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1 Diabetes Update 2013 Dr. Erin Koepf, PharmD, BCACP Assistant Professor, Ambulatory Care University of New England College of Pharmacy Maine Pharmacists.

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Presentation on theme: "1 Diabetes Update 2013 Dr. Erin Koepf, PharmD, BCACP Assistant Professor, Ambulatory Care University of New England College of Pharmacy Maine Pharmacists."— Presentation transcript:

1 1 Diabetes Update 2013 Dr. Erin Koepf, PharmD, BCACP Assistant Professor, Ambulatory Care University of New England College of Pharmacy Maine Pharmacists Association, September 7, 2013

2 2 Objectives: Based on the American Diabetes Association Standards of Medical Care in Diabetes – 2013: Identify the classification, risk factors, diagnosis, and screening criteria for diabetes Explain pharmacologic and non-pharmacologic treatments options for patients with diabetes or pre-diabetes Describe measures that can be taken to prevent diabetes progression and complications including immunization recommendations

3 3 Objectives: Identify the class, mechanism of action, dosing, and administration of new and common diabetes medications Discuss with patients and other health care practitioners diabetes treatment options, monitoring, and the goals for therapy Compare and contrast medication therapies available for the treatment of diabetes and select appropriate options for a given patient Develop a comprehensive care plan for a given patient with diabetes which included pharmacologic and non-pharmacologic measures, monitoring, and preventative measures

4 4 What is Diabetes? Warm-up Spend 60 seconds thinking about and writing down a description of Diabetes Spend the next 2 minutes sharing your description with someone next to you Write down some of the concepts you come up with

5 5 What is Diabetes? Warm-up Endocrine condition that increases risks of Cardiovascular events v. Cardiovascular disease with abnormal processing and distribution of glucose Others?

6 6 Review: Diabetes Pathogenesis Insulin deficiency Quantitative: decreased in production by the β-cells of the pancreas Qualitative: insulin resistance especially muscle, liver, adipose, myocardial Improvements in insulin function Weight loss to decrease insulin resistance Can in turn improve β-cell function

7 7 Review: Diabetes Pathogenesis Excess secretion of glucagon by α-cells of pancreas Glucose overproduction by liver; underutilized by body Gluconeogenesis (making glucose from glycerol and amino acids) Renal tubular transport of glucose to the urine due to hyperglycemia Incretin system deviations (relationship to DM still not fully clear) Glucagon-like peptide 1 (GLP-1) Glucose dependent insulinotropic peptide (GIP)

8 8 Who has Diabetes? Incidence of diabetes is rising (about 25 million adults in the US) Incidence is higher in certain populations Many risk factors/associated conditions are also rising in prevalence About 2/3 of patients with diabetes in the US also have hypertension (HTN) How does Maine compare to the US when it comes to incidence of Diabetes?

9 9 Incidence of Diabetes in the US Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; Centers For Disease Control and Prevention. Diabetes Data and Trends..http://apps.nccd.cdc.gov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.aspx?mode=DBThttp://apps.nccd.cdc.gov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.aspx?mode=DBT

10 10 Diabetes in the US Incidence increases with age Incidence ranges from 7.1% % between different racial/ethnic groups Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012.

11 11 New Cases of Diabetes Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012.

12 12 Rates of Diabetes in Maine have been similar to that of the US Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012.

13 13 Diabetes Incidence in Maine Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012.

14 14 Prevalence Varies throughout Maine from 7% to 10.7% Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012.

15 15 Diabetes Disease Burden 2009 in Maine, diabetes related deaths had incidence of 65.8 per 100,000 Decreased from 81.5 per 100,000 US 2008 incidence was 72.2 per 100,000 Significantly increased risk of cardiovascular diseases Including stroke and myocardial infarction (MI) Leading cause of Non-traumatic lower extremity amputations, blindness, and kidney failure Medical expenditures are on average 2.3 times higher in patients with diabetes than those without (~ $ 174 billion in direct + indirect costs in 2007) Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012.

16 16 Microvascular Complications: Nephropathy Retinopathy Neuropathy Foot ulcers/lesions Numbness, pain Sexual dysfunction Gastroparesis

17 17 Macrovascular Complications Cardiovascular Diseases (CVD) Coronary Artery Disease (CAD) Myocardial Infarction (MI) Stroke or transient ischemic attack (TIA) Peripheral Artery Disease (PAD)

18 18 Additional Concerns Depression and other mental disorders Dental disease Increased risk of infection Can affect fertility Severe hyper- or hypo- glycemic events

19 19 Diabetes Preventative Care Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012.

20 20 Preventative Care in Maine Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012.

21 21 How do we classify and diagnose diabetes? Types Diagnosis Screening Case

22 22 Diabetes Classification Type 1 Diabetes Type 2 Diabetes Gestational Diabetes (GDM) Other types related to other causes Exocrine diseases (i.e. cystic fibrosis) Genetic defects affecting insulin action or production Drug/chemically induced (i.e. HIV/AIDs treatments) American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

23 23 Diagnosis of Diabetes: Measurements that may be used Fasting Plasma Glucose (FPG) Blood glucose measured after 8 hours fasting Oral Glucose Tolerance test (OGTT) Blood glucose measured 2 hours after 75 gram glucose load (use of anhydrous glucose solution) Glycosylated hemoglobin or Hemoglobin A1c (A1C) Test without regard to meals, provides 3 month mean glucose Random plasma glucose (PG) For use in patients with symptoms of hyperglycemia/hyperglycemic crisis American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

24 24 Diagnosis of Diabetes: Symptoms/Presentation Assessment for signs and symptoms of hyperglycemia Excess thirst, urination, and/or hunger Blurry vision or vision changes In severe hyperglycemia (BG > 240 mg/dL) Ketones may be present in urine Ketoacidosis can occur when the body breaks down fat and other molecules for energy Can not use glucose for energy without insulin

25 25 Diagnosis of Diabetes: Values for Diabetes/Pre-Diabetes Measurement Criteria for Diabetes Criteria for Pre- Diabetes FPG 126 mg/dL mg/dL OGTT 200 mg/dL mg/dL A1C 6.5% % Random PG 200 mg/dLN/A American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

26 26 Pre-Diabetes Diagnosis Plasma glucose and/or A1C level between normal range and diabetes Risk for developing DM and CVD Estimates for developing diabetes over 5 years range from % Evaluate and treat other risk factors: Obesity/overweight, dyslipidemia, and hypertension American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

27 27 Who to Test/Screen for Diabetes? For which patients should you be recommending testing/screening for Diabetes? When/How often should they be screened? Evaluate individual patient risk Assess previous screening results What risk factors can you name?

28 28 Risk Factors* Obesity/overweight (BMI 25 kg/m 2 )History of CVD Physical inactivityPrior diagnosis of pre-diabetes First degree relative with DMHDL cholesterol < 35 mg/dL High risk ethnicity/race: African American Latino Native American Asian Amerian Pacific Islander Triglycerides > 250 mg/dL Hypertension: BP 140/90 mmHg or on treatment Conditions associated with insulin resistance: Severe obesity (BMI 40 kg/m 2 ) Acanthosis Nigrans Women with history of GDM or delivering a baby weighing > 9 lbs Women with Polycystic Ovarian Syndrome (PCOS)

29 29 Who to Screen for Diabetes? All adults ( 18 years old) with BMI 25 kg/m 2 and 1 or more additional risk factors* In adults without additional risk factors Screening should start at age 45 If results of screening are normal; repeat in 3 years Repeat yearly in those with Pre-diabetes values For diagnosis screening test must be repeated Is better to use same test (i.e. A1C, FPG, etc) for repeat American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

30 30 Screening in Children and Adolescents Test for type 2 diabetes and pre-diabetes in children/adolescents Overweight (BMI > 85 th percentile for age and gender or > 120% of ideal weight for height) Plus 2 risk factors: Family history in 1 st or 2 nd degree relative Race/ethnicity (same as in adults) Signs of insulin resistance or associated conditions Gestational DM in mother while child was in utero American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

31 31 Screening for Gestational Diabetes Screen at first pre-natal visit for those with risk factors Without risk factors screen at weeks Use OGTT for diagnosis (fasting, 1 hour, and 2 hour) FPG 92 mg/dL 1 hour 180 mg/dL 2 hour 153 mg/dL In women with gestational DM, screen for type 2 DM at 6-12 weeks post- delivery then every 3 years American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

32 32 Who to screen for Diabetes? 1.Which of the following symptom-free patients is due to be screened for diabetes today? A. 50 year old Latina female who delivered a baby weighing 10 lbs when she was 27, but had a negative diabetes screening test 24 months ago B. 25 year old Caucasian female with a BMI of 28 kg/m2 who reports low to no physical activity and is taking medication to treat his hypertension C. 40 year old African American male with a BMI of 24 kg/m2 and family history significant for diabetes in his mother and maternal grandfather D. 42 year old Caucasian male with a BMI of 26 kg/m2 who has no comorbidities and is physically active, but has never been screened

33 33 Meet Mr. L. Labor

34 34 Patient: L. Labor 25 year old Caucasian Male who frequents your community pharmacy and has just been to his doctors office (routine visit) Claims he is generally healthy (admits his diet could be better) BMI = 28 kg/m 2 (height: 73 inches; weight: 215 lbs) Has a wife and daughter (~ 1 year old) Previously had a very physically active job, but now spends most of his time sitting at a computer both at work and at home Carpentry and Coaching little league v. Webpage design and Watching games from the stands with snacks

35 35 Patient: L. Labor He mentions his doctor wants him to get lab work done to check for diabetes He does not understand why He feels he is young and healthy How can you explain to him the importance and potential benefit to having the tests done? Can you explain to him what diabetes is and what it means for his health?

36 36 Interpreting test results Which of the following values is one of the criteria for the diagnosis of pre-diabetes? A. Glycosylated Hemoglogbin (A1C) = 6.2 % B. Fasting Plasma Glucose (FPG) = 90 mg/dL C. Plasma Glucose 2 hours after a 75 grams glucose load = 130 mg/dL D. Glycosylated Hemoglogbin (A1C) = 5.7 %

37 37 Diagnosis of Diabetes: Values for Diabetes/Pre-Diabetes Measurement Criteria for Diabetes Criteria for Pre- Diabetes FPG 126 mg/dL mg/dL OGTT 200 mg/dL mg/dL A1C 6.5% % Random PG 200 mg/dLN/A

38 38 Interpreting test results What does it mean if LLs lab test shows: Glycosylated Hemoglogbin (A1C) = 6.0 % And Fasting Plasma Glucose (FPG) = 110 mg/dL What else would you like to know about him or test for? What should we recommend for him going forward?

39 39 Next Steps To prevent/delay the onset of Type 2 Diabetes in patients who have been diagnosed with Pre-diabetes, which of the following are recommended as part of an ongoing support plan: A. Weight loss of 7% of the patients initial body weight B. Moderate physical activity for a minimum of 150 minutes/week C. Initiation of canagliflozin therapy D. A and B are correct E. A, B, and C are all correct

40 40 Treatment for Pre-Diabetes

41 41 Lifestyle Modifications for Pre-Diabetes and Diabetes Medical Nutrition Therapy (MNT) Moderation, variety of carbohydrates Increased physical activity Minimum 150 minutes/week moderate level Weight loss/maintenance Initial 7% of body weight and maintenance of weight loss Smoking cessation Encourage and support with counseling and/or pharmacotherapy American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

42 42 Lifestyle Modifications for Pre-Diabetes and Diabetes Can decrease progression from pre-DM to DM Group and individual delivery methods have both been found to be effective Monitoring for and managing other CVD risk factors: Hypertension (HTN) Hyperlipidemia (HLD) Overweight/obesity (especially excessive abdominal fat) Tobacco use American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

43 43 Lifestyle Modifications for Pre-Diabetes and Diabetes What specifically could you recommend for LL? Work with 1 -2 others for 2-3 minutes writing down specific recommendations for LL

44 44 Specific Recommendations for LL: Smoking cessation (assessment of readiness to quit) Healthful diet and exercise plan with goal of 15 lbs weight loss Limit intake of high sugar beverages Increase intake of whole grains to obtain recommended intake of fiber Recheck BP, recommend treatment if it continues to be elevated Check fasting lipid panel, recommend treatment if levels are elevated Annual monitoring for development of DM Medication therapy for Pre-Diabetes? American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

45 45 Pharmacotherapy for Pre-Diabetes Which of the following answers lists medications that can help prevent/delay the progress from pre-diabetes to diabetes? A. Pioglitazone and Glipizide B. Orlistat and Sitagliptin C. Acarbose and Pioglitazone D. Any of the above

46 46 Metformin for Pre-Diabetes Can be considered for all patients with Pre-diabetes as adjunct to lifestyle modification Especially recommend for patients with Elevated FPG ( > 100 mg/dL) BMI > 35 kg/m2 Aged < 60 years old History of GDM (women) American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

47 47 Progress…. LL follows recommendations from you and his other health care providers He is able to quit smoking with nicotine patches and counseling, but during this time his weight goes up 2.5 kg About 6 months later he begins a diet and exercise program for patients with Pre-Diabetes He is able to loose ~ 20 lbs but has been struggling to keep from gaining it back

48 48 Progress…. LL has tolerated Metformin therapy and is now taking 1 gram BID He is exercising more, but he is still having difficulties balancing his diet He was diagnosed with high blood pressure Not currently on therapy - improved with smoking cessation and weight loss

49 49 8 years later…. He comes into the pharmacy today for his Metformin refill and reports bad news… Despite his lifestyle changes he has been diagnosed with type 2 diabetes His A1c has reached 8.1% and he has had two FPGs > 140 mg/dL drawn by the lab over 2 weeks He is motivated to continue with his lifestyle changes, but wants to know more about additional medications

50 50 Adding on more medications Individually take 1 minute to list additional diabetes therapies that could be added to LLs Metformin for better glycemic control In pairs take a few minutes to discuss your options Select and write down one agent/class that you would recommend for him based on his current status Write down why you think it is a good choice for him

51 51 Adding on Therapy While metformin is still the preferred first line therapy for patients with diabetes, if maximum doses of metformin do result in an A1C at goal, how should an additional agent be chosen? A. The second agent added on should be a Glucagon-Like-Peptide-1 (GLP-1) receptor agonist B. The second agent added on should be selected based on patient specific factors with consideration of cost, potential side-effects, and comorbidities C. The second agent should be insulin therapy with insulin glargine daily and insulin aspart or lispro TID with meals D. A second agent should not be added until diet and lifestyle goals have been achieved to reduce insulin resistance

52 52 A Patient Centered Approach American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) 2012 recommendations Patient be involvement in decision making Patient factors be considered in selecting treatments and goals of therapy Most add-on therapy will offer similar glycemic benefit, but compliance and risk of adverse events varies Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

53 53 Factors to Consider Think of each element as a continuous spectrum: Patient attitude and expected treatment efforts Risks of hypoglycemia and other adverse events Disease duration Life expectancy Important comorbidities Established vascular complications Resources, support system available Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

54 54 Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

55 55 Factors to Consider Factors should also be considered in prescribing lifestyle modifications Setting goals that are realistic Adapting to patient situations These may include: Access to healthful foods Access to a safe environment for exercise Patients physical ability (i.e. Fall risk, respiratory conditions)

56 56 Adding on Therapy While metformin is still the preferred first line therapy for patients with diabetes, if maximum doses of metformin do result in an A1C at goal, how should an additional agent be chosen? B. The second agent should be insulin therapy with insulin glargine daily and insulin aspart or lispro TID with meals This strategy of starting insulin as first line (with or without metformin) may be appropriate for patients with severe hyperglycemia at time of diagnosis or therapy initiation A1C 10% or Blood glucose > 300 mg/dL Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

57 57 Adding on Therapy While metformin is still the preferred first line therapy for patients with diabetes, if maximum doses of metformin do result in an A1C at goal, how should an additional agent be chosen? A. The second agent added on should be a Glucagon-Like-Peptide-1 (GLP-1) receptor agonist This may be appropriate for patients in whom weight gain is desirable, patient has insurance that will cover cost (reasonable copay), and patient feels comfortable with injectable therapy Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

58 58 Oral Medication Options Biguanides (metformin) Sulfonylureas Dipeptidyl peptidase IV (DPP-IV) inhibitor Sitagliptin Saxagliptin Linagliptin Alogliptin Meglitinides Thiazolidinediones (TZDs) Only Pioglitazone α-Glucosidase inhibitors Acarbose, Miglitol, Bile acid sequesterants Colesevelam Dopamine-2 agonists Bromocriptine

59 59 New Oral Options Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors Dapagliflozin (Forxgia) 2011, FDA declined approval (concerns over risk of breast and bladder cancer) July 2012 NDA resubmitted to FDA with new data Has been approved in the EU, Australia, New Zealand, Mexico, and Brazil Canagliflozin (Invokana) - approved earlier this year

60 60 New Oral Options Sodium-Glucose cotransporter 2 (SGLT2) inhibitors Lowers blood glucose by decreasing the amount of glucose re-absorbed by the kidneys Canagliflozin (Invokana®) Moderate A1C reduction and weight reduction Low incidence of hypoglycemia Renal monitoring and dose adjustment Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; Accessed: 08/28/13.http://www.invokanahcp.com

61 61 Canagliflozin (Invokana®) Approved for treatment of adults with type 2 Diabetes in conjunction with lifestyle interventions Initiate at 100 mg PO daily, before first meal of the day Can increase to 300 mg PO daily if eGFR 60 mL/min (if less max dose = 100 mg/day) Contraindicated with hypersensitivity, ESRD, dialysis Avoid or discontinue if eGFR < 45 mL/min Additional Warnings include: Hypotension, hyperkalemia, hypoglycemia, mycotic genital infections, and increased LDL cholesterol Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; Accessed: 08/28/13.http://www.invokanahcp.com

62 62 Canagliflozin (Invokana®) Significant Interactions Rifampin (UGT inducers) ~50% decrease in AUC Increased digoxin Cmax and AUC Pharmacokinetics ~ 65% absorption ~99% protein bound in plasma O-glucuronidation via UGT 1A9 and UGT 2B4 to inactive metabolites ~33% excreted in urine ~ 40 excreted unchanged in feces Common Adverse Events ( 5%) Urinary track infections (UTIs) Mycotic genital infections Increased frequency and/or volume of urination and nocturia Less common include: Hypersensitivity reaction Constipation Thirst Nausea and abdominal pain Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; Accessed: 08/28/13.http://www.invokanahcp.com

63 63 Injectable Medication Options Insulins Long acting, short acting, rapid acting, and premixes Insulin Degludec - FDA declined approval; requesting more data Glucagon-like peptide - 1 receptor agonists Exenatide, liraglutide Albiglutide - may be next agent in class (FDA petition submitted by GlaxoSmithKline Jan 2013); proposed for once weekly injection Amylin mimetics Pramlintide - use with insulin; mostly in patients with type 1 DM

64 64 Ultra-long Acting Insulin? Insulin Degludec Proposed to have > 24 hour activity to give better once daily dose coverage than other products Half-life ~ 42 hours FDA declined to approve as of Feb 2013 Requested more long term cardiovascular safety data from dedicated trial Has been approved in the European Union Tucker ME. FDA rejects Novo Nordisk s Insulin Degludec. Medscape News. Available at:

65 65 Injectable Agent Dosing Which of the following answers correctly lists medication name, strength, and starting dose for a Glucagon-Like Peptide-1 (GLP-1) receptor agonist? A. Liraglutide (Victoza®) 0.6 mg injected SubQ once daily without regard to meals B. Exenatide (Byetta®) 5 mg injected SubQ BID 60 minutes or less before a meal C. Exenatide (Bydureon®) 2 mg injected SubQ once weekly, must be with a meal D. Both A and C are correct E. A, B, and C are all correct

66 66 Back to adding on therapy Any changes in what you would like to recommend for LL? Comparative analysis of add-on therapy has indicated that most 2 drug combinations have similar A1C lowering effects Variance is greater in incidence of hypoglycemia and other side-effects For each patient must consider risk v. benefit of each medications positive and negative effects Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154:

67 67 Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

68 68 Goals for therapy Choosing an A1C goal for a patient should be individualized just like the therapy selected Guidelines recommend lowering A1C to below or around 7% to reduce microvascular complications (range 6.5% - 8%) May also reduce macrovascular complications in some patients if implemented soon after diagnosis For other patients, older, greater duration of disease, benefit of lower A1C may not outweigh risk of hypoglycemia Variance in cardiovascular outcomes between large trials Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient- centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:

69 69 Brief on Trials for Tight Glycemic Control UKPDS Intensive Control associated with improved microvascular outcomes ACCORD Intensive therapy/targets increased mortality without significantly reducing cardiovascular events ADVANCE Intensive control resulted in relative reduction of combined major cardiovascular events and microvascular events VADT No significant effect on rates of major cardiovascular events, death, or microvascular complications Stratton IM, Adler AI, Neil HAW, et al. BMJ. 2000;321: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. NEJM. 2008;358(24): The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Collaborative Group. NEJM. 2008;358(24): Duckworth W, Abraira C, Moritz T, et al. NEJM. 2009;360(2):

70 70 Meta-analysis on tight glycemic control Lancet 2009: based on 5 randomised trials Intensive therapy reduces coronary events without an increased risk of death Notes variance between populations and rate of A1C reduction BMJ 2011: based on 14 randomised trials (used trial sequence analysis) Intensive control has not been proven to reduce all cause mortality Increase in relative risk of hypoglycemia by 30 % Evidence insufficient to draw conclusions on cardiovascular mortality, non- fatal MI, composite microvascular complications, or retinopathy Ray KK, Kondapally Seshasai S, Wijesuriya S, et al. Lancet. 2009;373: Hemmingsen B, Lund SS, Gluud C, et al. BMJ. 2011;343:d6898 Doi: /bmj.d6898.

71 71 Meta-analysis on tight glycemic control BMJ 2011: based on 13 studies Limited benefits to all cause mortality and cardiovascular-related death Values on both sides of the debate can not be ruled out by this analysis Risk and benefit for microvascular and macrovascular complications - inconclusive Risk of harm with hypoglycemia noted Need for more trials Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. BMJ. 2011;343:d4169 doi: /bmj.d4169.

72 72 What should be goal for LL? What do you think we should set at LLs A1C goal? How about other goals/plans? Self-monitoring of blood glucose (SMBG) Preventative Care Cardiovascular risk reduction Medical Nutrition Therapy (MNT)

73 73 Potential Plans for LL A1C 7% (depending on response to therapy) Check A1C at least twice per year Check more often when changing therapies or above goal Diabetes Self-Management Education (DSME) and support Initial education plus follow-up Education should address quality of life and psychosocial issues May be recommended for patients with Pre-Diabetes as well American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

74 74 Potential Plans for LL SMBG Part of comprehensive DM education and care discussion with patient Daily monitoring is not required for most patients not taking insulin Consider patient comfort, access to testing supplies, and risk of hypoglycemia based on medication therapy Goals and frequency should be individualized; can consider: Fasting BG range mg/dL Peak Post-prandial BG < 180 mg/dL (taken 1-2 hours after meal) American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

75 75 Medical Nutrition Therapy Weight loss (overweight/obese) and weight maintenance Use of low carbohydrate, low fat calorie-restricted, or Mediterranean diet Monitor lipids, renal function, and protein intake Individual diet plan for intake of carbohydrates, proteins, and fats Saturated fat < 7 % of total calories (9 calories per gram of fat); limit trans fats Addition of physical activity (design to meet patients ability) Increase intake of whole grains to get recommended daily intake for fiber Limit alcohol intake to moderate (1 drink per day women; 2 per day men) Specific vitamin supplementation not currently supported by evidence American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

76 76 Cardiovascular Prevention Hypertension New goal option of systolic < 140 mmHg; Diastolic < 80 mmHg Lower targets (< 130 mmHg) may be appropriate for specific patients (younger) Preferred treatment DASH Diet and lifestyle modification Angiotensin Converting Enzyme (ACE) Inhibitors or Angiotensin Receptor Blocker (ARB) (monitor renal function and electrolytes) Addition of diurectics or other agents may be required to reach goal American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

77 77 Cardiovascular Prevention Hyperlipidemia Monitor fasting lipids annually Or every 2 years if at goal and stable Lifestyle modifications recommended for all patients Recommend addition of HMG-CoA Reductase Inhibitor (statin) therapy regardless of baseline lipid values if patient has CVD or Over the age of 40 with 1 or more CVD risk factors Family history of CVD, HTN, smoking, albuminuria, dyslipidemia

78 78 Cardiovascular Prevention Hyperlipidemia For lower risk individuals add statin if Lifestyle changes alone do not reduce LDL to < 100 mg/dL Patient has multiple CVD risk factors If patients do not meet goals (see next slide) on maximum tolerated statin dosing Alternative goal: LDL reduction by % from baseline Combination therapy has not been shown to have additional cardiovascular benefit American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

79 79 Cardiovascular Prevention Hyperlipidemia LDL Goals (primary target of therapy) < 100 mg/dL for patients without CVD < 70 mg/dL for patients with CVD Triglyceride goal < 150 mg/dL HDL goal for men > 40 mg/dL HDL goal for women > 50 mg/dL American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

80 80 Cardiovascular Prevention Anti-platelet agents Can use aspirin 81 mg daily as primary prevention in patients with type 1 or type 2 DM at increased risk( 10 year risk > 10%) Includes most men > 50, women > 60 with at least 1 risk factor For patients with lower risk (10 risk < 5%) with no risk factors - therapy is not recommended For patients at moderate risk, must weigh risks and benefits For secondary prevention, aspirin 81 mg is recommended May use clopidogrel with documented aspirin allergy American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

81 81 General Prevention Monitoring of renal function Treatment of elevated urinary albumin excretion with ACE Inhibitors or ARBs Eye exams yearly Foot care and exams Skin care Vaccinations Social support American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66.

82 82 Prevention: Immunizations You are working with a 30 year old gentleman who has just been diagnosed with type 2 Diabetes. Which vaccines would you recommend he receive if he has not done had them already? A. Hepatitis B series B. Influenza (to be repeated annually) C. Pneumoccal Polysaccharide D. Both B and C are correct E. A, B, and C are all correct

83 83 Useful Abbreviations: ADAAmerican Diabetes Association A1c or A1cHemoglobin A1c FPGFasting Plasma Glucose OGTTOral Glucose Tolerance Test BGBlood Glucose IFGImpaired Fasting Glucose IGTImpaired Glucose Tolerance DMDiabetes Mellitus HTNHypertension HLDHyperlipidemia MIMyocardial Infarction CADCoronary Artery Disease CVDCardiovascular Disease PADPeripheral Artery Disease TIATransient Ischemic Attack

84 84 References: American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes Diabetes Care. 2013;36(1): S11-S66. Centers for Disease Control and Prevention. Diabetes Report Card Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; Available at: Centers for Disease Control and Prevention. National Diabetes Fact Sheet, Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; Available at: Diabetes Surveillance Report, Maine Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; Available at: health/dcp/statistics.htmhttp://www.maine.gov/dhhs/mecdc/population Maine Center for Disease Control and Prevention. Maine Diabetes Prevention and Control Program, Health Fact Sheet: Diabetes in Maine. Maine Center for Disease Control and Prevention, Maine Department of Health and Human Services; Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35: Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; Accessed: 08/28/13.http://www.invokanahcp.com Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of intensive glucose lowering in type 2 diabetes. NEJM. 2008;358(24): The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. NEJM. 2008;358(24):

85 85 References (continued) Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. NEJM. 2009;360(2): Ray KK, Kondapally Seshasai S, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373: Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: a meta-analysis of randomised control trials. BMJ. 2011;343:d4169 doi: /bmj.d4169. Hemmingsen B, Lund SS, Gluud C, et al. Intensive glycaemic control for patients with type 2 diabetes: systemic review with meta analysis and trial sequence analysis of randomised clinical trials. BMJ. 2011;343:d6898 Doi: /bmj.d6898. Ismail-Beigi F, Moghissi E, Tiktin M, et al. Individualizing glycemic targets in type 2 diabetes mellitis: implications of recent clinical trials. Ann Intern Med. 2011;154: Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154: Matthews JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon- like peptide-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008;93: Garber AJ, King AB, Del Prato SD, et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomized, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379: Nisly SA, Kolanczyk DM, and Walton AM. Canagliflozin, a new sodium – glucose cotransporter 2 inhibitor, in the treatment of diabetes. Am J Health- Syst Pharm. 2013;70: Tucker ME. FDA rejects Novo Nordisk s Insulin Degludec. Medscape News. Accessed February 12, Available at:


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