Diabetic Management of the Cardiac Patient
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1 Diabetic Management of the Cardiac Patient Dr Peter A Senior BMedSci MBBS PhD FRCP(E) Associate Professor, Director Division of Endocrinology, University of Alberta
2 Disclosures Grants/Research Support: Boehringer-Ingelheim, BMS, GSK, ISIS, Lilly, Novo Speakers Bureau/Honoraria: Animas, Astra Zeneca, Bayer, BMS, Lilly, Novo Nordisk, Sanofi- Aventis, Servier Consulting Fees: Bayer, Janssen, Lilly, Medtronic, Novo Nordisk, GSK Other: Endocrinologist
3 Objectives Set appropriate Glycemic Targets for cardiac patients with diabetes Risks and benefits of glucose lowering therapies in the acute setting in the chronic setting
4 Financial Practice Guidelines Hypothesis: Investing in an RRSP is an effective strategy to ensure a financially secure retirement Recommendation: People should start an RRSP (grade A, level 1) 25 yr old Cardiology R1? 63 yr old Cardiologist?
5
6 Context Diabetes is bad for the cardiovascular system Hyperglycemia is bad for the CVS Good glycemic control is good for the CVS Hypoglycemia has CV risks Tight glycemic control by any means is good for the CVS
7 UKPDS+10 - glycemia
8 Vascular Protection Checklist 2013 A A1C optimal glycemic control (usually 7%) B BP optimal blood pressure control (<130/80) C Cholesterol LDL 2.0 mmol/l if decided to treat D Drugs to protect the heart A ACEi or ARB S Statin A ASA if indicated E Exercise regular physical activity, healthy diet, achieve and maintain healthy body weight S Smoking cessation guidelines.diabetes.ca BANTING ( ) diabetes.ca Copyright 2013 Canadian Diabetes Association
9
10 Case #1 64 yr Female, BMI 37 PMH MI 2004, angioplasty & stent LAD 2009 newly diagnosed T2DM, Dec 2013 HbA1c 8.2% metformin intolerant
11 Approach Glycemic target: <= 7.0% Diet & Lifestyle Metformin: try again at lower dose what next?
12 Case #2 56 year male, admitted with AMI T2DM x 8 years, HbA1c 10.4% EF 25%, Creatinine 263µmol/l post angiogram metformin 1g bid, glyburide 10mg od
13 Approach Diet & Lifestyle Metformin: hold until AKI resolves Glyburide: hold Start Insulin (MDI) while in-patient Glycemic target: % Discharge on Basal insulin + metformin + OHA
14 Sites of Action of Antidiabetic Agents Pancreas GLP-1 receptor agonist DPP-4i Liver Insulin SU/glinide Adipose tissue Metformin TZD Gut Blood glucose Kidney AGI Stimulatory or positive effect Inhibitory effect SGLT2i * * none licensed in Canada Adapted from Bailey CJ. Trends Pharmacol Sci Feb; 32(2):63-71
15 Metformin Biguanide, related to phenformin excreted unchanged by kidney reduces hepatic glucose production enhances insulin stimulated glucose uptake no weight gain, no hypoglycemia better outcomes in heart failure
16 Lower Mortality in Heart Failure Patients on Metformin
17 Secretagogues Dosing Metabolised Hypo Weight Gain Glyburide qd Liver active $ Gliclazide bid Liver inactive + ++ $ Glimepiride qd Liver partly active $$ Repaglinide ac meals Liver inactive + + $$
18 SU Monotherapy in T2D on ACM (Cochrane Database Review of 72 RCTS) First generation SU vs placebo 2 trials; 553 participants; high risk of bias (HRB) First generation SU vs insulin 2 trials; 1944 participants; HRB Second-generation sulphonylureas (SGS) vs metformin 6 trials; 3528 participants; HRB SGS vs TZDs 7 trials; 4955 participants; HRB SGS vs Insulin 4 trials; 1642 participants; HRB SGS vs meglitinides 7 trials; 2038 participants; HRB SGS vs incretin-based therapies 2 trials; 1503 participants; HRB RR CI P value P= P= P= P= P= P= P= RR (95% CI) Hemmingsen B et al. Cochrane Database of Systematic Reviews 2013 Apr 30;4
19 Acarbose Slows digestion of oligosaccharides to monosaccharides Slows delivery of glucose to circulation Prevents post-prandial hyperglycemia Reduced CV events Safe Modest reduction in A1c Poorly tolerated (gas++)
20 Probability of any CV event Adapted from Chiasson JL et al. JAMA 2003; 290: STOP NIDDM Acarbose and Development of CVD 0.06 Effect of Acarbose on the probability of remaining free of CV disease Effect of Acarbose on the development of CV disease P=0.04 (Log-rank test) P=0.03 (Cox proportional model) Placebo Coronary heart disease P value Myocardial infarction 0.02 Angina 0.13 Revascularization 0.18 Favors Acarbose Favors Placebo 0.02 Acarbose CV death 0.63 Cerebrovasc. event or stroke Peripheral vasc. Disease Any cardiovascular event 0.03 N at risk Placebo Acarbose Days after randomization The STOP NIDDM trial s primary endpoint was development of diabetes and therefore not powered for CVD, which was an a priori secondary objective Hazard ratio
21 TZDs
22 Meta-analyses of Rosiglitazone or Pioglitazone vs Comparators on Risk of MI, Ischemic Heart Disease or a Composite of Major Macrovascular Events Rosiglitazone meta-analyses Friedrich et al. (MI) Selvin et al. (CV morbidity) GSK-ICT (MI) Friedrich et al. (IHD) Shuster et al. (MI) FDA (Serious IHD) Nissen & Wolski (MI) Singh et al. (MI) FDA (IHD) Paaty & Furberg (MI) Diamond et al. (MI, highest estimate) Dahabreh & Economopoulos (MI, highest estimate) GSK-ICT (IHD) Bracken (MI, excl. RECORD) Diamond et al. (MI, lowest estimate) Bracken (MI, incl. RECORD) Dahabreh & Economopoulos (MI, lowest estimate) Monami et al. (MI) FDA (CV death/mi/stroke) GSK-ICT (CV death/mi/stroke) Mannucci et al. (non-fatal coronary events) Mannucci et al. (non-fatal MI) Pioglitazone meta-analyses Selvin et al. (CV morbidity, incl. PROactive) Selvin et al. (CV morbidity, excl. PROactive) Nagajothi et al. (MI) Lincoff et al. (death/mi) Perez et al. (death/mi/stroke, incl. PROactive) Lincoff et al. (death/mi/stroke, incl. PROactive) Mannucci et al. (non-fatal coronary events) Lincoff et al. (MI) Lincoff et al. (death/mi/stroke, excl. PROactive) Perez et al. (death/mi/stroke, excl. PROactive) 3.5 Hazard or Odds or Risk Ratio Schernthaner G et al. Diabetes Obes Metab 2010;12:
23 Cumulative (%) Cumulative (%) Cumulative (%) RECORD: Components of the Primary Endpoint 10 All-cause death CV death HR 0.86 (95% CI ) Active control HR 0.84 (95% CI ) Active control 2 0 Rosiglitazone Rosiglitazone 10 Myocardial infarction Stroke HR 1.14 (95% CI ) Rosiglitazone HR 0.72 (95% CI ) Active control 2 0 Active control Rosiglitazone CV death, MI, and stroke HR 0.93 (95% CI ) Active control Rosiglitazone Heart failure HR 2.10 (95% CI ) Rosiglitazone Time (years) Time (years) Home PD et al. Lancet 2009; 373:
24 Incretin Therapies Inhibit GLP-1 breakdown alogliptin linagliptin (Trajenta) saxagliptin (Onglyza) sitagliptin (Januvia) vildagliptin resistant to breakdown albiglutide exenatide (Byetta) exenatide ER (Bydureon) liraglutide (Victoza) lixisenatide GLP-1 mimetics that are italicized agents are not licensed for use in Canada
25 Incretin Therapies DPP-IV inhibitors GLP-1 analogues administration tablets injection glucagon secretion insulin secretion inhibit gastric emptying N Y nausea & vomiting N Y weight loss N Y
26 Cumulative incidence of primary end-point events (%) EXAMINE: Primary Efficacy Endpoint* HR 0.96 (upper boundary of the one-sided repeated CI: 1.16) Placebo Events, No. (%) Placebo: 316 (11.8) Alogliptin: 305 (11.3) 12 Alogliptin Months EXAMINE: n = 5,380 patients (median age 61 years) with type 2 diabetes (median duration 7.1 to 7.3 years) and acute coronary syndrome within days of randomization. Median duration of follow-up: 18 months. *Primary endpoint: composite of CV death, non-fatal MI or non-fatal ischemic stroke. White WB, et al. N Engl J Med 2013; [epub ahead of print].
27 % of patients SAVOR TIMI-53: Primary Efficacy* HR % CI p (non-inferiority) < p (superiority) = Months 7.3% 3.7/100 person-yrs Saxagliptin Placebo 7.2% 3.7/100 person-yrs SAVOR TIMI-53: n = 16,492 patients (mean age 65 years) with type 2 diabetes (mean duration 10.3 years) and established CVD (78-79%) or multiple risk factors (21-22%). Median duration of follow-up: 2.1 years. *Primary endpoint: composite of CV death, non-fatal MI or non-fatal ischemic stroke. Scirica BM, et al. N Engl J Med 2013; [epub ahead of print].
28 Older Drugs lower glucose CV benefit Weight Hypo acarbose + Y 1 0 glitinides + neutral 2 + metformin + Y 3 0 sulphonylureas +?Y 4 + insulin +?Y STOP-NIDDM, 2 NAVIGATOR, 3 UKPDS, 4 UKPDS extension
29 Newer Drugs lower glucose CV benefit Weight Hypo DPP4i GLP1-RA + 0 SGLT2i * + 0 TZD +? / SAVOR, EXAMINE. 2 FDA / RECORD / PROACTIVE. * none licensed in Canada
30 Conclusions Diabetes Management is challenging Good glycemic control is important Glycemic targets must be individualized Clinical judgement required to safely use the tools available
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