3/8/2011. Julie M. Sease, Pharm D, BCPS, CDE Associate Professor of Pharmacy Practice Presbyterian College School of Pharmacy

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1 Summarize revisions to the 2011 American Diabetes Association clinical practice guidelines. Evaluate bromocriptine as a therapeutic option in the management of type 2 diabetes. Compare and contrast the members of the glucagon like peptide 1 class and establish their place in the therapy of type 2 diabetes. Compare and contrast the members of the dipeptidyl peptidase 4 inhibitor class and establish their place in the therapy of type 2 diabetes. Julie M. Sease, Pharm D, BCPS, CDE Associate Professor of Pharmacy Practice Presbyterian College School of Pharmacy Recommend therapy for a patient with type 2 diabetes utilizing suggested treatment algorithms and knowledge of the most recently marketed agents. 1

2 Diagnosing diabetes with hemoglobin A1c >/=6.5% Diagnosing increased risk for diabetes with hemoglobin A1c % Aspirin for primary prevention: 10 year risk >10% Men over 50 or women over 60 with at least 1 additional major risk factor Diabetes care in the hospital: Critically ill: Intravenous insulin for >/= 180 mg/dl with goal range of mg/dl American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care 2010;33(Supplement 1):S11-S61. Gestational Diabetes Screen for type 2 diabetes at the first prenatal visit in women who have risk factors. In all pregnant women, not already known to have diabetes, screening is now recommended with use of a 75 gram 2 hour OGTT between 24 and 28 weeks gestation. Diagnostic cut points are: Fasting >/=92mg/dL 1 hour >/=180mg/dL 2 hour >/=153 mg/dl 1)American Diabetes Association. Standards of medical care in diabetes Diabetes Care. 2011;34(Supplement 1):S11 S61. 2)The HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358: )International Association of Diabetes and Pregnancy Study Groups Consensus Panel. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010;33: Blood Pressure Treatment Goals: Individualization ACCORD ACCORD Study Group, Cushman WC, Evans GW, et al. Effects of intensive blood pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362: ADVANCE Patel A, ADVANCE Collaborative Group, MacMahon S, et al. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 2007;370: INVEST Cooper DeHoff RM, Gong Y, Handberg EM, et al.tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA 2010;304: Population: Type 2 Diabetes High cardiovascular risk Treatment Goals: <120mmHg (119/64mmHg) vs mmHg 140mmHg (133/70mmHg) Composite Outcome: Nonfatal myocardial infarction, stroke, and CV disease death 0.88 (95% CI ; P=0.20) Pre defined secondary endpoints Stroke: 0.59 (95% CI ; P=0.01) Nonfatal Stroke: 0.63 (95% CI ; P=0.03) NNT x 5 years to prevent 1 stroke: 89 Population: Type 2 Diabetes plus >/=1 CV risk factor Treatment: Perindopril 2mg/indapamide 0.625mg vs. placebo Perindopril/indapamide doubled after 3 months Outcomes: Systolic blood pressure in treatment group: 135 mmhg 5.6 mmhg /2.2 mmhg lower in treatment than placebo group Primary Outcome: Composite of macrovascular and microvascular events 861 [15.5%] active vs. 938 [16.8%] placebo (0.91, 95% CI , p=0.04) Significant reduction in death 408 [7.3%] active vs. 471 [8.5%] placebo (0.86, 95% CI , p=0.03) Significant reduction in cardiovascular death 211 [3.8%] active vs. 257 [4.6%] placebo (0.82, 95% CI , p=0.03) NNT over 5 years to save 1 from death:79 2

3 Post hoc analysis of 6,400 patients with diabetes and coronary artery disease Treatment and Goals Tight control (<130mmHg) vs. Usual care ( mmHg) vs. Uncontrolled (>140) Verapamil versus atenolol followed by trandolapril or HCTZ or both Composite Outcome First occurrence of all cause death, nonfatal myocardial infarction, or nonfatal stroke 12.6% tight control vs. 12.7% usual care (1.11; 95% CI ; P=.24) Blood Pressure Treatment Goals: Individualization Consideration: Most benefit found when blood pressure < 140mmHg Suggested target remains < 130mmHg Consider individual, their response to therapy, medication tolerance, and keep in mind that outcomes worse with systolic > 140mmHg American Diabetes Association. Standards of medical care in diabetes Diabetes Care. 2011;34(Supplement 1):S11 S61. Mechanism of Action: Dopamine receptor agonist Indications and Limitations: Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Should not be used to treat type 1 diabetes or diabetic ketoacidosis Limited efficacy data in combination with thiazolidinediones Efficacy has not been confirmed in combination with insulin Dosing: Initial Dose: One 0.8 mg tablet daily Titration: Increase by 0.8 mg weekly to maximum dose of 1.6 to 4.8 mg daily Should be taken within 2 hours of waking with food Contraindications: Do not use in patients with syncopal migraines Do not use in nursing women. Can inhibit lactation. Stroke in this population. g/ Orthostatic hypotension Psychosis Somnolence Avoid use with dopamine antagonists and other dopamine agonists Does not increase risk of macrovascular 52 weeks (no evidence of reducing macrovascular events either) Hypoglycemia: Bromocriptine monotherapy (3.7%) 3

4 Drug Drug Interactions: May increase the unbound fraction of highly protein bound therapies May increase ergot related side effects or reduce ergot effectiveness for migraines if coadministered within 6 hours of ergot related drugs Extensively metabolized by CYP3A4 Hemoglobin A1c Description of Trial Reduction with Bromocriptine Bromocriptine Monotherapy (24 weeks) 0.1 Bromocriptine Add on to Sulfonylurea (24 weeks) 0.1 to 0.4 Bromocriptine Add on to Various Anti Diabetic Medications (52 weeks) Bromocriptine Add on to Sulfonylurea+Metformin (52 weeks) Approval: 2005 Initial Dosing: 5 mcg SQ twice daily prior to morning and evening meals May increase to 10 mcg twice daily after 1 month Pancreatitis Hypoglycemia when used with sulfonylurea Do not use in severe renal impairment and end stage renal disease Do not use in patients with severe gastrointestinal disease Adverse Effects (most common): nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia Byetta exenatide injection [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; Approval: January 2010 Initial Dosing: 0.6 mg SQ daily x 1 week; then increase to 1.2 mg daily (ok to dose irrespective of food) May increase to 1.8 mg daily if needed Pancreatitis Hypoglycemia with sulfonylurea Thyroid C cell tumors in animals Do not use in patients with personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 Adverse Effects (most common): headache, nausea, diarrhea, antiliraglutide antibody formation Victoza liraglutide (rdna origin) injection [package insert]. Princeton, NJ: Novo Nordisk, Inc.;2010. # Reaching Goal A1c < 7% Hemoglobin A1c Reduction Exenatide (Byetta ) Liraglutide (Victoza ) P value (95% CI) 43% 54% ( ) < ( ) Weight Loss NS Difference in Side Effects: Minor Hypoglycemia Different in Side Effects: Nausea Serious/Severe Adverse Events 2.6 events/patient/ year 8.6% with nausea at end of study 2.6%/4.7% Nausea, major hypoglycemia 1.93 events/patient/year 2.5% with nausea at end of study 5.1%/7.2% Dyspepsia, pancreatitis Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26 week randomised, parallel group, multinational, open label trial (LEAD 6). Lancet. 2009;374:

5 N=261 A1c 7.1% to 10.5% Glargine alone or in combination with metformin, pioglitazone, or both Treatment: Exenatide 10 mcg BID or placebo A1c decrease greater with exenatide 1.74% (95% CI 1.91% to 1.56%) vs. 1.22% (95% CI 1.22% to 0.86%) Difference 0.69% ( 0.93% to 0.46%); P<0.001 Weight change 1.8 kg with exenatide; 1 kg increase with placebo Adverse effects Greater incidence of nausea, diarrhea, vomiting, headache, constipation and treatment discontinuation with exenatide Buse J, Bergenstal RM, Glass LC, et al. Use of twice daily exenatide in basal insulin treated patients with type 2 diabetes. Ann Intern Med 2011;154(2): DURATION 3 Exenatide 2 mg weekly Insulin glargine A1c reduction 1.5% 1.3% Mean A1c after treatment 6.8% 7% Weight change 2.6 kg +1.4 kg Amylin Pharmaceuticals. Exenatide once weekly provided superior glucose control compared to Lantus in head to head DURATION 3 study. Available at: ir.net/phoenix.zhtml?c=101911&p=irol newsarticle&id= &highlight= Accessed Feb 23, DURATION 5 Exenatide 2 mg weekly Exenatide 10 mcg BID A1c reduction 1.6% 0.9% Mean A1c after treatment 7.1% 7.7% Weight change 2.3 kg 1.4 kg Eli Lilly and Company. Exenatide once weekly provided superior glucose control compared to Byetta in DURATION 5 study. Available at: Feb 23, Approval: 2006 Sitagliptin (Januvia ) dosing: 100 mg daily 50 mg daily (CrCl >/=30 to </=50 ml/min) 25 mg daily (CrCl <30 ml/min) Pancreatitis Hypoglycemia when used with sulfonylurea or insulin Severe allergic reaction including Stevens Johnson syndrome Adverse Effects (most common): nasopharyngitis, respiratory tract infection, headache Januvia sitagliptin tablets [package insert]. Whitehouse Station, NJ: Merck and Co., INC.; Approval: 2009 Saxagliptin (Onglyza ) dosing: 5 mg daily 2.5 mg daily (CrCl </=50 ml/min) Hypoglycemia when used with sulfonylurea Adverse Effects (most common): urinary tract infection, upper respiratory tract infection, headache, peripheral edema when used with thiazolidinedione (TZD) Onglyza saxagliptin tablets [package insert]. Princeton, NJ: Bristol Myers Squibb, Co.; Description of Trial Hemoglobin A1c Reduction with Saxagliptin Hemoglobin A1c Reduction with Sitagliptin Monotherapy 0.5% 0.6 Add on to Sulfonylurea 0.6% Add on totzd 0.9% 9 0.9% 9 2.4% (combo in treatment naïve) Add on to Metformin 0.7% 2.5% (combo in treatment naïve) 0.5% to 0.7% 1.9% (combo in treatment naïve) Add on to insulin Not studied 0.6% Triple therapy with metformin and sulfonylurea or TZD Sulfonylurea: 0.6 TZD: 1% Januvia sitagliptin tablets [package insert]. Whitehouse Station, NJ: Merck and Co., INC.; Onglyza saxagliptin tablets [package insert]. Princeton, NJ: Bristol Myers Squibb, Co.;

6 Diagnosis LSM+metformin A1c >8.5% or hyperglycemia sx 3 rd step A1c >8% : Consider insulin Add TZD Add sulfonylurea or basal insulin Add basal or intensify insulin Add sulfonylurea Add TZD or basal insulin Add basal or intensify insulin Add basal insulin (most effective) Intensify insulin Diabetes Care 2006;29: Intensive Insulin + Metformin +/ TZD Initiate MONOtherapy Options: Metformin DPP 4 inhibitors Incretin mimetics Insulin secretagogues Alpha glucosidase inhibitors or TZD Monitor and titrate medication over 2 3 months; consider combination if glycemic goals not met after 3 months Initiate COMBINATION therapy Options: Metformin + DDP 4 Metformin+secretagogue Metformin+alpha glucosidase inhibitor Metformin + TZD Fixed dose ratio combination single pills Initiate/Intensify COMBINATION therapy Monitor and titrate over 2 3 months; if glycemic goals not met, intensify therapy and monitor over 2 3 months. If goals not achieved, intensify therapy, add insulin, or transition to insulin. Initiate insulin therapy Options: Rapid acting insulin analog Premixed insulin analogs Long acting insulin analog Monitor and titrate over 2 3 months; if glycemic goals not met, intensify therapy. 6

7 AACE ADA A1c <6.5% Fasting/Pre Prandial <110 mg/dl 2 Hour Post Prandial <140 mg/dl A1c <7% Fasting mg/dl 2 Hour Post Prandial <180 mg/dl Diabetes Care 2010; 33 (Suppl 1):S11 S Saxagliptin (Onglyza) gy 5 mg daily 2. Bromocriptine (Cycloset) 0.8 mg daily with titration up to 4.8 mg 3. Liraglutide (Victoza) 0.6 mg daily with titration to 1.2 mg after 1 week 4. Insulin detemir (Levemir) 10 units nightly (with titration based on blood glucose measurements) 5. More than one of the above could be an appropriate recommendation 1. Saxagliptin (Onglyza) 5 mg daily 2. Bromocriptine (Cycloset) 0.8 mg daily with titration up to 4.8 mg 3. Liraglutide (Victoza) 0.6 mg daily with titration to 1.2 mg after 1 week 4. I would recommend no addition 7

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