saturday workshop 2 6 palmer final 6 up

7/27/2019 Saturday Workshop 2 6 Palmer FINAL 6 Up

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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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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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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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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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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


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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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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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


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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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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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.




Treatment

Aim for testosterone levels in mid-normal range

Any approved formulation

Choose based on

Patient's preference

Consideration of pharmacokinetics

Treatment burden

Cost





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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

saturday workshop 2 6 palmer final 6 up

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