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MEDS 2017 - diabetes

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Jessica Otte

on 11 February 2017

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Transcript of MEDS 2017 - diabetes

Canadian Task Force on Preventative Health Care (CTFPHC): Screening for Type 2 Diabetes:
Risk Calculators:

Canadian Diabetes Association (CDA): Clinical Practice Guidelines: Diabetes in the Elderly:
Palliative and Therapeutic Harmonization (PATH): Diabetes Guidelines for Elderly Residents in Long Term Care (LTC) Facilities and the Frail Elderly:

Unnecessary tests and treatments, Choosing Wisely:
Mayo Clinic Diabetes Medication Choice Decision Aid:
CADTH Diabetes Tools & Resources:

Treating Cardiovascular Risk:
Absolute CVD Risk/Benefit Calculator:
Towards Optimized Practice (TOP) Alberta Cardiovascular Prevention Guideline

De-prescribing Tools:
Antihyperglycemic Deprescribing Algorithm
The Goldilocks Approach
Management of Type 2 Diabetes in the Elderly
Dr Jessica Otte:
No conflicts of interest

The Slides:

The Handout:

Review the evidence and guidelines around testing and treatment of Type 2 Diabetes in the Elderly

Explore potential goals of therapy, considering harms of under- and over- treatment

Develop a patient-centered approach, including prescribing/de-prescribing medications and ordering/stopping tests in the context of diabetes
Cross-sectional study, VA patients receiving insulin and/or sulfonylureas and with an HbA1c test in 2009: 650k patients total:

Old Patients
patients who were 75+ with serum creatinine value greater than 2.0 mg/dL (177 µmol/L) or Dx cognitive impairment or dementia = 205 857 patients (31.5%):
50.0% had an HbA1c less than 7.0%
Complex Patients
The study also assessed the rates in patients with other significant medical, neurologic, or mental comorbid illness; with them included, 430 178 patients (65.9%) were identified as high risk for adverse outcomes:
44.3% of patients for HbA1c less than 7.0%

EVEN WORSE IN the Elderly
Andreotti F, Rocca B, Husted S, Ajjan RA, ten Berg J, Cattaneo M, Storey RF. Antithrombotic therapy in the elderly: Expert position paper of the european society of cardiology working group on thrombosis. European Heart Journal, 2015; ehv304. (adapted from Rocca B, Patrono C. Determinants of the interindividual variability in response to antiplatelet drugs. J Thromb Haemost 2005;3:1597–1602)
"Hypoglycemia in the elderly person with diabetes can be a serious and underestimated clinical problem that has significant morbidity and mortality."

Malnutrition common

Fewer symptoms, decreased awareness of hypoglycemia

Can be more severe and prolonged
McAulay V, Frier BM. Hypoglycemia. In: Sinclair AJ, Finucane P, ed. Diabetes in Old Age. 2nd ed. John Wiley & Sons Ltd; 2001:133-152.
Older AdultS
BC Clinical Guidelines aka Guidelines and Protocols Advisory Committee (GPAC) guidelines (2015)
little incorporation of elderly focus
mostly relies on CDA guidelines

Canadian Diabetes Association (CDA): Clinical Practice Guidelines: Diabetes in the Elderly (2013)
potential conflict of interest: industry sponsored
mostly expert consensus, not consistent with the evidence

Palliative and Therapeutic Harmonization (PATH): Diabetes Guidelines for Elderly Residents in Long Term Care (LTC) Facilities and the Frail Elderly (2013)
focus narrow: frail and institutionalized patients only

Canadian Task Force on Preventative Health Care (CTFPHC)
only looks at screening
no incorporation of elderly focus
Depends who it's for!
Functionally independent
Functionally dependent
[Dementia / Frailty]
What's the recipe?
Selph S, Dana T, Blazina I, Bougatsos C, et al. Screening for Type 2 Diabetes Mellitus: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015;162(11):765-776.
The goal of treatment of diabetes is to reduce microvascular morbidity (retinopathy, nephropathy and neuropathy) and macrovascular (cardiovascular) morbidity and mortality. . .

- Therapeutics Initiative
risks we are trying to reduce?
Can we actually reduce them?

Time horizon for benefit: How many years of intense glycemic control before patient reaps benefit of

Decreased microvascualar events?

Avoiding ESRD or blindness?

Does it
make sense to treat?
Impact of Intensive Therapy
- 4075 patients
- newly diagnosed
- mostly Caucasian men
- absence of significant comorbidities
- Avg age: 53/59
- >65 years excluded
United Kingdom Prospective Diabetes Study Group (UKPDS). Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes. Lancet. 1998;352:837-53.

The Advance Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-2572.

Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in Veterans with type 2 diabetes. N Engl J Med. 2009;360:129-39

The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-2559.

with notes from Andrews MA, O’Malley PG. Diabetes Overtreatment in Elderly Individuals: Risky Business in Need of Better Management. JAMA. 2014;311(22):2326-2327.
- 1791 US veterans
- 40% also had CAD
- Avg age: 60
Hypoglycemic Events
- 10251 people
- increased risk or had CV disease
- all pts got lipid & BP lowering Rx
- Avg age: 62
- >79 years excluded
- 11140 people
- Avg age: 66
Vijan S, Sussman JB, Yudkin JS, Hayward RA. Effect of Patients’ Risks and Preferences on Health Gains With Plasma Glucose Level Lowering in Type 2 Diabetes Mellitus. JAMA Intern Med. 2014;174(8):1227-1234.
Patients' values regarding HbA1c level:

Crucial for effective management
Most patients > 50 with an HbA1c under 9%:
further lowering: little gain in quality or quantity of life

Did generate unintended harms, eg. hypoglycemia
Increased the burden of treatment without decreasing the risk of earlier death or substantially impacting morbidity

"Glycemic control efforts
should individualize hemoglobin A1c targets
so that those targets and the actions necessary to achieve them reflect patients' personal and clinical context and their informed values and preferences. "
Montori VM, Fernández-Balsells M. Glycemic Control in Type 2 Diabetes: Time for an Evidence-Based About-Face? Ann Intern Med. 2009;150:803-808
It's personal
Terminated early due to ^mortality
Severely or Very Severely Frail

The goal for elderly residents with diabetes is to avoid the acute complications of poor glycemic control including hypoglycemia and prolonged, severe hyperglycemia
Mostly based on VADT findings
Endorses a wide range of acceptable HbA1c targets
Decisions based on the level of frailty and tolerability of hyperglycemia

It is unnecessary to alter therapy if an individual has tolerated high HbA1c levels (yes even 12%) for many years, has limited life expectancy and no hyperglycemia-associated symptoms
<8.5% or <7.0%
creatinine clearance < 30ml/min, metformin is contraindicated
reported incidence of lactic acidosis in clinical practice is very low (<10 cases per 100,000 patient-years)
some suggest current renal function cutoffs for metformin are too conservative

Metformin & Renal Failure
Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults: a consensus report. J Am Geriatr Soc 2012; 60(12):2342–56

McCoy RG et al. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Intern Med. Published online June 06, 2016.
Feb 11, 2017
33% thought patients could benefit from exceeding treatment guideline goals

25% concerned about potential malpractice suits from reducing treatment

20% worried that patients would be upset if they reduced their medications
U.S. Physicians surveyed:
100,000 emergency hospitalizations for adverse drug events in adults > 65

Of those visits,
1 in 4 is due to glucose-lowering drugs
(almost all of them for hypoglycemia)
Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-2012.

Lipska KJ, Ross JS, Wang Y, et al. National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med. 2014;174(7):1116-1124.
Of patients with stable, controlled DM2, 60% received too many HbA1c tests

q6months, may do q3m if poorly controlled
q6months is as effective as q3m for maintaining blood glucose levels

Capillary Glucose -
main use is to catch hypoglycemia (<4) or severe hypoglycemia (eg >20)
No need to test in diabetic patients with no Rx, or exclusively Rxs that don't cause hypoglycemia

In patients on Rx that can cause hypoglycemia
When first starting a new med that could cause hypoglycemia
While sick or on admission to a new facility
Test twice daily at alternate times, for about 1-2 weeks
STOP once stable and:
If feeling "unwell" - test right away

On regular/rapid insulin (meal time insulin), test once daily alternate times
McCoy Rozalina G, Van Houten Holly K, Ross Joseph S, Montori Victor M, Shah Nilay D. HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study. BMJ 2015; 351 :h6138

CADTH: Diabetes Evidence Bundle, Available at:
McCoy RG et al. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Intern Med. Published online June 06, 2016.

McCoy RG, Van Houten HK, Ziegenfuss JY, et al. Increased mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care 2012; 35: 1897–1901

Chopra S, Kewal A. Does hypoglycemia cause cardiovascular events? Indian Journal of Endocrinology and Metabolism. 2012;16(1):102-104.
Kalra S, Mukherjee JJ, Venkataraman S, et al. Hypoglycemia: The neglected complication. Indian Journal of Endocrinology and Metabolism. 2013;17(5):819-834.
Patients who experience hypoglycemia in hospital stayed
11.9 days on average, vs. 4.8 days
in those who did not

Their stays
cost 40% [£ 2235 GBP = $3655 CAD] more
They were more likely to
in hospital
McEwan P, Larsen Thorsted B, Wolden M, Jacobsen J, Evans M. Healthcare resource implications of hypoglycemia-related hospital admissions and inpatient hypoglycemia: retrospective record-linked cohort studies in England. BMJ Open Diabetes Research & Care. 2015;3(1):e000057.
Annual costs of hypoglycemia for older adults attaining very tight glycemic control with the use of insulin or sulfonylureas:

U.S. $509,214,473 in the U.S.
in Canada
Boulin M, Diaby V, Tannenbaum C. Preventing Unnecessary Costs of Drug-Induced Hypoglycemia in Older Adults with Type 2 Diabetes in the United States and Canada. Bjornstad P, ed. PLoS ONE. 2016;11(9):e0162951
20% too much:
Among patients with high clinical complexity,
intensive treatment nearly doubles the risk of
severe hypoglycemia

Self-report of severe hypoglycemia is associated with
3.4-fold increased risk of death.

Growing evidence:

hypoglycemia can provoke adverse cardiovascular outcomes
(MI, arrhythmia)
1 in 5

of All Type 2 Diabetics
BurdEn of
being a patient
Intense Treatment, Hypoglycemia, & Death
ARE Associated
"We spend so much time telling people that it's important to take their medications, it's tough to now say 'you're being overtreated.' But, people's needs change with age."
- Sussman
Sussman JB, et al. Rates of deintensification of blood pressure and glycemic medication treatment based on levels of control and life expectancy in older patients with diabetes mellitus. JAMA Internal Medicine 2015: 175(12), 1942-1949.
Maney M, Tseng C, Soroka O, Aron DC, Pogach LM. Assessing Potential Glycemic Overtreatment in Persons at Hypoglycemic Risk. JAMA Internal Medicine. 2014;174:259-268

Lipska KJ, Ross JS, Miao Y, Shah ND, Lee SJ, Steinman MA. Potential Overtreatment of Diabetes Mellitus in Older Adults With Tight Glycemic Control. JAMA internal medicine. 2015;175(3):356-362.
and what their goals & preferences are
Dr Jessica Otte, CCFP


. . . but, the evidence of our treatment doing either or both is not as robust as we may have been lead to believe.
Does it make sense?
~ 9 yrs

DeFronzo R, Fleming GA, Chen K, Bicsak TA. Metformin-associated lactic acidosis: current perspectives on causes and risk. Metabolism. 2016;65:20–29.

Microvascular benefits
surrogate outcomes, limited relevance in elderly:
Decreased photocoagulation, but no difference in vision
Less albuminuria, but no difference in creatinine
Less neuropathy, based on various signs and self-reported erectile dysfunction (but not other symptoms)
(0.) Print out the algorithm
http://deprescribing.org/resources/deprescribing-algorithms/ *
1. Next week, pick 5 patients in your practice >70 yrs who are diabetic
2. Look at their most recent HbA1c
3. Have a conversation with 2 of those patients, who might be overtreated
4. Stop one medication
5. Tell a colleague
(Open Book Test)
Unique ISSUES in the EldeRly
Schwartz AV, Vittinghoff E, Sellmeyer DE, et al. Diabetes-related complications, glycemic control, and falls in older adults. Diabetes Care 2008; 31:391.
^ with having & treating diabetes
—  more drugs mean more adverse events
- most elders are on pensions, may not be able to afford 'fancy' medications
Admin -
difficulty with mobility and vision can make it hard to take meds

Urinary Incontinence & Infections -
more common

Falls —  multifactorial
presence of peripheral and/or autonomic neuropathy
severe hyperglycemia --> polyuria and nocturia; trips to bathroom at night
reduced renal function
muscle weakness, functional disability
loss of vision
comorbidities like osteoarthritis
seizures, death, cardiovascular events
Dehydration – sustained hyperglycemia can lead to dehydration, death, coma
Feel Well
Stay at home
Keep it simple
blurred vision
peeing often
Since we aren't even sure if lowering glucose/HbA1c helps diabetics . . .
"The assumption that treatment of hyperglycemia can prevent all diabetes complications, including CVD, has been an “act of faith” in the diabetological community for many decades"

". . . glucose-lowering therapies, under certain circumstances, might even be detrimental. When all available evidence to date is considered, which includes a fair number of large-scale clinical trials, the improvement of glycemic control appears to be associated with a reduction in the incidence of major cardiovascular events, whereas hypoglycemia could increase cardiovascular mortality. The pursuit of accurate glycemic control, avoiding both hyper- and hypoglycemia, should be recommended for preventing CVD in diabetes, and thus an individualized approach for achievement of target HbA1c in type 2 diabetic patients should be adopted. At the same time, it should also be clearly recognized that the control of other risk factors (such as hypertension and hypercholesterolemia) is more effective than glucose-lowering therapy in reducing the incidence of cardiovascular events."
start low, go slow
INSULIN: NPH or glargine, no mixes!
Joint pain, ?CHF
SGLT2s: $$$$$, ugh side effects
might help CV outcomes?
- Wait for more evidence!
CHF, edema
TID, GI side effects
TID dosing (consider in CRF)
METFORMIN: yes, start low
1 in 2

of Elderly, Complex Diabetics
$185/month, rarely covered
NNH: 25 - stop for GI SEs
Mannucci E, Dicembrini I, Lauria A, Pozzilli P. Is Glucose Control Important for Prevention of Cardiovascular Disease in Diabetes? Diabetes Care Aug 2013, 36 (Supplement 2) S259-S263;
~ 24 yrs
if age >75
Don't test if low-mod risk (CANRISK tool)
Do HbA1c q3-5y if high risk, for adults >40
probably stop at age 70 (USPSTF)

Emerging data that treating screen-detected diabetes doesn't improve macrovascular events

Do test (HbA1c) if symptomatic
This is not screening
6.9% vs 8.4%
In the Veterans Affairs Diabetes Trial (VADT):
A recent severe hypoglycemic event was an important predictor for CV death (HR
; 95% CI 1.34–10.4; P < 0.01) and

all-cause mortality


; 95% CI 2.57–15.8; P = 0.0001) *

*as reported by Dr. William Duckworth and colleagues at the American Diabetes Association Scientific Sessions in 2009 in New Orleans, Louisiana
Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD, VADT Investigators. N Engl J Med. 2009 Jan 8; 360(2):129-39.
Don't kill with kindness! Good intentions can lead to bad outcomes
Hypoglycemia is very dangerous: avoiding it should be prioritized over tight control (which doesn’t help patients anyway)

Diabetes in the elderly is metabolically distinct; older patients are more prone to hypoglycemia

Treatment targets vary by individual; in most, aim for <7.5-8.5% and control of hyperglycemic symptoms; A1c can be higher for more frail patients
Use metformin if possible, next sulfonylureas (but probably not glyburide), or long-acting insulins, mainly to prevent symptoms

CBG should be mostly used to check for hypoglycemia when patient unwell

HBA1c should be done at most 2x/year, unless poorly controlled; deprescribe if trending below target

EMPA-REG: Empagliflozin

Only 1 study, funded by industry, but decently done
Doesn't actually meet FDA's minimum standard of 2 trials
1.6% absolute risk reduction (of composite endpoint: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke = "3pt MACE - Major Adverse Cardiac Events") over 3 years
vs 5% absolute increase in genital infections (candida, UTI, etc.)

James McCormack:
"There are two other trials looking at the same question; I would reserve judgement . . . "

"talk more about Jardiance"
Zinman, B, Wanner, C, Lachin, JM et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015
avg glucose (mmol/L)
Full transcript