2. For older adults…
Discuss the risks & benefits presented by tx options
to improve sleep complaints
Understand the risks & benefits of the various
antibiotic tx options for UTIs
Explore the various tx & scheduling options for
analgesics
Discuss shared-decision making, QoL issues, T2B &
the role of 1° prevention in CV risk reduction
3.
4. Difficulty falling asleep, staying asleep, waking up
too early, or sleep that is non-restorative
Sleep difficulty, lasting ≥ 1 month (for 3 nights/week),
occurs despite adequate opportunity for sleep
Insomnia is clinically relevant if associated with
significant distress or daytime impairment (fatigue,
mood, cognitive, social/work dysfunction, etc…)
5. Manage any underlying cause of insomnia or
associated comorbidities
Address any medication/substance use that may
be worsening sleep
6.
7. Encourage & facilitate as many non-drug measures as
possible
Non-pharmacological methods are essential for long-
term success (~75% of those treated will benefit)
Avoid the assumption that patients expect a sedative
prescription & are unwilling to modify sleep-related
behaviours.
• Sleep hygiene
• Light therapy
• Stimulus control
• Sleep restriction
• Relaxation techniques
• CBT
8.
9.
10.
11. Try to reserve for situations where poor
quality sleep is negatively impacting daytime
functioning
12.
13. Use the lowest effective dose, short-term (ideally ≤
2 weeks)
Re-evaluate chronic sedative use for efficacy &
potential harm
Taper & discontinue gradually if previously used
long-term
14. Trytophan
Might ↓ sleep latency & improve mood in healthy people
with insomnia compared to placebo
insufficient reliable evidence!!
Melatonin
Minimally effective, but reasonable option in terms of safety
1 to 3mg (max 5mg) 2-3 hours before bedtime
Age, neurodegenerative disorders (Alzheimer’s), T2DM, can
↓ melatonin secretions
15.
16. Benefits: improve short-term sleep outcomes
Estimate: ↓ sleep onset latency by 10 to 20 minutes
Estimate: ↑ total sleep time by ~30 minutes
17. Harms – a costly trade-off with the benefits:
Rebound insomnia when stopped abruptly may be a
trigger for chronic use
Development of tolerance, dependence & withdrawal
reactions: continuing long-term may serve only to
prevent withdrawal symptoms as effectiveness is
progressively reduced
~10-30% of chronic benzodiazepine users develop physical
dependence
50% suffer withdrawal symptoms
↑ risk with drugs of shorter duration of action, older patients,
daily long-term use, higher doses, alcoholism, etc.
18. Harms – a costly trade-off with the benefits:
Hangover effects (varies between agents, strongly dependent
on dose & duration of effect)
Other serious adverse effects: fall risk, fractures & memory or
performance impairment. Whether zopiclone or zolpidem is
any safer than benzos is uncertain
If using a benzo for elderly, short to intermediate-acting agents
(e.g. lorazepam, temazepam) are preferred
AVOID those with a very long half-life as well as those that are very short-
acting
19. Recommended starting dose has been ↓ to 3.75 mg
The lowest effective dose for each pt should be used
The prescribed dose should not exceed 5 mg in
elderly pts, in pts with hepatic or renal impairment or
those currently treated with potent CYP3A4
inhibitors. Dose adjustment may be required with
concomitant use with other CNS-depressant drugs.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2
20. Reserve for when other treatments fail or when
insomnia is associated with a co-morbid condition (e.g.
depression, pain) or in patients with a history of
substance abuse
Unknown whether sleep improves in elderly with 1°
insomnia
There is no single antidepressant or class of
antidepressants that is most effective for insomnia in
those with depression
21. Trazodone
Sedative dose lower than those used to treat depression
Lacks anticholinergic effects but is associated with CV
adverse effects (e.g. orthostatic hypotension), next-day
sedation (longer half-life in the elderly), & priapism (rare)
Start low & go slow
e.g. initial dose: 25-50mg
Usual sedative dose: 50-100mg
Lower than antidepressant dose which ranges from 150-600mg in
divided doses
Half-life ~6.4 hrs in younger adults & 11.6 hrs in elderly
22. Mirtazapine
Role in major depression with associated insomnia
Useful alternative or co-prescription for patients with
insomnia induced by other antidepressants (e.g. bupropion, some
SSRIs)
Associated with increased appetite & weight gain
Long half-life may cause daytime sedation caution: driving
Anecdotally: ≤ 15mg may be more sedating than higher doses
because of increased affinity for anticholinergic receptors at
the lower dose
Doxepin SILENOR 3,6mg
New ultra-low dose of old TCA indicated for insomnia
23. Tolerance to sedative effects occurs after day 3 to 4 of
continuous use
Avoid especially if glaucoma, asthma, & urinary
retention
It is unknown if these agents improve sleep quality in
older adults; poor evidence of efficacy & lacking long-
term safety data
24. A number of sleep studies have found that atypical antipsychotics,
as a class, can improve aspects of sleep in normal controls & those
with psychiatric disorders. However, quetiapine’s sleep effects in
older adults, especially with dementia, are relatively unstudied.
The PK alterations due to aging may contribute to ↑ AEs; use lowest
dose
Extended-release agents may not be an optimal choice due to slowed motility
of GIT & altered pharmacokinetic parameters
Many drug interactions are possible
May ↑ levels/effects of: alcohol, anticholinergics, CNS depressants,
methylphenidate, QTc-prolonging agents, quinine.
May ↓ levels/effects of: amphetamines, anti-parkinson’s agents (dopamine
agonist)
AEs include: ↑ risk of stroke, QT-prolongation, diabetes & death
25.
26. Ensure the individual has symptomatic versus
asymptomatic bacteriuria by looking for
symptoms!
31. 1. Allergies
2. Risk for infections with resistant organisms
Recent antibiotics (<3 – 6 months)
Recent hospitalization
Travel outside Canada/US within last 6 months
32. 1. Allergies
2. Risk for infections with resistant organisms
3. Local antibiogram
4. Renal function
Prevalence of CKD
30% age 65 or older living in community
50% amongst nursing home residents.
Of the 1st
& 2nd
line antimicrobial agents for treatment of
UTI, only one agent does not require consideration for
kidney function
Assess renal function to guide drug selection & dosing!
33. 1. Allergies
2. Risk for infections with resistant organisms
3. Local antibiogram
4. Renal function
5. Drug-Drug/Drug-Disease Interactions
34. Clinically significant hyperkalemia
SMX/TMP, trimethoprim alone
watch for high doses
older age
renal insufficiency
combination with other drugs that cause ↑ K+ (e.g. ACEI)
Often occurs within 4 to 5 days of starting therapy
monitor or select an alternative antibiotic when possible
Canadian Pharmacist’s Letter. Sept 2010; Vol 26.
35. Clinically significant serious bleeding
(hospitalization)
WARFARIN interacts with many abx’s used to treat
UTIs:
HIGH—RISK of interaction:
Cipro / levofloxacin, TMP--SMX
LOW—RISK of interaction:
cephalexin, amoxicillin
VERY LOW—RISK of interaction:
nitrofurantoin, trimethoprim, fosfomycin
The American Journal of Medicine (2014), doi:10.1016/j.amjmed.2014.01.044.
36. Remember: any antibiotic can ↑ INR (by reducing GI
flora)
Empiric dosing changes not recommended
Monitor INR on day 3-5, again if needed, and as
needed for any warfarin dose adjustments made
37. 1. Allergies
2. Risk for infections with resistant organisms
3. Local antibiogram
4. Renal function
5. Drug-Drug/Drug-Disease Interactions
6. Adverse effects
7. Comparative costs
8. Duration of therapy
Community-based adults
LTC uncomplicated
LTC complicated
38.
39. If pain is chronic non-cancer, consider both pain &
function!
Elimination of pain is often not realistic, & if pursued,
may come at a cost of functional impairment & adverse
events (e.g. confusion/fall risk)
Pain reduction: ↓ 30-50%
Improved Function
Self Report of Pain: important due to subjective
nature of pain
40. ↓ mobility & functional status
sleep disturbance
may contribute to depression, anxiety, agitation
may interfere with personal relationships
overall lower quality of life / needless suffering
“Pain is inevitable; suffering is optional.” – M. Kathleen Casey
41. Multiple age-related changes to the body can greatly
affect how medications work in the elderly
Expect ↑ drug levels / prolonged drug levels leading to
greater risk of side effects
Decreases in kidney function
Changes in the way the liver metabolises drugs
Body composition changes (e.g. fat stores)
Elderly often require ½ -1/3 of the usual adult dose
42. Analgesic but NOT for inflammation
Useful for musculoskeletal type pain (OA, LBP, etc.)
Well tolerated @ recommended doses
Short- & long-acting formulations available
e.g. Tylenol Arthritis, 2 phase release 1st
layer of caplet provides
quick relief, 2nd
layer slowly provides medicine over time – option for
night/early morning pain
Can be found in combination
e.g. Tylenol #3: acetaminophen & codeine; Caffeine; Cough & cold
Always be mindful of total daily dose from all sources
43. Maximum daily dose ≤ 4g/day. For chronic dosing
consider limiting to ≤3.25g/day.
Monitor: Liver function tests if used long-term OR with
high alcohol consumption
44. Potential for side effects needs to be seriously
considered with benefits vs. risks weighed
Heart – worsen heart failure, ↑ events (heart attacks)
Kidney – acute renal failure
Gastrointestinal – upset stomach, ulcers, bleeds
CNS – e.g. indomethacin (gout) – dizziness, vertigo, confusion
Monitor: new onset of breathing difficulty, swollen
ankles – fluid retention, signs of bleeding
Topicals
45. GI effects: constipation, bowel obstruction, nausea
Bowel regimen is essential (e.g. laxatives)
CNS: sedation, cognitive dysfunction, confusion
Most likely to occur upon starting & with dose changes
↑ risk of falls / fractures
Normal responses to continued exposure of opioids:
Tolerance: results in ↓ of one or more of the drug’s effects over time.
Will likely not develop to constipation; tolerance in a few days to
sedative/cognitive/nauseous effects; tolerance can happen to the pain
relieving effect requiring a dosage ↑
Dependence: (physical) withdrawal effects
START LOW & GO SLOW!!!
46. Addiction to pain medicine in older adults is RARE
(particularly if no history of substance abuse) when that medicine is
used as prescribed for relief of acute or chronic
conditions.
Pain medications can be misused in any population, but
treatment of significant pain is appropriate and not a
misuse.
Be mindful of the fear of addiction, the language you use
to describe opioids & be confident in providing
reassurance to your patients
47.
48.
49.
50. Respect for the pt’s values, preferences, & expressed
needs
Clear, high-quality information & education for the
patient and family
Involves at minimum a clinician & the pt
Both parties share information
Clinician: offers options & describes their risks & benefits
Pt: expresses his/her preferences & values
“What matters to you?” as well as “What is the
matter?”
Barry MJ, Edgman-Levitan S. Shared decision making--pinnacle of patient-centered care. N Engl J Med. 2012 Mar
51. Do something? Do nothing?
Statin everyday for
primary prevention?
Genetic & cancer
screening tests?
52. ↑ pt’s awareness & understanding of treatment options &
possible outcomes
Online, paper, videos
Can efficiently help patients absorb relevant clinical evidence
& aid them in developing & communicating informed
preferences
Result of using these tools (Cochrane review):
↑ knowledge
More accurate risk perceptions
↑ # of decisions consistent with pt’s values
↓ level of internal decisional conflict for pts
Fewer pts remaining passive or undecided
Barry MJ, Edgman-Levitan S. Shared decision making--pinnacle of patient-centered care. N Engl J Med. 2012 Mar
1;366(9):780-1.
56. ↓ polypharmacy
↓ risk of adverse events
↓ risk of drug interactions
↓ pill burden
↓ medication costs
In some circumstances, the only way to know
whether or not to stop a medicine is to actually
stop it & see what happens
Alexander GC, Sayla MA, Holmes HM, Sachs GA. Prioritizing and stopping prescription medicines. CMAJ
2006;174(8):1083-4.
57. Medicines can be grouped as:
1. Those that keep the pt well and improve day-to-
day QOL
2. Those that are used for the prevention of illness
in the future
A practical guide to stopping medicines in older people. Best Practice Journal 2012;27
58. Factors to consider when deciding if a
medicine can be stopped include:
The wishes of the pt
Clinical indication & benefit
Priority of medications to be discontinued
Appropriateness
Duration of use
Adherence
The prescribing cascade
59.
60. 82 year old female
Type II Diabetes (diagnosed 3 years ago)
Glycemic targets
A1c 6.5%?
A1c 7.0%?
A1c 8.5%?
62. UKPDS-34 (metformin vs standard tx in obese
T2DM)
↓ all-cause mortality NNT=14/10.7 years
↓ stroke NNT=48/10.7 years
A1C achieved was 7.4% vs 8%
~10 years
ADVANCE (mostly gliclazide ± metformin)
↓ microvascular events NNT=67/5 years
A1C: 6.5 vs7.3
~5 years
65. When individualizing targets, consider:
Limited life expectancy
Functional dependency
Extensive CAD at high-risk of CV events
Multiple co-morbidities
History of recurrent, severe hypoglycemia
Hypoglycemia unawareness
Available support & resources
66.
67. What to do when it comes to statins
& older adults??
This is an area of some controversy….
RCT studies only include up to age ≤82
Risk vs benefit of lowering cholesterol in the very old is
not well established. Is lower always better?
Risk of myopathy with: ↑ age & ↓ renal function
If treating, does the pt tolerate the statin well enough to
maintain an active lifestyle (relative to previous degree of
activity tolerated)?
some patients may "stop walking" if too much myalgia
68. Cardiovascular Disease
Older adults have ↑ risk of CV disease. However,
epidemiological studies suggest that the relative risk
for CHD associated with high cholesterol ↓ with age.
In old age, there is an inverse relationship between
high cholesterol & the risk of stroke & there are
conflicting data on the relationship between high
cholesterol & non-CV mortality.
Kronmal RA, Cain KC, Ye Z, Omenn GS. Total serum cholesterol levels and mortality risk as a function of age. A report based
on the Framingham data. Arch Intern Med 1993;153:1065-73.
Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, et al. Blood cholesterol and vascular mortality by age,
sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet
2007;370:1829-39.
69. Shorter life expectancy than younger adults
Chronological age often given greater weight than
physiological age
Substantial variation in physiological age between
individuals attributable to frailty, comorbid
disease, & cognitive decline
Risk factors for ASCVD do not predict outcomes as
well as they do for younger individuals
70. Competing causes of mortality mask the potential
benefits of some therapies
Frailty may exacerbate adverse effects of therapy
Polypharmacy may result in ↑ DIs & ↑ pill burden
Musculoskeletal function, pain, & cognition AEs of
therapies (not restricted to statins) are more severe
in older individuals because these factors predispose
to reduced physical activity, sarcopenia, & falls.
71. Are there other risk factors?
Smoking
Hypertension
Diabetes
Shared-informed decision-making
Risks versus benefits
72.
73. 1° Prevention
Statins lower risk of CV events in moderate to high risk
pts without a prior CV event
Absolute benefits are modest relative to 2° prevention
Mortality: NNT = NS over ~5yrs
CV Events: NNT = 91 over ~3.3yrs ASCOT
Those with lower CV risk have less absolute benefit
from a statin which must be weighed against the
uncertainties regarding potential benefits versus
harms over longer durations
Statins have not been well studied in very elderly patients (>age 82)
Consider ↑ potential for AEs, patient values, etc.
Discuss the risks & benefits presented by treatment options to improve sleep complaints in older adults
Understand the risks & benefits of the various antibiotic treatment options for UTIs in older adults
Explore the various treatment & scheduling options for analgesics in older adults
Discuss shared-decision making, quality of life issues, time-to-benefit & the role of primary prevention in cardiovascular risk reduction
How do you define “daytime impairment” in a LTC resident??
What it might look like for you or me – but with older adults perhaps it’s not participating in daytime activities (especially in LTC). Not doing the normal tasks they would normally in a day.
AVOID those with a very long half-life (flurazepam, diazepam & chlordiazepoxide) as well as those that are very short-acting (triazolam & alprazolam).
November 2014
The recommended starting dose has been reduced to 3.75 mg (one-half of the 7.5 mg tablet). IMOVANE should be taken once per night at bedtime. The lowest effective dose for each patient should be used.
The prescribed dose should not exceed 5 mg in elderly patients, in patients with hepatic or renal impairment or those currently treated with potent CYP3A4 inhibitors. Dose adjustment may be required with concomitant use with other CNS-depressant drugs.
Patients should be instructed to wait for at least 12 hours after dosing before driving or engaging in other activities requiring full mental alertness, especially for elderly patients and for patients who take the 7.5 mg dose.
10mg on formulary
3mg & 6mg $$$
Because if they are asymptomatic you are not going to treat!!!
• If on prophylactic antibiotics to prevent a UTI
– Not working!
– Stop and give a different antibiotic to treat
• If on prophylactic antibiotics to prevent a UTI
– Not working!
– Stop and give a different antibiotic to treat
• If on prophylactic antibiotics to prevent a UTI
– Not working!
– Stop and give a different antibiotic to treat
• If on prophylactic antibiotics to prevent a UTI
– Not working!
– Stop and give a different antibiotic to treat
How long to treat – community versus LTC residents 3 to 5 days or 7 to 10 days or 10 to 14 days??
Pain is commonly undertreated in individuals with communication challenges – stroke, dementia
Have to be cautious not to over-treat as well!
Start low, go slow and monitor for….
Crossroads of medical options – great place to apply shared decision making
Tools to support this process include decision aids
Might have to taper!!!
Medicines can be grouped as:
Those that keep the patient well and improve day-to-day quality of life e.g. analgesics, thyroxine or anti-anginals. In some cases, if these medicines are stopped, the patient may become ill or unable to function. However, some drugs may be able to be stepped down, stopped or used on an as required basis (prn) e.g. a protein pump inhibitor (PPI).
2. Those that are used for the prevention of illness in the future e.g. statins, aspirin, warfarin or bisphosphonates. A decision about whether to stop medicines such as these should include consideration of the risks and benefits of treatment for that particular patient, the length of time required for benefit and the life expectancy of the patient.
Go for the low hanging fruit – docusate!!!!
Intertwined concepts
Shift from quality of life to quantity of life
It is useful to consider how long an individual likely has to live when considering a therapy
Consider situations where benefit is only realized after several years of treatment
If the T2B is equal to, or longer than the life expectancy, the drug is unlikely to benefit the individual
But the question is, how long does it take to achieve these outcomes? What is the time-to-benefit of treatment?
What BIG outcomes are we trying to achieve by treating someone with diabetes?
Ultimately, why do we strive so hard to control someone’s sugar levels?
MACROvascular & MICROvascular outcomes
ADVANCE age 66; 5yrs
Intensive A1C lowering in trials offers modest benefit, mostly microvascular over 5+ yrs. There is some evidence for macrovascular benefit over the long-term (&gt;10-20yrs) UKPDS-80
Note that there are NO studies specifically assessing the risks and benefits of tight glycemic control in patients &gt;/= 75 or frail elderly patients. All data is extrapolated from trials in younger patients (mean age in the 60s, such as ACCORD, ADVANCE, and VADT)
Risk of severe hypoglycemia increased 2-3-fold with tighter glycemic control
Hypoglycemia has been associated with increased morbidity and mortality in diabetes -&gt; increased risk of falls, cognitive decline, autonomic dysregulation, cardiac effects
Studies with A1cs as high as 7.9-8.4% have shown marginal clinical outcome differences over the short-term but a much lower risk of hypoglycemia.
Thus, prevention of hypoglycemia becomes the primary goal of treatment in the frail elderly, followed by minimizing symptomatic hyperglycemia.
In the frail elderly, A1cs &lt; 7% should be considered a flag for possible overtreatment, and consideration given to stopping or reducing doses of meds (starting with those that predispose to hypoglycemia).
Data from the ACCORD, ADVANCE, and VADT studies (which all compared intensive vs conventional targets to reduce micro and macro-vascular complications from T2DM) suggest that the frequency of adverse events from intensive therapy (such as CV events, hypoglycemic episodes, and mortality) were increased in older T2DM patients with a longer duration of diabetes, established CV risk factors, severe hypoglycemic episodes, and/or without A1c reduction despite therapy intensification. (CDA 2013)
This is an area of some controversy. Here are a few things you may want to consider when assessing risk versus benefit:
RCT studies only include up to age 82
The risk vs benefit of lowering cholesterol in the very old is not well established. And here is where the conflicting data starts to present itself. You can one study in men aged 71-93 found that mortality rates may actually increase with lower cholesterol levels.[ii] Another study of those aged 85 and older found that those with a higher total cholesterol level had a lower rate of all-cause mortality.[iii] So, is lower always better? And perhaps LDL may be a better predictor.
Risk of myopathy increases with age & renal function.
if treating, does the patient tolerate the statin well enough to maintain an active lifestyle (relative to previous degree of activity tolerated); some patients may &quot;stop walking&quot; if too much myalgia.
Older people have an increased risk of cardiovascular disease. However, epidemiological studies suggest that the relative risk for coronary heart disease associated with high cholesterol decreases with age.
In addition, in old age, there is an inverse relationship between high cholesterol and the risk of stroke and there are conflicting data on the relationship between high cholesterol and non-cardiovascular mortality.
How does the individual feel on this medication?
Patients up to 79, can include PROSPER (up to 82)
Subgroup analyses, statistically significant decrease in the primary end points (with the exception of PROSPER), but not in all cause mortality.
PROSPER
Pravastatin 40mg x 3.2 years
Pts age 70-82 were included in secondary subgroup analysis
Significantly risk of the composite end point of coronary death, MI, or stroke HR 0.78 (0.66 – 0.93)
BUT all-cause mortality was only reported for the overall trial (2° & 1°combined) NOT significantly reduced
Note: this is the only study that included significant # of pts that did not have pre-existing vascular disease or diabetes.
Caveat…
Does not apply to patients meeting the diagnostic criteria for familial hypercholesterolemia (which includes LDL level, physical findings & family/personal history of CVD)
The role of statins in 1° prevention of CV disease in older people is unclear.
Their effects seem to over 2-5 years, with only minimal benefits over placebo seen in the first year.
It is therefore important to consider the patient’s probable lifespan when deciding whether to start or continue a statin.
Study of patients &gt; 65 without pre-existing vascular disease or diabetes has been limited
No studies have produced a significant difference in all cause mortality