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Diabetes: Overcoming Barriers and Achieving Excellence WithEvidenced-based Guidelines

Edward Shahady MDMedical Director Diabetes Master Clinician Program Florida Academy of Family Physicians Foundation

Clinical Professor of Family Medicine1

Objectives• Use diabetes registries to overcome the barriers

t hi t d d f di b t to reaching standards of diabetes care• Understand the metabolic defects in Diabetes

and which medications address which defects• Understand how to accomplish Diabetes

standards of care in your officestandards of care in your office.• Incorporate the above principles though case

presentations

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Excellent Excellent evidence documents evidence documents that when that when patients patients achieve control of their HbA1c, achieve control of their HbA1c, LDL and Blood pressureLDL and Blood pressure through life through life LDL and Blood pressureLDL and Blood pressure through life through life style changes and medication, obtain style changes and medication, obtain recommended immunizations, eye recommended immunizations, eye exams, foot exams, urine microalbumin exams, foot exams, urine microalbumin

d t k i i d il d t k i i d il i ifi t i ifi t and take aspirin daily, and take aspirin daily, significant significant reduction in complications will be reduction in complications will be achievedachieved..

Practices that measure individual and practice achievement of these evidenced based activities and share that information with clinicians, staff and patients achieve better diabetes

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and patients achieve better diabetes control and reduce costs and complications.”

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More Diabetes Facts• 20% of Medicare population has diabetes• 30% of the Medicare Budget is spent on diabetes• 30% of the Medicare Budget is spent on diabetes• Leading cause of blindness is diabetic retinopathy

and it is 90% preventable- National Eye Institute• Diabetic nephropathy is the leading cause of end

stage renal disease- most is preventable-NIDDKDstage renal disease most is preventable NIDDKD• Diabetes accounts for 60% of all non-traumatic

amputations-85% preventable- ADA CDCSklarSklar J, Atlas of Type 2 diabetes Preface Springer Science Philadelphia PA 2008 J, Atlas of Type 2 diabetes Preface Springer Science Philadelphia PA 2008

Registry Reports (tools)

• FAFP registry is internet based-used by over 200 li i i i Fl id 17 000 ti t 59 000 i itclinicians in Florida-17,000 patients,59,000 visits

• Point of Care Reports for the Clinician and the Patient- report cards

• Population based Reports that identify–•• Patients at increased risk because of increased Patients at increased risk because of increased •• Patients at increased risk because of increased Patients at increased risk because of increased

HbA1c, LDL, B/P, NonHbA1c, LDL, B/P, Non--HDL, TriglyceridesHDL, Triglycerides•• Patients who do not have documented annual Patients who do not have documented annual

recommendations or daily ASArecommendations or daily ASA

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Saves Saves Clinician 5 Clinician 5 minutesminutes

Empower Empower the the

P ti tP ti tPatientPatient

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Diabetes Master Clinician Program as of Diabetes Master Clinician Program as of June 9, 2009June 9, 2009

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ADA Quality Indicator

Yearly Cost Savings if

Towers Perrin actuarial evaluation Towers Perrin actuarial evaluation 2006 Bridges to Excellence2006 Bridges to Excellence

Indicator Savings if indicator achieved

HBA1C ≤ 7 $279.00LDL ≤ 100 $369.00Syst BP ≤ 130 $474.00Total yearly savings

$1122.00

http://http://www.bridgestoexcellence.org www.bridgestoexcellence.org

# Patients reaching goal for quality

Yearly Cost Savings if indicator achieved

Yearly Cost Savings using Bridges to Excellence data as of June 2009

indicator above national average in 2002HbA1c 1079 patients $301,041.00

LDL 3582 patients $1,321,758.00p $ , ,

BP 3938 patients $1,866,612.00

Total yearly savings $3,489,411.00

www.bridgestoexcellence.org

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CASECASE•• 42 Year old man comes to your office for routine 42 Year old man comes to your office for routine

physical. No complaintsphysical. No complaints•• Family Hx of diabetes and Father MI age 44Family Hx of diabetes and Father MI age 44•• BMI 28, Waist 42 in, B/P 142/90BMI 28, Waist 42 in, B/P 142/90•• Total Chol (TC)=180, Triglycerides=250, LDL Total Chol (TC)=180, Triglycerides=250, LDL

(calculated)=100 HDL=30 and FBS=132(calculated)=100 HDL=30 and FBS=132•• You obtain an A1C and it is You obtain an A1C and it is 6.06.0•• How would you treat him? What is your A1C goal? How would you treat him? What is your A1C goal?

What about the What about the Lipids?Lipids?13

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Natural History of Type 2 Diabetes

PostprandialIGT

Phase III25

75

50

HyperglycemiaIGT

Phase I Phase II

0‐12 ‐10 ‐6 ‐2 0 2 6 10 14

Years From Diagnosis

IGT = impaired glucose tolerance; Lebovitz H (1999), Diabetes Reviews 7:139-153 14

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Insulin sensitivity

Insulin secretion

Metabolic Syndrome Diabetes

Associated risk factors—

hypertension, dyslipidemia

Atherogenesis

Microvascular complications

IosmmaIosmma B, Diabetes Care 2001; 24(4):683B, Diabetes Care 2001; 24(4):683--689689

↑ blood glucose

Type 2 DiabetesAge (Years)

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Pre-Diabetes Treatment With Metformin (Level E)

• ADA Panel recommends lifestyle modification and metformin (850 mg twice per day) if patient has IFG (FPG≥100 and <126 mg/dL) or IGT 2 hour post prandial (≥140 and <200 mg/dL) <126 mg/dL) or IGT 2-hour post prandial (≥140 and <200 mg/dL) and any 1 of the following:– <60 years of age– BMI ≥35 kg/m2 – Family history of diabetes in first-degree

relatives – Elevated triglycerides – Reduced high-density lipoprotein– Hypertension – A1C >6.0%

Nathan DM et al. (2007), Diabetes Care 30(3):753-759 16

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ACE/AACE Diabetes Road Maps to achieve glycemic control in type 2 Diabetes Mellitus Endocrine Practice 2007;13:261‐268

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A1C ADA Recommendations • The A1C goal for patients in general is an A1C goal

of <7% (B)o % ( )• The A1C goal for the individual patient is an A1C as

close to normal (6%) as possible without significant hypoglycemia (E)

• Less stringent treatment goals may be appropriate for patients with a history of severe hypoglycemia, p y yp g y ,limited life expectancies, very young children or older adults, and individuals with comorbidconditions (E)

(2009), ADA Clinical Practice Recommendations Diabetes Care. Available at: www. (2009), ADA Clinical Practice Recommendations Diabetes Care. Available at: www. diabetes.org. Accessed 2diabetes.org. Accessed 2--2020--20092009 18

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June 2009 National ADA Meeting• If newly diagnosed or in the first 10 years after diagnosis attempt

to reach as close to 6% A1C as possible. UKPDS, Sub-analysis of ACCORD and VADT ACCORD and VADT.

• If they have had a CV event, are older?, prone to hypoglycemia 7 to 7.5% more appropriate

• Keeping the A1C as close to 6% as possible associated with – Pancreatic function survives longer period of time – Healthy endothelium

L f f tt id l d f di l t i l id – Less free fatty acid released from adipocye, so less triglyceride and less small dense LDL to penetrate the endothelium

– Platelets less sticky– Less Inflammation

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Ideal Medication sustains decrease

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Case 2 Choosing Diabetes Medications•• Mary is a 62 year old diabetic. She was diagnosed 3 years ago Mary is a 62 year old diabetic. She was diagnosed 3 years ago

and treated with lifestyle changes and Metformin. Her A1C was and treated with lifestyle changes and Metformin. Her A1C was 7.3 at diagnosis and decreased to 6.2. Recently she noticed 7.3 at diagnosis and decreased to 6.2. Recently she noticed 7.3 at diagnosis and decreased to 6.2. Recently she noticed 7.3 at diagnosis and decreased to 6.2. Recently she noticed her blood sugars are higher and her A1C is now 8.3. her blood sugars are higher and her A1C is now 8.3.

•• What would you do at this timeWhat would you do at this time??

–– Would you go back over the lifestyle issues to be sure she Would you go back over the lifestyle issues to be sure she understands them?understands them?

–– Would you add another oral medication? If so which one?Would you add another oral medication? If so which one?yy–– Would you consider adding Insulin?Would you consider adding Insulin?–– What about Byetta? (GLPWhat about Byetta? (GLP--1 Agonist)1 Agonist)

–– What would you do if a second oral agent did not help her What would you do if a second oral agent did not help her achieve goal? What goal did you try to achieve?achieve goal? What goal did you try to achieve?

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ADA guidelineADA guideline

Nathan et al Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Nathan et al Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy Diabetes Care 2009;32:Algorithm for the Initiation and Adjustment of Therapy Diabetes Care 2009;32:‐‐193193‐‐203203 25

ACE/AACE Diabetes Road Maps to achieve glycemic control in type 2 Diabetes Mellitus Endocrine Practice 2007;13:261‐268

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Case 3 Multiple lipid abnormalities • Sam is a 55 year old man with diagnosed diabetes of 6 months. • His initial lab values 6 months ago revealed an A1C of 7.5,

Cholesterol 200, LDL 100, Triglycerides 350, HDL 30, Non-HDL g y170. His blood pressure was 150/95. You treated the diabetes with lifestyle changes and Metformin and his blood pressure with an ACE inhibitor.

• He returns 6 months later and he has lost some weight, is exercising some and his B/P is now 125/78. His lab values now reveal an A1C of 6.5, Cholesterol 200, LDL 118, Triglycerides , , , g y250, HDL 32, Non-HDL 168. – Why did his LDL go up? – How would you treat this man?– Would you consider adding medications like a statin, fibrate,

fish oil, or Niacin? 28

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Non-HDL Cholesterol• Non-HDL represents all the bad ugly

small dense atherogenic LDL• Non HDL C = TC HDL = 200 25=175• Non HDL C = TC-HDL = 200-25=175• LDL is calculated TC-HDL- (Trigs/5) = LDL• 200-25 = 175 - (350/5 = 70) • Calculated LDL is therefore 175-70 which = 105

C D l h h i l id • Can not use LDL as only target when the triglycerides over 200

• HDL C goal is LDL goal + 30 **Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (2001), JAMA 285(19):2486-2497 29

2.5

NonNon––HDLHDL--C Is Superior to LDLC Is Superior to LDL--C C in Predicting CHD Riskin Predicting CHD Risk--especially in Diabetesespecially in Diabetes

1

1.5

2

lative CHD Risk

0

0.5

Liu J, et alLiu J, et al. Am J Cardiol.. Am J Cardiol. 2006;98:13632006;98:1363‐‐1368.1368.

LDLLDL--CC

NonNon––HDLHDL‐‐C C 

Rel

<<130130 130130‐‐159159 ≥160≥160

≥190≥190160160‐‐189189

<160<160

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Case 3 more ?• What goal do you attempt to achieve with LDL?

I th t d d d ti Is there a standard or recommendations we can follow.

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Diabetes Care April 2008 ADA & ACC recommendations for Lipid goals in diabetes. Diabetes Care April 2008 ADA & ACC recommendations for Lipid goals in diabetes. 32

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Case 3 more ?• What goal do you attempt to achieve with LDL?

I th t d d d ti Is there a standard or recommendations we can follow.

• Do you obtain an AST and ALT before your start a statin?

• Do you sometimes stop statins if the AST and • Do you sometimes stop statins if the AST and ALT go above a certain level?

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What if AST and ALT Are ↑• Nonalcoholic Fatty Liver Disease (NAFLD)/Nonalcoholic

Steatohepatitis (NASH) is common in patients with p ( ) phyperlipidemia and type II diabetes

• NAFLD/NASH may increase risk of CVD, so treat• Liver enzymes are often normal in NAFLD/NASH;

many hyperlipidemic patients with unsuspected NAFLD have likely been unsuspected NAFLD have likely been treated with statins without significant toxicity1

1Chalasani N (2005), Hepatology 41(4):690-695; 2Rallidis LS et al. (2004), Atherosclerosis 174(1):193-196; 3McKenney JM et al. (2006), Am J Cardiol 97(8A):89C-94C 34

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What if AST and ALT Are ↑ (Cont.)

• No supporting direct data that statins worsen hepatic histology 1 studies indicate statins may histology 1 studies indicate statins may improve liver histology in patients with NASH2

• If ALT or AST exceeds 3x UNL during statin therapy, follow the patient and repeat the measures; there is no need to D/C the ;statin; consider using a fractionated bilirubin to detect liver dysfunction (rather than ALT/AST)3

1Chalasani N (2005), Hepatology 41(4):690-695; 2Rallidis LS et al. (2004), Atherosclerosis 174(1):193-196; 3McKenney JM et al. (2006), Am J Cardiol 97(8A):89C-94C 35

Case 3 more ?• What goal do you attempt to achieve with LDL?

I th t d d d ti Is there a standard or recommendations we can follow.

• Do you obtain an AST and ALT before your start a statin?

• Do you sometimes stop statins if the AST and • Do you sometimes stop statins if the AST and ALT go above a certain level?

• What about Triglycerides and HDL?

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Kathiresan et al Framingham Heart Study Circulation Kathiresan et al Framingham Heart Study Circulation 2006;113:202006;113:20--2929 37

Kathiresan et al Framingham Heart Study Circulation Kathiresan et al Framingham Heart Study Circulation 2006;113:202006;113:20--2929 38

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Recommendations For Niacin• May have 5%–10% incidence of flushing that ↓ with use.

New formulation Niaspan combined with NSAID or ASA decreases chances to <5%. decreases chances to 5%.

• Niaspan start with 500 mg at night and increase by 500 mg a month up to 1500-2000mg may be enough

• Be aware of “creep effect” keeps improving• Minor increases (4%–5% on average) in glucose levels

often clinically insignificant often clinically insignificant. • Niacin co-administration with a statin does not potentiate

statin-related myopathy.• Active gout is a contraindication to niacin use

National Lipid AssociationNational Lipid Association

Recommendations for Fibrates • Measure serum creatinine before starting fibrates-If

impaired renal function is present, consider Gemfibrozil (Lopid) or a lower starting dose of Fenofibrate (Tricor)(48 mg) mg)

• Creatinine monitoring if taking metformin, which may need to be discontinued for creatinine elevations 1.4 mg/dL in women and 1.5 mg/dL in men,

• When combined with a statin use fenofibrate not gemfibrozil to decrease risk for myopathy and or rhabdomyolysis Fib t th l t h t i b t t i • Fibrate therapy elevates homocysteine but not sure is clinically relevant

• Fibrates may increase the risk for cholelithiasis

National Lipid Association

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Recommendations for fish oil

Rigorous purification processes in fish oil manufacturing reduces risk of environmental toxins.The efficacy of fish oil therapy is most dependent on the amount of omega-3 fatty acids (such as EPA and DHA) in each capsule, not the total amount of fish oil concentrate Fish oil supplements are not subject to FDA approval requirements. So amount of EPA DHA varies P ti t d 11 l f fi h il l t t Patients may need 11 capsules of fish oil supplements to match the amount of omega-3 fatty acid in 4 capsules of prescription fish oil (Lovaza).

National Lipid AssociationNational Lipid Association

Potential Dose Responses and Time Courses for Altering Potential Dose Responses and Time Courses for Altering Clinical Events of Physiologic Effects of Fish or Fish Oil IntakeClinical Events of Physiologic Effects of Fish or Fish Oil Intake

Mozaffarian, D. et al. JAMA 2006;296:1885-1899.

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QuestionsQuestions43

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