CASES DR TINA KADER MCGILL JGH; LMC CVPH CDE

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1 CASES DR TINA KADER MCGILL JGH; LMC CVPH CDE

2 Faculty/Presenter Disclosure Faculty/Presenter: tina kader Relationships with commercial interests: Grants/research support: BI; Sanofi Speaker s bureau/honoraria: eli lilly sanofi; medtronic; novonordisk;merck BMS; Astraxeneca;Jansen; Takeda Consulting fees: eli lilly sanofi; medtronic; novonordisk;merck Other: [insert company/organization name(s) here]

The Diabetes Care Team May Include Eye specialist Kidney specialist Local diabetes

Pharmacist Who is part of the diabetes care team in your region and how do you

Family and friends Heart specialist Nurse Mental Health Professional Foot care

3 The Diabetes Care Team May Include Eye specialist Kidney specialist Local diabetes education centre Doctor Dentist Physical activity specialist Dietitian Patient? Pharmacist Who is part of the diabetes care team in your region and how do you divide the responsibilities? Family and friends Heart specialist Nurse Mental Health Professional Foot care specialist Other people who have diabetes Adapted from: guidelines.diabetes.ca BANTING ( ) diabetes.ca Copyright Canadian Diabetes Association 3

4 Guideline Targets Achieved 60% 57% 50% % of patients 45% 30% 36% 15% 13% 0% A1c ( 7%) (n=5103) LDL ( 2.0 mmol/l) (n=5069) SBP/DBP (<130/80 mm HG) (n=5099) All 3 Endpoints (A1c, LDL, BP) (n=5104) Leiter LA et al. Can J Diabetes 2013; in press guidelines.diabetes.ca BANTING ( ) diabetes.ca Copyright 2013 Canadian Diabetes Association

Antihyperglycemic Medications Alpha-glucosidase Inhibitors Delay the absorption of

gluconeogenesis Liver Sulfonylureas and meglitinides stimulate insulin secretion

kidneys : glucosuria Pancreas Kidneys Intestine Thiazolidinediones Improve insulin

8 Antihyperglycemic Medications Alpha-glucosidase Inhibitors Delay the absorption of glucose from starch and sucrose Insulin Secretagogues Biguanides Reduce hepatic gluconeogenesis Liver Sulfonylureas and meglitinides stimulate insulin secretion Adipose Tissues Muscles SGLT2 Inhibitors Reduce the reabsorption of glucose by the kidneys : glucosuria Pancreas Kidneys Intestine Thiazolidinediones Improve insulin resistance DPP-4 Inhibitors and GLP1R Agonists Increase insulin secretion, inhibit glucagon secretion

9 Drugs with Different Mechanisms of Action are Required to Address the Numerous T2DM Pathophysiological Defects The ominous octet 1-3 GLP-1 RA; DPP4i; GLP-1 RA; TZDs, DPP4i, SU TZDs Decreased insulin secretion β Decreased incretin effect Increased lipolysis GLP-1 RA; DPP4i Increased glucagon secretion α SGLT2 inhibitors Hyperglycemia Increased glucose reabsorption Increased HGP TZDs, Metformin, GLP-1 RA Neurotransmitter dysfunction GLP-1 RA HGP, hepatic glucose production Decreased glucose uptake TZDs, metformin

10 secretagogues biguanides dpp4 inhibitors glp1 agonists slgt2 inhibitors tzd alphaglucosidase inhibitors basal insulin basal plus mdi

12 AT DIAGNOSIS OF TYPE 2 DIABETES Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C <8.5% A1C 8.5% Symptomatic hyperglycemia with metabolic decompensation L I F E If not at glycemic target (2-3 mos) Start / Increase metformin Start metformin immediately Consider initial combination with another antihyperglycemic agent Initiate insulin +/- metformin S If not at glycemic targets T Add another agent best suited to the individual by prioritizing patient characteristics: Y L E PATIENT CHARACTERISTIC PRIORITY: Clinical Cardiovascular Disease Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Cardiovascular disease or multiple risk factors Comorbidities (renal, CHF, hepatic) Preferences & access to treatment CHOICE OF AGENT SGLT2 inhibitor with demonstrated CV outcome benefit Consider relative A1C lowering Rare hypoglycemia Weight loss or weight neutral Effect on cardiovascular outcome See therapeutic considerations, consider egfr See cost column; consider access 2016 See next page

13 AT DIAGNOSIS OF TYPE 2 DIABETES Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C <8.5% A1C 8.5% Symptomatic hyperglycemia with metabolic decompensation L I F E If not at glycemic target (2-3 mos) Start / Increase metformin Start metformin immediately Consider initial combination with another antihyperglycemic agent Initiate insulin +/- metformin S If not at glycemic targets T Add another agent best suited to the individual by prioritizing patient characteristics: Y L E PATIENT CHARACTERISTIC PRIORITY: Clinical Cardiovascular Disease Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Cardiovascular disease or multiple risk factors Comorbidities (renal, CHF, hepatic) Preferences & access to treatment CHOICE OF AGENT Antihyperglycemic agent with demonstrated CV outcome benefit (empagliflozin, liraglutide) Consider relative A1C lowering Rare hypoglycemia Weight loss or weight neutral Effect on cardiovascular outcome See therapeutic considerations, consider egfr See cost column; consider access guidelines.diabetes.ca BANTING ( ) diabetes.ca Copyright 2016 Canadian Diabetes Association See next page 11/2016

14 Add another class of agent best suited to the individual (agents listed in alphabetical order): Class Relative A1C Lowering Hypoglycemia Weight Effect in Cardiovascular Outcome Trial Other therapeutic considerations Cost α-glucosidase inhibitor (acarbose) DPP-4 Inhibitors Rare Neutral to Improved postprandial control, GI side-effects $$ Rare Neutral to alo, saxa, sita: Neutral Caution with saxagliptin in heart failure $$$ GLP-1R agonists to Rare lira: Superiority in T2DM patients with clinical CVD lixi: Neutral GI side-effects $$$$ Insulin Yes Neutral (glar) No dose ceiling, flexible regimens $-$$$$ Insulin secretagogue: Meglitinide Sulfonylurea Yes Yes Less hypoglycemia in context of missed meals but usually requires TID to QID dosing Gliclazide and glimepiride associated with less hypoglycemia than glyburide $$ $ SGLT2 inhibitors to Rare empa: Superiority in T2DM patients with clinical CVD Genital infections, UTI, hypotension, dose-related changes in LDL-C, caution with renal dysfunction and loop diuretics, dapagliflozin not to be used if bladder cancer, rare diabetic ketoacidosis (may occur with no hyperglycemia) $$$ Thiazolidinediones Rare Neutral CHF, edema, fractures, rare bladder cancer (pioglitazone), cardiovascular controversy (rosiglitazone), 6-12 weeks required for maximal effect $$ Weight loss agent (orlistat) None GI side effects $$$ alo=alogliptin; glar=glargine; saxa=saxagliptin; sita=sitagliptin; lira=liraglutide; lixi=lixisenatide; empa=empagliflozin 11/2016

15 Add another class of agent best suited to the individual (agents listed in alphabetical order): Class Relative A1C Lowering Hypoglycemia Weight Effect in Cardiovascular Outcome Trial Other therapeutic considerations Cost α-glucosidase inhibitor (acarbose) Rare neutral to Improved postprandial control, GI sideeffects $$ Incretin agents: DPP-4 Inhibitors GLP-1R agonists to Rare Rare Neutral to Neutral (alo, saxa, sita) Neutral (lixi) Caution with saxagliptin in heart failure GI side-effects Insulin Yes Neutral (glar) No dose ceiling, flexible regimens $-$$$$ $$$ $$$$ Insulin secretagogue: Meglitinide Sulfonylurea Yes Yes Less hypoglycemia in context of missed meals but usually requires TID to QID dosing Gliclazide and glimepiride associated with less hypoglycemia than glyburide $$ $ SGLT2 inhibitors to Rare Superiority (empa in T2DM patients with clinical CVD) Genital infections, UTI, hypotension, doserelated changes in LDL-C, caution with renal dysfunction and loop diuretics, dapagliflozin not to be used if bladder cancer, rare diabetic ketoacidosis (may occur with no hyperglycemia) $$$ Thiazolidinediones Rare Neutral CHF, edema, fractures, rare bladder cancer (pioglitazone), cardiovascular controversy (rosiglitazone), 6-12 weeks required for maximal effect $$ Weight loss agent (orlistat) None GI side effects $$$ alo=alogliptin; glar=glargine; saxa=saxagliptin; sita=sitagliptin; lixi=lixisenatide; empa=empagliflozin 2016

16 Meet Juan-Garcia 61 years old Diagnosed 6 years ago BMI: 31 kg/m 2 Weight: 95 kg Occupation: supervisor Lifestyle: busy

17 Juan-Garcia s History Treated with metformin and gliclazide MR for 5 years, but A1C has crept up to 9.2% WHAT ARE OPTIONS Bedtime insulin Glp1 agonist dpp4 inhibitor Sglt2 inhibitor

18 GLYBERIDE METFORMIN (took years to get approved in the states)

19 secretagogues biguanides dpp4 inhibitors glp1 agonists slgt2 inhibitors tzd alphaglucosidase inhibitors basal insulin basal plus mdi

21 GP WISH LIST UPDATE ANNUALLY BE AWARE OF MEDS AND GUIDELINES HAVE MENTOR TO CALL AND HELP GUIDE HAVE SUPPORT STAFF ; NURSES ;DIETICIAN; PHARMACIST; EASY ACCESS TO REFER TO DIABETES TEAM AND ENDOCRINOLOGIST NO MORE FORMS AND CODES ENDOCRINOLOGIST SHOULD BE CONSISTENT 21

22 ENDOCRINOLOGY WISH LIST CORE OF GPS THAT LIKE DOING DIABETES SEE PATIENTS EARLIER ; BEFORE COMPLICATIONS AND THEN REFER BACK TO GP IF STABLE EASY ACCESS TO ALL MEDS AND INSULIN; GPS INITIATE AT LEAST BASAL THERAPY MORE NURSE EDUCATORS TO HELP SPORTS CENTER ; FREE ACCESS; EDUCATION 22

23 Key Findings of the Harris & al study FPs waited an average of 9.2 years before initiating insulin in T2DM Mean A1C level 9.5% Prevalence of complications 74% Initiation & intensification of insulin reduced A1C: From 9.5% pre-insulin to 7.9% post-insulin After >3 years, 20% of patients still had poor control: 68% were above the target A1C of <7.0%

24 Case scenario : Mrs. K. has just started taking a long-acting insulin oncedaily for management of her T2DM, in addition to metformin. How often would you suggest that she selfmonitor her blood glucose levels? Once a day in the morning At least once a day at variable times At least three times a day including pre- and post-prandial measurements When she feels that she might be having an episode of hypoglycemia

Regular SMBG is Required for: guidelines.diabetes.

Increased frequency of SMBG may be required: Daily SMBG is not usually required if patient:

27 cbgm results ; novolin NPH 18 qhs ac brkst ac lunch ac supper qhs /

28 Self-Management Education (SME) A systematic intervention that involves active patient participation in self-monitoring and/or decision-making guidelines.diabetes.ca BANTING ( ) diabetes.ca Copyright 2013 Canadian Diabetes Association

29 What is self-management education?

30 Sarah AGE: 69 BP: 125/78 mmhg BMI: 33.3 kg/m 2 Current Medications Ramipril 10 mg qd Rosuvastatin 20 mg qd Metformin 1000 mg bid Gliclazide MR 60 mg qd Medical History/Previous Medical Records Controlled hypertension and dyslipidemia T2DM diagnosed 1 year ago Metformin 500 mg bid initiated after 3 months of lifestyle management Dose increased to 1000 mg bid 6 months ago Gliclazide initiated 3 months ago at last visit when A1C was 7.5% Current Laboratory Results A1C: 7.5% LDL-C: 1.9 mmol/l egfr: 63 ml/min/1.73 m 2 bid = twice daily;bmi=body-mass index; egfr= estimated glomerular filtration rate; qd = once daily; T2DM=type 2 diabetes mellitus; 30

dyslipidemia T2DM diagnosed 1 year ago Metformin 500 mg bid initiated after 3 months of lifestyle management Dose increased to 1000 mg bid 6 months ago Gliclazide initiated 3 months ago

31 Sarah AGE: 69 BP: 125/78 mmhg What might account for the fact that Sarah s A1C level has not changed since her last visit? BMI: 33.3 kg/m 2 Current Medications Ramipril 10 mg qd Rosuvastatin 20 mg qd Metformin 1000 mg bid Gliclazide MR 60 mg qd Medical History/Previous Medical Records Controlled hypertension and dyslipidemia T2DM diagnosed 1 year ago Metformin 500 mg bid initiated after 3 months of lifestyle management Dose increased to 1000 mg bid 6 months ago Gliclazide initiated 3 months ago at last visit when A1C was 7.5% Current Laboratory Results A1C: 7.5% LDL-C: 1.9 mmol/l egfr: 63 ml/min/1.73 m 2 bid = twice daily;bmi=body-mass index; egfr= estimated glomerular filtration rate; qd = once daily; T2DM=type 2 diabetes mellitus; 31

32 Challenges in Achieving Glycemic Goals Physician-related Failure of some clinicians to adopt a treat-to-target approach 1 Suboptimal dosing of available therapies 1 Medication-related Inability of any single agent s mechanism of action to target all core defects of type 2 diabetes 2 Access to and cost of medications 4 Side effects 5 Patient-related Concern about adverse effects 3 Suboptimal adherence to medication or lifestyle measures 1 Underuse of medications as a result of costs 4 or complexity of therapy 1 1. Blonde L. Clin Cornerstone. 2005;7(Suppl 3):S6 S17; 2. Van Gaal LF, De Leeuw. IH. Diabetologia. 2003;46 Suppl 1:M44-50; 3. McDonald HP et al. JAMA. 2002;288(22): ; 4. Piette JD et al. Diabetes Care. 2004;27(2):384-91; 5. Wabe NT et al. N Am J Med Sci. 2011;3(9):

33 Clinical Inertia and A1C Median Time (Years) to Treatment Intensification for Patients on One Oral Antihyperglycemic Agent and with Various A1C Levels 3.8 Time (years) % (n = 35,988) 7.5% (n = 31,375) 8.0% (n = 25,096) A1C Cutoff Khunti K et al. Diabetes Care. 2013;36(11):

34 Adherence to Antihyperglycemic Therapy in Quebec Stopped at 1 year Persistent but nonadherent at 1 year Persistent and adherent at 1 year Total oral antihyperglycemic agents 20.7% 17.4% 61.9% Metformin 19.9% 17.7% 62.4% Secretagogue 25.6% 17.7% 56.7% Other 20.0% 13.4% 66.6% Note: Individuals with a medication possession ratio (MPR) 80% for oral antihyperglycemic agents or insulin were deemed adherent; those having a prescription filled for antihyperglycemic agents during the period leading up to the 1-year anniversary of their first claim were considered to be persistent with their antihyperglycemic therapy. Adapted from: Guénette L et al. Diabetes Metab ;39(3):

35 Impact of Treatment Non-adherence on Mortality in People with Type 2 Diabetes Treated with Oral Antihyperglycemic Agents and Insulin Non-adherence is associated with an increased risk of total mortality 70 P=0.003 vs. adherent P<0.001 vs. adherent Adjusted increase in all-cause mortality (%) P=0.007 vs. adherent Risk increase 0 Medication non-adherence Clinic non-attendance (1 2 missed appointments) Clinic non-attendance (>2 missed appointments) UKGP records of patients with type 2 diabetes mellitus patients (n=15984). Among those who were medication adherent, there was a significant (P <0.001) monotonic increase in mortality as nonattendance increased; among those who were medication non-adherent, there was no significant difference in mortality as nonattendance increased (P = 0.489). Adapted from Currie CJ et al. Diabetes Care. 2012;35(6):

36 Association between A1C and Adherence, Adjusted for Baseline A1C and Oral Antihyperglycemic Agent Regimen Adjusted A1C Every 10% in adherence is associated with 0.1 % in A1C Adherence (%) Rozenfeld Y et al. Am J Manag Care. 2008;14(2):

37 Morisky 4-item Medication Adherence Scale The 4-Item Morisky Scale Have you ever forgotten to take your diabetes medicine? Yes No At times, are you not careful about taking your diabetes medicine? Yes No When you feel better, do you sometimes stop taking your diabetes medicine? Yes No At times, if you feel worse when you take your diabetes medicine, do you stop taking it? Yes No Adapted from: Morisky DE, Green LW, Levine DM. Medical Care. 1986;24(1): No = 0 Yes = 1 Total score 0 = high adherence Total score of 1 to 2 = medium adherence Total score of 3 to 4 = low adherence 37

38 Assessing Adherence Predicts A1C Levels The 4-item Morisky scale predicts A1C Are you forgetful? Careless at times? Sometimes stop taking medication when feeling better? Sometimes stop taking medication when feeling worse? Each 1-unit increase in total score raises A1C by 0.16%, 6 months later Baseline endorsement of forgetting medication raises A1C by 0.43% 6 months later (P=0.005) Aikens JE, Piette JD. Diabet Med. 2013; 30:

English: 86% French: 14% Forget to take Careless at times Stop when feeling better Stop when

39 Results of a 2014 Survey on Adherence Using the Short Morisky Scale Yes No No answer n = 250 Canadian specialists in diabetes Ontario: 40% Quebec: 24% Atlantic: 9% Prairies: 12% West: 15% English: 86% French: 14% Forget to take Careless at times Stop when feeling better Stop when feeling worse Results from a 2014 survey by J-F Yale, Department of Medicine, McGill University. 39

40 Sarah Results of 4-Item Morisky Scale Have you ever forgotten to take your diabetes medicine? At times are you not careful about taking your diabetes medicine? When you feel better, do you sometimes stop taking your diabetes medicine? At times, if you feel worse when you take your diabetes medicine, do you stop taking it? Score Yes 1 No 0 No 0 Yes 1 No = 0 Yes = 1 Total score 0 = high adherence Total score of 1 to 2 = medium adherence Total score of 3 to 4 = low adherence Adapted from: Morisky DE, Green LW, Levine DM. Medical Care. 1986;24(1):

DIABETES DEBATE - IS NEW BETTER?

DIABETES DEBATE - IS NEW BETTER? WHAT MEDICATION CLASS AFTER METFORMIN TO CONTROL BLOOD SUGAR Dr. Lydia Hatcher, MD, CCFP, FCFP, CHE, D-CAPM Associate Clinical Professor of Family Medicine, McMaster Chief