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Diabetes Overcoming Barriers And Achieving Excellence
1. 7/20/2009
Diabetes: Overcoming Barriers
and Achieving Excellence With
Evidenced-based Guidelines
Edward Shahady MD
Medical Director Diabetes Master Clinician Program
Florida Academy of Family Physicians Foundation
Clinical Professor of Family Medicine
1
Objectives
• Use diabetes registries to overcome the barriers
to
t reaching standards of diabetes care
hi t d d f di b t
• Understand the metabolic defects in Diabetes
and which medications address which defects
• Understand how to accomplish Diabetes
standards of care in your office
office.
• Incorporate the above principles though case
presentations
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Excellent evidence documents that when
patients achieve control of their HbA1c,
LDL and Blood pressure through life
style changes and medication, obtain
recommended immunizations, eye
exams, foot exams, urine microalbumin
and t k aspirin d il significant
d take i i daily, i ifi t
reduction in complications will be
achieved.
Practices that measure individual and
practice achievement of these
evidenced based activities and share
that information with clinicians, staff
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
• 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-NIDDKD
disease preventable NIDDKD
• Diabetes accounts for 60% of all non-traumatic
amputations-85% preventable- ADA CDC
Sklar J, Atlas of Type 2 diabetes Preface Springer Science Philadelphia PA 2008
Registry Reports (tools)
• FAFP registry is internet based-used by over 200
clinicians in Fl id 17 000 patients,59,000 visits
li i i i Florida-17,000 ti t 59 000 i it
• Point of Care Reports for the Clinician and the
Patient- report cards
• Population based Reports that identify–
• Patients at increased risk because of increased
HbA1c, LDL, B/P, Non-HDL, Triglycerides
Non-
• Patients who do not have documented annual
recommendations or daily ASA
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6. 7/20/2009
Towers Perrin actuarial evaluation
2006 Bridges to Excellence
ADA Quality Yearly Cost
Indicator Savings if
indicator achieved
HBA1C ≤ 7 $279.00
LDL ≤ 100 $369.00
Syst BP ≤ 130 $474.00
Total yearly $1122.00
savings
http://www.bridgestoexcellence.org
http://www.bridgestoexcellence.org
Yearly Cost Savings using Bridges to Excellence
data as of June 2009
# Patients reaching Yearly Cost Savings if
goal for quality indicator achieved
indicator above
national average in
2002
HbA1c 1079 patients $301,041.00
LDL 3582 patients
p $ ,
$1,321,758.00
,
BP 3938 patients $1,866,612.00
Total yearly savings $3,489,411.00
www.bridgestoexcellence.org
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7. 7/20/2009
CASE
• 42 Year old man comes to your office for routine
physical. No complaints
• Family Hx of diabetes and Father MI age 44
• BMI 28, Waist 42 in, B/P 142/90
• Total Chol (TC)=180, Triglycerides=250, LDL
(calculated)=100 HDL=30 and FBS=132
• You obtain an A1C and it is 6.0
• How would you treat him? What is your A1C goal?
What about the Lipids?
13
Natural History of Type 2 Diabetes
100
75
50
25 Phase III
Postprandial
IGT
Hyperglycemia 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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Metabolic Syndrome Diabetes
Insulin
sensitivity
Insulin secretion
Associated risk
factors—
hypertension,
dyslipidemia
Atherogenesis
Microvascular
complications
↑ blood glucose
Age (Years) Type 2 Diabetes
Iosmma B, Diabetes Care 2001; 24(4):683-689
24(4):683- 15
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)
2-hour
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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9. 7/20/2009
ACE/AACE Diabetes Road Maps to achieve glycemic control in type 2 Diabetes Mellitus 17
Endocrine Practice 2007;13:261‐268
A1C ADA Recommendations
• The A1C goal for patients in general is an A1C goal
o %( )
of <7% (B)
• 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 comorbid
conditions (E)
(2009), ADA Clinical Practice Recommendations Diabetes Care. Available at: www.
diabetes.org. Accessed 2-20-2009
2-20- 18
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10. 7/20/2009
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 VADTVADT.
• 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
–LLess f f tt acid released from adipocye, so l
free fatty id l df di less t i l
triglyceride
id
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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12. 7/20/2009
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Case 2 Choosing Diabetes Medications
• Mary is a 62 year old diabetic. She was diagnosed 3 years ago
and treated with lifestyle changes and Metformin. Her A1C was
7.3 at diagnosis and decreased to 6.2. Recently she noticed
her blood sugars are higher and her A1C is now 8.3.
• What would you do at this time?
time?
– Would you go back over the lifestyle issues to be sure she
understands them?
– Would you add another oral medication? If so which one?
y
– Would you consider adding Insulin?
– What about Byetta? (GLP-1 Agonist)
(GLP-
– What would you do if a second oral agent did not help her
achieve goal? What goal did you try to achieve? 24
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13. 7/20/2009
ADA guideline
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:‐193‐203
Algorithm for the Initiation and Adjustment of Therapy Diabetes Care 2009;32:‐193‐ 25
ACE/AACE Diabetes Road Maps to achieve glycemic control in type 2 Diabetes Mellitus 26
Endocrine Practice 2007;13:261‐268
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14. 7/20/2009
27
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
gy
170. 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
, , , gy
250, 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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15. 7/20/2009
Non-HDL Cholesterol
• Non-HDL represents all the bad ugly
small dense atherogenic LDL
• Non HDL C = TC HDL = 200 25=175
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 not use LDL as only target when the triglycerides
Can D l h h i l id
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
Non–HDL-
Non–HDL-C Is Superior to LDL-C
LDL-
in Predicting CHD Risk-especially in Diabetes
Risk-
2.5
2
lative CHD Risk
1.5
1
Rel
0.5
≥190
160‐189 Non–HDL‐C
160‐ Non–HDL‐
0 <160
<130 130‐
130‐159 ≥160
LDL-
LDL-C
Liu J, et al. Am J Cardiol. 2006;98:1363‐1368.
Liu J, et al. Am J Cardiol. 2006;98:1363‐
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16. 7/20/2009
Case 3 more ?
• What goal do you attempt to achieve with LDL?
Is there t d d
I th a standard or recommendations we can
d ti
follow.
31
Diabetes Care April 2008 ADA & ACC recommendations for Lipid goals in diabetes.
32
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17. 7/20/2009
Case 3 more ?
• What goal do you attempt to achieve with LDL?
Is there t d d
I th a standard or recommendations we can
d ti
follow.
• Do you obtain an AST and ALT before your start
a statin?
• Do you sometimes stop statins if the AST and
ALT go above a certain level?
33
What if AST and ALT Are ↑
• Nonalcoholic Fatty Liver Disease (NAFLD)/Nonalcoholic
Steatohepatitis (NASH) is common in patients with
p ( ) p
hyperlipidemia 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
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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18. 7/20/2009
What if AST and ALT Are ↑ (Cont.)
• No supporting direct data that statins worsen hepatic
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?
Is there t d d
I th a standard or recommendations we can
d ti
follow.
• Do you obtain an AST and ALT before your start
a statin?
• Do you sometimes stop statins if the AST and
ALT go above a certain level?
• What about Triglycerides and HDL?
36
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Kathiresan et al Framingham Heart Study Circulation 2006;113:20-29
2006;113:20- 37
Kathiresan et al Framingham Heart Study Circulation 2006;113:20-29
2006;113:20- 38
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20. 7/20/2009
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%. 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
insignificant.
• Niacin co-administration with a statin does not potentiate
statin-related myopathy.
• Active gout is a contraindication to niacin use
National 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)
• 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 therapy elevates homocysteine but not sure is
Fibrate th l t h t i b t t i
clinically relevant
• Fibrates may increase the risk for cholelithiasis
National Lipid Association
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21. 7/20/2009
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
Patients
P ti t may need 11 capsules of fi h oil supplements to
d l f fish il l t t
match the amount of omega-3 fatty acid in 4 capsules of
prescription fish oil (Lovaza).
National Lipid Association
Potential Dose Responses and Time Courses for Altering
Clinical Events of Physiologic Effects of Fish or Fish Oil Intake
Mozaffarian, D. et al. JAMA 2006;296:1885-1899.
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