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Canadian Diabetes Association 2013 Clinical Practice Guidelines. The Essentials 5 th Annual CE LHIN CME . Dr. John Sigalas Endocrinologist Rouge Valley Health System Toronto. May 15 , 2013. Learning Objectives. By the end of this session, participants will be able to:
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Canadian Diabetes Association 2013 Clinical Practice Guidelines The Essentials5th Annual CE LHIN CME
Dr. John SigalasEndocrinologistRouge Valley Health SystemToronto May 15 , 2013
Learning Objectives By the end of this session, participants will be able to: • Understand the major changes within the 2013 CDA clinical practice guidelines • Understand the rationale behind these changes • Apply the recommendations in clinical practice
Faculty for slide deck development • Jonathan Dawrant, BSc, MSc, MD, FRCPC • Zoe Lysy, MDCM, FRCPC • GeethaMukerji, MD, FACP, FRCPC • Dina Reiss, MD, FACP, FRCPC • Steven Sovran, BSc, MD, MA, FRCPC • Alice Y.Y. Cheng, MD, FRCPC • Peter J. Lin, MD, CCFP • Catherine Yu, MD, FRCPC, MHSc
Victor 59 years old Type 2 Diabetes ACS 2001 Bypass 2001 PAD 2002 CKD 2002 MI 2003 Neuropathy 2003 Retinopathy 2004 MI 2004 Ischemic Toes Amputation 2004 TIA 2005 Stroke 2006
Reorganize his history Victor 59 years old Type 2 Diabetes He has EVERY complication of Diabetes That is what we need to avoid Macrovascular Microvascular TIA 2005 Retinopathy 2004 Stroke 2006 CKD 2002 ACS 2001 Bypass 2001 Neuropathy 2003 MI 2003 MI 2004 PAD 2002 Ischemic Toes Amputation 2004 Neuropathy 2002
Diagnosis of Diabetes 2013 2hPG = 2-hour plasma glucose; FPG = fasting plasma glucose; OGTT = oral glucose tolerance test; PG = plasma glucose
Diagnosis of Prediabetes* 2013 * Prediabetes = IFG, IGT or A1C 6.0 - 6.4% high risk of developing T2DM
2013 Individualizing A1C Targets Consider 7.1-8.5% if: which must be balanced against the risk of hypoglycemia
Diabetes in Canada: Prevalence by Province and Territory Age-standardized† prevalence of diagnosed DM among individuals ≥ 1 year, 2008/09 < 5.0 5.0 < 5.5 5.5 < 6.0 6.0 < 6.5 ≥ 6.5 YT 5.4% NT 5.5% NU 4.4% NL 6.5% BC 5.4% AB 4.9% MB 5.9% PE 5.6% SK 5.4% QC 5.1% ON 6.0% NS 6.1% NB 5.9% † Age-standardized to the 1991 Canadian population. NL, NS and ON had the highest prevalence, while NU, AB and QC had the lowest. Public Health Agency of Canada. Diabetes in Canada: Facts and figures from a public health perspective. Ottawa, 2011.
Diabetes in Canada: Prevalence of Diagnosed Diabetes by age and sex Prevalence of diagnosed diabetes among individuals aged ≥ 1 year, by age group and sex, 2008/09 • Overall Prevalence 30 • 6.4% Females 25 • 7.2% Males 20 • 6.8% Total Prevalence (%) 15 10 5 0 Age group (years) 1-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 ≥85 Canada Prevalence increased with age. The sharpest increase occurred after age 40 years. The highest prevalence was in the 75-79 year age group. Public Health Agency of Canada. Diabetes in Canada: Facts and figures from a public health perspective. Ottawa, 2011.
Patients with DM are more likely to be hospitalized for many conditions Public Health Agency of Canada (August 2011); using 2008/09 data from the Canadian Chronic Disease Surveillance System (Public Health Agency of Canada).
Guideline Targets Achieved % of patients Leiter LA et al. Can J Diabetes 2013; in press
Self-Monitoring of Blood Glucose (SMBG)What should we tell patients to do?
Increased frequency of SMBG may be required: Daily SMBG is not usually required if patient:
Pharmacotherapy in T2DM checklist 2013 • CHOOSE initial therapy based on glycemia • START with Metformin +/- others • INDIVIDUALIZE your therapy choice based on characteristics of the patient and the agent • REACH TARGET within 3-6 months of diagnosis
AT DIAGNOSIS OF TYPE 2 DIABETES L I F E S T Y L E Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C <8.5% A1C 8.5% Symptomatic hyperglycemia with metabolic decompensation If not at glycemic target (2-3 mos) Start metformin immediately Consider initial combination with another antihyperglycemic agent Initiate insulin +/- metformin Start / Increase metformin If not at glycemic targets Add an agent best suited to the individual: Patient Characteristics Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Comorbidities (renal, cardiac, hepatic) Preferences & access to treatment Other Agent Characteristics BG lowering efficacy and durability Risk of inducing hypoglycemia Effect on weight Contraindications & side-effects Cost and coverage Other 2013 See next page…
From prior page… L I F E S T Y L E If not at glycemic target • Add another agent from a different class • Add/Intensify insulin regimen 2013 Make timely adjustments to attain target A1C within 3-6 months
AT DIAGNOSIS OF TYPE 2 DIABETES L I F E S T Y L E Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C < 8.5% A1C 8.5% Symptomatic hyperglycemia with metabolic decompensation If not at glycemic target (2-3 mos) Start metformin immediately Consider initial combination with another antihyperglycemic agent Initiate insulin +/- metformin Start / Increase metformin If not at glycemic targets Add an agent best suited to the individual: Patient Characteristics Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Comorbidities (renal, cardiac, hepatic) Preferences & access to treatment Other Agent Characteristics BG lowering efficacy and durability Risk of inducing hypoglycemia Effect on weight Contraindications & side-effects Cost and coverage Other 2013 See next page…
Antihyperglycemic agents and Renal Function 1 5 CKD Stage: 4 3 2 < 15 15-29 30-59 60-89 ≥ 90 GFR (mL/min): 30 60 30 Metformin 50 Glyburide 15 Linagliptin 30 15 Gliclazide/Glimepiride 50 15 2.5 mg Saxagliptin Repaglinide 50 30 50 mg 25 mg Sitagliptin 30 Thiazolidinediones 50 Liraglutide 50 30 Exenatide 25 Acarbose Not recommended / contraindicated Safe Caution and/or dose reduction Adapted from: Product Monographs as of March 1, 2013; CDA Guidelines 2008; and Yale JF. J Am Soc Nephrol 2005; 16:S7-S10.
Serum Insulin Level Time Human Bolus: Humulin-R, Novolin ge Toronto Human Basal: Humulin-N, Novolin ge NPH Analogue Basal: Lantus, Levemir Analogue Bolus: Apidra, Humalog, NovoRapid
Serum Insulin Level Time Human Premixed: Humulin 30/70, Novolin ge 30/70 Analogue Premixed: Humalog Mix25, NovoMix 30
Definition of Hypoglycemia • Development of neurogenic or neuroglycopenic symptoms • Low blood glucose (<4 mmol/L if on insulin or secretagogue) • Response to carbohydrate load
Steps to Address Hypoglycemia • Recognize autonomic or neuroglycopenic symptoms • Confirm if possible (blood glucose <4.0 mmol/L) • Treat with “fast sugar” (simple carbohydrate) (15 g) to relieve symptoms • Retest in 15 minutes to ensure the BG >4.0 mmol/L and retreat (see above) if needed • Eat usual snack or meal due at that time of day or a snack with 15 g carbohydrate plus protein
Vascular Protection Checklist 2013 • A• A1C – optimal glycemic control (usually ≤7%) • B•BP – optimal blood pressure control (<130/80) • C•Cholesterol – LDL ≤2.0 mmol/L if decided to treat • D•Drugs to protect the heart A – ACEi or ARB │S – Statin │A – ASA if indicated • E• Exercise – regular physical activity, healthy diet, achieve and maintain healthy body weight • S•Smoking cessation
Who Should Receive Statins? 2013 • ≥40 yrs old or • Macrovascular disease or • Microvascular disease or • DM >15 yrs duration and age >30 years or • Warrants therapy based on the 2012 Canadian Cardiovascular Society lipid guidelines Among women with childbearing potential,statins should only be used in the presence of proper preconception counseling & reliable contraception. Stop statins prior to conception.
2013 Who Should Receive ACEi or ARB Therapy? • ≥55 years of age or • Macrovascular disease or • Microvascular disease At doses that have shown vascular protection (ramipril 10 mg daily, perindopril 8 mg daily, telmisartan 80 mg daily) Among women with childbearing potential,ACEi or ARB should only be used in the presence of proper preconception counseling & reliable contraception. Stop ACEi or ARB either prior to conception or immediately upon detection of pregnancy
ASA for 1⁰Prevention in DiabetesMeta analysis of 6 studies(n = 10,117) No. of events/No. in group ASA Control/placebo RR (95% CI) RR (95% CI) Major CV events JPAD POPADAD WHS PPP ETDRS Total 68/1262 105/638 58/514 20/519 350/1856 601/4789 86/1277 108/638 62/513 22/512 379/1855 657/4795 0.80 (0.59-1.09) 0.97 (0.76-1.24) 0.90 (0.63-1.29) 0.90 (0.50-1.62) 0.90 (0.78-1.04) 0.90 (0.81-1.00) Myocardial infarction JPAD POPADAD WHS PPP ETDRS PHS Total 28/1262 90/638 36/514 5/519 241/1856 11/275 395/5064 14/1277 82/638 24/513 10/512 283/1855 26/258 439/5053 0.87 (0.40-1.87) 1.10 (0.83-1.45) 1.48 (0.88-2.49) 0.49 (0.17-1.43) 0.82 (0.69-0.98) 0.40 (0.20-0.79) 0.86 (0.61-1.21) • No overall benefit for: • Major CV events • MI • Stroke • CV mortality • All-cause mortality Stroke JPAD POPADAD WHS PPP ETDRS Total 12/1262 37/638 15/514 9/519 92/1856 181/4789 32/1277 50/638 31/513 10/512 78/1855 201/4795 0.89 (0.54-1.46) 0.74 (0.49-1.12) 0.46 (0.25-0.85) 0.89 (0.36-2.17) 1.17 (0.87-1.58) 0.83 (0.60-1.14) Death from CV causes JPAD POPADAD PPP ETDRS Total 1/1262 43/638 10/519 244/1856 298/4275 10/1277 35/638 8/512 275/1855 328/4282 0.10 (0.01-0.79) 1.23 (0.80-1.89) 1.23 (0.49-3.10) 0.87 (0.73-1.04) 0.94 (0.72-1.23) JPAD = Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes POPADAD = Prevention of Progression of Arterial Disease and Diabetes PPP = Primary Prevention Project ETDRS = Early Treatment Diabetic Retinopathy Study PHS = Physicians’ Health Study WHS = Women’s Health Study De Beradis G, et al. BMJ 2009; 339:b4531. All-cause mortality JPAD POPADAD PPP ETDRS Total 34/1262 94/638 25/519 340/1856 493/4275 38/1277 101/638 20/512 366/1855 525/4282 0.90 (0.57-1.14) 0.93 (0.72-1.21) 1.23 (0.69-2.19) 0.91 (0.78-1.06) 0.93 (0.82-1.05) 2 0.03 0.125 0.5 1 8 Favors ASA Favors control/placebo
With Nephropathy, CVD or CV risk factors Diabetes Without the above Summary of Pharmacotherapy for Hypertension in Patients with Diabetes Threshold equal or over 130/80 mmHg and Target below 130/80 mmHg Combination of 2 first line drugs may be considered as initial therapy if the blood pressure is >20 mmHg systolic or >10 mmHg diastolic above target ACE Inhibitor or ARB 1. ACE Inhibitor or ARB or 2. Thiazide diureticor DHP-CCB > 2-drug combinations Monitor serum potassium and creatinine carefully in patients with CKD prescribed an ACEI or ARB Combinations of an ACEI with an ARB are specifically not recommended in the absence of proteinuria More than 3 drugs may be needed to reach target values If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of volume is desired
Vascular Protection Checklist 2013 • A• A1C – optimal glycemic control (usually ≤7%) • B•BP – optimal blood pressure control (<130/80) • C•Cholesterol – LDL ≤2.0 mmol/L if decided to treat • D•Drugs to protect the heart A – ACEi or ARB │S – Statin │A – ASA if indicated • E• Exercise – regular physical activity, healthy diet, achieve and maintain healthy body weight • S•Smoking cessation
What if we did all the right things? How much could we protect our patients?
STENO-2: Intensive Group Achieved Targets Gaede et al. NEJM. 2003: 348;383-393
Intensive Group had Improved CV Outcomes 60 P = 0.007 53 % RRR 50 Any CV event NNT = 5 Conventional therapy 40 Intensive therapy 30 20 10 0 12 24 36 48 60 72 84 96 Months of Follow-up RRR= relative risk reduction Gaede et al. NEJM. 2003: 348;383-393
STENO 2 Extended Follow-up: Effect of a multi- factorial vascular protective strategy on total mortality 60 50 40 30 20 10 HR = 0.54 (0.32-0.88) p = 0.015 Conventional therapy END OF TRIAL Total mortality (%) Intensive therapy 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Years of follow-up Gaede et al. N Engl J Med. 2008; 358(6):580-91.
STENO 2 – Microvascular Disease Gaede et al. NEJM. 2003: 348;383-393
What about Microvascular Disease? • Nephropathy • Retinopathy • Neuropathy
2013 Chronic Kidney Disease (CKD) Checklist • SCREEN regularly with random urine albumin creatinine ratio (ACR) and serum creatinine for estimated glomerular filtration rate (eGFR) • DIAGNOSE with repeat confirmed ACR ≥ 2.0 mg/mmol and/or eGFR < 60 mL/min • DELAY onset and/or progression with glycemic and blood pressure control and ACE inhibitor or angiotensin receptor blocker (ARB) • PREVENT complications with “sick day management” counselling and referral when appropriate
Counsel all Patients About Sick Day Medication List 2013
Retinopathy Checklist 2013 • SCREEN regularly • DELAY onset and progression with glycemic and blood pressure control ± fibrate • TREAT established disease with laser photocoagulation, intra-ocular injection of medications or vitreoretinal surgery
Delaying Retinopathy • Glycemic control: target A1C ≤7% • Blood pressure control: target BP <130/80 • Lipid-lowering therapy: fibrates have been shown to decrease progression and may be considered 2013