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  • The Omnicare HealthLine Page 1 of 7 References for all content available upon request ©2017 Omnicare

    The Omnicare HealthLine February 2017

    Focus on the 2017 ADA Diabetes Guidelines for Older Persons - by Allen Lefkovitz

    Type 2 diabetes mellitus (DM2) is estimated to affect 29.1 million Americans and is currently the seventh leading cause of death. It is estimated that 25.9% of older adults (65 years and older), representing 11.8 million individuals, have DM2, which means that 40.5% of all cases of DM2 involve older adults. Each year, the American Diabetes Association (ADA) releases guidance to patients and healthcare professionals “with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care.” Entitled “The Standards of Medical Care in Diabetes”, hereafter referred to as “the 2017 Standards”, this annual report is available free at: http://care.diabetesjournals.org/content/40/Supplement_1.

    The number of recommendations specific to older adults increased from 12 to 14 in 2017. Also, the strength of supportive evidence improved from “expert consensus or clinical experience” (Grade E) to “supportive evidence from poorly controlled or uncontrolled studies” (Grade C) for 5 of these recommendations (where grade A evidence is the strongest and grade E evidence is the weakest). This article provides an overview of selected recommendations (new and ongoing) from the 2017 Standards that impact the care of older adults with DM2.

    Glycemic Targets and Hypoglycemia

    Hypoglycemia should be avoided in older adults with diabetes. It should be assessed and managed by adjusting glycemic targets and pharmacologic interventions. (Grade B)

    Antidiabetics are the 3rd most common drug class and insulin is the 2nd most likely drug to result in an emergency department visit due to an adverse drug event. The most recent estimate is that approximately 282,000 emergency room visits occur each year due to hypoglycemia. A noteworthy change in the 2017 Standards involves the revised definition and classification of hypoglycemia as outlined in the table below.

    Classification Glycemic Criteria Description

    Glucose Alert Level ≤ 70 mg/dL Sufficiently low for treatment with fast- acting carbohydrate and dose adjustment of glucose-lowering therapy

    Clinically Significant Hypoglycemia

    < 54 mg/dL Sufficiently low to indicate serious, clinically important hypoglycemia

    Severe Hypoglycemia No specific value Hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery

    Within their “Choosing Wisely” document, the American Geriatrics Society’s (AGS) recommendation is to “Avoid using medications other than metformin to achieve hemoglobin A1c < 7.5% in most older adults.” In their explanation of this recommendation, the AGS goes on to say “Reasonable glycemic targets would be 7.0 – 7.5% in healthy older

    Inside This Issue 1-3 Focus on the 2017

    ADA Diabetes Guidelines

    4 Dosing Considerations for Newer Oral Anticoagulants

    5 Clinical Capsule: Adverse Effects of Select Antidiabetic Medications in Older Persons

    5 Regulatory Recap

    6 New Drug Eucrisa

    6 New Generic Medications

    7 HealthLine Quiz

    “Management of diabetes in the long-

    term care (LTC) setting (i.e., nursing homes and skilled nursing

    facilities) is unique.” - American Diabetes Association (2017)

  • The Omnicare HealthLine 2

    The Omnicare HealthLine Page 2 of 7 References for all content available upon request ©2017 Omnicare

    adults with long life expectancy, 7.5 – 8.0% in those with moderate comorbidity and a life expectancy < 10 years, and 8.0 – 9.0% in those with multiple morbidities and shorter life expectancy.”

    Glycemic goals for some older adults might reasonably be relaxed using individual criteria, but hyperglycemia leading to symptoms or risk of acute hyperglycemic complications should be avoided in all patients. (Grade C)

    Patients with diabetes residing in long-term care facilities need careful assessment to establish glycemic goals and to make appropriate choices of glucose lowering agents based on their clinical and functional status. (Grade E)

    Overall, relaxed goals are suitable for many elderly patients. The graphic below is intended to assist in individualizing glycemic goals for elderly diabetics. An awareness of factors such as an individual’s risk of hypoglycemia, life expectancy, and how long they have been diabetic, can impact dramatically the establishment of glycemic goals, such as the A1c. However, as recommended by the ADA, if an older adult is cognitively and functionally intact and if they have a significant life expectancy, they “may receive diabetes care with goals similar to those developed for younger adults.”

    Risk of hypogycemia and other drug adverse events

    How long have they been diabetic?

    Life expectancy

    Relevant comobidities

    Established vascular complications

    Low

    More Stringent

    Less StringentA1c 7%

    High

    Newly diagnosed Long-standing

    Long Short

    Absent Few/mild Severe

    Absent Few/mild Severe

    Adapted from ADA Standards of medical care in diabetes-2017. Diabetes Care 2017; 40(1):S53

    For more information on the risk of hypoglycemia with common drugs for DM2, please refer to the Clinical Capsule on page 5.

    Considerations in Treatment of DM2 Although the focus of this article is not the pharmacological treatment of diabetes, two new recommendations in the 2017 Standards are worth mentioning. The first new recommendation is actually included twice in the 2017 Standards: within the Prevention or Delay of DM2 section and the Pharmacologic Approaches to Glycemic Treatment section. This duplication may be understood by remembering that metformin “is the preferred initial pharmacologic agent” for DM2.

    Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy. (Grade B)

    The second new recommendation was based upon two larger clinical trials involving oral Jardiance (empagliflozin) or injectable Victoza (liraglutide). As indicated in the 2017 Standards “Ongoing studies are investigating the cardiovascular benefits of other agents in these drug classes.”

    In patients with long-standing suboptimally controlled type 2 diabetes and established atherosclerotic cardiovascular disease, empagliflozin or liraglutide should be considered as they have been shown to reduce cardiovascular and all-cause mortality when added to standard care. (Grade B)

  • The Omnicare HealthLine 3

    The Omnicare HealthLine Page 3 of 7 References for all content available upon request ©2017 Omnicare

    Although not a new recommendation, the 2017 Standards emphasize education for long-term care facility staff.

    Consider diabetes education for the staff of long-term care facilities to improve the management of older adults with diabetes. (Grade E)

    Areas of management that should be included in this recommended education are not clearly delineated in the 2017 Standards, but should likely include:

    • How to detect symptoms of DM2 • Policies and procedures for preventing hypoglycemia • Policies and procedures for managing hypoglycemia • Timely reporting of “out of range” blood glucose values detected during routine monitoring or symptoms that may

    indicate a hyperglycemic crisis • Nutritional considerations (e.g., individual diets, how to report decreased intake) • How to provide preventive and routine eye, foot, and oral care

    Comorbid Conditions Associated with DM2 In addition to recommending an overall “assessment of medical, mental, functional, and social geriatric domains”, since 2015 the Standards have specifically recommended depression screening, and in the 2017 Standards the ADA newly recommends a routine assessment for cognitive impairment.

    Annual screening for early detection of mild cognitive impairment or dementia is indicated for adults 65 years of age or older. (Grade B)

    Older adults (≥ 65 years of age) with diabetes should be considered a high priority population for depression screening and treatment. (Grade B)

    In addition to mental health-related recommendations, the 2017 Standards continue to address cardiovascular health by including 2 recommendation that focus on enhancing cardiovascular health.

    Treatment of hypertension to individualized target levels is indicated in most older adults. (Grade C)

    Treatment of other cardiovascular risk factors should be individualized in older adults considering the time frame of benefit. Lipid-lowering therapy and aspirin therapy may benefit those with life expectancies at least equal to the time frame of primary prevention or secondary intervention trials. (Grade E)

    The reason for individually addressing hypertension at a higher grade of evidence is because “There is strong evidence from clinical trials of the value of treating hypertension in older adults.” However, blood pressure targets, like glycemic control targets, have been relaxed to minimize the risk of hypotension, which can result in orthostasis and falls.

    End of Life Considerations for Individuals with DM2 Palliative care and end of life recommendations, which are particularly pertinent in the long