Case Studies in Type 2 Diabetes Mellitus: Focus on Cardiovascular Outcomes Trials

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1 Case Studies in Type 2 Diabetes Mellitus: Focus on Cardiovascular Outcomes Trials Louis Kuritzky MD Clinical Assistant Professor Emeritus Department of Community Health and Family Medicine College of Medicine University of Florida, Gainesville Statement of Sponsorship and Support This CME Symposium is sponsored by and supported by an educational grant from Janssen Pharmaceuticals, Inc., administered by Janssen Scientific Affairs, LLC. 1

2 CME Information This Live activity, Case Studies on Type 2 Diabetes Mellitus: Focus on Cardiovascular Outcomes Trials, from 05/01/ /30/2019, has been reviewed and is acceptable for up to 1.00 Prescribed credit(s) by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Faculty Disclosure Statement Primary Care Education Consortium adheres to the conflict of interest policy of the ACCME and the AMA. It is the policy of PCEC to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities. All individuals in a position to control the content in our programs are expected to disclose any relationships they may have with commercial companies whose products or services may be mentioned so that participants may evaluate the objectivity of the presentations. In addition, any discussion of off-label, experimental, or investigational use of drugs or devices will be disclosed by the faculty. Only those participants who have no conflict of interest or who agree to an identified resolution process prior to their participation were involved in the CME activity. 2

3 Disclosures Louis Kuritzky, MD, has no real or apparent conflicts of interest to report. Gregory Scott, PharmD, RPh, Editorial Support, has no real or apparent conflicts of interest to report. Learning Objectives After participating in this symposium, the learner will be able to: Characterize type 2 diabetes as a cardiovascular risk factor Differentiate traditional clinical outcomes trials from cardiovascular outcome trials Describe the results of cardiovascular outcome trials regarding cardiovascular safety Describe the results of cardiovascular outcome trials regarding cardiovascular benefit Integrate all available evidence, guideline recommendations, and approved product labeling in individualizing therapy 3

4 In patients with type 2 diabetes mellitus, the primary treatment goal is to control/reduce: 1. Blood glucose 2. Blood lipid 3. Blood pressure 4. Cardiovascular risk? The goal of cardiovascular safety trials is to demonstrate that the CV safety of the new therapy is? 1. similar to placebo 2. similar to metformin 3. superior to placebo 4. superior to metformin 4

5 Medications in which two classes have been shown to reduce the risk of cardiovascular events compared to placebo as part of standard care?? 1. Sulfonylurea and DPP-4i 2. DPP-4i and SGLT-2i 3. SGLT-2i and GLP-1RA 4. GLP-1RA and meglitinide Diabetes Mellitus as a Cardiovascular Risk Factor 45 Framingham Heart Study Annual age adjusted event rate per Women without Diabetes Men without Diabetes Women with Diabetes Men with Diabetes 0 Coronary Heart Disease Atherothrombotic Brain Infarction Intermittent Claudication Congestive Heart Failure Cardiovascular Death Cardiovascular Disease Kannel WB, McGee DL. JAMA. 1979;241:

6 UKPDS: 1% HbA1c Decrease and Reduced Risk of Complications 43% 37% 19% 16% 14% 12% Microvascular disease Lower extremity (P<0.0001) amputation or fatal peripheral vascular disease (P<0.0001) Cataract extraction (P<0.0001) Heart failure (P<0.05) Myocardial infarction (P<0.0001) Cardiovascular complications Stroke (P<0.05) UKPDS, United Kingdom Prospective Diabetes Study Stratton IM, et al. BMJ. 2000;321: Recommended Targets for Adults with T2DM ADA 1 AACE 2,3 HbA1c < 7.0% * 6.5% (Individualize) Pre-prandial plasma glucose mg/dl* 100 mg/dl Peak post-prandial glucose < 180 mg/dl* 140 mg/dl Blood pressure < 140/90 mm Hg < 130/80 mm Hg LDL Cholesterol < 100 mg/dl < 100mg/dL (high risk) < 70 mg/dl (very high risk) Triglycerides < 150 mg/dl < 150 mg/dl HDL Cholesterol 40 mg/dl (male) 50 mg/dl (female) *More or less stringent glycemic goals may be appropriate for individual patients. Goals should be individualized based on duration of diabetes, age/life expectancy, comorbid conditions, known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations. Postprandial glucose may be targeted if HbA1c goals are not met despite reaching preprandial glucose goals. Postprandial glucose measurements should be made 1 2 h after the beginning of the meal, generally peak levels in patients with diabetes. 1. American Diabetes Association. Diabetes Care. 2018;41(Suppl 1):S1 S Garber AJ, et al. Endocr Pract. 2018;24(1): Jellinger PS, et al. Endocr Pract. 2017;23(suppl 2):

7 Approach to the Management of Hyperglycemia Patient/Disease Features more stringent A1C 7% less stringent Risk of hypoglycemia/drug adverse effects low high Disease Duration newly diagnosed long-standing Life expectancy Important comorbidities long absent Few/mild short severe Established vascular complications absent Few/mild severe Patient attitude & expected treatment efforts Resources & support system highly motivated, adherent, excellent self-care capabilities readily available less motivated, nonadherent, poor self-care capabilities limited Reproduced with permission of the American Diabetes Association. American Diabetes Association. Diabetes Care. 2018;41(Suppl 1):S55-S64. Available at: 1/S55. Comprehensive Management of Diabetes Treating patients with T2DM is more than There s also: Antiplatelet therapy Blood pressure Cholesterol Dietary changes Exercise changes blood glucose control And let s not forget Smoking Weight Regular examination of Eyes Mouth/Teeth Feet/Skin Kidneys Plus Diabetes distress 7

8 Type 2 Diabetes Mellitus Type 2 diabetes mellitus is a chronic, progressive disease That requires ongoing collaboration, education, and support To help patients improve self-management With the goal of reducing cardiovascular risk and improving health outcomes Case Scenario: Rafael 62 yo man diagnosed with T2DM 4 months ago (HbA1c 8.6%) 3-y history of LDL hyperlipidemia, hypertriglyceridemia Lifestyle + Metformin initiated 4 mos ago Currently A1c 7.5% BMI 31.4 kg/m 2 BP 134/86 mmhg LDL-C 114 mg/dl Triglycerides 320 mg/dl Medications Metformin 1 g BID HCTZ 25 mg QD Enalapril 10 mg BID Simvastatin 20 mg QD ASA 81 mg QD 8

9 Was metformin monotherapy the appropriate initial treatment for Rafael s hyperglycemia?? 1. Yes 2. No 3. It depends Reprinted with permission from American Association of Clinical Endocrinologists 2018 AACE. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE/ACE comprehensive type 2 diabetes management algorithm Endocr Pract.2018;24:

10 Antihyperglycemic Therapy in Adults with T2DM Reproduced with permission of the American Diabetes Association. American Diabetes Association. Diabetes Care 2018;41(Suppl 1):S73-S85. Available at: Antihyperglycemic Therapy in Adults with T2DM Reproduced with permission of the American Diabetes Association. American Diabetes Association. Diabetes Care 2018;41(Suppl 1):S73-S85. Available at: 10

11 Since Rafael has a HbA1c of 7.5%, which class of medication would you add to metformin?? 1. DPP-4i 2. GLP-1RA 3. SGLT-2i 4. Sulfonylurea 5. Thiazolidinedione Pathophysiologic Defects and Sites of Action of Medications for T2DM DPP 4i CNS: Delayed satiety GLP 1RA Neurotransmitter dysfunction Bromocriptine GLP 1RA Gut: Diminished incretin effect Altered intestinal glucose absorption SGLT 2i Kidney: Glucose reabsorption Adipose tissue: Lipolysis HYPERGLYCEMIA Metformin Liver: Hepatic glucose secretion Muscle and TZD adipose tissue: Glucose uptake DPP 4i GLP 1RA Insulin SU Meglitinide Pancreas Insulin secre on Glucagon secre on 11

12 Antihyperglycemic Agents as Addon to Metformin: Effect on HbA1c DPP 4i GLP 1RA SGLT 2i SU TZD Additional HbA1c Reduction as Add on Therapy to Metformin Bolen S, et al. Agency for Healthcare Research and Quality report.pdf. Accessed May 11, Which of the following do you consider to be the most important in selecting further glucose-lowering treatment for Rafael?? 1. Glucose-lowering efficacy 2. Risk of hypoglycemia 3. Impact on weight 4. Cardiovascular safety/benefit 5. Barriers to adherence 12

13 Impact of Pioglitazone on Macrovascular Disease: PROactive 5238 patients with T2DM with macrovascular disease Randomized to Pioglitazone mg/d Placebo Continue baseline therapy Mean follow-up 34.5 months 25% 20% 15% 10% 5% 0% HR=0.90 P=0.095 Primary Endpoint HR=0.84 P=0.027 Secondary Endpoint Heart Failure Pioglitazone Placebo Primary endpoint=all cause mortality, nonfatal MI, stroke, acute coronary syndrome, endovascular/surgical intervention in the coronary/leg arteries, amputation above ankle Secondary endpoint=all cause mortality, nonfatal MI, stroke Dormandy JA, et al for the PROactive Investigators. Lancet. 2005;366(9493): Risk of Cardiovascular Outcomes: Meta- Analysis of 42 Randomized Controlled Trials Odds Ratio Comparator vs Rosiglitazone Risk of Cardiovascular Outcomes for Rosiglitazone vs Comparator Drugs None of the comparisons are statistically significant except Combined for Myocardial Infarction 2.78 P= Myocardial Infarction 1.42 Metformin SU Insulin Placebo Combined Cardiovascular Death At baseline: Mean age 56 y Mean HbA1c 8.2% P= CV Risk Favors Comparator CV Risk Favors Rosiglitazone Nissen SE, et al. N Engl J Med. 2007;356(24):

14 FDA Diabetes Mellitus Guidance US Food and Drug Administration. Accessed May 10, FDA Diabetes Mellitus Guidance (cont) Provides recommendations about how to demonstrate that a new antidiabetic therapy to treat T2DM is not associated with an unacceptable increase in CV risk That is, the new therapy is safe (noninferior to placebo) It is also possible to demonstrate that the new therapy offers CV benefit Assess major adverse CV events CV death, nonfatal MI, nonfatal stroke Other events possible Trial(s) should include patients with T2DM at higher risk of CV events Advanced disease, advanced age, renal impairment be 2 years in duration US Food and Drug Administration. guidances/ucm pdf. Accessed May 10,

15 Traditional Clinical Outcome Trial vs Diabetes Medication CV Safety Trial Traditional clinical outcome trial CV risk of new treatment is significantly less than comparator, ie, offers CV benefit Diabetes medication safety trial CV risk of new treatment is non-inferior (similar) to placebo If non-inferiority is demonstrated, the possible superiority (ie, CV benefit) of new treatment can be assessed Nomenclature Primary end point: Composite of: CV death, non-fatal MI, and non-fatal stroke Heart failure hospitalization All cause death Total number of deaths due to that condition during a specific time. Death from any cause. 15

16 Nomenclature (cont) Non-inferiority: No increase in CV risk compared to placebo Superiority: If non-inferiority is demonstrated, can look for superiority CV risk significantly reduced compared to placebo Diabetes Medication CV Safety Trials DPP 4i GLP 1RA SGLT 2i Alogliptin EXAMINE Albiglutide HARMONY CANVAS CARMELINA Dulaglutide REWIND CANVAS R Canagliflozin Linagliptin Exenatide CAROLINA EXSCEL CREDENCE QW Saxagliptin SAVOR TIMI53 Exenatide in EUROS a ITCA 650 Dapagliflozin DECLARE TIMI 58 Sitagliptin TECOS Liraglutide LEADER Empagliflozin EMPA REG OUTCOME Lixisenatide ELIXA Semaglutide SUSTAIN 6 Ertugliflozin NOTE: All trials are randomized, double blind, parallel, placebo controlled, multi center VERTIS CV 16

17 Medications Whose CV Safety Has Been Shown to Be Non- Inferior to Placebo DPP 4 Inhibitors Alogliptin 1 Saxagliptin 2 Sitagliptin 3 GLP 1 Receptor Agonists Exenatide QW 4 Liraglutide 5 Lixisenatide 6 Semaglutide 7 SGLT 2 Inhibitors Canagliflozin 8 Empagliflozin 9 1. White WB, et al. N Engl J Med. 2013;369(14): Scirica BM, et al. N Engl J Med. 2013;369(14): Green JB, et al. N Engl J Med. 2015;373(3): Holman RR, et al. N Engl J Med. 2017;377(13): Marso SP, et al. N Engl J Med. 2016;375(4): Pfeffer MA, et al. N Engl J Med. 2015;373(23): Marso SP, et al. N Engl J Med. 2016;375(19): Neal B, et al. N Engl J Med. 2017;doi: /NEJMoa Zinman B, et al. N Engl J Med. 2015;373(22): Case Scenario: Rafael 62 yo man diagnosed with T2DM 4 months ago (HbA1c 8.6%) Lifestyle + Metformin HbA1c 7.5% BMI 31.4 kg/m 2 BP 134/86 mmhg LDL-C 114 mg/dl Triglycerides 320 mg/dl Medications Metformin 1 g BID HCTZ 25 mg QD Enalapril 10 mg BID Simvastatin 20 mg QD ASA 81 mg QD 17

18 Which class of medication would you add to metformin?? 1. DPP-4i 2. GLP-1RA 3. SGLT-2i 4. Sulfonylurea 5. Thiazolidinedione Case Scenario: Julie 69 yo woman diagnosed with T2DM 3 years ago (HbA1c 9.4%) when she suffered a myocardial infarction Lifestyle + Metformin + SU HbA1c 6.9% (now 7.7%) BMI 36.8 kg/m kg/m 2 BP 130/78 mmhg egfr 63 ml/min/1.73 m 2 LDL-C 64 mg/dl Triglycerides 156 mg/dl Medications Metformin 1 g BID Glimepiride 6 mg QD Lisinopril/HCTZ 20 mg/25 mg QD Atorvastatin 80 mg QD ASA 81 mg QD 18

19 Case Scenario: Julie Adherence with glimepiride has been poor since she experienced a severe hypoglycemia episode 7 months ago Has experienced several episodes of asymptomatic hypoglycemia since HbA1c has risen over the past year (now 7.7%) Plan Discontinue glimepiride Start another medication Which class of medication would you add to metformin?? 1. DPP-4i 2. GLP-1RA 3. SGLT-2i 4. Thiazolidinedione 19

20 Antihyperglycemic Medications Demonstrating Cardiovascular Benefit: SGLT-2 Inhibitors Canagliflozin Endpoint Rate/100 patientyears Canagliflozin Placebo Hazard Ratio (95% CI) CV death, nonfatal MI, nonfatal stroke a ( ) HF hospitalization ( ) CV death or HF hospitalization ( ) Progression of albuminuria ( ) 40% reduction egfr, renal dialysis or transplantation, renal death ( ) CV, cardiovascular; egfr, estimated glomerular filtration rate; HF, heart failure; MI, myocardial infarction a Primary endpoint Neal B, et al. N Engl J Med. 2017;doi: /NEJMoa Antihyperglycemic Medications Demonstrating Cardiovascular Benefit: SGLT-2 Inhibitors (cont) Empagliflozin Endpoint Rate/100 patientyears Empagliflozin Placebo Hazard Ratio (95% CI) CV death, nonfatal MI, nonfatal stroke a ( ) All cause death b ( ) CV death ( ) HF hospitalization ( ) HF hospitalization or CV death (excluding fatal stroke) ( ) CV, cardiovascular; egfr, estimated glomerular filtration rate; HF, heart failure; MI, myocardial infarction a Primary endpoint b NNT=39 over 3 years Zinman B, et al. N Engl J Med. 2015;373(22):

21 Antihyperglycemic Medications Demonstrating Cardiovascular Benefit: GLP-1 Receptor Agonists Liraglutide Endpoint Rate/100 patientyears Liraglutide Placebo Hazard Ratio (95% CI) CV death, nonfatal MI, nonfatal stroke a,b ( ) CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for UA or HF ( ) All cause death c ( ) CV death ( ) Microvascular event ( ) Nephropathy ( ) a Primary endpoint b NNT=66 over 3 years c NNT=98 over 3 years Marso SP, et al. N Engl J Med. 2016;375(4): Antihyperglycemic Medications Demonstrating Cardiovascular Benefit: GLP-1 Receptor Agonists (cont) Semaglutide Endpoint Rate/100 patientyears Semaglutide Placebo Hazard Ratio (95% CI) CV death, nonfatal MI, nonfatal stroke a,b ( ) CV death, nonfatal MI, nonfatal stroke, revascularization, hospitalization for UA ( ) or HF All cause death, nonfatal MI, nonfatal stroke ( ) Nonfatal stroke ( ) Revascularization ( ) New or worsening nephropathy ( ) a Primary endpoint b NNT=45 over 2 years Marso SP, et al. N Engl J Med. 2016;375(19):

22 Cardiovascular Outcomes Over 30 Months: Canagliflozin vs Other non-sglt-2 Inhibitors Heart Failure Hospitalization Composite CV Endpoint* Incidence Rate per 1000 person years HR=0.70 P< HR=0.61 P< HR=0.51 P< Incidence Rate per 1000 person years HR=0.89 P=NS HR=1.03 P=NS HR=0.86 P=NS Cana/DPP 4i cohort, n=17,667 pairs Cana/GLP 1RA cohort, n=20,539 pairs Cana/SU cohort, n=17,354 pairs Patorno E, et al. BMJ. 2018;360:k119. *Admitted to hospital for acute myocardial infarction, ischemic stroke, or hemorrhagic stroke Summary & Implications for Primary Care Reducing cardiovascular risk is the key treatment objective for patients with diabetes Available evidence shows that medications from 3 classes do not pose an increased risk of major adverse cardiovascular events Canagliflozin, empagliflozin, liraglutide, semaglutide reduce the risk of key cardiovascular outcomes 22

23 In patients with type 2 diabetes mellitus, the primary treatment goal is to control/reduce: 1. Blood glucose 2. Blood lipid 3. Blood pressure 4. Cardiovascular risk? The goal of cardiovascular safety trials is to demonstrate that the CV safety of the new therapy is? 1. similar to placebo 2. similar to metformin 3. superior to placebo 4. superior to metformin 23

24 Medications in which two classes have been shown to reduce the risk of cardiovascular events compared to placebo as part of standard care?? 1. Sulfonylurea and DPP-4i 2. DPP-4i and SGLT-2i 3. SGLT-2i and GLP-1RA 4. GLP-1RA and meglitinide Case Studies in Type 2 Diabetes Mellitus: Focus on Cardiovascular Outcomes Trials THANK YOU! 24

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