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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Elissa J. Palmer, MD, FAAFP
Professor and Chair
Department of Family and
Community Medicine
University of Nevada School
of Medicine
Dr. Palmer disclosed no relevant financial relationships with any
commercial interests.
Complete management of our patients with cardiometabolic risk
includes preventing, and if necessary, treating the myriad of
comorbidities and complications associated with the components
of cardiometabolic syndrome.
Review current recommendations for antiplatelet therapy, eye care, foot care,vitamin D, and hormones for patients with cardiometabolic risk
Outline the evidence for the clinical practice recommendations
Assess your clinical practice activities and set up future goals to improve
outcomes for patients with cardiometabolic risk
Janine is your 41-year-old, married Caucasian patient who comes intoday to discuss labs you ordered after she had a prior first HbA1c of7.0%. Janine is a nonsmoker.
BP = 140/68 mm Hg; P = 68 Reg (no hx arrhythmias); Wt = 185 lbs
Diagnosis = DM type 2
Cardiac risk assessment: UKPDS Risk Engine(predicts risk of CHD in patients with diabetes)
TC LDL HDL HbA1C Urine Microalbumin
195 mg/dL 98 mg/dL 35 mg/dL 7.5% 40 mcg/min
HbA1c = hemaglobin A1c; BP = blood pressure; TC = total cholesterol; LDL = low-density lipoprotein; HDL = high-
density lipoprotein; DM = diabetes mellitus; UKPDS = UK Prospective Diabetes Study; CHD = coronary heart
disease.
POINTS Janine POINTS Janine
AGE years M F BP mm Hg
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Janine
13SCORE 10-Year
0-17 Average 30%
University of Oxford. D iabetes Trials Unit. http://www.dtu.ox.ac.uk/index.php?maindoc=/riskengine. Accessed July
23, 2012.
With her UKPDS score of 13 points, indicating a 10-year risk
60 Years
75 to 162 mg/day
DM + 10-Year Risk(Evidence Level E)
If 5%-10% andother risk factors:
Men
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
RESISTANCE
Occurrence of cardiovascularevents despite aspirin at
recommended doses
SENSITIVITY
Minority of patients
Symptoms
Respiratory tract disease
Lack of evidence to support
clinical relevance of aspirin
"resistance" in the CVD
events that occur
Rhinitis
Asthma
Urticaria/angioedema
Desensitization
Alternative: clopidogrel 75
mg/day (Evidence Level B)
Randomized studies lacking
Stevenson DD.Immunol Allergy Clin North Am. 2004;24:491-505. Gollapudi RR, et al.JAMA. 2004;292:3017-3023.
Antithrombotic Trialists' Collaboration1
75 to 325 mg/day
Post-hoc subset from CHARISMA trial2
Efficacy same comparing doses of 75 to 150 mg/day (low-dose and 160 to 325 m da medium-dose
United States Food and Drug Administration
75 to 325 mg/day
American College of Cardiology/American Heart Association3
75 to 162 mg/day
American College of Chest Physicians 3
75 to 100 mg/day
1. Antithrombotic Trialists' Colaboration. BMJ. 2002; 324:71-86. 2. Steinhubl SR, et al.Ann Intern Med. 2009;
150:379-386. 3. American Heart Association.J Am Coll Cardiol. 2006;47:2130-2139.
Which one of the following statements is correctregarding aspirin?
1. In studies, enteric-coated aspirin protects against the clinically relevant endpoint of GI bleeding.
2. Studies show that women who take aspirin have a better response tolowering CVD risk than men who are study matched controls.
3. Aspirin is underutilized in prevention of CVD.
4. Based on evidence from large-scale primary prevention trials of men andwomen without established CVD, aspirin produces a statistically significantand clinically important reduction in the risk of a first MI, stroke, and
cardiovascular death.
Enteric coated
Lack of protection against end point of GI bleeding1
Crush or chew in acute vascular events
Enteric versus plain2
Some studies show enteric less effective
1. Kelly JP, et al. Lancet. 1996; 348:1413-1416.2. Cox D, et al.Stroke. 2006; 37:2153-2158.
Study Aspirin Dose Reference
Physicians Health Study (PHS) 325 mg qod N Engl J Med. 1988;318:262
British Doctors Trial (BDT) 500 mg qdBr Med J (ClinRes Ed). 1988;296:313
Thrombosis Prevention Trial (TPT)75 mg + warfarinat INR 1.5
Lancet. 1998; 351:233.
Primary Prevention Project (PPP) Enteric 100 mg qd Lancet. 2001; 357:89
Hypertension Optimal TreatmentTrial (HOT)
75 mg qd Lancet. 1998; 351:1755
Women's Health Study (WHS)100 mg qdx 10years
N EnglJ Med. 2005;352:1293
Aspirin for AsymptomaticAtherosclerosis trial (AAAT)
100 mg qd JAMA. 2010;303:841
Japanese Primary Prevention ofAtherosclerosis With Aspirin for
Diabetes (JPAD)
81-100 mg qd JAMA. 2008;300:2134.
Prevention of Progression of Arterial
Disease and Diabetes (POPADAD)100 mg qdforpatients with DM
BMJ. 2008;337:a1840
AGE
6 large-scale randomizedtrials Over 90,000 subjects 40 to 89
ears of a e
GENDER
2002 meta-analysis
Trials of secondary prevention
2009 meta-analysis
Average 10-year risk of a firstCHD event is less than 5%
ARRIVE and ASPREE Patients at moderate to high risk
Average risk of a first CHDevent of 10% to 19%
22 trials of primary and
secondary prevention
About 135,000 patients
Conclusion: No difference in the
response to aspirin between menand women
Antithrombotic Trialists' Collaborat ion. Lancet. 2009;373:1849-1860. Antithrombotic Trialists' Collaboration. BMJ.
2002; 324:71-86.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Underutilized in Patients with prior occlusive vascular diseases
Acute MI
Improving
Unstable angina in hospital
Outpatients with CVD
Outpatients with DM
Anticoagulation and then adding aspirin
Not shown to improve outcomes (Grade 2C)
Risk of bleeding increased
Possible use with prior MI or 5 years in type 1 DM)
Management
Hyperglycemia
BP control
Laser treatment
AGE GENDER ETHNICITY
40-64 years 28.0 % Male 31.6% Caucasian 26.8%
>65 years 29.5% Female 25.7% African 38.8%mercan
Mexican
American34.0%
Other 19.7%
NHANES.JAMA. 2010;304(6):649-656.
UKPDS study Glucose control
ACCORD trial: subgroup analysis
FIELD study: subgroup analysis Fenofibrate
DCCT BP control
ACCORD = Action to Control Cardiovascular Risk in Diabetes; FIELD = Fenofibr ate Intervention and Event Lowering
in Diabetes; DCCT = Diabetes Control and ComplicationsTrial.
UKPDS. BMJ. 1998;317:708-713. EstacioRO, et al. Diabetes Care. 2000;23 (Suppl 2):B54-B64. ACCORD. N EnglJ Med.
2008;358:2545-2559. DCCT. N EnglJ Med. 1993;329:977-986.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Sudden monocular loss of vision in a patient
with diabetic retinopathy is most commonly due to:
. cute g aucoma.
2. Vertebrobasilar stroke.
3. Vitreous hemorrhage.
4. Central retinal vein occlusion.
5. Episcleritis.
Duration of DM Type 1 patients:
25% rate of retinopathy after 5 years
80% at 15 years
Type 2 patients: roun , retnopat y at agnoss
Potential increased risk of retinopathy
Puberty
Pregnancy
NOTE: Retinopathy is not a contraindication to aspirin therapy
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1).
Type of DM Type 1 Type 2
Pregnancy
(pre-existing DM)
Screen
Within 3-5 years of
diagnosis for > age 10
years
At time of diagnosisBefore conception
and first trimester
Follow-up
Annually
(can consider less
frequent, Level E)
(can consider less
frequent, Level E)At 1 year
Method Dilated ind irec t ophthalmoscopy with fundus photography
Retinopathy
SignsMore frequent screenings for all categories
Evidence Level B
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1).
Janines father has type 2 DM with neuropathy. She would like to knowwhat risk factors she could modify to prevent the development ofneuropathy.
Of the following, which is the biggest risk factor for developing diabeticneuropa y
1. Coronary artery disease
2. Retinopathy
3. Smoking
4. Uncontrolled high blood sugars over time
5. Uncontrolled high BP over time
Recommendation Type Method Evidence
Annual Examination
Inspection
Pulses
Loss sensation
10 g monofilament PLUS one:
128 Hz tuning fork
Pinprick sensation
Ankle reflexes
Vibration perception
B
EducationSelf care, shoes All patients with DM B
High risk/ulcers Multidisciplinary B
ReferralSmokers, high-risk
Sensation lossFoot care specialist B
Screen PADClaudication
Peripheral pulses
Consider ankle-brachial index
Older than 50 years of age
Younger than 50 years of
age with risk factors
C
PAD = peripheral arterial disease.
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1). American Diabetes Association. Diabetes Care
2008;26:3333-3341.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Clean daily
Lubricate
Avoid alcohol-based, avoid between toes
Callus debridement (reduce plantar pressure by 25%)
mory oar , pum ce stone not ng s arp
Nail trim
No bare feet
Exercise
If neuropathy, bicycling, swimming
Optimal footwear
Janine asks why the nurse always has her father remove his shoes
and socks before you see him. You explain that multiple research
studies have demonstrated that the a socks off examination can
reduce amputation rates by:
1. 10%.
2. 25%.
3. 50%.
4. 75%.
DCCT. N EnglJ Med. 1993;329:977-986. UKPDS. Lancet. 1998;352(9131):837-853. ACCORD-EYE. N EnglJ Med.
2010;363:233-244. ADVANCE. N EnglJ Med. 2008;358:2560-2572. VADT. N EnglJ Med. 2009;360:129-139.
Group Description Developed Ulcers Amputation
0 No evidence of neuropathy 5.1% 0.0%
1
Neuropathy present but no evidence
of foot deformity or peripheral
vascular disease
14.3% 0.0%
2
europa y w ev ence o
deformity or peripheral vascular
disease
18.8% 3.1%
3History of foot ulceration or lower
extremity amputation55.8% 20.9%
Peters E, et al. Diabetes Care. 2001;24(8):1442-1447.
Janines father, a diabetic with poor control and diagnosedneuropathy, comes in complaining of a sensation of burningin his feet.
Which one of the following has the closest correlation withamputations o t e ower extremity
1. Pins and needles sensation on feet
2. Loss of ankle reflex
3. Burning sensation on feet
4. Inability to feel pressure with monofilament test
5. Pale and blotchy skin on lower ankles and feet
Device
10-gram (5.07 Semmes-Weinstein) nylon filament
standardized to deliver a 10 gram force
Use for 40years
50%>60years50% are asymptomatic forneuropathic symptoms
Rith-Najarian SJ, et al.J Family Practice. 2000;49(11 Suppl):S30-S39. Rit h-Najarian SJ, et al. Diabetes Care.
1992;15(10):1386-1389.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Test characteristics
Negative predictive value = 90% - 98% Positive predictive value = 18% - 36%
80% of ulcers and 100% of amputations occur ininsensate feet
Superior predictive value compared to other testmodalities
Rith-Najarian SJ,et al.J Family Practice. 2000;49(11 Suppl):S30-S39. Rith-Najarian SJ,et al. Diabetes Care.
1992;15(10):1386-1389.
Tuning Fork (128 Hz)
Testing at each hallux Can use in conjunction
Biosthesiometer
Quantitatively assessesvibration sense
Inexpensive
Avoid calluses
Document as (+) or (-)
with monofilament
Expensive
Electrical tuning fork
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1). Miranda-Palma B, et al. Diabetes Res Clin
Pract. 2005;70(1):8-12.
Which one of the following is NOT suggestive ofautonomic neuropathy?
.
2. Third nerve palsy
3. Resting tachycardia
4. Exercise intolerance
5. Constipation
Autonomic
Increased morbidity and mortality
1. Focal2. Sensorimotor (peripheral)
3. Autonomic
Resting tachycardia (>100 bpm)
Exercise intolerance
Orthostatic hypotension (>20 mm Hg fall in BP with standing)
Constipation
Gastroparesis
Erectile dysfunction
Brittle diabetes
Hypoglycemic autonomic failure
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1).
Glucose Good control and minimize fluctuations
Smoking Encourage patient to quit
Peripheral vasculature Screen for PAD
Feet Evaluate for plantarpressure
Erythema, warmth, callus, or measured pressure
Shoes
Extrawide,custommolded
Accommodatebonydeformities
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1). Seaquist ER, et al.J Clin Endocrinol Metab.
2010;95:3103-3110.
Class Evidence Medication Dosage
Anticonvulsants 2
Carbamazepine 200-400 mg 3x day
Gabapenti n 300-1200 mg 3x day
Pregabalin 100 mg 3 x day
5-Hydroxytryptamine and Duloxetine 60-120 mg daily
Opioids 2 OxycodoneControlled-release10-40 mg 2x day
Substance P inhibitor 2 Capsaicin cream0.025%-0.075% applied 3
or 4 x day
Tricyclic drugs 2
Ami tr iptyline 10-75 mg at n ight
Imipramine 25-75 mg at night
Nortr iptyline 25-75 mg at n ight
American Diabetes Association. Diabetes Care. 2012:35(Suppl 1). Watson CP, et al.Pain. 2003;105(1-2):71-78.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Michael is a 57-year-old, married African American patient with
DM in for a 3-month follow-up visit.
BP = 122/68 mm Hg; P = 66 Reg (no hx arrhythmias); BMI = 33
TC LDL HDL HbA1c Vitamin D
198 mg/dL 120 mg/dL 39 mg/dL 6.1%
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Michael is your 57-year-old, married African American
patient who comes in today to discuss labs you ordered.BP = 122/68 mm Hg; P = 66 Reg (no hx arrhythmias); BMI = 33
estosterone
198 mg/dL 120 mg/dL 39 mg/dL 7.1% 215 ng/ml
Your lab normal is 270-1070 ng/dL. You would:
1. Diagnose Michael with androgen deficiency.
2. Start Michael on testosterone.
3. Both 1 and 2.
4. None of the above
Statistics
25% of Med
Manifestations
Bone loss
MetabolicSyndrome, InsulinResistance, Low T
Replacement
5.6% sx
50% of DM
>30 years, 1% a year
Fractures
Lose Muscle
Lethargy
Depression
? Corrects
Resistance
No RCTs withBenefit Unless
Deficient
RCTs = randomized control trials.
Dhindsa S, et al.J Clin Endocrinol Metab. 2004;89:5462-5468.
Routine testosterone levels Not recommended
Diagnosis Need consistent symptoms
Unequivocally low serum testosterone levels
Measure Morning total testosterone level
Confirm by repeating the measurement
Possibly measure free or bi oavailable testosterone level
Treat only symptomatic men with androgen deficiency Improve their sexual function
Sense of well-being
Muscle mass and strength
Bone mineral density
The Endocrine Society. Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine
Society Clinical Practice Guideline. http://www.endo-society.org/guidelines/final/upload/FINAL-Androgens-in-Men-
Standalone.pdf. Accessed July 23, 2012.
Recommend against testosterone in patients with: Breast or prostate cancer
Palpable prostate nodule or prostate-specific antigen greaterthan 3 ng/ml without further urological evaluation
Untreated obstructive sleep apnea
IPSS greater than 19
Class III or IV heart failure
IPSS = International Prostate Symptom Score.
The Endocrine Society. Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine
Society Clinical Practice Guideline. http://www.endo-society.org/guidelines/final/upload/FINAL-Androgens-in-Men-
Standalone.pdf. Accessed July 23, 2012.
Treatment
Aim for testosterone levels in mid-normal range
Any approved formulation
Choose based on
Patient's preference
Consideration of pharmacokinetics
Treatment burden
Cost
The Endocrine Society. Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine
Society Clinical Practice Guideline. http://www.endo-society.org/guidelines/final/upload/FINAL-Androgens-in-Men-
Standalone.pdf. Accessed July 23, 2012.
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EvidenceSupporting ClinicalPractice Activities:Antiplatelet Therapy, EyeCare,FootCare
Antiplatelet
Recommendations vary depending upon risks and with newest data,
risk/benefit discussion around GI bleeding needs to occur
Retinopathy
Control BP and blood su ar
Neuropathy
Control blood sugar
Vitamin D
Contributes to bone health
Testosterone
Treat symptomatic men
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