fallquality summit diabetes in the elderly...challenges of diabetes care in the elderly goal setting...
TRANSCRIPT
Fall Quality Summit
diabetes in the elderly
Michael Shannon, MD
Endocrinologist and PSW Medical Director
- Fall Quality Summit Agenda -
Welcome!
6:00 – 6:30 Networking & Appetizers
6:30 – 6:40 Dr. Gary Goin, MD
• Introductions
6:40 – 7:30 Michael Shannon, MD
• Rational Goal-Setting and
Management of Diabetes in Elderly
Dr. Michael Shannon
Michael H. Shannon, MD, is an
endocrinologist and Medical Director with
Physicians of Southwest Washington, an
Independent Practice Association managing
Medicare Advantage and ACO contracts, in
Olympia, Washington.
He is a Clinical Assistant Professor in the
Department of Medicine at the University of
Washington.
He serves on the Editorial Board of Clinical
Diabetes, and he is the Chair of the
Professional Education Committee for the
Washington chapter of the American
Diabetes Association.
Rational Goal-Setting and Management
of Diabetes in the Elderly
Michael Shannon, MD
Medical Director, Physicians of Southwest Washington
Clinical Assistant Professor, University of Washington
Outline of Talk
Challenges of diabetes care in the elderly Goal setting and A1c targets in elderly Interpret studies for diabetes agents
cardiovascular safety, released in last 48 months Current guidelines (ADA-EASD, AACE) and
review of treatment options for elderly
Disclosure: Speaker and Consultant, Novo Nordisk
and BI/Lilly Alliance
Epidemiology of Diabetes in Elderly
Estimated at 26% for those aged 65+
Long term care (2007-13): multiple studies
cite 25-34% in LTC facilities (SNF and ALF)
Several Challenges in Managing These Patients
Hypoglycemia in the Elderly
Presentation overlaps other frailty syndromes
Confusion, word-finding errors, altered LOC
Tremors / dizziness
No one goes wrong getting a UA and Fingerstick
Limited ability to self-manage hypoglycemia
Limited vision/transfer ability to self-rescue
Increased fall risk, sedation from other medication
In institution, limited access to self-correction
Hyperglycemia in the Elderly
Symptomatic hyperglycemia
Polyuria: glycosuria load, UTI risk
Dehydration (impaired thirst, impaired access)
Blurry vision (increased falls)
Impaired wound healing
Unlike hypoglycemia, these are more subtle
and slower to emerge -> need more vigilance
Polypharmacy and Complex PMH
Increases Hyperglycemia
Steroids
Antipsychotics
Infections / immobility
Increases Hypoglycemia
Sedative Agents
Renal impairment
Poor nutrition
Cirrhosis (limited synthesis)
Diabetes Assessment in the Elderly
Goal-Setting for General Diabetes Plan
Physical Assessment
Nutritional Assessment
Physical Assessment
11
Nutritional Assessment
Malnutrition Poverty / isolation
Dentition
WWII Widower
Depression
Cognitive Impairment
12
Physical Assessment
Ophthalmic
Higher rates of cataracts, glaucoma and macular
degeneration.
Dexterity/Hands:
Vials vs pens, choice of meters
General Home Safety Eval (cords, rugs, cats)
A1c Goals in the Elderly
Standards of
Medical Care in
Diabetes - 2019
A1C Goals in Adults: Recommendations (2)
• Less stringent goals (such as <8% [64 mmol/mol]) may
be appropriate for patients with a history of severe
hypoglycemia, limited life expectancy, advanced
microvascular or macrovascular complications, or long-
standing diabetes in whom the goal is difficult to achieve
despite diabetes self-management education,
appropriate glucose monitoring, and effective doses of
multiple glucose-lowering agents including insulin. B
Approach to the Management of Hyperglycemia
low high
newly diagnosed long-standing
long short
absent severeFew/mild
absent severeFew/mild
highly motivated, adherent, excellent self-care capabilities
readily available limited
less motivated, nonadherent, poor self-care capabilities
A1C7%
more stringent
less stringentPatient/Disease Features
Risk of hypoglycemia/drug adverse effects
Disease Duration
Life expectancy
Important comorbidities
Established vascular complications
Patient attitude & expected
treatment efforts
Resources & support system
Glycemic Targets:
Standards of Medical Care in Diabetes - 2018. Diabetes Care 2018; 41 (Suppl. 1): S55-S64
Elderly DM Goals: My 3 Levels
For those with good functional status, same as
others post-ACCORD study (probably about
7-7.5% depending on CV disease)
For life expectancy < 5 years, < 8%
For palliative care patients: avoid symptoms
Glucose > 180 = glycosuria, dehydration, UTIs
Glucose over ~225 = poor wound healing,
increased decubitus ulcers
Diabetes: Recent CV Outcome Trials
Landmark Trials for Elderly DM
DCCT: For DM1, enrolled people < 39 years of age
UKPDS: did not enroll past 59 years of age
Last round of trials without CV benefit include
ACCORD (mean age 62), VADT (mean age 60), and
ADVANCE (mean age 66) but few > 75 years old
No outcome trial focused on elderly (no HYVET)
No major trials at all for frail/institutionalized elderly
Empagliflozin, Cardiovascular Outcomes, and
Mortality in Type 2 Diabetes
Addition of empagliflozin, an SGLT2 inhibitor, to
individuals with DM2 and established CVD (Prior
myocardial infarction, coronary artery disease, stroke,
unstable angina or occlusive peripheral arterial disease)
7000 patients, mean age 63, 72% male
Criteria: BMI < 45, A1c 7-10%, CrCl > 30
B Zinman et al, NEJM 2015
Patients with event/analysed
Empagliflozin Placebo HR (95% CI) p-value
3-point MACE 490/4687 282/2333 0.86(0.74,
0.99)*0.0382
CV death 172/4687 137/2333 0.62 (0.49, 0.77) <0.0001
Non-fatal MI 213/4687 121/2333 0.87 (0.70, 1.09) 0.2189
Non-fatal stroke 150/4687 60/2333 1.24 (0.92, 1.67) 0.1638
0.25 0.50 1.00 2.00
EMPA REG: CV death, MI, stroke
Favours empagliflozin Favours placebo
EMPA REG by Age
EMPA-REG OUTCOME: Summary
Empagliflozin reduced risk for 3-point MACE by 14%
Empagliflozin reduced hospitalization for heart failure
by 35%
Empagliflozin reduced CV death by 38%
Empagliflozin improved survival by reducing all-cause
mortality by 32%
Increase in genital infections, otherwise well tolerated
LEADER - Analysis by Age
Clinical Outcomes with Canagliflozin
N=10,142 patients with T2D and high CV risk CANVAS: n=4330
CANVAS-R: n=5812
Endpoints Primary endpoint: composite of CV death, nonfatal
MI, or nonfatal stroke
Secondary endpoints: All-cause death
CV death
Albuminuria progression
Composite of CV death and HF hospitalization
CANVAS Program Study Design
Neal B, et al. N Engl J Med. 2017;377:644-657.
Hazard ratio (95% CI) P value
Primary composite endpoint* 0.86 (0.75-0.97) 0.02†
CV death 0.87 (0.72-1.06)
Nonfatal MI 0.85 (0.69-1.05)
Nonfatal stroke 0.90 (0.71-1.15)
Fatal or nonfatal MI 0.89 (0.73-1.09)
Fatal or nonfatal stroke 0.87 (0.69-1.09)
HF hospitalization 0.67 (0.52-0.87)
CV death or HF hospitalization 0.78 (0.67-0.91)
All-cause death 0.87 (0.74-1.01)
Progression of albuminuria 0.73 (0.67-0.79)
40% reduction in eGFR, renal replacement
therapy, or renal death
0.60 (0.47-0.77)
Clinical Outcomes with CanagliflozinCANVAS Program
(N=10,142)
Neal B, et al. N Engl J Med. 2017 Jun 12 [epub ahead of print].
0.00 0.50 1.00 1.50
Favors canagliflozin
Adverse Events with CanagliflozinCANVAS Program* Safety Results
*Includes patients from CANVAS and CANVAS-R (N=10,142). †CANVAS-only population (n=4330).
Neal B, et al. N Engl J Med. 2017 Jun 12 [epub ahead of print].
Event Canagliflozin Placebo P value
Events per 1000-patient years
All serious adverse events 104.3 120.0 0.04
Adverse events leading to discontinuation 35.5 32.8 0.07
Diabetic ketoacidosis (adjudicated) 0.6 0.3 0.14
Events of interest occurring in significantly more canagliflozin-treated patients
Amputation 6.3 3.4 <0.001
Bone fracture (adjudicated)
All 15.4 11.9 0.02
Low trauma 11.6 9.2 0.06
Infection of male genitalia 34.9 10.8 <0.001
Osmotic diuresis† 34.5 13.3 <0.001
Volume depletion† 26.0 18.5 0.009
Mycotic genital infection in women† 68.8 17.5 <0.001
Diagnosis is a fairly soft endpoint,
but death is unequivocal.
Edwin AM Gale, Lancet 2003
ADA 2019 Cardiovascular Disease:
Treatment
10.39 Among patients with type 2 diabetes who have established
atherosclerotic cardiovascular disease, sodium-glucose
cotransporter 2 inhibitors or glucagon-like peptide 1 receptor
agonists with demonstrated cardiovascular disease benefit
(Table 9.1) are recommended as part of the antihyperglycemic
regimen. A
10.40 Among patients with atherosclerotic cardiovascular
disease at high risk for heart failure or in whom heart failure
coexists, sodium-glucose cotransport 2 inhibitors are
preferred. C
Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123
• In patients with T2DM and established ASCVD, antihyperglycemic therapy should begin with lifestyle management and metformin and subsequently incorporate an agent proven to reduce major adverse CV events and CV mortality (currently empagliflozin and liraglutide), after considering drug-specific and patient factors (Table 8.1). A
• In patients with T2DM and established ASCVD, after lifestyle management and metformin, the antihyperglycemic agent canagliflozin may be considered to reduce major adverse CV events, based on drug-specific and patient factors (Table 8.1). C
Pharmacologic Approaches to Glycemic Treatment:
Standards of Medical Care in Diabetes - 2018. Diabetes Care 2018; 41 (Suppl. 1): S73-S85
Pharmacologic Therapy For T2DM: Recommendations (4)
Guidelines: AACE vs ADA (vs me)
Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S90-S102
41
42
• If A1C is above target despite
recommended first-line treatment and
the patient has ASCVD or CKD:
• ASCVD Predominates:
• Add GLP-1 RA with proven CVD
benefit, OR
• Add SGLT-2 inhibitor with proven
CVD benefit (if eGFR adequate)
• If HF or CKD Predominates:
• Add SGLT-2 inhibitor with
evidence of benefit
• If can’t take an SGLT-2 inhibitor,
use a GLP-1 RA with proven CVD
benefit
43
44
2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients With Type 2 Diabetes and ASCVD (Fig 2)
The Diabetes Toolbox 2019
Drug Class (First in Class) FDA Approval
Insulin (subcutaneous) 1922 (first use)
Sulfonylurea (chlorpropamide) 1958
Biguanide (metformin) 1995
Alpha-glucosidase inhibitors (acarbose) 1995
Thiazolidinedione (troglitazone) 1997
Meglitinide (repaglinide) 1997
Incretins (pramlintide, exenatide) 2005
DPP-IV Inhibitors (sitagliptin) 2006
Bile acid sequestrant (colesevelam) 2008 (DM)
Dopamine agonist (bromocriptine QR) 2009
SGLT-2 inhibitor (canagliflozin) 2013
The Toolbox in 2019
Metformin: great – with new GFR guidance –
please use metformin ER
Sulfonylureas: cheap, but risk of
hypoglycemia; no more glyburide (and its evil
metabolite norglyburide cleared through
kidneys) -> now $4 monthly glimepiride
TZDs: no hypoglycemia but risks of edema,
CHF, and possibly fractures and malignancies
Available for Q&A: colesevelam, bromocriptine
Metformin
FDA (April 2016): “We have concluded
from the review of studies published in the
medical literature that metformin can be
used safely in patients with mild impairment
in kidney function and in some patients with
moderate impairment in kidney function.”
Label update: now “contraindicated” if
eGFR is <30mL/min/1.73m2
2014 update from the International Society
of Nephrology: metformin may still be
appropriate for eGFR 14-29mL/min/1.73m2
GLP-1 Agonists
Modest benefit in HbA1c 0.7-1.1% and some
weight loss as well but some nausea
Safety warnings about pancreatitis and
medullary thyroid cancer
Cardiovascular studies complete for several
Can be used in combination with basal insulin
at same time of day, for probably best efficacy
with reasonably low risk of hypoglycemia
Most have CV studies
DPP-IV Inhibitors
Sitagliptin, saxagliptin, linagliptin, alogliptin
Modest decrease in HbA1c of 0.5% - 0.8%;
Minimal side effects (possible more minor
infections) except saxagliptin showed increased
congestive heart failure (seen in ADA guideline)
SGLT-2 Inhibitors
Approved starting in 2013; blocks renal re-
absorption of glucose and lowers blood sugars
Associated with similar modest HbA1c decrease
of 0.5% - 0.7%) as DPP-IV inhbitors (UTDOL)
Risks: infections and dehydration, DKA
Independent of resistance (can use with insulin)
but limit dose eGFR 45-60 and don’t use < eGFR
45 or with hepatic impairment
CV Studies: EMPA REG, CANVAS, DECLARE
Final Words on Newer Agents
None of these have been in wide use for long
Lessons of rosiglitazone: hemoglobin A1c is
a surrogate endpoint, not the true goal of care
All the new drugs cost upwards of $10/day
Final Words on Newer Agents
None of these have been in wide use for long
Lessons of rosiglitazone: hemoglobin A1c is
a surrogate endpoint, not the true goal of care
All the new drugs cost upwards of $10/day
For elderly, hypoglycemia safety probably is
main reason to use, or dosing convenience,
EXCEPT with coexisting CV disease, choose
one of the ADA and ACC recommended Rx
Indications for Insulin Therapy
Severe hyperglycemia at diagnosis
Hyperglycemia despite maximum doses of
non-insulin agents
Decompensation of other organ systems that
limits use of other oral agents
Early potent treatment with non-hypo safety
Combination Injectable Therapy in T2DM
To Infinity and Beyond
Insulin Pens = KEY for elderly (easier than
ever: CTS, visual impairment, neuropathy)
Insulin pumps appropriate if motivated and
fulfill strict Medicare criteria
Continuous monitors approved for Medicare
AMDA has excellent LTC guidelines for also
incorporating multidiscipinary team
Conclusion
Diabetes is common in the elderly and care of
these individuals is more challenging
ADA and AACE have slightly different goals
of care and treatment pathways, and toolbox
can be viewed with focus on elderly
Multiple new cardiovascular studies support
the preferential use of certain GLP-1 and
SGLT-2 drugs for those with DM & CVD
Questions and Appreciation