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Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European.

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Presentation on theme: "Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European."— Presentation transcript:

1 Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

2 Writing Group American Diabetes Association Richard M. Bergenstal MD Int’l Diabetes Center, Minneapolis, MN John B. Buse MD, PhD University of North Carolina, Chapel Hill, NC Anne L. Peters MD Univ. of Southern California, Los Angeles, CA Richard Wender MD Thomas Jefferson University, Philadelphia, PA Silvio E. Inzucchi MD (co-chair) Yale University, New Haven, CT European Assoc. for the Study of Diabetes Michaela Diamant MD, PhD VU University, Amsterdam, The Netherlands Ele Ferrannini MD University of Pisa, Pisa, Italy Michael Nauck MD Diabeteszentrum, Bad Lauterberg, Germany Apostolos Tsapas MD, PhD Aristotle University, Thessaloniki, Greece David R. Matthews MD, DPhil (co-chair) Oxford University, Oxford, UK

3 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM: A Patient-Centered Approach 1. PATIENT-CENTERED APPROACH 2. BACKGROUND Epidemiology and health care impact Relationship of glycemic control to outcomes Overview of the pathogenesis of Type 2 diabetes 3. ANTI-HYPERGLYCEMIC THERAPY Glycemic targets Therapeutic options - Lifestyle - Oral agents & non-insulin injectables - Insulin Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

4 3. ANTIHYPERGLYCEMIC THERAPY Implementation Strategies - Initial drug therapy - Advancing to dual combination therapy - Advancing to triple combination therapy - Transitions to and titrations of insulin 4. OTHER CONSIDERATIONS Age Weight Sex/racial/ethnic/genetic differences Comorbidities (Coronary artery disease, Heart failure, Chronic kidney disease, Liver dysfunction, Hypoglycemia) 5. FUTURE DIRECTIONS / RESEARCH NEEDS ADA-EASD Position Statement: Management of Hyperglycemia in T2DM: A Patient-Centered Approach Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

5 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 1.Patient-Centered Approach “...providing care that is respectful of and responsive to individual patient preferences, needs, and values - ensuring that patient values guide all clinical decisions.” Gauge patient’s preferred level of involvement. Explore, where possible, therapeutic choices. Utilize decision aids. Shared decision making – final decisions re: lifestyle choices ultimately lie with the patient. Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

6 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 2. BACKGROUND Epidemiology and health care impact Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

7 Age-adjusted Percentage of U.S. Adults with Obesity or Diagnosed Diabetes Obesity (BMI ≥30 kg/m 2 ) Diabetes No Data 26.0% No Data 9.0% CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at OBESITOBESITYYOBESITOBESITYYY OBESITOBESITYYOBESITOBESITYYY DIABETESDIABETESDIABETESDIABETES DIABETESDIABETESDIABETESDIABETES

8 The Diabetes Epidemic: Global Projections, 2010–2030 IDF. Diabetes Atlas 5 th Ed. 2011

9 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 2. BACKGROUND Relationship of glycemic control to outcomes Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

10 Impact of Intensive Therapy for Diabetes: Summary of Major Clinical Trials StudyMicrovascCVDMortality UKPDS DCCT / EDIC* ACCORD ADVANCE VADT Long Term Follow-up Initial Trial * in T1DM Kendall DM, Bergenstal RM. © International Diabetes Center 2009 UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854. Holman RR et al. N Engl J Med. 2008;359:1577. DCCT Research Group. N Engl J Med 1993;329;977. Nathan DM et al. N Engl J Med. 2005;353:2643. Gerstein HC et al. N Engl J Med. 2008;358:2545. Patel A et al. N Engl J Med 2008;358:2560. Duckworth W et al. N Engl J Med 2009;360:129. (erratum: Moritz T. N Engl J Med 2009;361:1024)

11 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 2. BACKGROUND Overview of the pathogenesis of T2DM - Insulin secretory dysfunction - Insulin resistance (muscle, fat, liver) - Increased endogenous glucose production - Deranged adipocyte biology - Decreased incretin effect Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

12 + +     peripheral glucose uptake hepatic glucose production pancreatic insulin secretion pancreatic glucagon secretion Main Pathophysiological Defects in T2DM gut carbohydrate delivery & absorption incretin effect HYPERGLYCEMIA ? Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011

13 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 3. ANTI-HYPERGLYCEMIC THERAPY Glycemic targets  HbA1c < 7.0% (mean PG  mg/dl [ mmol/l ]) - Pre-prandial PG <130 mg/dl (7.2 mmol/l ) - Post-prandial PG <180 mg/dl (10.0 mmol/l ) - Individualization is key:  Tighter targets ( %) - younger, healthier  Looser targets ( % + ) - older, comorbidities, hypoglycemia prone, etc. - Avoidance of hypoglycemia PG = plasma glucose Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

14 Figure 1 Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596 (Adapted with permission from: Ismail-Beigi et al. Ann Intern Med 2011;154:554)

15 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 3. ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Lifestyle - Weight optimization - Healthy diet - Increased activity level Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

16 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 3. ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Oral agents & non - insulin injectables - Metformin - Sulfonylureas - Thiazolidinediones - DPP-4 inhibitors - GLP-1 receptor agonists - Meglitinides -  - glucosidase inhibitors - Bile acid sequestrants - Dopamine-2 agonists - Amylin mimetics Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

17 ClassMechanismAdvantagesDisadvantagesCost Biguanides (Metformin) Activates AMP-kinase  Hepatic glucose production Extensive experience No hypoglycemia Weight neutral ?  CVD events Gastrointestinal Lactic acidosis B-12 deficiency Contraindications Low SUs / Meglitinides Closes KATP channels  Insulin secretion Extensive experience  Microvascular risk Hypoglycemia Weight gain Low durability ?  Ischemic preconditioning Low TZDs Activates PPAR-   Insulin sensitivity No hypoglycemia Durability  TGs,  HDL-C ?  CVD events (pio) Weight gain Edema / heart failure Bone fractures ?  MI (rosi) ? Bladder ca (pio) High  -GIs Inhibits  -glucosidase Slows carbohydrate absorption No hypoglycemia Nonsystemic  Post-prandial glucose ?  CVD events Gastrointestinal Dosing frequency Modest  A1c Mod. Table 1. Properties of anti-hyperglycemic agents Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

18 ClassMechanismAdvantagesDisadvantagesCost DPP-4 inhibitors Inhibits DPP-4 Increases GLP-1, GIP No hypoglycemia Well tolerated Modest  A1c ? Pancreatitis Urticaria High GLP-1 receptor agonists Activates GLP-1 receptor  Insulin,  glucagon  gastric emptying  satiety Weight loss No hypoglycemia ?  Beta cell mass ? CV protection GI ? Pancreatitis Medullary ca Injectable High Amylin mimetics Activates amylin receptor  glucagon  gastric emptying  satiety Weight loss  Post-prandial glucose GI Modest  A1c Injectable Hypo w/ insulin Dosing frequency High Bile acid sequestrants Binds bile acids  Hepatic glucose production No hypoglycemia Nonsystemic  LDL-C GI Modest  A1c  TGs Dosing frequency High Dopamine-2 agonists Activates DA receptor Modulates hypothalamic control of metabolism  Insulin sensitivity No hypoglycemia ?  CVD events Modest  A1c Dizziness/syncope Nausea Fatigue High Table 1. Properties of anti-hyperglycemic agents Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

19 ClassMechanismAdvantagesDisadvantagesCost Insulin Activates insulin receptor  Glucose disposal  Hepatic glucose production Universally effective Unlimited efficacy  Microvascular risk Hypoglycemia Weight gain ? Mitogenicity Injectable Training requirements “Stigma” Variable Table 1. Properties of anti-hyperglycemic agents Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

20 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 3. ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Insulin - Human Neutral protamine Hagedorn (NPH) - Human Regular - Basal analogues (glargine, detemir) - Rapid analogues (lispro, aspart, glulisine) - Pre-mixed varieties Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

21 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM Long (Detemir) Rapid (Lispro, Aspart, Glulisine) Hours Long (Glargine) Short (Regular) Hours after injection Insulin level 3. ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: Insulin Intermediate (NPH)

22 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 3. ANTI-HYPERGLYCEMIC THERAPY Implementation strategies: - Initial therapy - Advancing to dual combination therapy - Advancing to triple combination therapy - Transitions to & titrations of insulin Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

23 Fig. 2. T2DM Antihyperglycemic Therapy: General Recommendations Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

24 Fig. 2. T2DM Antihyperglycemic Therapy: General Recommendations Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

25 Fig. 2. T2DM Antihyperglycemic Therapy: General Recommendations Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

26 Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

27 Fig. 3. Sequential Insulin Strategies in T2DM Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

28 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Age Weight Sex / racial / ethnic / genetic differences Comorbidities -Coronary artery disease -Heart Failure -Chronic kidney disease -Liver dysfunction -Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

29 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Age: Older adults -Reduced life expectancy -Higher CVD burden -Reduced GFR -At risk for adverse events from polypharmacy -More likely to be compromised from hypoglycemia Less ambitious targets HbA1c <7.5–8.0% if tighter targets not easily achieved Focus on drug safety Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

30 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Weight -Majority of T2DM patients overweight / obese -Intensive lifestyle program -Metformin -GLP-1 receptor agonists -? Bariatric surgery -Consider LADA in lean patients Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

31 T2DM Anti-hyperglycemic Therapy: General Recommendations Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

32 Adapted Recommendations: When Goal is to Avoid Weight Gain Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

33 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Sex/ethnic/racial/genetic differences -Little is known -MODY & other monogenic forms of diabetes -Latinos: more insulin resistance -East Asians: more beta cell dysfunction -Gender may drive concerns about adverse effects (e.g., bone loss from TZDs) Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

34 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities -Coronary Disease -Heart Failure -Renal disease -Liver dysfunction -Hypoglycemia  Metformin: CVD benefit (UKPDS)  Avoid hypoglycemia  ? SUs & ischemic preconditioning  ? Pioglitazone &  CVD events  ? Effects of incretin-based therapies Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

35 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities -Coronary Disease -Heart Failure -Renal disease -Liver dysfunction -Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596  Metformin: May use unless condition is unstable or severe  Avoid TZDs  ? Effects of incretin-based therapies

36 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities -Coronary Disease -Heart Failure -Renal disease -Liver dysfunction -Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596  Increased risk of hypoglycemia  Metformin & lactic acidosis  US: SCr ≥ 1.5 (1.4 women)  UK: GFR < 45 & GFR < 30  Caution with SUs (esp. glyburide)  DPP-4-i’s – dose adjust for most  Avoid exenatide if GFR < 30

37 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities -Coronary Disease -Heart Failure -Renal disease -Liver dysfunction -Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596  Most drugs not tested in advanced liver disease  Pioglitazone may help steatosis  Insulin best option if disease severe

38 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. OTHER CONSIDERATIONS Comorbidities -Coronary Disease -Heart Failure -Renal disease -Liver dysfunction -Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596  Emerging concerns regarding association with increased morbidity / mortality  Proper drug selection is key in the hypoglycemia prone

39 T2DM Anti-hyperglycemic Therapy: General Recommendations Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

40 Adapted Recommendations: When Goal is to Avoid Hypoglycemia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

41 Adapted Recommendations: When Goal is to Minimize Costs Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

42 Guidelines for Glucose, BP, & Lipid Control American Diabetes Assoc. Goals HbA1C < 7.0% (individualization) Preprandial glucose mg/dL ( mmol/l) Postprandial glucose < 180 mg/dL Blood pressure < 130/80 mmHg Lipids LDL: < 100 mg/dL (2.59 mmol/l) < 70 mg/dL (1.81 mmol/l) (with overt CVD) HDL: > 40 mg/dL (1.04 mmol/l) > 50 mg/dL (1.30 mmol/l) TG: < 150 mg/dL (1.69 mmol/l) ADA. Diabetes Care 2012;35:S11–S63 HDL = high-density lipoprotein; LDL = low-density lipoprotein; PG = plasma glucose; TG = triglycerides.

43 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM 4. FUTURE DIRECTIONS / RESEARCH NEEDS Comparative effectiveness research  Focus on important clinical outcomes Contributions of genomic research Perpetual need for clinical judgment! Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

44 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM KEY POINTS Glycemic targets & BG-lowering therapies must be individualized. Diet, exercise, & education: foundation of any T2DM therapy program Unless contraindicated, metformin = optimal 1st-line drug. After metformin, data are limited. Combination therapy with 1-2 other oral / injectable agents is reasonable; minimize side effects. Ultimately, many patients will require insulin therapy alone / in combination with other agents to maintain BG control. All treatment decisions should be made in conjunction with the patient (focus on preferences, needs & values.) Comprehensive CV risk reduction - a major focus of therapy. Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596

45 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM Invited Reviewers Professional Practice Committee, American Diabetes Association Panel for Overseeing Guidelines and Statements, European Association for the Study of Diabetes American Association of Diabetes Educators The Endocrine Society American College of Physicians James Best, The University of Melbourne, Australia Henk Bilo, Isala Clinics, Zwolle, Netherlands John Boltri, Wayne State University, Detroit, MI Thomas Buchanan, Univ of So California, LA, CA Paul Callaway, University of Kansas,Wichita, KS Bernard Charbonnel, University of Nantes, France Stephen Colagiuri, The University of Sydney, Australia Samuel Dagogo-Jack, Univ of Tenn, Memphis, TN Margo Farber, Detroit Medical Center, Detroit, MI Cynthia Fritschi, University of Illinois, Chicago, IL Rowan Hillson, Hillingdon Hospital, Uxbridge, U.K. Faramarz Ismail-Beigi, CWR Univ, Cleveland, OH Devan Kansagara, Oregon H&S Univ, Portland, OR Ilias Migdalis, NIMTS Hospital, Athens, Greece Donna Miller, Univ of So California, LA, CA Robert Ratner, MedStar/Georgetown Univ, DC Julio Rosenstock, Dallas Diab/Endo Ctr, Dallas, TX Guntram Schernthaner, Rudolfstiftung Hosp, Vienna, Austria Robert Sherwin, Yale University, New Haven, CT Jay Skyler, University of Miami, Miami, FL Geralyn Spollett, Yale University, New Haven, CT Ellie Strock, Int’l Diabetes Center, Minneapolis, MN Agathocles Tsatsoulis, University of Ioannina, Greece Andrew Wolf, Univ of Virginia Charlottesville, VA Bernard Zinman, University of Toronto, Ontario, Canada


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