9/29/ Disclosure. Learning Objectives. Diabetes Update: Guidelines, Treatment Options & Trends
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1 + Diabetes Update: Guidelines, Treatment Options & Trends Melissa Max, PharmD, BC-ADM, CDE Assistant Professor of Pharmacy Practice Harding University College of Pharmacy + Disclosure Conflicts Of Interest and Financial Relationships Disclosures: Melissa Max, PharmD, BC-ADM, CDE No COI/Financial Relationships to Disclose. Learning Objectives Analyze differences between the recommendations of the ADA/EASD and the AACE regarding the treatment of diabetes. Interpret recent recommendations regarding interventions for patients with prediabetes/at increased risk for developing diabetes. Describe the place in therapy for newer pharmacotherapeutic agents. Apply knowledge of evidence-based recommendations to specific patient cases. Identify trends in pharmacotherapeutic management of diabetes. 1
2 + Type 2 Diabetes (T2D) Overview Hallmarks of T2D Decreased insulin sensitivity Progressive loss of β cell function Therapeutic goals are not exclusively glucocentric Optimizing physical activity, weight loss and healthy eating are key Progressive disease Monotherapy failure Next steps? + Inpatient Use Insulin remains gold standard Significant concerns regarding the use of metformin, secretagogues and GLP1 RAs in inpatient setting Imperative that pharmacists be familiar with various diabetes pharmacotherapeutic agents as patients will be admitted and discharged on these therapies + Current Guidelines American Diabetes Association annual clinical practice recommendations, released each January American Diabetes Association and European Association for the Study of Diabetes 2012 Position Statement for T2D American Association of Clinical Endocrinologists Comprehensive Diabetes Management Algorithm
3 9/29/2014 Diabetes Care 2012;35: Diabetologia 2012;55: ADA/EASD Summary Metformin first line Consider insulin as initial therapy if significant hyperglycemia or high A1C If noninsulin monotherapy not effective over 3 months, add a second oral agent, GLP-1 agent, or insulin Each new class of agent added lowers A1C ~1% 3
4 + AACE & ADA/EASD Comparison AACE A1C target <6.5% Monotherapy if A1C < 7.5% Dual therapy for A1C 7.6-9% Consider use of insulin as initial therapy A1C > 9% Focus on total cost of therapy ADA/EASD A1C target < 7%* May consider lifestyle alone for 3 months if A1C < 7.5% Dual therapy if A1C 9% Consider use of insulin as initial therapy A1C 10% 4
5 + Multifactorial Interventions Glucose lowering Lipid modification Optimal CV risk reduction Lifestyle modification & tobacco cessation BP lowering Goals for Glycemic Control ADA 1 AACE 2 A1C (%) <7 a 6.5 Fasting/preprandial glucose Peak postprandial glucose mg/dl <110 mg/dl <180 mg/dl <140 mg/dl b a Goal for most adult patients. Goal for individual patients is A1C as close to normal (<6%) as possible without significant hypoglycemia. b 2-hour postprandial. 1. ADA Position Statement Available at: 2. AACE Guidelines Available at: + Individualization of A1C Goal Tighter targets ( %) younger, healthier Looser targets ( % or more) older, comorbidities, risk of hypoglycemia Avoidance of hypoglycemia 5
6 + Diabetes Care 2012;35: Diabetologia 2012;55: (Adapted with permission from: Ismail-Beigi et al. Ann Intern Med 2011;154:554) + Antihyperglycemic Therapy Nonpharmacologic Weight optimization Healthy diet Increased physical activity Pharmacotherapeutic options Oral agents Parenterals Non-insulin GLP-1 RA Amylin mimetic Insulin + 12 Drug Classes Biguanides Sulfonylureas Meglitinides Thiazolidinediones Alpha Glucosidase Inhibitors Dopamine-2 Agonists Bile Acid Sequestrants DPP-4 Inhibitors GLP-1 Receptor Agonists* Amylin Mimetic* Insulin* Sodium Glucose Co- Transporter-2 (SGLT2) Inhibitors 6
7 + Drug Selection Considerations Duration of disease Which blood glucose level is not at target Patient preference for route of administration The degree of A1C-lowering effect required to achieve goal Adverse effect profile and the patient s tolerability Comorbidities + Primary Glucose Lowering Effect Fasting Metformin TZD SU Long-acting insulin Post-prandial GLP-1 Agonists* DPP-4 Inhibitors SU Rapid-acting insulin Alpha-glucosidase inhibitors Meglitinides Pramlintide + Weight Weight Loss/Neutral GLP-1 Agonists* DPP4 Inhibitors (neutral) SGLT2 Inhibitors Weight Gain Insulin SU TZD Metformin (neutral) Pramlintide 7
8 + Pharmacotherapy Pearls + SU Cautions Risk of hypoglycemia is substantially increased in the elderly Even a mild episode of hypoglycemia may lead to adverse outcomes in frail elderly patients. Avoidance of hypoglycemia is an important consideration in choosing therapeutic agents and establishing glycemic goals in elderly adults. Effective dose generally about ½ maximum dose + Sulfonylureas (SU) Avoid glyburide in older adults Assess patients for hypoglycemia regularly More likely to occur: After exercise/missed meals Eat poorly or abuse alcohol Impaired renal or cardiac function Following hospitalization In patients with T2D, hypoglycemia risk is linked more to treatment strategies than A1C If recurrent/severe hypoglycemia occurs, strongly consider changing therapy and/or targets 8
9 + Metformin Cautions Use in renal dysfunction CI: Scr> 1.5 mg/dl male, > 1.4 mg/dl female Decrease dose if GFR < 45, d/c if < 30 Other cautions Heart failure History of alcoholism/binge drinking Age > 80 years Active liver disease GI intolerance & weight loss Hypoxic conditions lactic acidosis Iodinated contrast material + Metformin Pearls Effective treatment dose generally mg daily Patient counseling GI distress in ~30%, transient Administer with meals, consider XR formulation B12 + TZD Pearls May be used in renal impairment Do not cause hypoglycemia Should not be used in patients with class III or IV HF AE: edema, fractures, bladder CA 9
10 + Recent Approvals SGLT2 Inhibitors Canagliflozin Dapagliflozin Empagliflozin DPP4 Inhibitor/Combo Alogliptin Alogliptin + metformin Alogliptin + pioglitazone + Recent Approvals GLP1 Agonist Albiglutide Once weekly; SQ 30 mg once weekly; may increase to 50 mg once weekly if inadequate glycemic response New Indication Liraglutide 3 mg daily FDA committee recommendation 9/12/14 + SGLT2 Inhibitors Sodium-glucose co-transporter type 2 (SGLT2) Inhibitors MOA: inhibition of SGLT2 receptors in kidney responsible for glucose reabsorption in proximal tubule Action reduce reabsorption of filtered glucose, lower the renal threshold for glucose, and increase urinary glucose excretion Insulin independent MOA; decreases fasting and post-prandial glucose concentrations 10
11 + SGLT2 Pearls Benefit Weight loss Blood pressure Low incidence of hypoglycemia Pleiotropic benefit Similar to DPP4 inhibitors in A1C lowering efficacy AE/Risk Genital mycotic infections UTI Hypotension Lipid effects Renal effects Bladder cancer + SGLT2 Dosing & Administration Canagliflozin mg daily dose; before the first meal of the day Moderate renal impairment [egfr] 45 to 59 ml/min max dose 100 mg daily Not indicated in patients with GFR <45 ml/min or in patients with severe hepatic impairment Dapagliflozin 10 mg once daily, with or without food Not recommended for use in patients with egfr < 60 ml/min or in patients with active bladder cancer For patients with severely reduced liver function, starting dose of 5 mg is recommended + SGLT2 Dosing & Administration Empagliflozin 10 mg and 25 mg tablet CI Severe renal impairment (egfr <30 ml/minute/1.73 m2) ESRD or dialysis Anticipated availability currently undetermined 11
12 + SGLT2 Place in Therapy Add-on to metformin, after trying usual second-line therapies Not mentioned in the ADA guidelines, as these guidelines were published before the approval of SGLT2 inhibitors The AACE consider these agents to use with caution: as monotherapy in patients with an A1C less than 7.5%; as part of a dual or triple regimen in those with an A1C of 7.5% to 9.0%. Incretin Hormones + DPP- 4 Inhibitors MOA: prolong the t½ of GLP-1 and stimulate glucosedependent insulin secretion, reducing postprandial glucose elevations Efficacy: decrease A1C 0.7-1% Adverse effects: Upper respiratory infections, UTI, HA Pancreatitis Low incidence of hypoglycemia Weight neutral 12
13 + DPP-4 Inhibitors Sitagliptin Dose: mg daily CrCl 50 ml/min, dose is 100 mg daily CrCl <50 but 30 ml/min, dose is 50 mg daily CrCl <30 ml/min, dose is 25 mg daily Linagliptin Dose: 5 mg daily + DPP-4 Inhibitors Saxagliptin Dose: mg daily 2.5 mg dose for patients with CrCl 50 ml/min Alogliptin Dose mg daily Reduce by half for patients with CrCl ml/min + DPP- 4 Inhibitors: Place in Therapy ADA considers these as second-line therapies to be added on to metformin. AACE recommends these as one of several preferred agents, after metformin, as monotherapy. They can be used as part of a dual therapy regimen. They can be considered as part of a multi-drug regimen with metformin, in drug-naïve, asymptomatic patients with A1C > 9%. 13
14 + GLP-1 Receptor Agonists MOA: similar to human GLP-1 Enhance insulin secretion Suppress postprandial glucagon when blood glucose elevated; reduce hepatic glucose production Exenatide, exenatide extended-release Liraglutide Albiglutide + GLP-1 Agonists Benefit Weight loss Low risk of hypoglycemia Efficacy Blood pressure/lipid improvement β-cell preservation Risk/Disadvantage Expensive Injectable dosage form Pancreatitis Renal insufficiency Thyroid cell cancer in rodents long-acting formulations N&V Gastroparesis + GLP-1 Agonists: Place in Therapy ADA considers these as second-line therapies to be added on to metformin, if target A1C not met. AACE recommend these as the preferred agent, after metformin, as monotherapy or as first choice of agents for add-on therapy to metformin in patients with A1C values 6.5% to 7.5%, or as metformin addon therapy for A1C of 7.6% to 9%. Additionally, these agents can be considered as part of a multi-drug regimen with metformin, in drugnaïve, asymptomatic patients with A1C > 9%. 14
15 + New GLP-1 RA formulation FDA has approved extended-release exenatide in a pen form. Indication adjunctive therapy, T2D Dose 2 mg SQ once weekly Advantage Ease the self-injection process by eliminating the need for the patient to transfer the medication between vial and syringe. Efficacy Up to 1.6% reduction in A1C + Emerging therapies + Insulins Ultra rapid-acting Afrezza Insulin human (rdna origin); ultra rapid-acting mealtime inhalable powder Approved July 2014 Lung function testing Less hypoglycemia 15
16 + Ultra rapid-acting Conversion + Ultra Long-Acting Insulins Insulin degludec Approved EU; FDA rejected Feb 2013; requested additional safety data Consistency, efficacy, safety, flexibility Peg-lispro Phase III trials complete; NDA expected first quarter 2015 Improved glycemic control; IMAGINE-1 & IMAGINE-3 U300 EDITION II less nocturnal hypoglycemia compared to glargine Flatter and longer PK/PD profile; DOA 40 hours + Insulin Combination Insulin degludec + insulin aspart Fixed combination basal with bolus Once-daily for T1 and T2 (remaining meals with aspart) Rejected Feb 2013 by FDA; requested additional CV data 16
17 + Trends Increasing use of basal insulin and GLP1 RA More effective at lowering A1C Not associated with increased hypoglycemia Weight loss Insulin and SGLT2 inhibition Prevention of disease progression in patients at increased risk for developing diabetes + GLP1/Insulin Combinations Insulin degludec and liraglutide Once-daily basal insulin and once-daily GLP-1 analogue T2DM Lixisenatide and insulin glargine GLP-1 agonist and basal insulin analog T2DM + Pipeline Incretins GLP-1 RA Lixisenatide Once daily for T2D NDA expected 2015 Dulaglutide Once weekly T2D AWARD; REWIND Semaglutide Once-weekly T2D SUSTAIN DPP4 inhibitor Omarigliptin Once-weekly, adults, T2 Phase III trials Trelagliptin succinate Once-weekly for T2D Phase III trials 17
18 + Case 1 A 47-year-old woman, newly diagnosed with T2D, presents with an A1C of 11.6% and a fasting glucose concentration of 350 mg/dl. In addition to improvements in physical activity and food choices, which one of the following is the best initial treatment option for this patient? A. Metformin B. Extended release exenatide C. Insulin glargine and insulin aspart D. Canagliflozin + Case 2 Which one of the following drugs, if coadministered with exenatide, would be most likely to increase hypoglycemia risk? A. Metformin B. Glyburide C. Saxagliptin D. Pioglitazone + Case 3 A 52-year-old woman with a 10-year history of T2D has an A1C of 7.6%. She has a history of metformin intolerance. Current antihyperglycemic therapy is pioglitazone 45 mg/day. Her SCr is 2.1 mg/dl, and her estimated CrCl is 26 ml/minute. Which one of the following would be most appropriate to add to this patient s drug regimen? A. Sitagliptin 100 mg/day B. Liraglutide 0.6 mg/day C. Extended-release exenatide 2 mg/week D. Linagliptin 5 mg/day 18
19 + Case 4 HW is a 45-year-old obese white male with T2D, currently receiving metformin 1 g twice daily, whose postprandial BG is higher than desired. His most recent A1C is 7.5%. Which of the following is the best option for HW? A. increase metformin to 850 mg three times daily B. substitute metformin with a SU C. add a bedtime dose of insulin detemir D. add sitagliptin 100 mg daily + Questions? + References American Diabetes Association American Association of Clinical Endocrinologists Standards of Medical Care in Diabetes Diabetes Care. January 2014; 35: S11-S63 Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European ssociation for the Study of Diabetes (EASD); Diabets Care June : DeFranzo, R.A., Davidson, J.A., & del Prato, S. (2012). The role of the kidneys in glucose homeostasis: A new path towards normalizing glycaemia. Diabetes, Obesity & Metabolism, 14 (1), Inzucchi, S. Oral Antihyperglycemic Therapy for Type 2 Diabetes: Scientific Review. JAMA. 2002; 287: DeWitt, D. Outpatient Insulin Therapy in Type 1 and Type 2 Diabetes Mellitus: Scientific Review. JAMA. 2003;289:
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