Beyond Metformin A Primary Care View of Diabetes Treatment. DeAnn Cummings, MD March 12, 2016

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1 Beyond Metformin A Primary Care View of Diabetes Treatment DeAnn Cummings, MD March 12, 2016

2 Goals Review safety, tolerability, efficacy and cost of current meds available for treatment of type 2 diabetes mellitus Discuss strategies to figure out what med to use when

3 What I Will Not Cover Classification of DM Diagnosis of DM Type 1 DM Prevention of DM/ Pre-diabetes Lifestyle change Insulin mgt

4 Primary Resources AACE/ACE Comprehensive Type 2 Diabetes Management 2016 ADA Guidelines 2016 Up Do Date

5 Ways to Lower Glucose Decrease intake Diet Decreased gastric motility resulting in satiety Decrease absorption Increase amount of insulin Increase tissue sensitivity to insulin Decrease creation of glucose (gluconeogenesis) Increase excretion of glucose

6 The Alphabet Soup

7

8 Metformin (Biguanides) Actions Decreases creation of glucose in liver, increases insulin sensitivity, decrease intake of glucose Efficacy Decreases A1C by 1.5% UK Prospective Diabetes Study Decreased microvascular and neuropathic complications in intensive glycemic control group (A1C <7). At 10 year follow-up, decreased MI by 33% and decreased all-cause mortality by 27%

9 Metformin (Biguanides) Side effects GI can be mitigated if dose escalated slowly Decreased absorption of B12 Lactic acidosis (limits use in renal disease pts?) 9 cases/100,000 person-years of experience Cost generic, cheap ($)

10 Insulin Actions Increases insulin, decreases hepatic glucose production Efficacy Decreases HgBA1C by Safety Hypoglycemia Weight gain Cost moderate to expensive ($$ - $$$)

11

12 Sulfonylureas and Glinides Action Increase amount of insulin Efficacy Decreases A1C by 1-2 % Safety Lots of experience Hypoglycemia Weight gain Cost cheap (unless using glinide) - $-$$

13 Sulfonylureas and Glinides Meglitinides (glinides) Repaglinide (Prandin) Nateglinide (Starlix) Mitiglinide (Glufast) Sulfonylureas Glipizide (Glucotrol) Glyburide (Glynase, Micronase) Glimepride (Amaryl)

14 Sulfonylureas and Glinides Which do we choose? Glinides don t work quite as well as SFUs but have less hypoglycemia. They are also more costly. SFUs are much cheaper and work well to decrease blood glucose, but are more likely to cause hypoglycemia. Shorter-acting SFUs, like glipizide, are less likely to cause hypoglycemia

15 GLP-1 Receptor Agonists ( The Tides ) Action (Incretin-based) Decreases intake via decreased gastric motility and increased satiety Increases insulin secretion Decreases glucagon secretion Efficacy Decreases A1C by % Weight loss

16 The Tides Side effects GI symptoms?pancreatitis Cost expensive ($$$)

17 The Tides Exenatide (Byetta) Liraglutide (Victoza, Saxenda) Albiglutide (Tanzeum) Dulaglutide (Tulicity) Which one to choose? One has not been shown to be better than another Medicaid will cover Byetta Cannot use Byetta if GFR < 30

18 SGLT2 inhibitors (The Flozins ) Action Blocks glucose reabsorption by kidney Doesn t work if GFR < 45 Efficacy Decreases A1C by % Decreases weight and BP Possible decreased mortality (needs more study)

19 The Flozins Safety Increased genitourinary infections (fungal and bacterial) Polyuria, volume depletion, hypotension Increased LDL Cost Expensive ($$$)

20 The Flozins Canagliflozin (Invokana) Dapagliflozin (Farxiga) Empagliflozin (Jardiance) Which to choose? No difference identified in efficacy or safety Medicaid will cover Invokana

21 DPP-4 inhibitors (The Gliptins ) Action (Incretin-based) Increases insulin secretion Decreases glucagon secretion Efficacy Decreases A1C by % Side effects Not much Need to adjust dose in renal disease Cost Expensive ($$$)

22 The Gliptins Sitagliptin (Januvia) Vildagliptin (Galvus) Saxagliptin (Onglyza) Linagliptin (Tradjenta) Alogliptin (Takeda) Which to choose? No clear differences. Lingagliptin better in renal disease. Medicaid will cover Januvia

23 Thiazolidinediones (The Glitazones ) Action Increases insulin sensitivity Efficacy Decreases A1C by % Side effects Weight gain Increased risk bone fracture Increased risk CHF? Bladder cancer Cost Cheap ($)

24 The Glitazones Pioglitazone (Actos) Rosiglitazone (Avandia) withdrawn from market in Europe due to cardiac concerns

25 Alpha-Glucosidase Inhibitors Action Decreased intestinal absorption of glucose Efficacy Decreases A1C by % Side effects Diarrhea, flatulence Cost low-moderate ($-$$)

26 Alpha-Glucosidase Inhibitors Acarbose (Precose) Miglitol (Glyset) Voglibose No guidelines are excited about these Too frequent dosing Too many side effects Don t work that well

27 Amylin Analog Action Decreases glucagon secretion Slows gastric emptying Efficacy Decreases A1C by % Side effects Hypoglycemia, GI Cost expensive Pramlintide (Symlin) Guidelines not excited

28 Colesevelam Action Bile acid sequestrant? Decreases hepatic glucose production? Increase incretin levels Efficacy Modest Side Effects constipation, increased TG Cost Expensive ($$$)

29 Bromocriptine Action Increases insulin sensitivity Efficacy Modest Side effects Nausea, dizziness, fatigue Cost Expensive ($$$) Definitely bottom-of-the-list

30 Case #1 45 year old female presents to your office for follow-up of routine labs. She has a strong family history of diabetes. PMH is significant for HTN, treated with Lisinopril. She denies any symptoms of hyper or hypoglycemia. HgBA1C = 8.0 Random glucose = 210 Creatinine = 1.0, GFR = 65 All other labs are normal.

31 Case #1 Exam BP = 140/90, HR = 92, BMI = 34 Other than obesity, her exam is normal What is your initial recommendation? Lifestyle change OR Lifestyle change + metformin

32 Initial Management ADA Guidelines Can try lifestyle modification alone for 3-6 months if A1C close to goal (< 7.5%) Should start metformin if it looks like lifestyle changes are not working. AACE Guidelines Start with both metformin and lifestyle intervention

33 Case #1 After 3 months of lifestyle modification and max dose metformin, pt s A1C is still 8.0. What is her target A1C?

34 Target A1C ADA Guidelines For many adults, a goal of 7.0% is appropriate For patients at high risk for hypoglycemia, aim for < 8.0% Older patients Patients with history hypoglycemia Patients with co-morbidities Long duration of DM Aim for < 6.5% in younger, healthier people

35 Target A1C UK Prospective Diabetes Study Intensive glucose control decreased rate of microvascular complications and neuropathic complications (A1C < 7%) No significant difference in CV events during trial HOWEVER, at 10 year follow-up, rate of MI was decreased by 15% in the sulfonylurea group and 33% in metformin group All-cause mortality was decreased by 13% in the sulfonylurea group and by 27% in the metformin group Patients in this study had shorter duration of DM

36 Target A1C ACCORD, ADVANCE and VADT All had increased mortality in the intensive glycemic control arm. ACCORD A1C < 6 ADVANCE A1C < 6.5 VADT 1.5% decrease in A1C ACCORD was halted early due to increased mortality Pt population for these studies different than UKPDS

37 Target A1C ADA guidelines Risks of lower glycemic targets outweigh the potential benefits on microvascular complications in high risk patients.

38

39 Target A1C AACE guidelines Goal A1C of for younger, healthier people Goal A1C of 7-8 in older, high risk people Should definitely NOT try to get these patients < 6.5

40 Target A1C Take Home Message Individualize target A1C to patient Getting the A1C as low as possible may not be a good idea

41 Case #1 What treatment will you add to metformin and lifestyle modification? Sulfonylurea Basal insulin GLP-1 receptor agonist SGLT-2 inhibitors DPP-4 inhibitors Thiazolidinediones (TZDs)

42 Dual Therapy ADA Guidelines If after 3 months of lifestyle intervention plus metformin there is no improvement in A1C, start a second agent They DO NOT specify which one However they do not recommend alpha-glucosidase inhibitors, amylin analogs, bromocriptine or colesevalam They also suggest that the newer drugs may be low-value (BIG price and not much efficacy)

43

44 Dual Therapy AACE Guidelines Rank options GLP-1 agonists (tides) SGLT-2 inhibitors (flozins) DPP-4 inhibitors (gliptins) TZDs Basal insulin Colesevalam Bromocriptine Alpha-glucosidase inhibitors Sulfonylureas/glinides

45 Dual Therapy AACE Guidelines Sulfonylureas and glinides are on the bottom!! Basal insulin close to the bottom! Their rationale is that the high risk of hypoglycemia and weight gain pushes these agents down the list.

46

47 Dual Therapy Up To Date STRONGLY recommends sulfonylurea or basal insulin as the next add-on therapy after metformin Their reasoning is that these agents have the best efficacy and, for sulfonylureas, there may be decrease in CV events (macrovascular complications).

48 Dual Therapy SO WHAT DO WE DO??? There are advantages and disadvantages to all options. Must individualize for each patient A healthy 40 year old might benefit more from insulin or sulfonylurea An elderly, frail patient might be better off with something that causes less hypoglycemia

49 Dual Therapy GRADE Trial On going study comparing sulfonylureas, basal insulin, DPP-4 inhibitors (gliptins), and GLP-1 agonists (tides) as add on therapy to metformin Stay tuned

50 Case #1 After 3 months on metformin and glipizide, her A1C = 9 and her BMI has increased to 38. What do you want to do now? Add another agent and, if so, which one? OR do you want to work on her obesity? OR BOTH

51 Triple Therapy ADA guidelines Any agent is okay but leans toward basal insulin AACE guidelines Basal insulin moves up on the list but is still behind the tides, the flozins and the TZDs Up to Date definitely recommends insulin If starting insulin, should probably stop sulfonylurea.

52 Case #2 80 year old male presents for follow-up DM. He has been on max dose metformin for 15 years and his latest A1C is 8. He has no hyper or hypoglycemia symptoms. PMH HTN, DM, Hyperlipidemia BMI = 29, GFR = 65 What would you like to add? OR are you happy with A1C of 8?

53 Case #2 According to guidelines, you could keep him at an A1C of 8 It really depends on the patient A GOOD 80 year old might benefit from lower A1C but need to watch closely for hypoglycemia. Probably would not select a sulfonylurea and some concern with insulin as well. Would this patient be better off with one of the newer agents that does not cause hypoglycemia??

54 Case #3 65 year old female with DM treated with lifestyle intervention up to this point. Now with A1C = 9.0 Her BMI = 33, GFR = 40 Can we use metformin?

55 Metformin in Renal Insufficiency Package insert Contraindicated in women with creatinine of 1.4 or more and in men with creatinine of 1.5 or more (= GFR < 60 in older adults) However, lactic acidosis is very rare if GFR > 30 and no acute progression of renal disease. Therefore many recommend use of metformin at half dose (max 1000 mg/day) in pts with GFR 30-60

56 Metformin Contraindications Anything causing hypoperfusion and/or hypoxia Acute or progressive renal failure Acute or progressive heart failure Acute pulmonary decompensation Sepsis Dehydration Basically, pts should stop metformin if acutely ill

57 Case #4 55 year old female, with no PMH, presents due to abnormal labs. No symptoms. Her A1C = 13 and random blood sugar = 310 Her BMI = 40. Normal renal function. What do you want to do?

58 Initial Severe Hyperglycemia ADA Guidelines Start basal insulin initially if A1C >10 and/or random blood sugar of AACE Guidelines Consider starting basal insulin initially if A1C > 9 Both guidelines suggest taking patient off insulin once blood sugars controlled.

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