Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy

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1 Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy Jeffrey Boord, MD, MPH Advances in Cardiovascular Medicine Kingston, Jamaica December 7, 2012 VanderbiltHeart.com

2 Outline Glycemic targets and cardiovascular outcomes- recent trials Diabetes agents and cardiovascular outcomes Putting it in practice- ADA/EASD Guidelines VanderbiltHeart.com

3 ACCORD ADVANCE VADT # subjects Mean age (Yr) Baseline A1C (%) History of CVD (%) 10, , , A1C Goal (%) (Intensive vs. Standard) <6 vs vs. local guideline <6.0 vs. separation of 1.5 with standard Achieved A1C (%) 6.4 vs vs vs outcome Nonfatal MI /stroke, CVD death HR 1 outcome (95% CI) HR mortality (95% CI) 0.90 ( ) 1.22 ( ) Microvascular plus macrovascular (nonfatal MI/stroke, CVD death) 0.9 ( ) 0.93 ( ) Nonfatal MI/stroke, CVD death, CHF hospitalization, revascularization 0.88 ( ) 1.07 ( ) Skyler, JS et al Diabetes Care 2009; 32:

4 CV benefit of intensive glycemic control: it depends on how you look at it Subset analyses of ACCORD, ADVANCE, VADT suggested significant benefit of intensive control in patients with shorter duration of DM, lower A1C at entry, and/or absence of known CVD Meta-analysis of ACCORD, ADVANCE, VADT, and PROACTIVE (Lancet 2009;373: ) showed intensive glycemic control resulted in: 17% reduction in nonfatal MI 15% reduction in CV events (nonfatal MI+ CV death) No effect on stroke or all-cause mortality

5 Baseline Coronary Artery Calcium (CAC) and CV Outcomes in VADT (Diabetes 2009; 58: )

6 Association Between Symptomatic Hypoglycemia and Mortality in ACCORD (Bonds, DE et al BMJ 2010; 340:b4909) Retrospective epidemiological analysis of ACCORD trial data Defined hypoglycemia as one or more episodes of glucose <50 mg/dl, or symptoms requiring assistance of another that resolved with treatment Annual mortality for intensive control arm was 2.8% for patients with hypoglycemia, vs. 1.2% without (adjusted HR 1.41) Annual mortality for standard control arm was 3.7% for patients with hypoglycemia, vs. 1.0% without (adjusted HR 2.30) However, for patients with at least one hypoglycemia episode requiring ANY assistance, a non-significantly lower risk of death was seen in the intensive arm compared to the standard arm (HR 0.74, 95% CI ) A significantly lower risk was observed in the intensive arm compared to the standard arm for those with hypoglycemia requiring MEDICAL assistance (HR 0.55, 95% CI ) Conclusion: symptomatic severe hypoglycemia was associated with higher mortality risk in both arms. However, among patients with hypoglycemia the risk of death was LOWER in patients in the intensive arm compared to the standard arm

7 PROactive Trial Design and Baseline Characteristics Prospective randomized double blind placebo controlled study Patients with type 2 DM age with A1C>6.5% AND CVD CAD CVA PAD Excluding: class II-IV CHF, ESRD, liver dz 5238 subjects randomized to pioglitazone (titrated to 45 mg/d) or placebo + existing Tx Male - 66% Caucasian 98% Mean age 62 Mean weight 88 kg/bmi 31 Mean A1C 7.8% ACE/ARB 61% B-blocker 55% Antiplatelet 85% Statin 43% Fibrate 10% Mean LDL 112 mg/dl Mean HDL 43 mg/dl Mean Triglyceride 159 mg/dl Lancet. 2005;366(9493):

8 Key Results 0.6% net reduction in A1c in Pio group (6.9% vs. 7.5% final A1C) Modest improvement in lipids in Pio group (11% reduction trigs, 9% increase HDL) 3 mm Hg improvement in BP in Pio group 50% reduction for Pio group in progression to permanent insulin use for patients not on insulin at baseline Increased risk of hypoglycemia in Pio group 3.6 kg weight gain in Pio group NNH to cause CHF with Pio (requiring or not requiring hospitalization) = 30 (ARI 3.3%) Lancet. 2005;366(9493):

9 Death, nonfatal MI, stroke, amputation, ACS, coronary or leg revascularization

10 NNT to prevent first major cardiac event in 3 years= 48 (ARR 2.1%)

11 Rates of Myocardial Infarction and Death from Cardiovascular Causes with Rosiglitazone Nissen SE, Wolski K. N Engl J Med 2007;356:

12 Intensive Glycemic Control and CV Prevention: Joint Statement by ADA and AHA The general recommendation for a target A1C <7% in adults remains the same For selected individual patients, providers may recommend a goal even lower than the target of <7%, if it can be achieved without significant hypoglycemia or other adverse treatment effects Consider in patients with long life expectancy, no baseline CAD, shorter duration of diabetes Conversely, less stringent A1C goals may be appropriate for patients with history of severe hypoglycemia, limited life expectancy, advanced macrovascular or microvascular complications, or extensive comorbidities with longstanding diabetes where the goal is difficult to obtain despite intensive management Circulation 2009;119;

13 Comparative Effectiveness of Sulfonylurea and Metformin Monotherapy on Cardiovascular Events in Type 2 Diabetes Mellitus: A Cohort Study Retrospective cohort study of US Veterans who initiated metformin (n=155,025) or sulfonylurea (n=98665 therapy for DM Excluded subjects with CKD (Cr 1.5), cancer, HIV, organ transplant, end stage liver disease, respiratory failure Outcome: Composite outcome of hospitalization for acute MI or stroke; or death, adjusted for: baseline demographic characteristics; medications; cholesterol, hemoglobin A1c, and serum creatinine levels; blood pressure; body mass index; health care utilization; and comorbid conditions Adjusted Hazard Ratio (ahr) for propensity score-matched cohort for CV event or death: ahr = 1.20 ( ) for sulfonylurea compared to metformin users Results were similar for glyburide ahr 1.21 ( ) compared to glipizide ahr 1.15 ( ) VanderbiltHeart.com

14 Comparative Effectiveness of Sulfonylurea and Metformin Monotherapy on Cardiovascular Events in Type 2 Diabetes Mellitus: A Cohort Study Ann Intern Med. 2012;157(9): VanderbiltHeart.com

15 ORIGIN (Outcome Reduction with Initial Glargine Intervention) N=12,537 subjects with dysglycemia (DM2, IFG or IGT) on none or one glucose lowering drug + additional CV RF Randomized to: Insulin glargine daily to target FPG 95 mg/dl Standard care per local guidelines Secondary outcomes: 28% reduction in development of new DM in IFG/IGT in glargine group 0.7% higher risk of severe hypoglycemia (1 vs. 0.3%) in glargine group N Engl J Med 2012; 367: VanderbiltHeart.com

16 Reported pleiotropic effects of GLP-1 or GLP-1 receptor agonists on various tissues and organs under experimental conditions Meier, J. J. (2012) Nat. Rev. Endocrinol. doi: /nrendo

17 Exenatide reduces reperfusion injury in STEMI: Infarct size plotted against area at risk potential cardioprotective signalling pathways Lønborg J et al. Eur Heart J 2012;33: Hausenloy D J, Yellon D M Eur Heart J 2012;33:

18 Main Pathophysiological Defects in T2DM incretin effect gut carbohydrate delivery & absorption - pancreatic glucagon secretion pancreatic insulin secretion HYPERGLYCEMIA? - + hepatic glucose production peripheral glucose uptake Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011

19 Tier 1 Therapies Tx ΔA1C (%) Advantages Disadvantages Lifestyle 1-2 -Broad benefits -No risk Metformin 1-2 -Weight neutral Sulfonylurea (glipizide, glimepiride, glyburide) Insulin or > -Cheap 1-2 -Cheap -Good tolerance -Rapidly effective -Good tolerance -Rapidly effective -Broad utility -Durability -Poor adherence -Insufficient over time -GI side effects -Contraindicated renal failure -Hypoglycemia -Weight gain -Insufficient over time -Hypoglycemia -Weight gain -Monitoring/complexity Diabetes Care 2009; 32:

20 Tier 2 Therapies Tx ΔA1C (%) Advantages Disadvantages TZD (rosiglitazone, pioglitazone) GLP1 agonist (exenatide, liraglutide) Glinide (repaglinide, nateglinide) DPP4 inhibitor (sitagliptin, linagliptin, saxagliptin) Low hypoglycemia risk as monotherapy -Better durability Weight loss -Can use with SU, metformin, or TZD Rapidly effective -Good tolerance Weight neutral -Can use with SU, metformin, or TZD -Edema/ CHF, Osteoporosis, Bladder CA risk, weight gain -Expensive -GI side effects -Expensive -Injections -Hypoglycemia, wt. gain -Expensive -3x/day dosing -Expensive -Limited data Diabetes Care 2009; 32:

21 Figure 1 Diabetes Care 2012;35: Diabetologia 2012;55: (Adapted with permission from: Ismail-Beigi et al. Ann Intern Med 2011;154:554)

22 Diabetes Care 2012;35: Diabetologia 2012;55:

23 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities - Coronary Disease - Heart Failure Metformin: CVD benefit (UKPDS) Avoid hypoglycemia? SUs & ischemic preconditioning? Pioglitazone & CVD events? Effects of incretin-based therapies Diabetes Care 2012;35: Diabetologia 2012;55:

24 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities - Coronary Disease - Heart Failure Metformin: May use unless condition is unstable or severe Avoid TZDs? Effects of incretin-based therapies Diabetes Care 2012;35: Diabetologia 2012;55:

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