Philippine Practice Guidelines for the Diagnosis & Management of Type 2 Diabetes Mellitus

Transcription

1 Philippine Practice Guidelines for the Diagnosis & Management of Type 2 Diabetes Mellitus Iris Thiele Isip Tan MD, MSc, FPCP, FPSEM Chief, Medical Informatics Unit Associate Professor IV, UP College of Medicine Adapted from the presentation of Dr. Cecilia Jimeno

2 UNITE FOR DIABETES PHILIPPINES Diabetes Philippines Institute for Studies on Diabetes Foundation, Inc. Philippine Society of Endocrinology & Metabolism Philippine Center for Diabetes Education Foundation, Inc.

3 UNITE FOR DIABETES PHILIPPINES Goals & Areas of Collaboration Encourage best diabetes practices - development of a unified CPG Establishment of a national diabetes database Spearhead the fight for patients rights & safety - vigilance on false claims

4 UNITE FOR DIABETES PHILIPPINES Objectives for the Clinical Practice Guideline To develop clinical practice guidelines on the screening, diagnosis and management of diabetes which reflect the current best evidence and which incorporate local data into the recommendations, in view of aiding clinical decision making for the benefit of the Filipino patient GUIDELINES THAT ARE SUITED FOR LOCAL REALITIES

5 UNITE FOR DIABETES PHILIPPINES Organizations in the Consensus Panel Diabetes Philippines Institute for Studies on Diabetes Foundation, Inc. Philippine Society of Endocrinology & Metabolism Philippine Center for Diabetes Education Foundation, Inc. 23 other specialty, subspecialty organizations lay representatives of persons with diabetes

6 Scope of the Philippine CPG development Screening and diagnosis Screening for complications Outpatient setting Prevention and treatment Special groups: GDM, elderly

7 Philippine Clinical Practice Guideline for Diabetes Mellitus Part 1: SCREENING & DIAGNOSIS

8 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement 2.1 All individuals being seen at any physician s clinic or by any healthcare provider should be evaluated annually for risk factors for type 2 diabetes. (Table 1) [Grade D, Level 5]

9 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement 2.2 Universal screening using laboratory tests is NOT recommended as it would identify very few individuals who are at risk. [Grade D, Level 5]

10 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Table 1. Demographic and Clinical Risk Factors for Type 2 Diabetes Testing should be considered in all adults >40 years old.

11 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Consider earlier testing if with at least one other risk factor as follows: history of IGT or IFG history of GDM or delivery of a baby weighing 8 lbs or above polycystic ovary syndrome (PCOS) overweight (BMI >23 kg/m 2 ) or obese (BMI >25 kg/m 2 ) waist circumference >80 cm ( ) and >90 cm ( ) or waist-hip ratio (WHR) >1 ( ) and >0.85 ( )

12 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Consider earlier testing if with at least one other risk factor as follows (con t): first-degree relative with type 2 diabetes sedentary lifestyle hypertension (BP >140/90 mm Hg) diagnosis or history of any vascular diseases including stroke, peripheral arterial occlusive disease, coronary artery disease

13 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Consider earlier testing if with at least one other risk factor as follows (con t): acanthosis nigricans schizophrenia serum HDL <35 mg/dl (0.9 mmol/l) and/or serum triglycerides >250 mg/dl (2.82 mmol/l)

14 Which of the following will you NOT screen for diabetes? a.42/f on follow-up for hypertension b.35/m consulting for cough c.45/m with tuberculosis d.28/f diagnosed with PCOS

15 Why 40? Recommendation from other guidelines ADA 2010 CDA 2008 AACE 2007 IDF 2005 All >45 y (B) Earlier if BMI >25 kg/m2 and with >1 risk factor(s) (B) All > 40 y Earlier if with risk factors >30 y with risk factor (B) Target high risk people by risk factor assessment

16 Why 40? NNHeS 2008 Prevalence of Diabetes Mellitus Age (y) Based on FBS a Based on 2h postprandial glucose Based on DM questionnaire True Diabetes > Overall a Based on FBS >125 mg/dl b Based on 2h-PPG > 200 mg/dl c Based on DM questionnaire (previous diagnosis by nurse or physician or on medication) d True diabetes (positive in any of the three assessment methods

17 You screen the 42 y.o. hypertensive. FBS is 5.2 mmol/l. What next? a.reassure patient she is not diabetic. There is no need to repeat the test. b.repeat FBS after 1 year. c.order an OGTT after 6 months. d.ask for an HbA1c after 3 months.

18 If initial test(s) are negative, when should repeat testing be done? Repeat testing should ideally be done annually for Filipinos with risk factors owing to the significant prevalence and burden of diabetes in our country. (Level 5, Grade D)

19 CANDI Manila Fojas MC, Lantion-Ang FL, Jimeno CA, Santiago D, Arroyo M, Laurel A, Sy H, See J. Complications and cardiovascular risk factors among newly-diagnosed type 2 diabetics in Manila. Phil. J. Internal Medicine, 47: , May-June, 2009 Local study: newly-diagnosed diabetics in Manila 20% peripheral neuropathy 42% proteinuria 2% diabetic retinopathy COMPLICATIONS FOUND AT DIAGNOSIS!

20 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Recommended tests for diagnosing diabetes: Fasting plasma glucose (FPG) hours Random plasma glucose (RPG) 2-h plasma glucose in 75-g OGTT

21 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Criteria for diagnosis of diabetes (Level 2, Grade B) FPG >126 mg/dl (7.0 mmol/l) Random plasma glucose >200 mg/dl (11.1 mmol/l) in a patient with classic symptoms of hyperglycemia (weight loss, polyuria, polyphagia, polydipsia) or with signs and symptoms of hyperglycemic crisis 2-h plasma glucose in 75-g OGTT >200 mg/dl (11.1 mmol/l)

22 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Fasting plasma glucose (FPG) is the preferred test due to its wide availability, lower cost and better reproducibility (Level 3, Grade B) If the FPG falls within the impaired fasting glucose range ( mmol/l) then a 75-g OGTT is recommended (Level 3, Grade B) Symptomatic patients - random or FPG

23 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Among asymptomatic individuals with positive results, any of the three tests should be repeated within two weeks for confirmation (Level 4, Grade C).

24 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Diabetes can be diagnosed when any of the three tests are positive in a symptomatic patient (weight loss, polyuria, polyphagia, polydipsia).

25 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS A 75-g OGTT is preferred as the first test for the following (Level 3, Grade B): Previous FBS showing IFG mg/dl ( mmol/l) Previous diagnosis of CVD (CAD, stroke, peripheral arteriovascular disease) or who are at high risk of CVD A diagnosis of Metabolic Syndrome

26 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS At the present time, we cannot recommend the routine use of the following tests in the diagnosis of diabetes (Level 3, Grade C): HbA1c Capillary blood glucose Fructosamine Urinalysis (Level 3, Grade B) Plasma insulin (Level 3, Grade B)

27 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS HbA1c Capillary blood glucose Fructosamine Urinalysis Interpret an available result with caution and confirm with any of the three standard tests (Level 2, Grade B).

28 Why NOT Hba1C? Until standardization has been done in the Philippines, use HbA1c only as a tool for monitoring control among those with established DM. HbA1c not readily available in some areas NGSP certification not easily verified in laboratories Studies needed to determine effect of ethnicity

29 You screen the 42 y.o. hypertensive. FBS is 5.2 mmol/l. What next? a.reassure patient she is not diabetic. There is no need to repeat the test. b.repeat FBS after 1 year. c.order an OGTT after 6 months. d.ask for an HbA1c after 3 months.

30 Algorithm for Screening Diabetes Among Asymptomatic Individuals Screen for risk factors for DM, prediabetes and MetS

31 Algorithm for Screening Diabetes Among Asymptomatic Individuals Screen for risk factors for DM, prediabetes and MetS YES Risk factors (Table 1)

32 Algorithm for Screening Diabetes Among Asymptomatic Individuals Screen for risk factors for DM, prediabetes and MetS YES Risk factors (Table 1) YES Lab testing using FBS, RBS, OGTT (Fig 3)

33 Algorithm for Screening Diabetes Among Asymptomatic Individuals Screen for risk factors for DM, prediabetes and MetS YES Risk factors (Table 1) NO Age >40 y YES YES Lab testing using FBS, RBS, OGTT (Fig 3)

34 Algorithm for Screening Diabetes Among Asymptomatic Individuals Screen for risk factors for DM, prediabetes and MetS YES Risk factors (Table 1) NO Age >40 y NO No further testing; re-evaluate annually for risk factors YES YES Lab testing using FBS, RBS, OGTT (Fig 3)

35 Age >40 y Age <40 y with risk factors for DM No 3 P s or weight loss (asymptomatic) No known CAD, PAD, CVD, No MetS Diagnosed CAD, PAD, CVD or with MetS Symptomatic (polyuria, polydipsia, polyphagia, weight loss)

36 Age >40 y Age <40 y with risk factors for DM No 3 P s or weight loss (asymptomatic) No known CAD, PAD, CVD, No MetS Diagnosed CAD, PAD, CVD or with MetS Symptomatic (polyuria, polydipsia, polyphagia, weight loss) Fasting plasma glucose <100 mg/dl mg/dl >126 mg/dl No diabetes Repeat testing after 1 y 75-g OGTT Diabetes

37 Age >40 y Age <40 y with risk factors for DM No 3 P s or weight loss (asymptomatic) No known CAD, PAD, CVD, No MetS <100 mg/dl Fasting plasma glucose mg/dl >126 mg/dl Diagnosed CAD, PAD, CVD or with MetS FBS <100 & 2h <140 mg/dl 75-g oral glucose tolerance test (OGTT) FBS or 2h mg/dl FBS >126 mg/dl or 2h >200 Symptomatic (polyuria, polydipsia, polyphagia, weight loss) No diabetes Repeat testing after 1 y 75-g OGTT Diabetes No diabetes Repeat testing after 1 y IFG or IGT Repeat after 6 mos Diabetes

38 Age >40 y Age <40 y with risk factors for DM No 3 P s or weight loss (asymptomatic) No known CAD, PAD, CVD, No MetS <100 mg/dl Fasting plasma glucose mg/dl >126 mg/dl Diagnosed CAD, PAD, CVD or with MetS FBS <100 & 2h <140 mg/dl 75-g oral glucose tolerance test (OGTT) FBS or 2h mg/dl FBS >126 mg/dl or 2h >200 Symptomatic (polyuria, polydipsia, polyphagia, weight loss) <140 mg/dl Random plasma glucose mg/dl >200 mg/dl No diabetes Repeat testing after 1 y 75-g OGTT Diabetes No diabetes Repeat testing after 1 y IFG or IGT Repeat after 6 mos Diabetes No diabetes Repeat testing after 1 y 75-g OGTT Diabetes

39 Philippine Clinical Practice Guideline for Diabetes Mellitus Part 2: MANAGEMENT & MONITORING

40 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Initial evaluation - comprehensive medical history and PE Coronary heart disease risk assessment Foot evaluation: assess risk for foot ulcer (identify high-risk feet) Eye exam: fundoscopy on diagnosis Dental history or oral health history

41 RED FLAGS of dental disease tooth ache pain when chewing sensitivity to cold/hot drinks badly broken teeth swelling of gums bad breath

42 PERIODONTITIS gum bleeding on brushing swelling and redness of gums looseness or mobility of teeth Prevalence among T2DM 68% (SLMC, n =192) Bitong et al PJIM 2010 teeth that fall off in adults

43 Which of the following will you NOT request as initial tests for a person with diabetes? a.fasting blood glucose, HbA1c b.complete lipid profile c.blood uric acid, 12-lead ECG d.alt, AST, serum creatinine

44 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Minimal initial tests to be requested Fasting blood glucose, complete lipid profile HbA1c Liver function tests Urinalysis; spot urine albumin-to-creatinine ratio Serum creatinine and calculated GFR

45 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Optional tests ECG and TET TSH in type 1 diabetes, dyslipidemia or women over age 50 y

46 Which of the following will you NOT request as initial tests for a person with diabetes? a.fasting blood glucose, HbA1c b.complete lipid profile c.blood uric acid, 12-lead ECG d.alt, AST, serum creatinine

47 Which of the following statements is true about monitoring diabetes? a. Monitor Hba1c ideally twice a year. b. Check FBS and postprandial blood sugar every 2-4 weeks. c. Estimate trends in blood sugar control by checking CBGs once a week. d. Achieve glycemic goals within three months.

48 Glycemic targets HbA1c <7% FBS <4-7 mmol/l ( mg/dl) 2h PPG <5-10 mmol/l ( mg/dl) Individualize targets. Capillary (ADA) fasting mg/dl PPBG <180 mg/dl

49 Glycemic targets HbA1c <6.5% FBS <6 mmol/l 2h PPG <8 mmol/l Newly diagnosed Relatively young (age <60 y) No complications No risk factors for hypoglycemia Individualize targets.

50 Ideally, HbA1c every 3-6 months; 2x a year if controlled on stable therapy FBS, postprandial sugar every 2-4 weeks Capillary blood glucose 2x a week to estimate trends

51 Glycemic targets should be achieved within 6 months of diagnosis or first prescription.

52 Which of the following statements is true about monitoring diabetes? a. Monitor Hba1c ideally twice a year. b.check FBS and postprandial blood sugar every 2-4 weeks. c. Estimate trends in blood sugar control by checking CBGs once a week. d. Achieve glycemic goals within three months.

53 Targets to Decrease CV Risk Lipid control ASA BP control

54 Which of the following statements is true about reducing CV risk in diabetes? a. Statins should be given regardless of baseline lipid levels. b. There is insufficient evidence to recommend aspirin for primary prevention in men <60 y. c. Give clopidogrel 75 mg/day for those with diabetes and a history of CVD. d. The goal BP for most persons with diabetes is <140/80 mm Hg.

55 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS The goal BP for most persons with diabetes is <140/80 mm Hg. Lifestyle therapy alone for 3 months if pre-hypertensive (SBP mm Hg or DBP mm Hg) Pharmacologic + lifestyle therapy if SBP>140 mm Hg or DBP >90 mm Hg, or pre-hypertensive uncontrolled with lifestyle therapy alone

56 Lifestyle therapy Weight loss if overweight DASH-style dietary pattern (reduce Na, increase K, moderation of alcohol, increased physical activity).

57 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement 7.3 ACE inhibitors & ARBs are generally recommended as initial therapy. If one class is not tolerated, the other should be substituted. Multiple drug therapy (>2 agents at maximal doses) is generally required to achieve BP targets. Thiazide-type diuretics, calcium channel blockers and B-blockers may be given as additional agents.

58 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Recommendations are consistent with Philippine Practice Guidelines for the Treatment of Dyslipidemia. LDL is the primary target for dyslipidemia management in persons with diabetes.

59 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement Statin therapy should be added to lifestyle therapy, regardless of baseline levels for diabetics with overt CVD (A) without CVD who are >40 y and have >1more other CVD risk factors (A)

60 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement For patients at lower risk (e.g. without overt CVD and <40 y), statin therapy should be considered in addition to lifestyle therapy if - LDL-C remains >100 mg/dl those with multiple risk factors (hypertension, familial hypercholesterolemia, LVH, smoking, family history of premature CAD, male sex, age >55 y, proteinuria, albuminuria, BMI>25)

61 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS The rule Without overt CVD, goal is LDL-C <100 mg/ dl (2.6 mmol/l) [A] With overt CVD, goal is LDL-C <70 mg/dl (1.8 mmol/l). Use of high dose statin is an option. [B]

62 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Recommendation 9.2 Insufficient evidence to recommend aspirin for primary prevention in lower risk individuals Men < 50 y Women <60 y * Clinical judgement if with multiple risk factors

63 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Recommendation 9.3 Use aspirin therapy for secondary prevention strategy in those with DM and a history of CVD [A]. For patients with CVD and documented aspirin allergy, clopidogrel (75 mg/day) should be used.

64 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Recommendation 9.4 Combination therapy of ASA ( mg/day) and clopidogrel (75 mg/day) is reasonable up to a year after an acute coronary syndrome [B].

65 Which of the following statements is true about reducing CV risk in diabetes? a. Statins should be given regardless of baseline lipid levels. b. There is insufficient evidence to recommend aspirin for primary prevention in men <60 y. c. Give clopidogrel 75 mg/day for those with diabetes and a history of CVD. d.the goal BP for most persons with diabetes is <140/80 mm Hg.

66 Initiation of Drug Therapy among Newly Diagnosed Type 2 Diabetes Patients Newly diagnosed T2DM

67 Initiation of Drug Therapy among Newly Diagnosed Type 2 Diabetes Patients Newly diagnosed T2DM HbA1c <9% FBS < 250 HbA1c >9% FBS > 250

68 Initiation of Drug Therapy among Newly Diagnosed Type 2 Diabetes Patients Newly diagnosed T2DM HbA1c <9% FBS < 250 HbA1c >9% FBS > 250 Monotherapy Option for combination therapy

69 Initiation of Drug Therapy among Newly Diagnosed Type 2 Diabetes Patients Newly diagnosed T2DM HbA1c <9% FBS < 250 HbA1c >9% FBS > 250 Monotherapy Option for combination therapy Combination therapy Insulin therapy

70 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement 10.1 Initiate treatment with metformin for monotherapy unless with contraindications or intolerance of its ADE s - diarrhea severe nausea abdominal pain

71 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS When optimization of therapy is needed, choose the second drug according to the following - degree of HbA1c lowering hypoglycemia risk weight gain patient profile (dosing complexity, renal/hepatic problems, other contraindications and age)

72 Drug Therapy HbA1c reduction (%) MONOTHERAPY Sulfonylureas 0.9 to 2.5 Biguanide (Metformin) 1.1 to 3.0 Thiazolidinedione 1.5 to 1.6 Alpha-glucosidase inhibitors 0.6 to 1.3 DPP-4 inhibitors 0.8 NON-INSULIN INJECTABLE Exenatide 0.8 to 0.9 COMBINATION THERAPY SU + Metformin 1.7 SU + Pioglitazone 1.2 SU + Acarbose 1.3 Repaglinide + Metformin 1.4 Pioglitazone + Metformin 0.7 DPP-4 inhibitor + Metformin 0.7 DPP-4 inhibitor + Pioglitazone 0.7 Adapted from AACE Diabetes Mellitus Guidelines Endocr Pract 2007

73 Safety and Tolerability Risk of hypoglycemia Insulin secretagogues alpha-glucosidase Metformin inhibitors TZDs Insulin Weight gain GI side effects Lactic acidosis Edema 1 DeFronzo RA. Ann Intern Med 1999; 131: UKPDS. Lancet 1998; 352: Nesto RW, et al. Circulation 2003; 108:

74 Contraindications Renal insufficiency Sulfonylurea Meglitinide Biguanide AGI TZD Liver disease Inflammatory bowel disease Congestive heart failure Known hypersensitivity

75 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Since HbA1c reduction is the overriding goal, the precise combination used may not be as important as the glucose level achieved. There is no evidence that a specific combination is any more effective in lowering glucose levels or preventing complications than another. SU + Pio = SU + Metformin (Hanefield et al, 2004 & Nagasaka et al, 2004) SU + Met = SU + DPP-IV inhibitors (?)

76 UNITE PHILIPPINE CPG FOR DIABETES MELLITUS Statement The following patients must be referred to internists or diabetes specialists (endocrinologists or diabetologists) - Type 1 diabetes Moderate to severe hyperglycemia Co-morbid conditions (infections, acute CV events i.e. CHF or acute MI) Significant hepatic and renal impairment Women with diabetes who are pregnant

77 Clinical practice guidelines aim to help physicians and patients reach the best healthcare decisions. Steinbrook R. NEJM 2007

78 If you write it, and it is good, then they will follow. Keefer JH. Clin Chem 2001

79 THANK YOU