an evidence-based algorithm for deprescribing diabetes ... · support and practical strategies....

2019 MICNP Conference 3/23/2019

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An Evidence-Based Algorithm for Deprescribing

Diabetes Medications

Caroline Trapp, DNP, ANP-BC, CDE, FAANP, DiplomateACLM

Director of Diabetes Education and Care

Physicians Committee for Responsible Medicine

Washington, DC

Disclosure of Financial Conflicts of Interest for Caroline Trapp

• None

• Nada

• Zip

• Zero

• Not a bit

• Not an iota

• Not a hint

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Objectives

1. Describe the risks of antihyperglycemicmedication use in elderly patients with type 2 diabetes.

2. Discuss appropriate use of an algorithm to safety deprescribe certain medications.

NPs and Rxs – A reasonable effort to prevent complications of T2DM

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What 3 classes of medications for T2DM can cause hypoglycemia?

• Insulin

• Sulfonylureas

• Meglitinides

Hypoglycemia

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Severe Hypoglycemia - 20191

• Impaired cognition and physical function

• Depression and reduced quality of life

• Confusion, delirium

• Loss of consciousness

• Seizure

• Coma

• Falls

• MVI or other injury

• ER visits and hospitalizations

• Major cardiovascular events (within 3 months – VADT)2

• Death1. ADA Diabetes Care 2019;42(Suppl.1)S61-702. Davis SN et al. Diabetes Care 2018; doi:10.2337/dc18-1144

Repeated episodes of hypoglycemia:

• Hypoglycemia Unawareness

• Dementia

ADA Diabetes Care 2019;42(Suppl.1)S61-70

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• Serious hypoglycemia: a national public health issue.1-2

• Defined as requiring third-party assistance.3

• Any reading <70 mg/dL may have clinical implications due to hypoglycemic unawareness.3

1. Tseng C-L, et al. JAMA Intern Med. 20142. Pogach L & Aron D. JAMA. 2010;303(20):2076-20773. ADA Diabetes Care 2019;42(Suppl.1)S61-70.

Morbidity

Mortality

Finding Balance

From Overtreatment

Prevent DM Complications

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Tight control – the holy grail of diabetes management

Factors to consider with A1c target

• Age

• Life expectancy

• Comorbid conditions

• Duration of diabetes

• Risk of hypoglycemia

• Motivation and adherence

• Quality of life

• Patient satisfaction

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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 stringent

Patient/Disease Features

Risks associated with hypoglycemia& other drug adverse effects

Disease Duration

Life expectancy

Important comorbidities

Established vascular complications

Patient attitude & expected treatment efforts

Resources & support system

American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46

Choosing Wisely

Avoid using all medications other than metformin to achieve A1c <7.5% in most older adults; moderate control is generally better.

Among non-older adults, …using medications to achieve (A1c < 7% is associated with harms, including higher mortality rates.

American Geriatrics SocietyFeb. 21, 2013; revised April 23, 2015ChoosingWisely.org

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New Guidelines! March 6, 2018, American College of Physicians

Qaseem et al. Ann Intern Med.2018;168:569-576.

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American College of Physicians• Five large-scale international trials.

• Problems with major guidelines.

• Evidence does not support using medications to aggressively lower A1c for most patients.

• Greater use of lifestyle interventions – A1c reduction with lifestyle is SAFE! And Effective!

– #1: Discuss benefits and harms, individualize care.

– #2: A1c range of 7-8% for most patients.

– #3: No target A1c for frail elderly: treat symptoms only.

Not without controversy…

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There is agreement re: need to use less in older adults.

How?

Deprescribing.org

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Besides hypoglycemia, are there other reasons to

deprescribe?

Polypharmacy

29.4% of elderly patients have been prescribed 6 or more concurrent drugs.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2546482/

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COST

Over the past 11 years, insulin prices have increased 197%.

Herman et al. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886177http://care.diabetesjournals.org/content/42/Supplement_1/S90

The Miracle of Insulin

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Unforseen Risks of Specific Medications

Consider:Troglitizone – Off the market 2000Insulin inhalation – Off the market 2007Exenatide and sitagliptin –concerns re: pancreatitisRosiglitazone – FDA restricted access due to cardiovascular risks May 2011Pioglitazone – FDA linked to bladder cancer June 2011

Cartoon by permission of Dan Piraro, creator of Bizarro, Bizarro.com

Opportunity Costs vs. Gains

Costs:

• John Abrahamson, MD: “A prescription is a missed opportunity to empower the patient to change lifestyle.”

Gains:

• Lifestyle changes get at the underlying problem(s).

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Meet Debbie, RNA1c 6.6%

2013

Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622.

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“Glycemic control [with medication] had no effect on mortality or clinically relevant complications.”

Makam & Nguyen. Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622

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The reported benefits of tight control (UKPDS)

Retinopathy

Neuropathy

Nephropathy

Nonfatal MI

29% ↓ per 0.9% A1c drop

19% ↓ ‘’ ‘’

33% ↓ ‘’ ‘’

15% ↓ per 1% A1c drop

Makam, AN & Nguyen OK. Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622

What outcomes were studied?

Outcomes

Retinopathy

Neuropathy

Nephropathy

Nonfatal MI

Risk Reduction

29% ↓ per 0.9% A1c drop

19% ↓ ‘’ ‘’

33% ↓ ‘’ ‘’


Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622

Reported Outcomes: Surrogate, not Meaningful• Progression of retinopathy on exam, vs. loss of vision• Loss of reflexes or sensation, vs. symptomatic neuropathy or

amputation• Microalbuminuria vs. kidney failure requiring dialysis• Non-fatal MI vs. stroke or death from CV disease

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Can you spot the surrogate marker?

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% drop, compared to what?

Outcomes

Retinopathy

Neuropathy

Nephropathy

Nonfatal MI

Relative Risk

Reduction

29% ↓ per 0.9% A1c drop

19% ↓ ‘’ ‘’

33% ↓ ‘’ ‘’


Circulation.2017;135:180-195. DOI:10:1161/CIRCULATIONAHA.116.022622

ADVANCE Study: Benefit of intensive control

NEPHROPATHY

20% relative risk reduction; 1.1% absolute risk reduction

• 4.1% (intensive control)

• 5.2% (standard treatment)

1 in 100 people in 5 years did not

develop nephropathy

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Figure 6. Conceptual model for classifying hemoglobin A1c distribution among US adults with diabetes, NHANES, 2011-2012

Makam & Nguyem. Circulation. 2017;135:180-195. DOI: 10.1161/CIRCULATIONaha.116.022622.

Erlich DR, Slawson DC, Shaughnessy AF. Am Fam Phys 2014;89(4):257-258

Lending a Hand to Patient with Type 2 Diabetes: A Simple Way to Communicate Treatment Goals

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How do we best advise patients when:

• Guidelines for clinical targets are not in agreement.

• We are exhorted to aggressively use medications to fix “uncontrolled” diabetes.

• Quality measures look at intermediate measures (e.g. A1c); prevention of hypoglycemia or other adverse outcome(s) are usually not measured.

Evidence-based medicine framework for clinical decision making. a Estimated on the basis of age, comorbidities, and functional status. b Includes an individual’s lifestyle, social support,

financial circumstances, and workload capacity.

Anil N. Makam, and Oanh K. Nguyen Circulation. 2017;135:180-195

Copyright © American Heart Association, Inc. All rights reserved.

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STEPS Mnemonic

1. How safe is the drug for various patient populations?

2. Is the drug well tolerated or do its adverse effects cause patients to stop taking it?

3. Has the drug been shown to be effectivefor various patient populations?

4. How will the price of the drug affect adherence?

5. Will addition of this drug be simple or difficult for various patient populations?

Management of Hyperglycemia in T2DMADA, 2018

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Glucose-lowering medication in type 2 diabetes: overall approach.

American Diabetes Association Diabetes Care 2019;42:S90-S102

©2019 by American Diabetes Association

2019

How not to choose

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Medication Sample Closet and Refrigerator

If all you have is a hammer, everything looks like a nail.

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K.I.S.S.*

Keep It Simple, Sister!

Lifestyle

Safest Intervention?

Medications

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Treat the Cause

Deprescribing medications, while prescribing evidence-based lifestyle intervention(s), may lead to prevention or remission of type 2 diabetes.

Plant-Based Dietary Pattern

• Whole grains

• Vegetables

• Beans, Peas, Lentils

• Fruit

• Water (not cow’s milk)

• Small amounts of nuts and seeds

• Vitamin B12

The Power Plate – Physicians Committee for Responsible Medicine

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Debbie, RN, 2017

A plant-based dietary pattern is recommended by:

• American Association of Clinical Endocrinologists (2018)

• American Diabetes Association (2010-2019)

• Canadian Diabetes Association

• Canada Food Guide (2019)

• Dietary guidelines of Sweden, Brazil, Germany, Qatar, the Netherlands, Denmark, Finland, Iceland, Norway & Sweden

• USDA Dietary Guidelines Advisory Committee (2015)

• American Institute for Cancer Research (2009)

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Acceptability

A Plant-Based Diet has been found to be highly acceptable in diverse populations with various disease states.

Trapp C, Barnard ND, et al. A plant-based diet for type 2 diabetes: scientific support and practical strategies. Diabetes Educ. 2010;36:33-48.

Plant-Based Dietary Pattern: Significant Benefits

Beyond Diabetes*

• Acne

• Appendicitis

• Arthritis

• Atherosclerosis (CMS, 2014)

• Cancer (WHO, 2015)

• Constipation

• Erectile Dysfunction

• High Cholesterol

• Hypertension

• Irritable Bowel Disease

• Multiple Sclerosis

• Osteoporosis

• Renal Insufficiency/CKD

• Stroke

• Weight Control

*More information: NutritionMD.org and NutritionFacts.org

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https://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pubmed/29659968

Easy. Delicious! Affordable.

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“Cross Titrate*”Up-prescribe Plants

1. Assess interest.

2. Assess diet (typical meals, likes and dislikes, etc.)

3. Basic instruction (plan some meals)

4. Resources (Pt and Family)

5. Referrals

De-prescribe Meds1. Identify medications that

can become too strong with diet change.

2. Identify medications that patient would most like to discontinue.

3. Discuss known benefits and risks, establish priorities, and document discussion.

4. Determine targets for BP, lipids, A1c/glucose.

5. Schedule follow ups. * Term from Michelle McMaken, MD

Special Considerations

• Hypoglycemia: Patients on insulin or sulphonylureas

• Hypotension

• Anticoagulants (warfarin)

• Add Vitamin B12 (recommended with plant-baseddiet, and/or over the age of 50, and/or metformin)

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What to do with those de-prescribed drugs?

Do Not Flush!!!

Find a local program: search “drug disposal/takeback.”Last resort: mix with wet cat litter or used coffee grounds and put in sealed container in trash.

Summary – Type 2 Diabetes• Prevention of hypoglycemia is a greater priority than tight control,

especially in elderly patients.

• Patients on SFUs, meglitinides or insulin should be regularly assessed for reduction or discontinuation (see deprescribing.org). Hypoglycemia s&s, prev. and tx should be regularly reviewed.

• Medication might be reserved for patients who are symptomatic and unwilling or unable to make lifestyle changes.

• A plant-based dietary pattern over any medication offers benefits beyond glycemic control and is a safe, affordable and an acceptable option that may be offered to all patients.

• Nurse practitioners should resist calls to intensify treatment, in favor of patient-centered care and shared decision making.

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Resources

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21-Day Vegan Kickstart (Free!)

21DayKickstart.org

App Website

https://nutritionguide.pcrm.org

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Coding/Billing• E & M Codes (99212-99215)

(document: “>50% of time spent on counseling & education”)

• ICD-10 Codes

– Type 2 Diabetes (e.g.E11.65 w/hyperglycemia)

Plus Z codes (help to explain the time spent)

– Dietary counseling and surveillance Z71.3

– Inappropriate diet and eating habits Z72.4

– Long Term Insulin Use Z79.4

PreventionOfDisease.org

Sat. May 18 – Mon. May 20, 2019

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July 25-27, 2019

Be a joyful NP!

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Cartoon used with permission of Dan Piraro

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