CDA CPG 2016 Interim Update. Preferences & access to treatment. Program Director Knowledge Translation & Optimizing Care Models

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1 Safety of New Antihyperglycemics in Patients with Cardiovascular Disease Lori MacCallum, BScPhm, PharmD, RPh, CDE Assistant Professor, Leslie Dan Faculty of Pharmacy Sun Life Financial Professor in Wellness and Diabetes Education Program Director Knowledge Translation & Optimizing Care Models Banting & Best Diabetes Centre Faculty of Medicine, University of Diabetes and Lifetime Risk for CVD % 57% 3% 6% Adjusted cumulative incidence CV Safety Trial Design No increased CV risk vs placebo Dose adjustment to maintain AC the same in both groups Test for non-inferiority +/- test for superiority. DM Non DM Attained Age Circulation. 6;3: CV Trials DPP- Inhibitors EXAMINE N = 5,38 SAVOR-TIMI N = 6,9 N ~,67- Alogliptin vs Saxagliptin vs Sitagliptin vs Population Median duration of diabetes, yrs 5 to 9 days Established CVD and/or multiple risk factors.3.6 Baseline HbA c % Number of events 6, >,3 Median duration of exposure, yrs Primary end point.5. ~3. or Nonfatal stroke or Nonfatal stroke Nonfatal stroke, or UA req. hospitalization N Engl J Med. 3;369: N Engl J Med. 3;369: N Engl J Med. 5;373:3. Individualizing Treatment Add another agent best suited to the individual by prioritizing patient characteristics: PATIENT CHARACTERISTIC CHOICE OF AGENT Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity CV disease or multiple risk factors Comorbidities (renal, CHF, hepatic) Preferences & access to treatment Consider relative AC lowering Rare hypoglycemia Weight loss or weight neutral Effect on cardiovascular outcome See therapeutic considerations See cost column; consider access CDA CPG 6 Interim Update 3 Composite CV Primary Endpoint Study Drug Hazard Ratio 95% CI P value SAVOR-TIMI 53 (saxagliptin vs. placebo) 63/88 (7.%) 69/8 (7.%)..89,..99 EXAMINE (alogliptin vs. placebo) 35/7 (.3%) 36/679 (.8%).96 NA,.6.35 (sitagliptin vs. placebo) 75/733 (.%) 76/7339 (.%).99.89,..8 SAVOR + EXAMINE + TECOS 663/833 (9.%) 67/83 (9.%).99.9,.6 Favours treatment Favours placebo N Engl J Med. 3;369: N Engl J Med. 3;369: N Engl J Med. 5;373:3. Peterson ED. Results from the Trial to Evaluate Cardiovascular Outcomes after Treatment with 6 Sitagliptin (TECOS). American Diabetes Association, 75th Scientific Sessions, June 5-9, 5, Boston, MA.

2 Hospitalization for Heart Failure Study Drug Hazard Ratio 95% CI P value SAVOR-TIMI 53 (saxagliptin vs. placebo) 89/88 (3.5%) 8/8 (.8%).7.7,.5.7 EXAMINE (alogliptin vs. placebo) 6/7 (3.9%) 89/679 (3.3%).9.89, (sitagliptin vs. placebo) 8/733 (3.%) 9/7339 (3.%)..8,.. Favours Treatment Favours placebo N Engl J Med. 3;369: N Engl J Med. 3;369: N Engl J Med. 5;373:3. JAMA Cardiol. 6;E E. 7 Hospitalization for Heart Failure Who? HR.6. SAXA.8 HR HR HR.3.7. HR.5.3. HR HR Hospitalization for HF (-year K-M %) >6 No Yes Neither egfr (ml/min) Prior Heart Failure Prior HF Both # of excess HHF events/ pt-year N= Circulation. ;3: Hospitalization for Heart Failure When? 3 Saxagliptin HR.8 (.9-.55) P=. HR.6 (.5-.88) P=. HR.7 (.7-.5) P=.7 3.5% Hospitalization for Heart Failure (%) Potential Reasons for Differences in Heart Failure Play of chance Differences in patients enrolled Differences in background care provided Variation in acquisition/definition of HF events among trials Intrinsic pharmacologic differences among the DPP- inhibitors Baseline Characteristics DPP- Inhibitors GLP-RA SAVOR-TIMI 53 EXAMINE ELIXA STUDY DRUG Saxagliptin Alogliptin Sitagliptin CV Risk Established CVD/MRF 5-9 days Preexisting CVD 8 days Sample size, N 6,9 5,38,67 6,68 Mean duration of diabetes, years 7 9 Mean AC,% Mean age, years 65 6 (median) 66 6 BMI, kg/m 3 9 (median) 3 3 N Engl J Med. 3;369: N Engl J Med. 3;369: N Engl J Med. 5;373:3. N Engl J Med. 5;373: NO. AT RISK Days from Randomization Saxagliptin Circulation. ;3: Primary Endpoint: ELIXA Time to the first occurrence of the primary CV event (CV death, non-fatal MI, non-fatal stroke, hospitalization for UA) 5 HR =. (.89,.7) : 6/33 = 3.% : 399/33 = 3.% Percent 5 NO. AT RISK 36 Months N Engl J Med. 5;373:7 57.

3 Hospitalizations for Heart Failure: ELIXA 5 HR=.96 (.75,.3) : /33 =.% : 7/33 =.% Percent 5 36 Months N Engl J Med. 5;373: Health Canada WARNINGS AND PRECAUTIONS Saxagliptin Caution in patients with history of congestive heart failure (especially in those patients who also have renal impairment and/or history of myocardial infarction [MI]) Sitagliptin NYHA class I, II, III, IV not recommended Alogliptin NYHA class III and IV caution 6 Bottom Line In patients with established CV disease or multiple CV risk factors, the DPP- inhibitors, sitagliptin, saxagliptin, alogliptin demonstrated CV safety vs placebo In patients with CV disease, GLP- agonist lixisenatide demonostrated CV safety vs placebo Saxagliptin increased the risk of hospitalization for heart failure Particularly in first months Incremental risk was greatest in patients at high risk of heart failure History of heart failure, impaired renal function Confirmation is required Sodium-Glucose Co-transporter Inhibitors Inhibition of the sodium glucose co-transporter (SGLT) in the kidney Glucose reduction occurs by reducing renal glucose reabsorption and thus increasing urinary glucose excretion In patients with type diabetes, leads to: Significant reductions in HbAc Weight loss Reductions in blood pressure without increases in heart rate 7 FDA Update April 5, 6 Consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure. 5 SGLT Inhibitors CV Safety Trials Currently In Progress CANVAS N = 365 6/8 CREDENCE N = 37 / CANVAS-R N = 57 /7 DECLARE-TIMI 58 Dapagliflozin vs. placebo N = 7,5 /9 8

4 Baseline Characteristics DPP- Inhibitors GLP-RA SGLT Inhibitor SAVOR-TIMI 53 EXAMINE ELIXA EMPA-REG 5 STUDY DRUG Saxagliptin Alogliptin Sitagliptin Empagliflozin Sample size, N CV background Established CVD and/or multiple risk factors* 5 to 9 days 8 days Females, % Mean age, y 65 6 (median) Duration of diabetes, y % had DM for > years Mean AC, % Mean BMI, kg/m 3 9 (median) * active smoking. N Engl J Med. 3;369: N Engl J Med. 3;369: N Engl J Med. 5;373:3. N Engl J Med. 5;373: N Engl J Med. 5;373: Cardiovascular Death, MI and Stroke Patients with event/analysed Empagliflozin HR (95% CI) P value 3-point MACE 9/687 8/ (.7,.99)*.38 CV death 7/687 37/333.6 (.9,.77) <. Non-fatal MI 3/687 / (.7,.9).89 Non-fatal stroke 5/687 6/333. (.9,.67) Favours empagliflozin Favours placebo *Cox regression analysis. N Engl J Med. 5;373:7-8. Empa-reg Outcome Trial Design (n=333) Screening (n=53) Randomised and treated (n=7) Empagliflozin mg (n=35) Empagliflozin 5 mg (n=3) Study medication was given in addition to standard of care Glucose-lowering therapy was to remain unchanged for first weeks Treatment assignment double masked The trial was to continue until at least 69 patients experienced an adjudicated primary outcome event Cardiovasc Diabetol. ;3:. Cardiovascular and Total Mortality CV Mortality Total Mortality N Engl J Med. 5;373: Cardiovascular Death, Non-Fatal MI or Non-Fatal Stroke HR.86 (95.% CI.7,.99) P =. N Engl J Med. 5;373:7-8. Hospitalization for Heart Failure HR.65 (95% CI.5,.85) P =.7 N Engl J Med. 5;373:7-8.

5 EMPA-REG OUTCOME : Bottom Line In people with type diabetes and CVD, empagliflozin reduced risk for 3-point MACE by % reduced CV death by 38% reduced hospitalization for heart failure by 35% reduced all-cause mortality by 3% 5 CDA Interim Update 6 In people with clinical CV disease in whom glycemic targets are not met, an SGLT inhibitor with demonstrated CV outcome benefit should be added to antihyperglycemic therapy to reduce the risk for CV and all cause mortality (Grade A, level A for empagliflozin) CDA CPG 6 Interim Update 8 Reduction in MACE with Liraglutide LEADER to be presented at ADA Type diabetes mellitus at high risk of cardiovascular events Liraglutide. mg and.8 mg versus placebo Primary endpoint: Time to occurrence of CVA, MI, CV death Met noninferiority and superiority Results to be presented at the American Diabetes Association Annual Meeting in June 6. 6 Individualizing Treatment Add another agent best suited to the individual by prioritizing patient characteristics: PATIENT CHARACTERISTIC CHOICE OF AGENT PRIORITY: Clinical Cardiovascular Disease SGLT inhibitor with demonstrated CV outcome benefit Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity CV disease or multiple risk factors Comorbidities (renal, CHF, hepatic) Preferences & access to treatment Consider relative AC lowering Rare hypoglycemia Weight loss or weight neutral Effect on cardiovascular outcome See therapeutic considerations See cost column; consider access CDA CPG 6 Interim Update 9 Add another class of agent best suited to the individual (agents listed in alphabetical order): Class Relative AC Lowering Hypoglycemia Weight Effect in Cardiovascular Outcome Trial Other therapeutic considerations Cost -glucosidase inhibitor (acarbose) Rare neutral to Improved postprandial control, GI sideeffects Incretin agents: DPP- Inhibitors GLP-R 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 $ SGLT inhibitors to Rare Superiority (empa in TDM 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- weeks required for maximal effect Weight loss agent (orlistat) None GI side effects $ 7 alo=alogliptin; glar=glargine; saxa=saxagliptin; sita=sitagliptin; lixi=lixisenatide; empa=empagliflozin

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