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10/26/2012 Diabetes Pharmacotherapy Update: What’s the News? 3rd Annual Regional Healthcare Symposium L. Brian Cross, PharmD, BCACP, CDE October 27, 2012 Objectives At the completion of this presentation the participant will be able to: • Describe recent changes to national diabetes treatment guidelines. • Describe newer evidence concerning various approved medication classes for the treatment of diabetes. • Describe recently approved and yet-to-beapproved pharmacotherapy agents for the treatment of diabetes. • Describe new technology issues related to the treatment of diabetes. RECENT DIABETES GUIDELINE CHANGES 1 10/26/2012 DM Disease Related Issues • Intensive A1C lowering in trials offers modest benefit, mostly microvascular over 5+ yrs. There is some evidence for macrovascular benefit over the long long‐term term (>10‐20yrs). • Intensive A1C lowering may increase risk of harm including major hypoglycemia & increased all‐cause death in some. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD008143.9 N EnglJ Med. 2008 Jun 12;358(24):2545‐59. Diabetes Care. 2008;31:1913-19. DM Disease Related Issues • In studies with A1Cs as high as 7.9% and 8.4% in the less intensive Tx arms, there were only marginal clinical outcome differences, but much less hypoglycemia in the less intensive Tx arms. arms Since frail elderly patients are even more likely to experience potential harms, these A1Cs provide some insight as to potentially reasonable A1C targets/ranges. 2 10/26/2012 IS THERE A J-CURVE IN BLOOD GLUCOSE? GPRD Retrospective Cohort Analysis Lancet. 2010;375:481-9. DM Disease Related Issues • The cohort study in aging found that the mortality risk is a U‐ shaped curve which increases for A1Cs <6% and >9%. Risk of any complication increased with A1Cs >8%. A similar study of patients with diabetes and CKD found a similar U‐curve where mortality was increased with A1C <6.5% and >8.0%. • Some guidelines have provided specific recommendations on how to individualize glycemic control in the elderly. Diabetes Care. 2011Jun;34(6):1329‐36. Arch Intern Med. 2011 Nov 28;171(21):1920‐7 3 10/26/2012 Endocrine Practice. 2011;17(suppl2):1-53. PT CENTERED APPROACH!!! TREAT THE PT NOT THE TARGET Diabetes Care. 2012;35:1364-79. Less stringent A1C goals (such as <8% or even slightly higher) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, and extensive comorbid conditions and for those with longstanding diabetes in whom the general goal is difficult to attain despite diabetes self‐management education, appropriate glucose monitoring, and effective doses of multiple glucose‐lowering agents including insulin. Diabetes Care. 2012;35:1364-79. 4 10/26/2012 Diabetes Care. 2012;35:1364-79. Diabetes Care. 2009;32:193-203. 5 10/26/2012 TIER 1 Lifestyle + Metformin + Basal insulin Lifestyle + Metformin + Intensive insulin Lifestyle + Metformin Lifestyle + Metformin + Sulfonylurea Step 1 Step 2 Lifestyle + Metformin + Pioglitazone No hypoglycemia Edema, CHF, Bone loss Lifestyle + Metformin + GLP-1 agonistb TIER 2 Diabetes Care 2009;32:193-203. No hypoglycemia; Weight loss, Nausea/vomiting Step 3 Lifestyle + Metformin + Pioglitazone + Sulfonylurea Lifestyle + Metformin + Basal insulin NEWER EVIDENCE FOR APPROVED PHARMACOTHERAPIES DM Medication Related Issues • Metformin – still foundational therapy, more debate on dose adjustments with renal function (GFR < 30 = D/C; 30 = <850mg/day; 60 = <1700mg/day), GI issues & elderly may be more difficult in some, lactic acidosis risk unclear • SU’s – ↑hypoglycemia, ↑h pogl cemia esp with ith decreased dec eased renal enal function, ? CV events, repaglinide (Prandin®) might be useful for pts with varying appetites • TZD’s – less useful due to concerns (HF, edema, weight gain, fractures), cost • DPP-4’s/GLP-1’s – limited beta-cell function?, cost, less hypoglycemia vs. SU’s & insulin 6 10/26/2012 DM Medication Related Issues • Insulin – basal & premix sometimes helpful if mealtimes / activity times are predictable, MDI OK in some but need to assess pt & caregiver ability, glargine & detemir may have less hypos, AVOID sliding scales, • FIX LOW’s LOW’ FIRST, FIRST THEN HIGH’S • SMBG – growing controversial data on utility Am Health Drug Benefits. 2011;4(5):303-11. Am Health Drug Benefits. 2011;4(5):303-11. 7 10/26/2012 YET-TO-BE APPROVED PHARMACOTHERAPIES Am Health Drug Benefits. 2011;4(5):303-11. NEW TECHNOLOGY ISSUES FOR DIABETES 8 10/26/2012 9