Barriers to Achieving A1C Targets: Clinical Inertia and Hypoglycemia. KM Pantalone Endocrinology

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1 Barriers to Achieving A1C Targets: Clinical Inertia and Hypoglycemia KM Pantalone Endocrinology

2 Disclosures Speaker Bureau AstraZeneca, Merck, Novo Nordisk, Sanofi Consultant Novo Nordisk, Eli Lilly, Merck Research Support Novo Nordisk and Merck

3 How Are We Doing? According to ADA: A1C goals should be individualized on the basis of patient-specific factors. A reasonable A1C goal for many patients is <7%. More or less stringent A1C goals may be appropriate for some patients Percentage of people aged 20 years with previously diagnosed diabetes and an A1C of 7% NHANES , N=1,343 NHANES=National Health and Nutrition Examination Survey; ADA=American Diabetes Association. American Diabetes Association. Diabetes Care. 2014;37(suppl 1):S14 S80. Casagrande SS, et al. Diabetes Care. 2013;36(8):

4 Individualize Goals A higher A1C goal (<8%) may be more appropriate for those with: Established CV disease Elderly Recurrent hypoglycemia Hypoglycemia unawareness A lower A1C goal may be more appropriate for younger/healthy individuals who will experience a longer duration of disease, if it can be reached safely

5 Clinical Inertia Challenges in Achieving A1C Goals Failure of health care providers to initiate or intensify therapy when indicated Hypoglycemia Limits our ability to obtain optimum glycemic control Fear of hypoglycemia Patient and/or physician

6

7

8 Few Patients Have A1C Evaluated and Addressed in a Timely Manner

9 Khunti K et al. Diabetes Care Nov;36(11): Nichols GA et al. J Gen Intern Med Apr;22(4): Fu AZ et al. Diabetes Obes Metab Aug;13(8):765-9.

10 Cleveland Clinic Study

11 Objective To evaluate the intensification of diabetes therapy and A1C goal attainment among patients with newly-diagnosed T2D who fail metformin monotherapy To identify the factors associated with clinical inertia (lack of early intensification) To identify the physician and patient contributions to the development of clinical inertia

12 Definitions Early intensification < 6 months of metformin failure Late intensification > 6 months (late or never) Baseline A1C 1st A1C after at least 3 months of metformin monotherapy Follow-up A1C 1 st A1C after the baseline A1C

13 Intensification Types of Interventions

14 Methods The EHR at Cleveland Clinic was used to identify patients with newly-diagnosed T2D between who failed to reach A1C goal after Diagnosis of T2D First-line Metformin Monotherapy 3 months of metformin monotherapy 1st A1C after at Least 3 months of Metformin Monotherapy N=5,239 A1C >7% N=1,168 A1C >7.5% N= 679 A1C >8% N= 429 At Least 3 Months Intensification within 6 Months of Elevated Baseline A1C

15 Methods Time-dependent survival analysis was performed to compare the time until A1C goal attainment in patients who received early vs late intensification The median time until intervention in the overall cohort was 14 months Follow-up A1C measurement available in 89% of patients Median (IQR) time to follow-up A1C for the entire cohort (N=5,239) was 5.9 months (3.7, 9.3) The analysis was performed for A1C goals of 7% (N=1,168), 7.5% (N=679), and 8% (N=429)

16 Results Baseline A1C >7% 38% did not undergo early intensification Baseline A1C >7.5% 31% did not undergo early intensification Baseline A1C >8% 28% did not undergo early intensification

17 Results The probability of undergoing an early intensification was greater the higher the baseline A1C category

18 Results Kaplan-Meier curves of time until A1C is under control Baseline A1C >7% Baseline A1C >7.5% Baseline A1C >8% Time until A1C goal attainment was shorter among patients who received early intensification regardless of the A1C goal (all P<0.05)

19 Additional Factors Compared descriptive statistics for the inertia vs. non-inertia groups Chi-square tests for categorical variables Wilcoxon Sign Rank test for continuous variables The only additional variable found to be associated with development of clinical inertia was patient age Late intervention vs early intervention in patients with baseline A1C>7%: Median age 56.0 (46.6, 64.8) vs (47.0, 61.3) P=0.038

20 No differences observed between the patients who underwent early vs. late intervention for the following patient characteristics/variables: Race Insurance status Smoking status DCSI egfr Modified Deyo comorbidity index # of active non-diabetes related prescription medications Preventative exams within the past 3 years History of coronary artery disease History of cerebrovascular accident History of heart failure History of hypertension Specialist vs PCP encounter

21 Patient and Physician Contributions to the Development of Clinical Inertia 20 random cases of identified clinical inertia underwent chart review Clinical inertia, or lack of intensification, was found to be: Patient-driven in 11 cases (55%) Physician-driven in 9 cases (45%)

22 Chart Review Patient Inertia Every patient inertia case demonstrated multiple noncompliance behaviors: Missed appointments Clinical, lab, or nutrition consultations Non-adherence to treatment regimens Medications, diet, or exercise No case documented non-compliance to medication due to intolerance

23 Chart Review Physician Inertia Cases of physician inertia were simply related to the physician s failure to intensify therapy as indicated (per A1C) Continued granting of refills for medications without adjustment/intensification to address an A1C elevation

24 Strengths Large number of patients with newly-diagnosed T2D that were included in the analysis Novel approach Large amount of clinical information available on the patients Included numerous interventions in the definition of intensification Follow-up A1C information was available on the majority of subjects Allowed us to analyze the effects of an intervention on long-term glycemic goal attainment

25 Limitations A patient s personal A1C goal may have been different/individualized A switch from metformin to metformin XR, which is often better tolerated than immediate-release metformin, was not counted as an intervention Unable to explore the relationship between early intensification and health outcomes

26 Conclusions A significant number of patients with newly-diagnosed T2D fail to undergo intensification of therapy within 6 months of metformin monotherapy failure Early intervention was observed to occur quicker in the patients with higher A1Cs Early interventions help patients achieve glycemic goal attainment Future studies are warranted to determine if early intensification is also associated with a reduction in the development of long-term diabetes-related complications

27 Inertia, or Just Too Complicated? Sulfonylureas Metformin Insulin Sulfonylureas Metformin Insulin Glinides Thiazolidinediones α-glucosidase inhibitors Dipeptidyl peptidase-4 inhibitors Bromocriptine Sodium-glucose co-transporter 2 inhibitors Colesevelam GLP-1 receptor agonists Pramlintide (Amylin agonist)

28 Inertia, or Does Our Management Approach Need to Change?

29 T2D is a Progressive Disease 50%

30 Campbell IW. Br J Cardiol. 2000;7: A Conservative Approach Results in Delayed Intensification of Treatment

31 Lovshin JA, Zinman B. Nat Rev Endocrinol. 2013;9(11): Fu AZ et al. Diabetes Obes Metab. 2011;13(8):

32 Proactive, Early, Aggressive Intensification: The Future What we have been doing has not worked The guidelines have evolved but translation of new recommendations into clinical practice is often delayed Recommendation for initial therapy: Lifestyle Modification Lifestyle Modification + metformin Lifestyle Modification + metformin + Drug B

33 Initial Combination Therapy With a Modern Regimen Allows for Sustained A1C Lowering

34 Modern Medications Lower A1C AND Mitigate weight gain or are associated with weight loss Avoid/minimize hypoglycemia

35

36 Hypoglycemia Glinides

37 Hypoglycemia Generally defined as < 70 mg/dl Patients will have different tell symptoms Need to recognize relative hypoglycemia

38 Hypoglycemia Is a barrier to achieving optimum A1C level Often related to inappropriate therapy choices and/or management decisions A1C value itself yields valuable information

39 Monnier L et al. Diabetes Care. 2003;26:881.

40 Shifting down the plasma glucose, but wide glycemic excursions continue

41 Shapiro ET et al. J Clin Endocrinol Metab 1989;69: It is interesting that in many patients who fail metformin, who have an A1C < 8.5%, a SFU is added, despite the fact that it does NOT address the postprandial hyperglycemia, which is largely responsible for the residual A1C elevation!

42 Pantalone KM et al. BMJ Open Diabetes Res Care Jul 22;3(1):e Sulfonylureas Our EHR derived data has found that the use of sulfonylureas has not decreased much Despite the availability of several new agents which are not associated with hypoglycemia Do physicians just continue to prescribe what they are used to prescribing? Is this because of cost/formularies?

43 Cleveland Clinic Pantalone KM et al. BMJ Open Diabetes Res Care Jul 22;3(1):e

44 Cleveland Clinic Pantalone KM et al. Clin Med Insights Endocrinol Diabetes Jun 30;9:23-30.

45 Hypoglycemia Decreased adherence Fear of hypoglycemia

46 Hypoglycemia Communication is Key

47 Conclusions Early and more aggressive intensification Multiple oral agents Injectables Avoid agents associated with hypoglycemia (if possible) Avoiding Clinical Inertia Inappropriate delays in intensification Check A1C and intensify therapy every 3 months until at goal Cleveland Clinic Approach Care Pathways Help guide care, reduce variation, contain cost

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