Download Weighing The Risks and Benefits of Treatment in Older Adults

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

?????? What do you think of when

you think of “Geriatrics”……

Quips…  Benjamen Franklin: 

“All would live long, but none would be old”

 Abraham Lincoln: 

“And in the end, its not the years in your life that count. It’s the life in your years.”

Geriatric “Domains”  Palliative Care  Dementia  Incontinence  Falls  Delirium  Frailty  Constipation

Geriatric “Catch Phrases”  Start low and go slow…  The Dying Patient…. “?Moriatrics…”  Life expectancy…  Quality of Life….  Falls Risk….  Polypharmacy

Geriatric “Realities”  “Graying” of America…  Increasing population of oldest of the old

(number of people over age 80 will increase form 6.9 million in 1990 to 25 million by year 2050)

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…

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

Do we “undertreat” older adults with chronic conditions?  Probably Yes….

Outline  Why we might undertreat older patients  Problems with clinical trials  New perspectives on life expectency  Examples  Importance of Absolute Risk reduction

and determination of baseline risk

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!

Why would we undertreat?  Ageism  Exclusion of older adults from clinical trials  Assumption that the older adult may not want   

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“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

Ageism  Coined 1969 by Dr. Robert Butler (first director of

the National Institute on Aging)  “Systematic stereotying 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

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

Assumption that Older Adult may not want “aggressive” therapy  Literature suggests that we tend to

underestimate “Quality of Life” equivalents for others  Data 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

Ideas Based upon Life Expectency  Average Life Expectancy” can be misleading 

Overall average 77 years in 2002

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But, a 70 year old woman on average can expect to live another 18 years!

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10% of 90 year olds will live to 100

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

Some Examples  Acute Coronary Syndrome  Atrial Fibrillation and anticoagulation  Lipid lowering therapy in older adults

Common Theme  Increasing age 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

Acute Coronary Syndrome

% Eligible AMI patients given ASA in ED (Annals Em Med 2005) 100 90 80 70 60 50 40 30 20 10 0 90

Treatment with Aspirin  Aspirin:  Same relative benefit in older patients 

Overall 20+ % lower death rate in patients who receive ASA after MI

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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

% given Beta Blockers in ED

(Ann Em Med 2005)

80 70 60 50 40 30 20 10 0 90

% Eligible AMI patients given reperfusion (Ann Em Med 2005) 90 80 70 60 50 40 30 20 10 0 90 (n=9)

Who has an Acute MI? Numbers from the ED…  8%  15%  20%  30%  22% 5%

younger than 50 50-59 60-69 70-79 80-89 >90

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 

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6% US population over age 75 60% MI related deaths in people over age 75

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!

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 % people over age 85 have baseline LBBB

Risk Stratification  Age is 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

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

Age and Stroke Risk  Incidence of Stroke with afib increases with

age:

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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

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But it is much more complicated…

  

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 80 Low risk

Intermediate risk

High risk

(25% 3 year mortality)

( 40% mortality)

(60 % 3 year mortality)

13%

6%

4%

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

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%)

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

Relation between baseline risk and NNT by various relative efficacies of treatment (Alter, Am J Med 2004) Age Group

NNT with relative efficacy of 25% 175

NNT with relative efficacy of 50%

74

27

37

15

7

87

What does this all mean?

Take Home Points  Age is only one factor; frailty and age are not

the same  There need to be increased numbers of older

adults included in trials, and these patients should be of similar to older community patients and younger trial patients

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

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 Those at highest risk stand to gain the most – and risk of treatment may be completely outweighed by this potential gain

P.S.  Case Study: Just to complicate matters 

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85 healthy man with distant history of TURP and HTN was admitted 2 weeks prior with a NSTEMI that was uncomplicated; he had early catheterization and a stent to his RCA, was placed on aspirin, clopidogrel He returned a few days later with a nosocomial pneumonia and atrial fibrillation, was started on warfarin. In the CCU, he had a foley catheter placed. He again returned a few days later with E coli UTI and sepsis syndrome He again returned a few days later with gross hematuria He stayed in the hospital for over a month with bleeding, urologic procedures ?Did he need the cath or intervention? The anticoagulation?