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Oral Hypoglycemic Update
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  1. Oral Hypoglycemic Update Anita Schwartz, PharmD, BCPS August 8th, 2012 For Lafayette Medical Education Foundation, Inc.

  2. Conflicts • This speaker has no conflict of interest with regard to this presentation.

  3. Objectives • Review diagnostic tests and treatment goals for diabetes • List oral hypoglycemic agents currently on the market • Classify oral hypoglycemic agents based on their mechanism, onset, duration, and place in therapy • Describe pros and cons of the different oral hypoglycemic agents available • Summarize limitations and contraindications of oral hypoglycemic agents

  4. Pre-Assessment Questions • True or False: • A HgbA1C of 6.7% on two occasions is diagnostic of diabetes. • True or False: • Giving rapaglinide (Prandin®) with meals and glimepiride (Amaryl®) daily is a very good therapy option as it mimics basal bolus insulin. • True or False: • Rosiglitazone (Avandia®) can decrease LDL cholesterol and is a good option for patients with heart disease.

  5. Classification and Diagnosis

  6. Normal Carbohydrate Metabolism ↑ Glucose Glycogenolysis Gluconeogenesis Postprandial metabolism Counterregulatory Hormones: Glucagon Epinephrine Cortisol Growth Hormone Insulin Incretin Amylin Turns On Glucose  Glycogen AA  Protein FFA  TG Turns Off Fasting metabolism ↓Glucose

  7. Classification of Diabetes • Type 1 diabetes • β-cell destruction • Type 2 diabetes • Progressive insulin secretory defect • Other specific types of diabetes • Genetic defects in β-cell function, insulin action • Diseases of the exocrine pancreas • Drug- or chemical-induced • Gestational diabetes mellitus ADA. I. Classification and Diagnosis. Diabetes Care 2012;35(suppl 1):S11

  8. Testing for Diabetes in Asymptomatic Patients • Consider testing overweight/obese adults (BMI ≥25 kg/m2) with one or more additional risk factors • In those without risk factors, begin testing at age 45 years • If tests are normal • Repeat testing at least at 3-year intervals • Use A1C, FPG, or 2-h 75-g OGTT • In those with increased risk for future diabetes • Identify and, if appropriate, treat other CVD risk factors ADA. II. Testing in Asymptomatic Patients. Diabetes Care 2012;35(suppl 1):S13.

  9. Diagnostic Criteria Note: In the absence of unequivocal hyperglycemia, result(s) should be confirmed by repeat testing. ADA. I. Classification and Diagnosis. Diabetes Care 2012;35(suppl 1):S12. Table 2.

  10. Prevention, Prevention, Prevention! • Refer patients with IGT, IFG, or A1C 5.7–6.4% to ongoing support program • Target weight loss = 7% of total body weight • Minimum of 150 min/week of moderate physical activity • Follow-up counseling important for success • Based on cost-effectiveness of diabetes prevention, third-party payers should cover such programs • In those with pre-diabetes, monitor for development of diabetes annually ADA. IV. Prevention/Delay of Type 2 Diabetes. Diabetes Care 2012;35(suppl 1):S16

  11. Prevention, Prevention, Prevention! • Medications shown to delay progression of IGT/IFG to T2DM • Metformin (US DPP, NEJM 2002) • Acarbose (STOP-NIDDM, Lancet 2002) • Piaglitazone (ACT NOW, presentation 2008) • Consider metformin for prevention of type 2 diabetes if IGT, IFG, or A1C 5.7–6.4% • Especially for those with BMI >35 kg/m2, age <60 years, and women with prior GDM • None are FDA approved for Diabetes Prevention ADA. IV. Prevention/Delay of Type 2 Diabetes. Diabetes Care 2012;35(suppl 1):S16

  12. Testing

  13. A1c Monitoring • Twice Yearly in those who have stable glycemic control and no therapy changes • Quarterly in patients whose therapy has changed or who are not meeting glycemic goals • Use of point-of-care (POC) testing for A1c provides the opportunity for more timely treatment changes ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S18.

  14. A1C Correlation ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S18. Table 8.

  15. Easy A1c Correlation • NOTE: This is an estimate only • (A1C -2) x 30 • i.e. A1C= 7%; (7-2) x30 = 150mg/dL

  16. Goals

  17. Glycemic Recommendations *Individualize goals based on these values. †Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak levels in patients with diabetes ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S20. Table 9.

  18. Goals: A1c • Goal: <7% • Lowering A1c <7% has been shown to reduce microvascular complications and, if implemented soon after the diagnosis of diabetes, is associated with long-term reduction in macrovascular disease • More stringent goals (i.e. 6.5%)are reasonable in patients if it can be achieved without significant hypoglycemia or side effect • New diagnosis of diabetes, long life expectancy and no significant CVD • Less stringent goals (i.e. 8%) may be reasonable for those who have experienced severe hypoglycemia, limited life expectancy, advanced complications, or extensive comorbidities. ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S18-19.

  19. Studies ACCORD TRIAL Primary Outcomes: nonfatal MI, nonfatal stroke, CVD ADVANCE Primary Outcomes: Microvascular and Macrovascular Complications HR=0.90 (0.78-1.04) HR=0.90 (0.82-0.98) Gerstein HC, et al, for the Action to Control Cardiovascular Risk in Diabetes Study Group.N Engl J Med 2008;358:2545-2559 Patel A, et al,. for the ADVANCE Collaborative Group. N Engl J Med 2008;358:2560-2572

  20. Blood Pressure and Lipid Goals †Based on patient characteristics and response to therapy, higher or lower systolic blood pressure targets may be appropriate. ‡In individuals with overt CVD, a lower LDL cholesterol goal of <70 mg/dL (1.8 mmol/L), using a high dose of statin, is an option. ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S32. Table 11.

  21. Oral Hypoglycemic Treatment

  22. Type 2 Diabetes Recommendations • Metformin + lifestyle changes at diagnosis providing no contraindication • Medications are ALWAYS to be used in combination with healthy meal planning and regular physical activity (150 minutes per week) • If marked elevation of A1c /blood glucose and/or symptomatic consider insulin (+ or – other agents) from the outset • If noninsulin monotherapy at maximal tolerated dose does not achieve /maintain the A1c goal over 3–6 months, add a second oral agent, a GLP-1 receptor agonist, or insulin ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S21

  23. Non-Insulin Hypoglycemic Agents Oral • Biguanides • Sulfonylureas • Meglitinides • Thiazolidinediones • Alpha Glucosidase inhibitors • Incretin Enhancers (DPP-IV inhibitors) • Resin binder Parenteral • Amylin analogs • Incretin mimetics

  24. Pharmacology - Biguanides ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University

  25. Pharmacology - Sulfonylureas ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University.

  26. Pharmacology – Meglitinides ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University.

  27. Pharmacology – Thiazolidinediones (TZD) ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University.

  28. Pharmacology – Thiazolidinediones (TZD) ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University.

  29. TZDs and the FDA • Rosiglitazone • Restricted by FDA – can only be used by patients currently benefiting from therapy or do not get adequate DM treatment from other agents and not willing to use pioglitazone • 1-800-AVANDIA • Pioglitazone • FDA alert – ongoing analysis of risk of bladder cancer (with prolonged use >12 months) Lexi-Drugs Online [Internet]. Hudson (OH) : Lexi-Comp, Inc. 1978-2012[cited 2012 August 1].

  30. Pharmacology – Alpha-Glucosidase Inhibiters ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S22. Adapted with permission from Silvio Inzucchi, Yale University.

  31. Pharmacology – Incretin Enhancers ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S23. Adapted with permission from Silvio Inzucchi, Yale University.

  32. Pharmacology – IncretinMimetics ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S23. Adapted with permission from Silvio Inzucchi, Yale University.

  33. Pharmacology – Amylin Analog Lexi-Drugs Online [Internet]. Hudson (OH) : Lexi-Comp, Inc. 1978-2012[cited 2012 August 1].

  34. Pharmacology – Bile Acid Sequestrants ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S23. Adapted with permission from Silvio Inzucchi, Yale University.

  35. Typical A1c Reductions Unger J et al. Postgrad Med 2010; 122: 145-57

  36. Fasting vs. Postprandial Effect

  37. Fasting vs. Postprandial Effect AACE/ACE Consensus Panel for Type 2 Diabetes. Endocrine Practice 2009; 25: 540-559

  38. Considerations When Selecting Therapy • How long has the patient had diabetes (duration of disease – preservation of β-cell function)? • Which blood glucose level is not at target (fasting, postprandial, or both)? • Patient preference for route of administration (oral, injection)? • The degree of A1c lowering effect required to achieve goal? • Side effect profile and the patients tolerability? • Co – existing conditions ( CVD, osteoporosis, obesity, etc)?

  39. Drug Pearls

  40. Other Therapies to Consider

  41. Antihypertensives • ACEi or ARBs • If ACEi is not tolerated secondary to cough may try ARB • If ACEi is not tolerated secondary to angioedema DO NOT TRY ARB • Multiple medications are often needed to obtain blood pressure goals ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S29

  42. Dyslipidemic Agents • Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels • with overt CVD • without CVD >40 years who have one or more other CVD risk factors • For patients at lower risk (without overt CVD, <40 years, etc.) • Consider statin therapy in addition to lifestyle therapy if LDL cholesterol remains >100 mg/dL • In those with multiple CVD risk factors ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S30-31

  43. Antiplatelet Agents – Primary Prevention • Consider aspirin therapy (75–162 mg/day) • In those with type 1 or type 2 diabetes at increased cardiovascular risk (10-year risk >10%) • Includes most men >50 years of age or women >60 years of age who have at least one additional major risk factor • Family history of CVD • Hypertension • Smoking • Dyslipidemia • Albuminuria ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S32.

  44. Antiplatelet Agents – Secondary Prevention • Use aspirin therapy (75–162 mg/day) • Secondary prevention strategy in those with diabetes with a history of CVD • For patients with CVD and documented aspirin allergy • Clopidogrel (75 mg/day) should be used • Combination therapy with ASA (75–162 mg/day) and clopidogrel (75 mg/day) • Reasonable for up to a year after an acute coronary syndrome ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S32.

  45. Coronary Heart Disease Treatment • To reduce risk of cardiovascular events in patients with known CVD use the following if not contraindicated: • ACE inhibitor • Aspirin • Statin therapy • In patients with a prior MI • Beta-blockers should be continued for at least 2 years after the event ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S33.

  46. QUESTIONS