An Evidence-Based Algorithm for Deprescribing Diabetes Medications

 
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2019 MICNP Conference                                                              3/23/2019

                                                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

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                             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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2019 MICNP Conference                                           3/23/2019

                                        Objectives
                        1. Describe the risks of
                           antihyperglycemic
                           medication use in elderly
                           patients with type 2
                           diabetes.
                        2. Discuss appropriate use of
                           an algorithm to safety
                           deprescribe certain
                           medications.

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                         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

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                                  Hypoglycemia

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                          Severe Hypoglycemia - 20191
                        • Impaired cognition               • Coma
                          and physical function            • Falls
                        • Depression and                   • MVI or other injury
                          reduced quality of life          • ER visits and
                        • Confusion, delirium                hospitalizations
                        • Loss of                          • Major cardiovascular
                          consciousness                      events (within 3
                        • Seizure                            months – VADT)2
                                                           • Death
                                1. ADA Diabetes Care 2019;42(Suppl.1)S61-70
                                2. Davis SN et al. Diabetes Care 2018; doi:10.2337/dc18-1144
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                         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
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                        Tight control – the holy grail of diabetes management

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                        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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2019 MICNP Conference                                                                                                           3/23/2019

                             Approach to the Management
                                  of Hyperglycemia
                                                                        more                   A1C                less
                   Patient/Disease Features                                                    7%
                                                                        stringent                            stringent
                   Risks associated with hypoglycemia
                   & other drug adverse effects                         low                                          high

                   Disease Duration
                                                                        newly diagnosed                 long-standing

                   Life expectancy
                                                                        long                                        short
                   Important comorbidities
                                                                        absent                Few/mild            severe
                   Established vascular complications
                                                                        absent                Few/mild            severe

                   Patient attitude & expected treatment
                   efforts                          highly motivated, adherent,             less motivated, nonadherent,
                                                         excellent self-care capabilities       poor self-care capabilities
                   Resources & support system
                                                                         readily available                        limited

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

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                                           Choosing Wisely
                        Avoid using all                                  Among non-older
                        medications other than                           adults, …using
                        metformin to achieve                             medications to achieve
                        A1c
2019 MICNP Conference                                                    3/23/2019

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

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

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2019 MICNP Conference                                                             3/23/2019

                        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.

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                             Not without controversy…

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

                                    How?

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                               Deprescribing.org

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                           Besides hypoglycemia, are
                             there other reasons to
                                  deprescribe?

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                                    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/PMC4886177
                   http://care.diabetesjournals.org/content/42/Supplement_1/S90

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                                The Miracle of Insulin

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                              Unforseen Risks of Specific Medications

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

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

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                            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, RN
                           A1c 6.6%

                              2013
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                         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                           29% ↓ per 0.9% A1c drop

                        Neuropathy                            19% ↓ ‘’                      ‘’

                        Nephropathy                           33% ↓ ‘’                      ‘’

                        Nonfatal MI                           15% ↓ per 1% A1c drop

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

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                                      What outcomes were studied?

                                             Outcomes                    Risk Reduction
                                    Retinopathy                 29% ↓ per 0.9% A1c drop
                                    Neuropathy                  19% ↓ ‘’            ‘’
                                    Nephropathy                 33% ↓ ‘’            ‘’
                                    Nonfatal MI                 15% ↓ per 1% A1c drop

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

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2019 MICNP Conference                                        3/23/2019

                        Can you spot the surrogate marker?

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                                        % drop, compared to what?
                        Outcomes                        Relative Risk
                                                        Reduction

                        Retinopathy                29% ↓ per 0.9% A1c drop
                        Neuropathy                 19% ↓ ‘’            ‘’
                        Nephropathy                33% ↓ ‘’            ‘’

                        Nonfatal MI                15% ↓ per 1% A1c drop

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

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                                          ADVANCE Study:
                                      Benefit of intensive control

                         NEPHROPATHY

                         20% relative risk reduction;
                         1.1% absolute risk                                   1 in 100 people
                         reduction                                           in 5 years did not
                            • 4.1% (intensive                                     develop
                               control)                                         nephropathy
                            • 5.2% (standard
                               treatment)

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

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

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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.

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                      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 effective
                              for 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?

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                             Management of Hyperglycemia in T2DM
                                         ADA, 2018

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                                                                                 2019
                           Glucose-lowering medication in type 2 diabetes: overall approach.

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

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                                                           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!

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                               Safest Intervention?

                                                 Lifestyle

                        Medications

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2019 MICNP Conference                                                                    3/23/2019

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

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                                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

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                        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.

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                            Plant-Based Dietary Pattern: Significant Benefits
                                          Beyond Diabetes*
                        •    Acne
                        •    Appendicitis                           •   Hypertension
                        •    Arthritis                              •   Irritable Bowel Disease
                        •    Atherosclerosis (CMS,                  •   Multiple Sclerosis
                             2014)                                  •   Osteoporosis
                        •    Cancer (WHO, 2015)                     •   Renal Insufficiency/CKD
                        •    Constipation                           •   Stroke
                        •    Erectile Dysfunction                   •   Weight Control
                        •    High Cholesterol

                            *More information: NutritionMD.org and NutritionFacts.org

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

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                               Easy. Delicious! Affordable.

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                                           “Cross Titrate*”
                          Up-prescribe Plants                  De-prescribe Meds
                        1. Assess interest.              1. Identify medications that
                        2. Assess diet (typical             can become too strong with
                           meals, likes and                 diet change.
                           dislikes, etc.)               2. Identify medications that
                        3. Basic instruction (plan          patient would most like to
                           some meals)                      discontinue.
                        4. Resources (Pt and             3. Discuss known benefits
                           Family)                          and risks, establish
                                                            priorities, and document
                        5. Referrals                        discussion.
                                                         4. Determine targets for BP,
                                                            lipids, A1c/glucose.
                      * Term from Michelle McMaken, MD   5. Schedule follow ups.
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                                  Special Considerations

                   • Hypoglycemia: Patients on insulin or sulphonylureas

                   • Hypotension

                   • Anticoagulants (warfarin)

                   • Add Vitamin B12 (recommended with plant-based
                     diet, 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.

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                                   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

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                             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

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                            PreventionOfDisease.org

                                Sat. May 18 – Mon. May 20, 2019

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                        July 25-27, 2019

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                          Be a joyful NP!

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                      Cartoon used with permission of Dan Piraro

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