Weighing The Risks and Benefits of Treatment in Older Adults

1. Weighing The Risks and Benefits of Treatment in Older Adults Do Our Scales Need Recalibration? Debra L. Bynum, MD Division of Geriatric Medicine University of North Carolina

2. ?????? • What do you think of when you think of “Geriatrics”?

3. Quotes • Benjamin Franklin: • “All would live long, but none would be old.” • Abraham Lincoln: • “And in the end, it’s not the years in your life that count. It’s the life in your years.”

4. Geriatric “Domains” • Palliative Care • Dementia • Incontinence • Falls • Delirium • Frailty • Constipation

5. Geriatric “Catch Phrases” • Start Low and Go Slow… • The Dying Patient “?Moriatrics” • Life Expectancy • Quality of Life • Falls Risk • Polypharmacy

6. Geriatric “Realities” • “Graying” of America • Increasing population of oldest of the old (number of people over age 80 will increase from 6.9 million in 1990 to 25 million by 2050).

7. Geriatric “Realities” • With an increase in older adults comes an increase in chronic diseases. • Many older adults are not “dying” but are living healthy, active lives with several chronic diseases.

8. New Geriatric Domains • Myocardial Infarction • Congestive Heart Failure • Atrial Fibrillation • Stroke • Hypertension • Hyperlipidemia • Osteoporosis • Aortic Stenosis

9. Do We “Undertreat” Older Adults with Chronic Conditions? • Probably Yes….

10. Outline • Why we might undertreat older patients • Problems with clinical trials • New perspectives on life expectancy • Examples • Importance of Absolute Risk reduction and determination of baseline risk

11. Objectives • Appreciate the need to individualize care of older patients with complex medical problems • Understand the importance of Baseline Risk in determining the overall impact, or absolute risk reduction, that any certain therapy may have– patients at highest risk for a bad outcome stand to gain the most from a treatment that has even modest benefit!

12. Why would we undertreat? • Ageism • Exclusion of older adults from clinical trials • Assumption that the older adult may not want “aggressive” treatment • Ideas based upon Life Expectancy • Concern for Polypharmacy • Concern that relative efficacies may be less for certain treatments in older subgroups • Overestimation of Risks of Treatment and underestimation of Benefits of Treatment

13. Ageism • Coined 1969 by Dr. Robert Butler (first director of the National Institute on Aging) • “Systematic stereotyping of and discrimination against people because they are old” • Fostered in clinical training • Students and residents see older adults from nursing homes and in the hospital • The Aging Game • The “Unwritten Curriculum” • Age is NOT EQUAL to frailty.

14. Exclusion of Older Adults from Clinical Trials • 1/3 of all major, original research papers in 1997 and 15% in 2004 excluded older people without justification • Potential concerns: • More comorbid illnesses, more difficulty to follow, higher drop out • Increased risks with treatment • Polypharmacy • Protocol restrictions on comorbidities • Older population as “vulnerable” study group • Barriers with transportation and mobility

15. Assumption that Older Adult May Not Want “Aggressive” Therapy • The literature suggests that we tend to underestimate “Quality of Life” equivalents for others. • There is data showing that physicians tend to assume that older adults do not want certain treatments, including ICU care, even though older patients, when asked, actually do want such care.

16. Ideas Based upon Life Expectancy • “Average Life Expectancy” can be misleading • Overall average 77 years in 2002 • But, a 70-year-old woman on average can expect to live another 18 years! • 10% of 90 year olds will live to 100

17. Polypharmacy • Legitimate concern • Medications seem to exponentially increase with each additional diagnosis! • Balance standard of care • Risk for Adverse Drug Event directly related to number of medications • Need to actively discontinue any unnecessary medications

18. Some Examples • Acute Coronary Syndrome • Atrial fibrillation and anticoagulation • Lipid lowering therapy in older adults

19. Common Theme • Increasing age is associated with increased bad outcome (stroke with afib, death/recurrent MI with acute coronary syndrome, cardiovascular event with hyperlipidemia). • With increase in age, there is a decrease in the number of eligible patients who receive the standard of care treatment.

20. Acute Coronary Syndrome

21. % Eligible AMI patients given ASA in ED(Annals Emergency Medicine 2005)

22. Treatment with Aspirin • Aspirin: • Same relative benefit in older patients • Overall 20+ % lower death rate in patients who receive ASA after MI • GREATER absolute benefit in older patients because of higher ABSOLUTE risk of bad outcomes • ARR of death 4.5 % in > 65 vs 3.3 % in those younger than 65

23. % Given Beta Blockers in ED(Annals Emergency Medicine 2005)

24. % Eligible AMI patients given reperfusion(Annals Emergency Medicine 2005)

25. Who has an Acute MI? Numbers from the ED… • 8% younger than 50 • 15% 50–59 • 20% 60–69 • 30% 70–79 • 22% 80–89 • 5 % >90

26. Ischemic Heart Disease in the Elderly • Leading cause of death • 35% of all deaths in people over age 65 • Among people who die of IHD, 83% are over age 65 • CV mortality and morbidity rates increase exponentially after age 75 • 6% US population over age 75 • 60% MI related deaths in people over age 75

27. Pitfalls… Trial Patients are Different • Skewed Numbers in trials: • Patients over 85 = 2% of trial patients with ACS but for 11% of ACS events in community registries • Older patients in trials are different than community elders who have Acute Coronary Events • Older trial patients have lower traditional CV risk factors, less comorbidity, better hemodynamics, and better renal function than community elders with ACS AND than younger trial patients!

28. Pitfalls… Delay in Diagnosis • Increased prevalence of Atypical symptoms • Dyspnea, syncope, n/v • Increased prevalence of acute heart failure • Increased prevalence of nondiagnostic EKG • 34% of people over age 85 have baseline LBBB

29. Risk Stratification • Age is a huge risk factor for bad outcomes (even when controlled for). • ACC/AHA guidelines: patients over age 75 are at high risk for death/recurrent MI. • Patients < 65 with NSTE ACS have 1% hospital mortality. • Patients > 85 have 10% hospital mortality with NSTE ACS. • Complications of recurrent MI, CHF, bleeding increase with age.

30. Atrial Fibrillation and Anticoagulation • Prevalence: 5% of people over age 65 • 10% of people over age 80 • 50% of all patients with afib are over age 80 • Dreaded outcome: Stroke • Strokes with afib have higher mortality/disability

31. Age and Stroke Risk • Incidence of stroke with afib increases with age: • 1.3 %/year in patients 50–59 • 2.2 %/year in 60–69 • 4.2 %/year in 70–79 • 5.1 %/year in 80–89 • But it is much more complicated…

32. Predicting Risk of Stroke • CHADS2 • CHF: 1 point • HTN: 1 point • Age over 75: 1 point • DM: 1 point • Prior Stroke/TIA: 2 point • Score 0 = annual stroke risk <1% (ASA alone) • 2 or more: annual stroke risk over 4%: warfarin • Score 1= individualized treatment decision • Score 5 = over 10%/year stroke rate • Score 6 = over 15%/year stroke rate

33. Benefit of Warfarin • Overall decreases risk of stroke by 60–70%, ARR of 2.7–3 %/year • Beneficial in all age groups, even those over age 75 • ?Quality of life of preventing a stroke

34. Risks of Warfarin • Risk of warfarin associated bleeding increases with age • Risk ICH: .34 %/year in age less than 60, .76% /year in those over 80 • Absolute risk of major bleeding = 2.2% /year (increases to near 3% in those on warfarin plus asa)

35. Warfarin Use • Older patients less likely to receive anticoagulation • Older patients more likely to be “underanticoagulated” -- even though data is clear that there is no significant stroke protection at an INR of less than 2. • Overestimation of “Falls Risk”

36. Warfarin in Older Patients: Bigger Bang for the Buck… • Patients under age 65 with afib and risk factors for stroke: warfarin decreases risk of stroke from 4.9 %/year to 1.7 %/year • In patients over 75 with risk factors (highest risk group), warfarin reduces risk of stroke from 12 %/year to 2–4 % /year. • Those at highest risk for stroke (older, prior stroke, chf, dm, htn) are less likely to be given warfarin because of concerns for their “comorbidities.”

37. Lipid Lowering Therapy in Older Adults

38. Lipid Lowering Therapy in High Risk Elderly Patients(JAMA 2004) • Retrospective cohort study • Databases of over 1 million elderly in Ontario, study looked at nearly 400,000 over age 66 with history of CV disease or DM (SECONDARY PREVENTION) • Outcome: likelihood of statin use for each CV risk group

39. Results • Only 19% prescribed statins • Likelihood of statin prescription was 6.4% lower for each year of increased age AND each 1% increase in predicted 3-year mortality risk.

40. Likelihood of Statin Prescription:Ages 66 – 74

41. Likelihood of Statin Rx:Ages 75 – 80

42. Likelihood of Statin Rx:Age > 80

43. Treatment-Risk Paradox • Those at the highest risk of certain outcome (CV mortality) are often those NOT treated because of fear of risk of treatment. • Highest risk population may see the greatest ABSOLUTE benefit in reduction of events given the high baseline risk.

44. Importance of Absolute Risk Reduction and Number Needed to Treat (NNT) • NNT to prevent one patient from having event • Clinically more meaningful than relative risk • 1/ absolute risk reduction (example: 10% ARR = 1/.10 = NNT of 10) • RRR of 50% may be good or not so good, depending on the number at risk • Decrease events from 2% to 1% (ARR of 1%) • Decrease from 30% to 15% (ARR of 15%)

45. Risk Reduction • In high risk populations, the BASELINE RISK has MORE impact than relative efficacy of a treatment on determining the absolute risk reduction and NNT.

46. Relation between Baseline Risk and NNT by Various Relative Efficacies of Treatment(Alter, American Journal Medicine 2004)

47. What Does this All Mean?

48. Take Home Points • Age is only one factor; frailty and age are not the same thing. • There need to be increased numbers of older adults included in trials, and these patients should be similar to older community patients and younger trial patients.

49. Take Home Points • Care of complicated older patients with multiple chronic comorbidities must be individualized and cannot be totally driven by standard guidelines. • But guidelines and standards of care should not be ignored in patients just because they are older.

50. Take Home Points… • Weighing Risks and Benefits in treatment of an individual older patient requires: • Knowing risks and benefits of a therapy (not overestimating risk or underestimating benefit) • Looking at the ARR and NNT • Understanding the impact that Baseline Risk has upon absolute risk reduction • Knowing that those at highest risk stand to gain the most – and risk of treatment may be completely outweighed by this potential gain.