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© www.bhtinfo.com Management of Type 2 Diabetic patients in Daily Clinical Practice KO KO NOGH,UM(2)

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© www.bhtinfo.com

Management of Type 2 Diabetic

patients in Daily Clinical Practice

KO KONOGH,UM(2)

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The majority of diabetic patients (greater than 90 percent) receive their care from primary care physician.

generalist and the specialist

A large observational study (the Medical Outcomes Study) found

little advantage for patients under the care of endocrinologists,

when compared with family practitioners,

except for improved foot care and lower infection risk [77,78] .

Overall functional status at four years and mortality at seven years were similar.

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• A 40 years old lady is found to have A 40 years old lady is found to have hyperglycaemia at your clinics. Her hyperglycaemia at your clinics. Her RBS isRBS is 220 mg/dl.220 mg/dl.

Is she diabetic?Is she diabetic?

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• Diagnosis of DM should not be made by Diagnosis of DM should not be made by single single measurement of blood sugar alone.measurement of blood sugar alone.

• It is important to assessIt is important to assessHyperosmolar symptoms(polyuria,polydipsia)Hyperosmolar symptoms(polyuria,polydipsia)Weight lossWeight lossPrevious history of poor wound healingPrevious history of poor wound healingFamily history of DMFamily history of DMSigns of DM complicationsSigns of DM complications

(e.g. diabetic shin spots, retinopathy)(e.g. diabetic shin spots, retinopathy)

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AACE Diabetes Mellitus Guidelines, Endocr Pract. 2007; 13 (Suppl 1) 2007

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ADA 2012 Guidelines on ADA 2012 Guidelines on Diagnosing diabetesDiagnosing diabetes

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Prediabetes: IFG, IGT, Increased A1CPrediabetes: IFG, IGT, Increased A1C

Categories of increased risk for diabetes (Prediabetes)*

FPG 100-125 mg/dl (5.6-6.9 mmol/l): IFGor

2-h plasma glucose in the 75-g OGTT140-199 mg/dl (7.8-11.0 mmol/l): IGT

or

A1C 5.7-6.4%

*For all three tests, risk is continuous, extending below the lower limit of a range and becoming disproportionately greater at higher ends of the range.

ADA. I. Classification and Diagnosis. Diabetes Care 2011;34(suppl 1):S13. Table 3.

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Definition of DiabetesDefinition of Diabetes

IndicatorIndicator AmericanAmerican(mg/dL)(mg/dL)

SISI(mmo/L)(mmo/L)

Glucose – FastingNormalNormal 65 - 9965 - 99 3.6 – 5.53.6 – 5.5

DMDM >> 126 126 >> 7.0 7.0

Random (with symptoms) DMDM >> 200 200 > > 11.111.1

GTT (2 hr.) DMDM >> 200 200 > > 11.111.1

HbA1c DMDM >> 6.5% 6.5%

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Number of People with Diabetes Number of People with Diabetes by Age Group, 2010 and 2030by Age Group, 2010 and 2030

Mill

ions

Mill

ions

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Number of People with Impaired Glucose Number of People with Impaired Glucose Tolerance by Age Group, 2010 and 2030Tolerance by Age Group, 2010 and 2030

Mill

ions

Mill

ions

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CHALLENGESCHALLENGES

• PrediabetesPrediabetes

SOLUTIONSSOLUTIONS

• Early diagnosis &Early diagnosis &• Life style changesLife style changes

PREDIABETES DIABETES

Early diagnosisLife style changes

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Criteria for Testing for Diabetes in Criteria for Testing for Diabetes in Asymptomatic Adult Individuals (1)Asymptomatic Adult Individuals (1)

•Physical inactivity

•First-degree relative with diabetes

•High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander)

•Women who delivered a baby weighing >9 lb or were diagnosed with GDM

•Hypertension (≥140/90 mmHg or on therapy for hypertension)

• HDL cholesterol level<35 mg/dl (0.90 mmol/l) and/or a triglyceride level >250 mg/dl (2.82 mmol/l)

• Women with polycystic ovarian syndrome (PCOS)

• A1C ≥5.7%, IGT, or IFG on previous testing

• Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)

• History of CVD

*At-risk BMI may be lower in some ethnic groups.

1. Testing should be considered in all adults who are overweight (BMI ≥25 kg/m2*) and have additional risk factors:

ADA. Testing in Asymptomatic Patients. Diabetes Care 2011;34(suppl 1):S14. Table 4.

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2. In the absence of criteria (risk factors on previous slide), testing for diabetes should begin at age 45 years

3. If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent testing depending on initial results and risk status

ADA. Testing in Asymptomatic Patients. Diabetes Care 2011;34(suppl 1):S14. Table 4.

Criteria for Testing for Diabetes in Criteria for Testing for Diabetes in Asymptomatic Adult Individuals (2)Asymptomatic Adult Individuals (2)

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• The lady is tested again the next The lady is tested again the next day. Her FBS isday. Her FBS is 170mg/dl170mg/dl. So DM is . So DM is diagnosed.diagnosed.

What should I do What should I do next?next?

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Doctors should doDoctors should do

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What a Doctor should do for medical care of What a Doctor should do for medical care of patient with DM?patient with DM?

• DiagnosisDiagnosis• ScreeningScreening• Evaluation of diabetes complications-macro and microvascularEvaluation of diabetes complications-macro and microvascular• Detection of comobiditiesDetection of comobidities• Reducting the risk of microvascular complicationsReducting the risk of microvascular complications

Glycemic controlGlycemic control• Reducting the risk of Macrovascular complicationsReducting the risk of Macrovascular complications

smoking cessationsmoking cessationcontrol of control of BP,Lipid,asprinBP,Lipid,asprin

• Monitoring of complicationsMonitoring of complications• Prevention of DiabetesPrevention of Diabetes• DSME (Diabetes self management education)DSME (Diabetes self management education)

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• Diabetes never come aloneDiabetes never come alone

• It come in hand with It come in hand with ObesityObesityHypertensionHypertensiondyslipidemiadyslipidemiaComplications (Microvascular & Complications (Microvascular &

Macrovascular)Macrovascular)

So look for them!So look for them!

•Diabetes•Hypertension•IHD•Increased Lipid•Stroke

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Patient Education in Diabetes Mellitus:Patient Education in Diabetes Mellitus:10 Content Areas10 Content Areas

Diabetes Self-Management

Education

Diabetes Disease Process

Physical Activity

UtilizingMedicationMonitoring

Blood Glucose

Preventing,Detecting & Treating Acute Complications

Preventing,Detecting & Treating

Chronic Complications

Goal setting forHealth &

Daily Living

IntegratingPsychosocial Adjustment

To Daily Living

Promoting Care prior to and during

Pregnancy

Nutritional Management

Funnell et. al. Diabetes Care 2010:33 (Suppl1) S89-96

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ATP III : General features of the ATP III : General features of the Metabolic SyndromeMetabolic Syndrome

• Abdominal obesityAbdominal obesity(waist circumference)(waist circumference)

MenMen > 102cm (>40inches)> 102cm (>40inches)WomenWomen >88cm (>35inches)>88cm (>35inches)

• Elevated triglyceridesElevated triglycerides > or = 150mg/dl> or = 150mg/dl• Low HDL cholesterolLow HDL cholesterol

MenMen < 40mg/dl< 40mg/dlWomenWomen <50mg/dl<50mg/dl

• Raised blood pressureRaised blood pressure > or = 130/85mmHg> or = 130/85mmHg• FBSFBS > or = 110mg/dl> or = 110mg/dl

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The Metabolic Syndrome

Low HDL cholesterol Borderline

triglycerides Central obesity Prehypertension Impaired fasting

glucose

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ComplicationsComplications

• MicrovascularMicrovascular Retinopathy (Fundoscopy)Retinopathy (Fundoscopy) Nephropathy (microalbuminuria, Urine RE, Urea, Cr)Nephropathy (microalbuminuria, Urine RE, Urea, Cr) NeuropathyNeuropathy

• MacrovascularMacrovascular Stroke, TIAStroke, TIA IHD (ECG)IHD (ECG) Peripherial vascular diseasePeripherial vascular disease

(pulse examination & claudication pain)(pulse examination & claudication pain)

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• Examination and investigations of the Examination and investigations of the lady showedlady showedBMIBMI 3232Waist circumference Waist circumference 90cm90cmBPBP 150/90mmHg150/90mmHgTotal cholesterolTotal cholesterol 250mg/dl250mg/dlLDLLDL 160mg/dl160mg/dlHDLHDL 30mg/dl30mg/dlTriglycerideTriglyceride 300mg/dl300mg/dl

How would I manage How would I manage her?her?

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ProblemsProblems

1.1. Newly diagnosed Type (2)DMNewly diagnosed Type (2)DM

2.2. Obesity(BMI 32)Obesity(BMI 32)

3.3. HypertensionHypertension

4.4. HyperlipidaemiaHyperlipidaemia

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0

10

20

30

40

50

%of deaths

Ischemicheart

disease

Otherheart

disease

DiabetesCancer Stroke Infection Other

Geiss LS et al. In: Diabetes in America. 2nd ed. 1995; chap 11.

Mortality in People With Diabetes:Causes of Death

©2006. American College of Physicians. All Rights Reserved.

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Evidence level of the recommendationsEvidence level of the recommendations

In type 2 DM managementIn type 2 DM management

Strategy Strategy Evidence-based benefit Evidence-based benefit Quality of evidenceQuality of evidence

Glycemic Glycemic 30% decrease in microvascular30% decrease in microvascular IIControlControl complications/1% fall in HbA1ccomplications/1% fall in HbA1c

BP controlBP control 35-58% decrease in macro & 35-58% decrease in macro & IIMicro vascular complicationsMicro vascular complicationsdeathdeath

Lipid controlLipid control 19-55% decrease in CHD events19-55% decrease in CHD events II-1II-1

Aspirin useAspirin use 28-61% decrease in AMI 28-61% decrease in AMI II15-18% decrease in CVD15-18% decrease in CVD

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Treatment of Type 2 DiabetesTreatment of Type 2 Diabetes

Combination Therapy - Oral Drug with InsulinCombination Therapy - Oral Drug with Insulin

DiagnosisDiagnosis

Therapeutic Lifestyle ChangeTherapeutic Lifestyle Change

Combination Therapy - Oral Drugs OnlyCombination Therapy - Oral Drugs Only

MonotherapyMonotherapy

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Do we need to get good glycemic control?

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Optimal Glycaemic Control

Is important to prevent death ,disability & complications of DM

-FBS - 90-130mg% -2HPP - <180mg% -RBS - <200mg% -Bed time - 110-150mg% -HbA1c - <7%

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Glycemic Recommendations for Non-Glycemic Recommendations for Non-Pregnant Adults with Diabetes (1)Pregnant Adults with Diabetes (1)

A1C <7.0%*

Preprandial capillary plasma glucose

70–130 mg/dl* (3.9–7.2 mol/l)

Peak postprandial capillary plasma glucose†

<180 mg/dl* (<10.0 mmol/l)

*Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak levels in patients with diabetes.

ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S21. Table 10.

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Recommendations:Recommendations:Glycemic Goals in Adults (2)Glycemic Goals in Adults (2)

ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S19.

• Additional analysis from several randomized trials suggest a small but incremental benefit in microvascular outcomes with A1C values closer to normal

• Providers might reasonably suggest more stringent A1C goals for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment

– Such patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease (B)

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Recommendations:Recommendations:Glycemic Goals in Adults (3)Glycemic Goals in Adults (3)

ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S19.

• Conversely, less stringent A1C goals may be appropriate for patients with– History of severe hypoglycemia, limited life

expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions

– Those with longstanding diabetes in whom the general goal is difficult to attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose lowering agents including insulin (C)

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How Can we get good control of How Can we get good control of DM?DM?

How Can we get good control of How Can we get good control of DM?DM?

?

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Diabetes food pyramidDiabetes food pyramid

Cereals, whole Cereals, whole grains and starch: grains and starch:

6-11 servings6-11 servings

Fruits: 1- 2 Fruits: 1- 2 servingsservings

Vegetables:Vegetables:3-4 servings3-4 servings

Low fat milk and milkLow fat milk and milkproducts: 2-3 servingsproducts: 2-3 servings

Lean meat, fish, Lean meat, fish, poultry, pulses: poultry, pulses:

1-2 servings1-2 servings

Fats, oils, sugars, refined foods, Fats, oils, sugars, refined foods, fatty foods: eat sparinglyfatty foods: eat sparingly

Exercise for at least 30 minutes every dayExercise for at least 30 minutes every day

Therapeutic Lifestyle change

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Plate modelPlate model

Vegetable

Milk/yoghurt

Fruit

Vegetable

Protein

Starch/cereal

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Rate Your PlateRate Your Plate

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Slides current until 2008

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Physical activityPhysical activity

RecommendationsRecommendations

• People with diabetes should be advised to perform People with diabetes should be advised to perform

at least 150 min/weekat least 150 min/week of moderate-intensity of moderate-intensity

aerobic physical activity aerobic physical activity (50 – 70% of maximum (50 – 70% of maximum

heart rate).heart rate). (A) (A)

• In the absence of contraindications, people with In the absence of contraindications, people with

type 2 diabetes should be encouraged to perform type 2 diabetes should be encouraged to perform

resistance training three times per week. (A)resistance training three times per week. (A)

Standard of Medical Care in Diabetes 2010Standard of Medical Care in Diabetes 2010

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Medical Nutrition Therapy and Physical

Activity

Prevent

Diabetes

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Pharmacological Pharmacological treatmenttreatment

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Diabetes And Glycemic Control: A Rational Approach

• As low as possible

• As early as possible

• For as long as possible

• As safely as possible

• And as rationally as possible

Lifestyle +MET + TZD + SU

HbA1c < 6%

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Basic Steps in the Management of Basic Steps in the Management of Type 2 DiabetesType 2 Diabetes

+ +

diet &exercise

Oral monotherapy

insulin

+

Oralcombination

Oral plusInsulin

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MedicationMedication RouteRoute YearYear Efficacy as monotherapy: % Efficacy as monotherapy: % in HgbA1cin HgbA1c

Insulin s.c. 1921 2.5

Sulfonylureas Oral 1946 1.5

Glinides Oral 1997 1.0-1.5

Metformin Oral 1995 1.5

-glucosidase inhibitors OralOral 19951995 0.5-0.80.5-0.8

TZDs OralOral 19991999 0.8-1.00.8-1.0

GLP analogue s.c.s.c. 20052005 0.60.6

DPP-IV Inhibitors OralOral 20062006 0.5-0.80.5-0.8

Amylin analogue s.c.s.c. 20052005 0.60.6

Colesevelam OralOral 20082008 0.50.5

Bromocriptine mesylate OralOral 20092009 0.2-0.40.2-0.4

Type 2 Diabetes Medication ChoicesType 2 Diabetes Medication ChoicesExperience and PotencyExperience and Potency

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Mechanisms of Action of Pharmacologic Mechanisms of Action of Pharmacologic Agents for Diabetes Agents for Diabetes

Improving Outcomes in Patients With Type 2 Diabetes Mellitus: Practical Solutions for Clinical ChallengesJames R. Gavin, III, MD, PhD; Mark W. Stolar, MD; Jeffrey S. Freeman, DO; Craig W. Spellman, DO, PhDJAOA • Vol 110 • No 5suppl6 • May 2010 • 2-14

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NEWNEW IDF IDF20112011

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Early combination approach

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MonitoringMonitoring

• SMBGSMBG• HbA1CHbA1C

52

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Glycemic controlGlycemic controlRecommendations for A1CRecommendations for A1C• Perform the A1C test at least Perform the A1C test at least two times two times a year in patients who a year in patients who

are meeting treatment goals (and who have stable glycemic are meeting treatment goals (and who have stable glycemic control) (E)control) (E)

• Perform the A1C test Perform the A1C test quarterlyquarterly in patients whose therapy has in patients whose therapy has changed or who are not meeting glycemic goals. (E)changed or who are not meeting glycemic goals. (E)

• Use of point-of-care testing for A1C allows for timely decisions Use of point-of-care testing for A1C allows for timely decisions on therapy changes, when needed. (E)on therapy changes, when needed. (E)

Standard of Medical Care in Diabetes 2010Standard of Medical Care in Diabetes 2010

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Self-monitoring of Blood Glucose Self-monitoring of Blood Glucose (SMBG)(SMBG)

• SMBG should be carried out SMBG should be carried out three or more times daily three or more times daily for for

patients using multiple insulin injections or insulin pump therapy.patients using multiple insulin injections or insulin pump therapy.

• For patients using less frequent insulin injections, noninsulin For patients using less frequent insulin injections, noninsulin

therapies, or medical nutrition therapy (MNT) alone, therapies, or medical nutrition therapy (MNT) alone, SMBG may SMBG may

be useful in achieving glycaemic goals.be useful in achieving glycaemic goals.

• To achieve postprandial glucose targets, To achieve postprandial glucose targets, postprandial SMBGpostprandial SMBG may may

be appropriate.be appropriate.

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Which one is important?Which one is important?

• FPG ------basal for microvascular FPG ------basal for microvascular complicationcomplication

• 2HPG ----for macrovascular 2HPG ----for macrovascular complication(mainly CVS)complication(mainly CVS)

Both are importantBoth are important

55

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What Do We Look For In Anti-diabetic What Do We Look For In Anti-diabetic Drug?Drug?• Effectiveness in lowering glucose

• Extra-glycemic Effects

• Long-term complications

• ? Effect on β cell mass

• Tolerability and Safety

• Easy of Use

• Expense

Body WtLipids

BP

Body WtLipids

BP

Obviously no such agent available, nor likely to be available in near or medium-term future

Unwise to anticipate “golden” Rx; rather, would be preferable to learn how to better use available pharmacologic tools

Obviously no such agent available, nor likely to be available in near or medium-term future

Unwise to anticipate “golden” Rx; rather, would be preferable to learn how to better use available pharmacologic tools

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Fast onset of action

To stimulate insulin secretion (including first phase)

Decrease fasting and post prandial blood glucose

Preservation of the beta cells

Decrease insulin resistance

Prevent complications

Long duration of action (once daily administration)

An Ideal OHA should have…

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Control FPG & PPG effectively

Lowest risk of hypoglycemia

Should not produce hyperinsulinemia & weight gain

Less drug interactions

An Ideal OHA should have…

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Sulfonylureas

Non-Sulfonylureas

Biguanides

Thiozolidinediones (Glitazones)

Alpha Glucosidase enzyme inhibitors

Newer Antidiabetic drugs (ADA)

▪ GLP-1 (Incretin Mimetics )-exenatide-liraglutide

▪ DPP-IV inhibitor (Incretin enhancer) -Sitagliptin

-Vildagliptin-Saxagliptin

ADA (antidiabetic drugs)

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SU/Non-SU

Metformin/Glitazones

α-glucosidase inhibitors

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Effect SU and NSU Metformin TZA AGI

Mechanism Increase in insulin secretion

Decrease in HGO plus increases muscle sensitivity

Decrease in HGO plus increases muscle sensitivity

Decrease in glucose absorption

Decrease in FPG 60-70 mg% 60-70 mg% 35-40 mg% 20-30 mg%

Decrease in HbA 1.5-2.0% 1.5-2.0% 1.0-1.2% 0.7-1.0%

TG level No effect Decrease Decrease No effect

HDL level No effect Slight increase Increase No effect

LDL level No effect Decrease Increase No effect

Body weight Increase Decrease Increase No effect

Insulin level Increase Decrease Decrease No effect

Adverse effects Hypoglycemia GI disturbances Anemia, hepatic GI disturbances

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Anti-hyperglycemic agents in T2DMAnti-hyperglycemic agents in T2DM

Class AIC reduction

Fasting versus PPG

Hypoglycemia

Weight change

Dosing

MET 1.5 Fasting No Neutral 1-3

INS-LA 1.5-2.5 Fasting Yes Gain 1

INS-RA 1.5-2.5 PPG Yes Gain 1-4

SU 1.5 Fasting Yes Gain 1-3

GLIT 0.5-1.4 Fasting No Gain 1

GLIN 1-1.5 Both Yes Gain 3

AGI 0.5-0.8 PPG No Neutral 3

PRAM 0.5-0.8 PPG No Loss 3

EXE 0.5-1 PPG No Loss 2

DPP-IV 0.5-0.8 PPG No Neutral 1

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Initial Therapy with OHAs

Initial Add Add

Thin/normal Wt SU Metformin Insulin

Obese Metformin SU TZD/Insulin

Obese not tolerating MET TZD SU

MET contraindicated TZD SU

Severe IR Metformin TZD SU

Elderly SU Insulin

PPHG prominent MEG/AGI

PPHG prominent in Sec Failure

AGI/Exenatide

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Metformin - Drug ProfileMetformin - Drug Profile

Advantages

No hypoglycemiaNo hypoglycemia

Weight lossWeight loss

Cardiovascular benefitCardiovascular benefit

Reduces LDL-C (approx 10 mg/dL), Reduces LDL-C (approx 10 mg/dL), reduces TGreduces TG

Disadvantages

Diarrhea is commonDiarrhea is common

Contraindicated in renal impairment, Contraindicated in renal impairment, liver failure, advanced cardiac failureliver failure, advanced cardiac failure

Risk of lactic acidosis not increased Risk of lactic acidosis not increased in meta-analyses and systematic in meta-analyses and systematic reviewsreviews

Concomitant use with other drugs Can be used as monotherapy and Can be used as monotherapy and with all classes including insulinwith all classes including insulin

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Sulfonylureas - Drug ProfileSulfonylureas - Drug Profile

AdvantagesPotent glucose lowering effect

Favorable adverse effect profile

Disadvantages

Hypoglycemia, more with Glyburide

Glyburide contraindicated in renal impairment

?Glyburide impairs ischemic preconditioning in heart (UKPDS did not reveal increased cardiac risk)

Concomitant use with other drugsCan be used as monotherapy and with all classes including insulin

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Repaglinide and Nateglinide: Drug Profiles Repaglinide and Nateglinide: Drug Profiles

Advantages

Less hypoglycemia than sulfonylureas

Favorable adverse effect profile

Disadvantages

Less potent than sulfonylureas; target mainly post-prandial glucose

Nateglinide less potent than Repaglinide

Concomitant use with other drugs

Can be used with all classes including insulin

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TZDs - Drug ProfileTZDs - Drug Profile

Advantages

No hypoglycemia

May be useful in nonalcoholic fatty liver disease

Disadvantages

Increased fracture risk

Weight gain

Edema and exacerbation of CHF Rosiglitazone increases LDL-C (10mg/dL), TG (15-50mg/dL) and possible increase in MI

?? Bladder Ca

Concomitant use with other drugs

Can be used with other classes including insulin!. Increased fluid retention and weight gain with insulin

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Alpha Glucosidase Inhibitor (AGI) - Alpha Glucosidase Inhibitor (AGI) - Drug ProfileDrug Profile

AdvantagesNo hypoglycemiaNo hypoglycemia

Weight neutralWeight neutral

Disadvantages

Targets only postprandial Targets only postprandial glucoseglucose

GI side effectsGI side effects

Concomitant use with other drugs

Can be used as Can be used as monotherapy and with all monotherapy and with all classes including insulinclasses including insulin

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Combination Therapy with OHAs

• Drug combinations should be based on A. Therapeutic efficacy (“fire power”)B. Complementary mechanisms of actionC. Ancillary benefits (CVD risk factors)D. Safety and tolerabilityE. ? Compliance with multiple dosing regimens

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Estimated Improvements with Combination Rx

Combination AIC% reduction FPG reduction

SU + MET 1.7% 65 mg/dl

SU + ROS 1.4% 60 mg/dl

SU + PIO 1.2% 50 mg/dl

SU + ACAR 1.3% 40 mg/dl

REP + MET 1.4% 40 mg/dl

MET + ROS/PIO 0.7-0.8% 40 mg/dl

INS + OHA Open to targets Open to targets

De Fronzo, NEJM 1995Horton, Diabetes Care 1998Coniff, Diabetes Care 1995Moses, Diabetes Care 1999Schneider, Diabetes 1999Egan, Diabetes 1999Fonseca, Diabetes 1999

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Strategies for Antidiabetic Treatment

Oral Triple Combination Therapy plus Basal Insulin or plus GLP-1-Mimeticum

Oral Monotherapy

Oral Dual Combination Therapy

Oral Triple Combination Therapy

NPG, Glargine, Levemir

Metformin + Sulfonylureas + TZDs

Metformin + Sulfonylureas+DPP-4-Inhib.

Metformin

DPP-4 Inhibitors

Glinides

TZDs

Sulfonylureas

-Glucosidase-Inhibitors

Metformin + DPP-4-InhibitorsSulfonylureas + DPP-4-Inhibitors

Metformin + Sulfonylureas

Sulfonylureas + TZDsMetformin + TZDs

Exenatide, Liraglutide

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ADA/EASD Consensus Algorithm for the Initiation and Adjustment of

Therapy Diabetes Care 2009; 32:193–203

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Master Decision Path Master Decision Path Type 2 Diabetes Glycemic ControlType 2 Diabetes Glycemic Control

Medical Nutrition TherapyMedical Nutrition Therapy&& Activity Plan Activity Plan If target not reached within 3 If target not reached within 3 months --months --start oral agent start oral agent

Medical Nutrition TherapyMedical Nutrition Therapy&& Activity Plan Activity Plan If target not reached within 3 If target not reached within 3 months --months --start oral agent start oral agent

Oral Agent-Monotherapy Oral Agent-Monotherapy If target not reached after maximumIf target not reached after maximum

dose for 4 - 8 weeks - - start oral agentdose for 4 - 8 weeks - - start oral agent

Oral Agent-Monotherapy Oral Agent-Monotherapy If target not reached after maximumIf target not reached after maximum

dose for 4 - 8 weeks - - start oral agentdose for 4 - 8 weeks - - start oral agent

Insulin TherapyInsulin TherapyInsulin TherapyInsulin Therapy Oral Agent(s) + InsulinOral Agent(s) + InsulinOral Agent(s) + InsulinOral Agent(s) + Insulin

Oral Combination RxOral Combination RxIf target not reached after maximum If target not reached after maximum doses for 4 - 8 weeks -- start insulindoses for 4 - 8 weeks -- start insulin

Oral Combination RxOral Combination RxIf target not reached after maximum If target not reached after maximum doses for 4 - 8 weeks -- start insulindoses for 4 - 8 weeks -- start insulin

FPG < 200FPG < 200Casual < 250Casual < 250

FPG < 200FPG < 200Casual < 250Casual < 250

FPG 200-300FPG 200-300Casual 250-350Casual 250-350

FPG 200-300FPG 200-300Casual 250-350Casual 250-350

FPG > 350FPG > 350Casual > 350Casual > 350

FPG > 350FPG > 350Casual > 350Casual > 350

At Diagnosis(mg/dl)

Targets for Targets for Glycemic ControlGlycemic Control

HbA1c <7%HbA1c <7%SMBG 80-140SMBG 80-140

Targets for Targets for Glycemic ControlGlycemic Control

HbA1c <7%HbA1c <7%SMBG 80-140SMBG 80-140

FPG > 300FPG > 300Casual > 350Casual > 350

with severe symptomwith severe symptom

FPG > 300FPG > 300Casual > 350Casual > 350

with severe symptomwith severe symptom

KK/ESSENTIAL DRUG/3.4.11/tAUNGGHU

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GlitazonesGlitazones

• Monotherapy if • MET contraindicated• Intolerant to MET

• Combination Rx• SU• MET (high IR)• Insulin (Bbox in US)

• Disadvantages• Wt gain• Fluid retention ? CHF• Possibly hepatotoxicity• Fracture risk in

• ROS/PIO• PPAR-γ agonists• Insulin action at muscle/fat cells (?

liver)• Pleiotropic effects• Beta cell preservation

Pioglitazone – 15 – 45 mg ODRosiglitazone – 2- 8 mg OD

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SulfonylureasSulfonylureas

• Which ?

• When?

• Why?

1st line in underwt/normal wt type 2 patients

Along with insulin sensitizers: metformin or glitazones

Along with insulin to facilitate reduction/frequency of insulin dosing

1st line in underwt/normal wt type 2 patients

Along with insulin sensitizers: metformin or glitazones

Along with insulin to facilitate reduction/frequency of insulin dosing

All have same MOA

Require some viable β cell mass to work

Do not work in type 1 and after sec failure sets in type 2

Differential effects amongs SUs

All have same MOA

Require some viable β cell mass to work

Do not work in type 1 and after sec failure sets in type 2

Differential effects amongs SUs

• Can use in heart failure, renal failure• SE - Weight gain, hypoglycemia• Choice of SU – Newer SU to prevent cardiac side effect, prolong hypoglycemia

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Comparison between 3 generations of Sulphonylureas

Drug Duration of action

Range of dosage

Relative potency

Doses per day

1st generation Tolbutamide 6-12 hrs 500-3000 mg 1 2-3

Tolazamide 14-16 hrs 100-1000 mg 3 1-2

Chlorpropamide 24-72 hrs 100-500 mg 6 1-22nd generation Glipizide 12-24 hrs 2.5-40 mg 75 1-2

Glipizide-ER 24 hrs (lesser fluctuations compared to

regular Glipizide)

2.5-20 mg 150 1

Glyburide (Glibenclamide)

18-24 hrs 1.25-20 mg 150 1-2

Micronized Glyburide

24 hrs 3-12 mg 250 1-2

3rd generation Glimepiride 24 hrs 1-8 mg 350 1

Drugdex Evaluations; Vol.133,2007

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Sulfonylureas: How to Choose?

• Cardiac patients: Glimepiride/GLICLAZIDE

• Elderly patients: Glimepiride/GLICLAZIDE

• Economy: Glibenclamide

• Mild renal insufficiency: Glimepiride

• Severe Renal : Gliclazide and glipizide

• Require high potency: Glibenclamide

• Relatively younger patients: Glibenclamide

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Metformin: Crucial Part of TherapyMetformin: Crucial Part of Therapy

Metformin Effects on Risk FactorsMetformin Effects on Risk Factors

Hundal RS, Inzucchi SE. Metformin New Understandings, New Uses. Drugs 2003; 63(18): 1879-1894

Dose – 500 to 3000 mgCI - serum creatinine >1.5 mg%, Advanced Heart FailureSE - Reduce appetite, nausea, vomiting, diarrhoea

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No Single Class of Oral Antihyperglycemic Monotherapy Targets All Key Pathophysiologies

Alpha-Alpha-Glucosidase Glucosidase InhibitorsInhibitors1,21,2

MeglitinidesMeglitinides33 SUsSUs4,54,5 TZDsTZDs6,76,7 MetforminMetformin88

DPP-4 DPP-4 InhibitorsInhibitors

Insulin deficiency

Insulin resistance

Excess hepatic glucose output

Maj

or P

atho

phys

iolo

gies

1. Glyset [package insert]. New York, NY: Pfizer Inc; 2004. 2. Precose [package insert]. West Haven, Conn: Bayer; 2004.3. Prandin [package insert]. Princeton, NJ: Novo Nordisk; 2006. 4. Diabeta [package insert]. Bridgewater, NJ: Sanofi-Aventis; 2007.5. Glucotrol [package insert]. New York, NY: Pfizer Inc; 2006. 6. Actos [package insert]. Lincolnshire, Ill: Takeda Pharmaceuticals; 2004.7. Avandia [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2005.8. Glucophage [package insert]. Princeton, NJ: Bristol-Myers Squibb; 2004.

Intestinal glucose absorption

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TWO basic INSULIN TWO basic INSULIN REGIMENSREGIMENS

SupplementarySupplementarySupplementarySupplementary SubstitutionSubstitutionSubstitutionSubstitution

(OHD +Bed time insulin)(OHD +Bed time insulin) ( No OHD +Only insulin)( No OHD +Only insulin)

Premixed/split mixedPremixed/split mixedPremixed/split mixedPremixed/split mixedBasal bolus insulinBasal bolus insulinBasal bolus insulinBasal bolus insulin

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Insulin Regimen for Type 2 Diabetes Mellitus

Guidelines for Starting insulin therapy(Asia Pacific Type 2 Diabetes Policy group)

0.15 units /kg /BW /Day

OAD + 10 iu NDP insulin (Bedtime)OAD + 10 iu NDP insulin (Bedtime)

Test FPG/ Adjust 3-4 daysTest FPG/ Adjust 3-4 days

>30-40 iu – stopping OAD>30-40 iu – stopping OAD

SupplementarySupplementarySupplementarySupplementary

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Insulin Regimen for Type 2 Diabetes Mellitus

Guidelines for Starting insulin therapy(Asia Pacific Type 2 Diabetes Policy group)

In normal person = 0.5 units /kg /BW /Day

Pre-mixed insulin 30/70Pre-mixed insulin 30/70

Morning 2/3

Pre-Mix 30/70

Morning 2/3

Pre-Mix 30/70

SubstitutionSubstitutionSubstitutionSubstitution

Evening 1/3

Pre-Mix 30/70

Evening 1/3

Pre-Mix 30/70

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60

0

20

40

Insu

lin

PREMIX 30/70 PREMIX 30/706 AM 6 PM12 AM 12 PM

Insulin Regimen for Type 2 Diabetes Mellitus

PREMIXPREMIXPREMIXPREMIX

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Basal Bolus Regimen Basal Bolus Regimen (Substitution)(Substitution)

85

• Mimics physiological insulin profile: starting dose- 40% daily dose as basal insulin (Intermediate-acting insulin- Insulatard or Humulin N) - 60% as short acting insulin (Actrapid or Humulin R) divided into

20% at breakfast 20% at lunch 20% at dinner

• Insulin dose adjusted if needed

• Requires highly motivated patients with constant monitoring

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Total Mealtime Insulin (lispro, aspart or regular) = 60% of

TDI

eg: 60% x 30 units = 18 units

Total Basal insulin (NPH, glargine, ultralente) =

40 % of TDI

eg: 40% x 30 units = 12 units

Breakfast dose = 1/3 of

mealtime insulin

eg: 1/3 x 18 units = 6 units

Lunch dose = 1/3 of mealtime

insulin

eg: 1/3 x 18 units = 6 units

Dinner dose = 1/3 of

mealtimeinsulin

eg: 1/3 x 18 units = 6 units

Bed-time dose = total basal

insulin

eg: 40% x 30 units = 12 units

Calculate Total Daily Insulin (TDI) =

0.5 units x weight (kg) OR (sum of current doses)

eg: if weight is 60 kg, TDI = 30 units

Initiation of Basal Bolus insulin regimen

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“ Small Steps. Big Rewards.

Prevent type 2 Diabetes”

Diabetes Prevention

• Yes. We can

Can we prevent Diabetes Mellitus?

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0 1 2 3 4

0

10

20

30

40Placebo (n=1082)Metformin (n=1073, p<0.001 vs. Plac)Lifestyle (n=1079, p<0.001 vs. Met , p<0.001 vs. Plac )

Percent developing diabetes

All participants

All participants

Years from randomization

Cum

ulat

ive

inci

denc

e (%

)

Placebo (n=1082)

Metformin (n=1073, p<0.001 vs. Placebo)

Lifestyle (n=1079, p<0.001 vs. Metformin , p<0.001 vs. Placebo)

Incidence of Diabetes Incidence of Diabetes

Risk reductionRisk reduction31% by metformin31% by metformin58% by lifestyle58% by lifestyle

The DPP Research Group, NEJM 346:393-403, 2002

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Standards of Medical Care in Diabetes—2011

PREVENTION/DELAY OF TYPE 2 DIABETES

Recommendations ● Patients with IGT (A), IFG (E), or an A1C of 5.7–6.4% (E) should be

referred to an effective ongoing support program targeting weight loss of 7% of body weight and increasing physical activity to at least 150 min/week of moderate activity such as walking.

● Metformin therapy for prevention of type 2 diabetes may be considered in

those at the highest risk for developing diabetes, such as those with multiple risk factors, especially if they demonstrate

progression of hyperglycemia

(e.g., A1C 6%) despite lifestyle interventions. (B)

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Are we achieving good control?Are we achieving good control?Are we achieving good control?Are we achieving good control?

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Treatment Strategies for Diabetes:Treatment Strategies for Diabetes:Are Patients Achieving Good Control?Are Patients Achieving Good Control?

Controlled

Uncontrolled

Hypertension Hyperlipidemia Diabetes

59%

41%

Harris MI et al. Diabetes Care. 2000;23:754

BP <140/90 mm Hg LDL-C <130 mg/dL A1C <7.0

59%

41%

58%

42%

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If RBS control is difficultIf RBS control is difficult• Always ask about other medicationsAlways ask about other medications

SteroidsSteroids ThiazideThiazide Beta-blockersBeta-blockers

• Always check dietsAlways check diets

• Always check sepsisAlways check sepsis Skin – carbuncle, abscess, gangreneSkin – carbuncle, abscess, gangrene Foot – ulcerFoot – ulcer Lungs – TB, PneumoniaLungs – TB, Pneumonia Renal – UTI, pylonephritisRenal – UTI, pylonephritis

Compliance of drugsCompliance of drugs

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Measures to improve drug-Measures to improve drug-compliancecompliance

• Patient’s educationPatient’s education

• Promoting patient’s involvement in managementPromoting patient’s involvement in management

• Reducing pill load (Reducing pill load (longacting drugs eg.metformin longacting drugs eg.metformin XR)XR)

• Encouraging family involvement in patient’s careEncouraging family involvement in patient’s care

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DRUGSDRUGS

• Correct DrugsCorrect Drugs

• Correct DosesCorrect Doses

• Correct TimingCorrect Timing

• Correct CombinationCorrect Combination

• ComplianceCompliance

• ?steroid?steroid

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Correct DrugsCorrect Drugs• InsulinInsulin Type(1)DM/Type 2 DM with Stress/OHA FailureType(1)DM/Type 2 DM with Stress/OHA Failure

• TZD/MetforminTZD/Metformin Insulin ResistanceInsulin Resistance

• Postprandial HyperglycemiaPostprandial Hyperglycemia Glinites/Acarbose/voglibose/Soluble insulinGlinites/Acarbose/voglibose/Soluble insulin

• Insulin DeficiencyInsulin Deficiency SU/GliniteSU/Glinite

• Beta cell PreservationBeta cell Preservation TZDTZD

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Correct CombinationCorrect Combination

• SU+MFMSU+MFM

• SU + AcarboseSU + Acarbose

• SU + ThiazolidinedionesSU + Thiazolidinediones

• MFM + ThiazolidinedionesMFM + Thiazolidinediones

• MFM + AcarboseMFM + Acarbose

• SU + MFM + AcarboseSU + MFM + Acarbose

• SU SU ++MFM + INSULATARDMFM + INSULATARD

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Correct Drugs

Insulin Resistance

Postprandial Hyperglycemic Insulin Deficiency

• Glinides

• Acarbose

• Voglibos

• Solube Insulin

• Thiazolidine diones

• Metformin

• Insulin Secretogogues

• Sulphonylurea Glinides

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JNC 7 and ADA recommendations JNC 7 and ADA recommendations • Hypertension blood pressure: Hypertension blood pressure: ≥≥140/90mmHg 140/90mmHg

• Target blood pressure goal in diabetes: Target blood pressure goal in diabetes: 130/80mmHg130/80mmHg

• 125/ 75 mmHg in Diabetes Nephropathy125/ 75 mmHg in Diabetes Nephropathy

• Many people require Many people require three or more drugsthree or more drugs to achieve the to achieve the recommended target recommended target

ADA 2004, JNC7

Blood Pressure ManagementBlood Pressure Management

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ACE inhibitor or ARB should be first choice If not controlled add diuretic (thiazide if

GFR>50ml, or loop diuretic if GFR≤) If ACE inhibitor, ARB, or diuretics are used- kidney

function & serum potassium levels – closely monitor

In pregnant patients BP goals 110-129/65-79mmHg

ACE inhibitor, ARB are contraindicated. Amlodipine,beta blocker

99

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ESH/ESC Guidelines recommend initiating a ESH/ESC Guidelines recommend initiating a

two-drug combination in high risk patientstwo-drug combination in high risk patients

ESH/ESC Guidelines recommend initiating a ESH/ESC Guidelines recommend initiating a

two-drug combination in high risk patientstwo-drug combination in high risk patients

Treat as a function of total CV risk

High Risk patients: diabetes, cardio renal disease

A combination is preferred as first step treatment for patients at risk

Mancia, De Backer et al. J Hypertens 2007: 25 1105-1187

High risk patient:Eg Diabetes

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Management of DyslipidiaemiaManagement of Dyslipidiaemia

• Main predictors of CVD mortalityMain predictors of CVD mortalityLDL and HDL cholesterolLDL and HDL cholesterol

• Lipid profile in type 2 diabetesLipid profile in type 2 diabetesraised triglyceridesraised triglycerideslow HDLlow HDLraised small dense LDL particlesraised small dense LDL particles

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Target for lipidsTarget for lipids

• HDLHDL >50 mg/dl>50 mg/dl

• LDLLDL <100 mg/dl<100 mg/dl

• TGTG <150 mg/dl<150 mg/dl

• TCTC <200 mg/dl<200 mg/dl

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Treatment and goalTreatment and goal

• Increased physical activityIncreased physical activity• Reduction of saturated fat and cholesterolReduction of saturated fat and cholesterol• Statin therapy should be added to life-style therapy, Statin therapy should be added to life-style therapy,

regardless of baseline lipid levels, for regardless of baseline lipid levels, for Diabetes patients ± CVD, > 40yrs of ageDiabetes patients ± CVD, > 40yrs of age

• Statin therapy in addition to life style – LDL Statin therapy in addition to life style – LDL >100mg/dl>100mg/dl

• In overt CVD < 70mg/dl is goal.In overt CVD < 70mg/dl is goal.• TG <150mg/dl, HDL>40mg/dl in men, HDL>50mg/dl TG <150mg/dl, HDL>40mg/dl in men, HDL>50mg/dl

in women.in women.• Statin is contraindicated in pregnancy.Statin is contraindicated in pregnancy.

103

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Dyslipidemia ManagementDyslipidemia ManagementDyslipidemia ManagementDyslipidemia Management

• Lifestyle modifications are essential. Lifestyle modifications are essential. (Grade D)(Grade D)

• Statins are the pharmacologic treatment of choice. Statins are the pharmacologic treatment of choice.

(Grade A)(Grade A)

• Exetimibe in patients who are intolerant of statins Exetimibe in patients who are intolerant of statins

or in combination therapy and other lipid modifying or in combination therapy and other lipid modifying

agent. agent. (Grade B)(Grade B)

• Use Use Fibrates as primary therapy if TG level > 400 Fibrates as primary therapy if TG level > 400

mg/dl mg/dl (Grade C)(Grade C)

• Use low dose aspirin prophylaxis Use low dose aspirin prophylaxis (Grade A)(Grade A)

AACE Diabetes Mellitus Guidelines, Endocr Pract. 2007; 13 (Suppl 1) 2007

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Dyslipidemia ManagementDyslipidemia ManagementDyslipidemia ManagementDyslipidemia Management

• Combination therapy in patients who Combination therapy in patients who

have not achieved the desired goals have not achieved the desired goals

with monotherapy. with monotherapy. (Grade C)(Grade C)• Statin + FibrateStatin + Fibrate

• Statin + niacinStatin + niacin

• Statin + ezetimibeStatin + ezetimibe

• Statin + bile-acid sequestrantStatin + bile-acid sequestrant

• Statin + omega-3 fatty acidsStatin + omega-3 fatty acids

AACE Diabetes Mellitus Guidelines, Endocr Pract. 2007; 13 (Suppl 1) 2007

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Diabetes UK recommends that aspirin should be offered to people with diabetes who already have a history of CVD.

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107

Antiplatelet AgentsAntiplatelet Agents

• Use aspirin therapy (75-162 mg/day) as a Use aspirin therapy (75-162 mg/day) as a secondary secondary

prevention strategyprevention strategy in diabetic individuals with a in diabetic individuals with a

history of CVD.history of CVD.

• Use aspirin therapy (75-162 mg/day) as a Use aspirin therapy (75-162 mg/day) as a primary primary

prevention strategyprevention strategy in those with type 1 or type 2 in those with type 1 or type 2

diabetes diabetes at increased cardiovascular riskat increased cardiovascular risk, including , including

those who are those who are >40 years of age>40 years of age or who or who have additional have additional

risk factorsrisk factors (family history of CVD, hypertension, (family history of CVD, hypertension,

smoking, dyslipidemia, or albuminuria).smoking, dyslipidemia, or albuminuria).

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108

• Aspirin therapy is Aspirin therapy is not recommended in people under 30 not recommended in people under 30

yearsyears of age, due to lack of evidence of benefit, and is of age, due to lack of evidence of benefit, and is

contraindicated in patients under the age of 21 yearscontraindicated in patients under the age of 21 years

because of the associated risk of Reye's syndrome.because of the associated risk of Reye's syndrome.

• Combination therapy using other antiplatelet agents Combination therapy using other antiplatelet agents

such as such as clopidogrel in addition to aspirin should be used clopidogrel in addition to aspirin should be used

in patients with severe and progressive CVD.in patients with severe and progressive CVD.

Antiplatelet AgentsAntiplatelet Agents

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Is it necessary to hospitalize the Is it necessary to hospitalize the patient?patient?

• High blood sugar alone is not an High blood sugar alone is not an indication for hospitalizationindication for hospitalization

• When to refer to hospitalWhen to refer to hospitalDKA, HONKDKA, HONKDM with sever sepsisDM with sever sepsisDM with pregnancyDM with pregnancyDifficult - to - control DMDifficult - to - control DM

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Indications for insulin therapy in Indications for insulin therapy in Type 2 DMType 2 DM

• Failure to achieve glycemic control with diet, exercise and Failure to achieve glycemic control with diet, exercise and oral medicationsoral medications

• Before and during pregnancyBefore and during pregnancy• During surgeryDuring surgery• Poor Diabetic control in any medical illness (e.g. septicaemia, Poor Diabetic control in any medical illness (e.g. septicaemia,

TB, diabetic foot)TB, diabetic foot)• Critically ill patient in ICUCritically ill patient in ICU• Glucose toxicityGlucose toxicity

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Take Home MessageTake Home Message

Glycemic controlGlycemic control: HbA1c <7% ADA, <6.5% AACE : HbA1c <7% ADA, <6.5% AACE

(ADVANCE)(ADVANCE)

Blood pressure Blood pressure <130/ 80 mmHg<130/ 80 mmHg

Lipid controlLipid control

LDL-C: <100 mg/dl (<70 mg/dl in very high risk)LDL-C: <100 mg/dl (<70 mg/dl in very high risk)

HDL-C: men >45 mg/dl; women >55 mg/dlHDL-C: men >45 mg/dl; women >55 mg/dl

Triglycerides: <150 mg/dlTriglycerides: <150 mg/dl

Prothrombotic stateProthrombotic state: : ASA Rx (75 - 162 mg/day)ASA Rx (75 - 162 mg/day)

People with DM + CVDPeople with DM + CVD

> 40 years of age with DM + >1 other CV risk > 40 years of age with DM + >1 other CV risk

factorfactor

Cigarette smokingCigarette smoking: : CessationCessation

Diabetes Care. 2005; Supplement 1.

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The Pill BurgerThe Pill Burger

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Diabetes And Glycemic Control: A Rational Approach

• As low as possible

• As early as possible

• For as long as possible

• As safely as possible

• And as rationally as possible

Lifestyle +MET + TZD + SU

HbA1c < 6%

Page 114: Dm talk npt,tmo)

Need for global treatment to reduce complications

Hypertension

Dyslipidemia

Obesity

Smoking

Hyperglycem

ia

Exercise

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Diabetes And Glycemic Control: A Rational Approach

A = Advice – Diet, Exercise, Stop smoking B = BP – 130/80 mm Hg C = Cholesterol – LDL 70 mg/dl D = Diabetes – FBG, PP BG, HbA1c E = Eye checkup regularly F = Foot examination daily G = Guardian Drugs – Aspirin, Statin, ACE-I

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Avoid bad habits...Avoid bad habits...

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118

jyHK;yg/ (pdwfzdpD;rIrsm;

avsmhenf;EdkiforQ avsmhenf;atmif BudK;pm;yg/)

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Don’t worryI will take care of DMSave big Money

Don’t worryI will take care of DMSave big Money

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Thank you

Confused?

But

The end is here

Page 121: Dm talk npt,tmo)

Thank You for Kind Attention