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1 Accreditation Information The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The self-study learning portion of The Pharmacist & Patient-Centered Diabetes Care is approved for 15 contact hours (1.5 CEUs) of continuing pharmacy education credit (UAN 202-999-12-108-H04-P). The seminar is approved for 8 contact hours (0.8 CEUs) of continuing pharmacy education credit (UAN 202-999-12-107-L04-P). The live seminar is a required component of the certificate training program. This practice-based activity was developed by the American Pharmacists Association in co-sponsorship with the American Association of Diabetes Educators. 2 Speakers [insert session speakers] 3 Advisory Board • • • • • • Tommy Johnson, PharmD, CDE, BC-ADM Jonathan Marquess, PharmD, CDE, CPT Staci-Marie Norman, PharmD, CDE Charles Ponte, PharmD, CDE, BCPS Philip Rodgers, PharmD, BCPS, CPP, FCCP Jennifer Smith, PharmD, CDE 4 Disclosures Jonathan Marquess serves on the Speakers’ Bureaus for Abbott Diabetes Care, Novo Nordisk, and Sanofi. Staci-Marie Norman is a speaker for Eli Lilly and Company and LifeScan, Inc. Dr. Norman’s spouse is employed by Takeda Pharmaceutical Company. Philip Rodgers holds stock in Novo Nordisk. All other individuals involved in the development of this material declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. 5 6 Section 1 Comprehensive Diabetes Care Treating Type 2 Diabetes 7 Patient Case Leroy Davis 8 Leroy Davis (Part 1) • Assess Leroy’s status relative to comprehensive diabetes care goals and recommendations 9 Leroy Davis (Part 1) • What are your initial impressions of Leroy? 10 Leroy Davis (Part 1) • Is Leroy meeting the goals for glycemic control? 11 Goals for Glycemic Control A1C (%) Fasting/preprandial glucose Peak postprandial glucose ADA1 AACE2 <7a ≤6.5 70–130 mg/dL <110 mg/dL <180 mg/dL <140 mg/dLb aGoal for most adult patients. Goal for individual patients is A1C as close to normal (<6%) as possible without significant hypoglycemia. b2-hour postprandial. Abbreviations: AACE, American Academy of Clinical Endocrinologists; ADA, American Diabetes Association. 1. ADA Position Statement 2012. Available at: http://care.diabetesjournals.org/content/35/Supplement_1/S11.full.pdf+html. 2. AACE Guidelines 2011. Available at: https://www.aace.com/sites/default/files/DMGuidelinesCCP.pdf. 12 Leroy Davis (Part 1) • Is Leroy meeting the goals for blood pressure management? • Recommendations related to antihypertensive therapy? 13 Hypertension Goals ADA JNC 8 • <140/80 for most • <130/80 for younger individuals • <150/90 for >60 w/o DM or kidney disease • <140/90 for 18-59 w/o comorbidity or >60 w/comorbidity Diabetes Care Vol 37, Supp 1, January 2014 JNC 8: http://jama.jamanetwork.com 1/12/2014 Hypertension Treatment ADA JNC 8 • First-line agents: • BP >120/80: life-style – thiazide diuretics modification – calcium channel blockers – ACE Inhibitors • BP >140/80 life-style and – ARBs appropriate drug therapy • Second and third-line – ACE or ARBs – Multiple-drug therapy will probably be needed – One dose administered at bedtime Diabetes Care Vol 37, Supp 1, January 2014 JNC 8: http://jama.jamanetwork.com 1/12/2014 agents: high dose first line agents • Later-line alternatives include: the rest of the antihypertensive medications JNC 8 Hypertension Guidelines • Initial therapy in African-Americans is CCBs and thiazides instead of ACEIs • ACEIs and ARBs is recommended in all patients with chronic kidney disease regardless of ethnic decent • ACEIs and ARBs should not be used together • CCBs and thiazide diuretics should be used instead of ACEIs and ARBs in patients >75 with impaired kidney function JNC 8: http://jama.jamanetwork.com 1/12/2014 Leroy Davis (Part 1) • Is Leroy meeting the goals for cholesterol management? • Recommendations related to lipidmodifying therapy? 17 Cholesterol Goals Lipid Goal Low-density lipoprotein (LDL) cholesterol <100 mg/dLa High-density lipoprotein (HDL) cholesterol >40 mg/dL men >50 mg/dL women Triglycerides <150 mg/dL aLDL <70 mg/dL is an option in some patients. American Diabetes Association Standards of Medical Care in Diabetes—2012 18 Cholesterol Goals • Statin therapy + lifestyle modification for patients: – With overt cardiovascular disease (CVD) – >40 years of age with at least one other CVD risk factor • For other patients, consider adding statin therapy to lifestyle modification if: – LDL cholesterol remains >100 mg/dL – Multiple CVD risk factors are present American Diabetes Association Standards of Medical Care in Diabetes—2012 19 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol • Changed the paradigm for goals and therapy – Focuses on those most likely to benefit • 4 Statin Benefit Groups: – Individuals with clinical CVD – Individuals with primary elevated LDL ≥ 190mg/dL – Individuals 40-75 with diabetes and LDL 70-189 mg/dL – Individuals 40-75 without CVD or diabetes with LDL 70189 mg/dL with 10-year risk of CVD ≥ 7.5% • Statin therapy goal is maximum tolerated intensity – Not focused on LDL of <100 or <70mg/dL 2013 ACC/AHA Blood Cholesterol Guidelines http://circ.ahajournals.org 1/12/13 Leroy Davis (Part 1) • What additional care might Leroy need? 21 Comprehensive Care Needs • • • • Aspirin therapy Dental/oral examination Depression screening Diabetes selfmanagement education • Dilated eye examination • Foot examination • Annual influenza vaccination • Pneumococcal vaccination • Hepatitis B vaccination • Serum creatinine measurement • Smoking cessation counseling • Urine test for albuminto-creatinine ratio 22 Leroy Davis (Part 1) • What about self-monitoring of blood glucose (SMBG)? 23 SBGM with Intensive Insulin Regimen At least prior to meals and snacks • • • • • • Occasionally postprandial At bedtime Prior to exercise When suspect low blood glucose After treatment of low blood glucose Prior to critical tasks – such as driving Continuous Blood Glucose Monitoring • May be useful in helping lower A1c • May be a supplemental tool to SMBG in those with hypoglycemia unawareness or frequent hypo episodes 24 Continuous Blood Glucose Monitoring When and Why would we use this: • May be useful in helping lower A1c • May be a supplemental tool to SMBG in those with hypoglycemia unawareness or frequent hypo episodes 25 “For patients using less-frequent insulin injections, noninsulin therapies, or medical nutrition therapy alone, SBGM may be useful as a guide to management.” American Diabetes Association Standards of Medical Care in Diabetes—2012 26 SBGM with Non-Insulin Type 2 Regimens For patients not using insulin the recommendations are open and geared to individualizing the regimen to the patient’s needs. Reasons to Use • Improve patient awareness of effects of lifestyle habits (e.g., food, exercise) • Identify variability of glucose levels • Aid in treating to target • Help patients recognize episodes of hypoglycemia Factors to Consider • Cost • Patient motivation • How will results be used? 27 Leroy Davis (Part 1) • Which of Leroy’s care needs will you address first? • How will you ensure that all of Leroy’s care needs are addressed? 28 Leroy Davis (Part 2) • Recommend possible changes to Leroy’s diabetes medication regimen to meet glycemic goals 29 Leroy Davis (Part 2) • What are the possible options for intensifying Leroy’s antihyperglycemic regimen? • What specific change would you recommend? Why? 30 Treatment Intensification • Based on adding another agent from a different class – Second oral agent – Glucagon-like peptide-1 (GLP-1) receptor agonist – Insulin • Each new class of noninsulin agents added to initial therapy lowers A1C ~0.9%–1.1% 31 Drug Selection Considerations • Efficacy (A1C-lowering capacity) • Effect on fasting plasma glucose and postprandial plasma glucose • Mechanism of action • Route of administration • Ease of use • Contraindications in hepatic or renal failure • Impact on weight • Impact on nonglycemic factors (e.g., serum lipids) • Adverse effects/ tolerability • Risk of hypoglycemia • Likely adherence • Cost 32 T2DM Anti-hyperglycemic Therapy: General Recommendations Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print] 33 Benefits are classified according to major effects on fasting glucose, postprandial glucose, and nonalcoholic fatty liver disease (NAFLD). Eight broad categories of risks are summarized. The intensity of the background shading of the cells reflects relative importance of the benefit or risk.* * The abbreviations used here correspond to those used on the algorithm (Fig. 1). ** The term ‘glinide’ includes both repaglinide and nateglinide. AACE/ACE Consensus Statement Algorithm 2009. Available at: www.aace.com/pub. © AACE December 2009 Update. May not be reproduced in any form without express written permission from AACE. 35 Drug Therapy Updates 36 Emerging Agents SGLT2 Inhibitors • Empagliflozin (BI10773) :filed by Eli Lilly (+) Boehringer Ingelheim • Ertugliflozin (MK-8835; PF-04971729): Phase II, Merck + Pfizer GLP1 Agonists (once weekly SQ formulations) • Albiglutide BLA (formerly Syncria): filed by GSK • Dulaglutide (LY2189265): filed by Eli Lilly • Semaglutide (NN9535): Phase III; Novo Nordisk Emerging Agents DPP4 Inhibitors • Trelagliptin (SYR-472): Phase III, Takeda • Omarigliptin: once weekly oral; Phase III, Merck Inhaled Insulin • Afrezza: Ultra-rapid-acting bolus insulin using Dreamboat™ inhaler; NDA submitted October 2013 GPR 40 Agonist • Fasiglifam (TAK-875): Development terminated due to concerns of liver safety Questions? 39