatin 4444 58 HOPE Ramipril 6717 66 Age of patients in major placebo controlled cardiovascular trials

  5. HF in the elderly • mostly diastolic dysfunction • complex diagnostic process because of comorbidites • treatment more complex than in younger patients • frequent monitorings • complications of treatment (renal insufficiency, bleeding, cognitive impairment, etc.)

  6. Number of comorbid factors per patient n = 86 094 HF patients, 85 ± 9 years SAGE database 1 - 3 27 % 4 - 5 41 % > 5 32 % Gambassi GAm Heart J 2000 ;139:85-93

  7. 1% ESRD (Dialysis) 4% Parkinson 9% Cancer 17% Depression 19% COPD 20% Anemia AF 20% 30% Falls 36% Dementia COMORBIDITIES 86 094 residents with heart failure, 85 ± 9 years Gambassi GAm Heart J 2000 ;139:85-93

  8. HOPE Study InvestigatorsNew Engl J Med 2000;342:154-160. HOPE (ramipril) - subgroup analysis No. of Incidence of MI, RR on ramipril patients stroke or CV death (95% CI) on placebo (%) Overall 9297 17.8 CVD 8162 18.7 No CVD 1135 10.2 Diabetes 3577 19.8 No diabetes 5720 16.5 Age < 65 yr 4169 14.2 Age ³ 65 yr 5128 20.7 Men 6817 18.7 Women 2480 14.4 Hypertension 4355 19.5 No hypertension 4942 16.3 0.6 0.8 1.0 1.2 • Ramipril was beneficial in all subgroups analysed

  9. EUROPA - sub-groups analysis RRR (%) Perindopril better Placebo better Male 19.3 Female 22.0 Age £ 56 yrs 27.3 Age 57 - 65 14.3 Age > 65 yrs 18.2 Previous MI 22.4 No previous MI 12.1 0.5 1.0 2.0

  10. ACE inhibitors and elderly • Observation studies suggest that elderly with LVSD are as likely to benefit from ACE-i as younger patients • ACE-i are underused in older persons despite guideline recommendations • In spite of common comorbidites, polypharmacy and cognitive impairment, the judicious use of ACE-i in eligible older patients will likely improve health outcomes

  11. US Carvedilol Program Survival 1.0 0.9 0.8 0.7 0.6 0.5 Carvedilol (n=696) 58 years b blockers in CHF – all-cause mortality Placebo (n=398) Risk reduction=65% P<0.001 0 50 100 150 200 250 300 350 400 Days Packer et al (1996) Survival Mortality (%) 64 years 60 years CIBIS-II MERIT-HF 1.00.80.6 0 20 Placebo Bisoprolol 15 Metoprolol CR/XL 10 Placebo Risk reduction=34% Risk reduction=34% 5 P=0.0062 P<0.0001 0 0 200 400 600 800 0 3 6 9 12 15 18 21 Months of follow-up Time after inclusion (days) The MERIT-HF Study Group (1999) CIBIS-II Investigators (1999)

  12. SENIORS Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure A randomised, double-blind, placebo-controlled study Eur Heart J 2005;26:215-25.

  13. Inclusion criteria • age > 70 years (average 76,1) • N=2,128 (1,067 nebivolol, 1,061 placebo) • clinical diagnosis of chronic heart failure and either of: a) documented LVEF < 35% within previous 6 months or b) hospital admission within previous 1 year for congestive HF

  14. All cause mortalityor CV hospitalisation

  15. Death or CV hospitalisationby subgroup

  16. Conclusions • Nebivolol significantly reduced death or hospitalisation in elderly heart failure patients • The effect was similar regardless of ejection fraction, age or gender • Partly nebivolol greater effectiveness could be attributed to its action through NO vasodilatatory and other effects

  17. The HYpertension in the Very Elderly Trial N. Beckett, R. Peters, A. Fletcher, C. Bulpitt on behalf of the HYVET committees and investigators ClinicalTrials.gov: NCT00122811

  18. The Trial: International, multi-centre, randomised double-blind placebo controlled Inclusion Criteria:Exclusion Criteria: Aged 80 or more, Standing SBP < 140mmHg Systolic BP; 160 -199mmHg Stroke in last 6 months + diastolic BP; <110 mmHg, Dementia Informed consent Need daily nursing care Primary Endpoint: All strokes (fatal and non-fatal) Target blood pressure 150/80 mmHg

  19. All stroke (30% reduction)

  20. Total Mortality (21% reduction)

  21. Heart Failure (64% reduction)

  22. 0.1 0.2 0.5 0 2 ITT – Summary

  23. Conclusions Antihypertensive treatment based on indapamide (SR) 1.5mg (± perindopril) reduced stroke mortality and total mortality in a very elderly cohort. NNT (2 years) = 94 for stroke and 40 for mortality Large and significant benefit in reduction of heart failure events and for combined endpoint of cardiovascular events Benefits seen early Treatment regime employed was safe

  24. Extending Benefits of Pravastatin to the Elderly: PROSPER Study PROSPER Study Group. Lancet. 2002; 360:1623-30.

  25. PROSPER - summary of results • Pravastatin achieved a 15% RRR (p= 0.014) in the primary endpoint over 3.2 years of follow-up in elderly (mean age 75+ years) • Pravastatin significantly reduced CHD events by 19% (p= 0.006); CHD mortality decreased by 24% (p= 0.043) • No effect on stroke or cognitive function was observed in 3.2 years; TIAs decreased by 25% (p=0.051) PROSPER Study Group. Lancet. 2002; 360:1623-30.

  26. Lipid lowering interventions in the elderly • have a proven correlation with a significant reduction in morbidity and mortality • the improvement in CV risk, according to clinical studies of statins, cannot be attributed solely to a reduction in cholesterol levels • more prudent to give small/medium doses of statins: • the half life of statins is prolonged • the pts may be taking other drugs metabolised to the same cytochrome • combination of ezetimibe and statin is well tolerated and lead to a significant reduction in LDL-C levels compared with statin monotherapy in all age groups Review: Kalantzi KI, et al. Hellenic J Cardiol 2006;47:93-9.

  27. Prevalence of atrial fibrillation (AF) prevalence (%) age (years)

  28. Risk of stroke in patients with AF low risk < 2 %/year • age < 65 years, no risk factors intermediate risk 2-7 %/year • age 65 -75 years with no risk factors or • 1 risk factor: CAD, DM, AH high risk 8-18 %/year • age >75 years • more than 1 risk factor : stroke, TIA, AF, HF

  29. Anticoagulation in patients with AF low risk ASA ASA or varfarin ( INR 2,5; 2,0-3,0) intermediate risk varfarin (INR 2,5; 2,0-3,0) high risk

  30. Myocardial revascularization in the elderly • percutaneous angioplasty can be considered the technique of choice for rapid reperfusion in acute phase MI with elderly pts: • PAMI Study – mortality/reinfarction rate of 5.1 % vs. 12% in the group treated with fibrinolysis (age over 70 years: mortality 2% in PCI group vs. 10% in the thrombolysis group) • GUSTO-IIb – a trend towards mortality reduction at 30 days with primary PCI compared with thrombolysis in the over 70 years of age • Primary Coronary Angioplasty Trial (meta-analysis) – primary PCI more effective in terms of mortality reduction at 30 days in pts over 70 years of age Review: Filali T, Carrie D. Int Coron Adv 2006; 3:3-4.

  31. Myocardial revascularization in the elderly • chronic coronary insufficiency: • the treatment strategy must balance the benefit/risk ratio obtained with medical or surgical solutions • very critical pts contraindicated for surgical revascularization may possibly benefit from rescue angioplasty designed to treat the culprit artery • pts in more favourable condition must receive a complete percutaneous or surgical myocardial revascularization Review: Filali T, Carrie D. Int Coron Adv 2006; 3:3-4.

  32. TIME • 301 patients • 80±4 years old • 42% women • 153 invasive treatment • 148 medical treatment • follow-up 3,1 years Circulation 2004;110:1213-8

  33. TIME • Long-term survival was similar for patientsassigned to invasive and medical treatment. • The benefits ofboth treatments in angina relief and improvement in QoL weremaintained, but nonfatal events occured more frequently inpatients assigned to medical treatment. • Irrespective of whetherpatients were catheterized initially or only after drug therapyfailure, their survival rates were better if they were revascularizedwithin the first year.

  34. Elderly and revascularisation • Older patients do not represent a homogeneous group and age alone should not be a barrier to invasive revascularisation strategies. • Careful evaluation of each patient’s fitness and preference for different management strategies must be considered. • In well selected older adults revascularisation procedures could be rewarding.

  35. Conclusions Based on the results of recent studies, we can conclude that pharmacotherapy in the elderly is necessary, but needs selection of appropriate medications, knowledge of their interactions, adequate dosage and of course more frequent monitoring of the patients. Pharmacological treatment of older patients is at least as effective as it is in younger if all complex clinical specifics for the elderly are considered.

  36. To be seventy years young is sometimes far more cheerful and hopeful than to be forty years old. Oliver Wendell Holmes

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