J . T H O M A S C R O S S , J R . , M D , M P H , F A A P , F A C P P R E S I D E N T , A - C R O S S M E D I C I N E R E V I E W S

C O L O R A D O S P R I N G S , C O I M M E D I A T E P A S T C H A I R , M E D - P E D S S E C T I O N O F A A P

J O I N T A A P S E C T I O N O N S E N I O R M E M B E R S / M E D - P E D S W E B I N A R

M A R C H 4 , 2 0 1 4

Health Issues/Controversies Affecting ALL Seniors

Health Issues/Controversies Affecting ALL Seniors

Disclosure: “Neither Dr. Tommy Cross nor Dr. J. M. Aronson have any relevant financial relationships with the manufacturers of any commercial products or providers of commercial services discussed in this webinar.” Dr. Cross does not intend to discuss any unapproved/investigative use of a commercial product/device in his presentation.

Disclaimer: Statements and opinions expressed during this webinar are those of the moderator and the speaker and not necessarily those of the AAP Section on Senior Members or the American Academy of Pediatrics.

Tommy Cross MD

Tulane Medical School Board certified by the American Board of

Medical Specialties in Internal Medicine, Pediatrics, Adult Infectious Diseases, and Pediatric Infectious Diseases.

Former Associate professor in the Department of Internal Medicine and Pediatrics at Louisiana State University Health Sciences Center.

Clinical Efficacy Subcommittee of the American College of Physicians, which writes and directs the formulation of ACP guidelines for Internists. (Former)

ACP’s Performance Measurement Committee (current)

Past President – AAP Section Med-PEDS President – Medical Education Company, home

care and “free” clinics

Senior Health: Outline and Objectives Discuss the new lipid guidelines

Are seniors being “overtreated”? What is the best drug to take? How to calculate your cardiac risk.

Review the new Hypertension guidelines What are the best drugs to take? Are drugs always necessary? What if I have diabetes?

I or my significant other has erectile dysfunction. Should I/they be evaluated for Low-Testosterone? What is the data? What are the effective treatments? What are the side-effects?

GoToWebinar Housekeeping: What You See

GoToWebinar Housekeeping: Attendee Participation

GoToWebinar Housekeeping: Time for Questions

NCEP’s ATP III Update Recommendations—Valid until 11/2013 This is what we used to do! Add up all these!

Risk Factor Assessment Framingham 10-year Risk Assessment (Use calculator) Then “count” the following:

Age (males ≥ 45 and females ≥ 55) FH premature CHD in 1st degree relative (males ≤ 55 and females ≤ 65) Current cigarette smoking Hypertension (≥ 140/90 or on medication) HDL ≤ 40 CHD “risk equivalents”

PAD AAA TIA or CVA or carotid stenosis DM 10 Y CHD risk ≥ 20% CKD

Perform a Fasting Lipid Panel Then determine LDL “target” and assess value that should be treated with drugs.

NCEP’s ATP III Update Recommendations

Risks & Risk Assessment

LDL Goal Treat with Drugs Non-HDL Goal

CHD & CHD Risk

Equivalents

< 100 (< 70 optional)

≥ 100 < 130 (< 100 optional)

2+ Risk Factors & 10-Y CHD 10-20%

< 130 (< 100 optional)

≥ 130 < 160 (<130 optional)

2+ Risk Factors & 10-Y CHD < 10%

< 130 ≥ 160 < 160

0-1 Risk Factors < 160 ≥ 190

2013 ACC/AHA Lipid Guidelines

11/2013: American Heart Association/American College of Cardiology Cardiovascular Risk Guideline Blood Cholesterol Guideline Obesity Guideline Lifestyle Management Guideline

2013 ACC/AHA Guidelines

Disclosures of “Relationships with Industry and Other Entities” 17 Work Group Members: “primary care, cardiologists, endocrinologist, experts in

lipidology, clinical trials, CV epidemiology, and guideline development” 5/17 with disclosures

Poll Question #1

66 YO white male presents for annual evaluation. No signficant PMH. Has hypertension and is on lisinopril 20 mg daily. FH: AMI, mother, age 52 YO VS: Afebrile, 110/75, HR 70 Normal PE. Screening labs: A1c 5.2%; normal chemistry and CBC TC 210 TG 95 HDL 37 LDL 160

Poll Answer Choices #1 - Which of the following is most appropriate?

1. Count his risk factors (male, etc.) and determine target LDL 2. Prescribe a statin to reduce his Total Cholesterol to < 190 3. Start fish oil to reduce his LDL 4. Use the Pooled Cohort Risk Assessment to calculate 10Y risk

VOTE NOW 15 Seconds…

CLOSE POLL

Poll Question #1 - Review

66 YO white male presents for annual evaluation. No signficant PMH. Has hypertension and is on lisinopril 20 mg daily. FH: AMI, mother, age 52 YO VS: Afebrile, 110/75, HR 70 Normal PE. Screening labs: A1c 5.2%; normal chemistry and CBC TC 210 TG 95 HDL 37 LDL 160

Poll Answer Review #1 - Which of the following is most appropriate?

1. Count his risk factors (male, etc.) and determine target LDL 2. Prescribe a statin to reduce his Total Cholesterol to < 190 3. Start fish oil to reduce his LDL 4. Use the Pooled Cohort Risk Assessment to calculate 10Y risk

Poll Question #2

68 year-old female with no PMH presents for evaluation of fatigue. ROS negative. PMH: Negative No meds VS: Afebrile, 110/75, HR 70 Normal exam Labs: Normal chemistry and CBC TC 230 TG 275 HDL 27 LDL 175

Poll Answer Choice #2 - Which of the following is most appropriate?

A. Start fish oil B. Start simvastatin 20 mg QHS C. Start atorvastatin 40 mg QHS D. Start niacin E. Check TSH and UA

VOTE NOW 15 Seconds…

CLOSE POLL

Poll Question #2 - Review

68 year-old female with no PMH presents for evaluation of fatigue. ROS negative. PMH: Negative No meds VS: Afebrile, 110/75, HR 70 Normal exam Labs: Normal chemistry and CBC TC 230 TG 275 HDL 27 LDL 175

Poll Answer Review #2 - Which of the following is most appropriate?

A. Start fish oil B. Start simvastatin 20 mg QHS C. Start atorvastatin 40 mg QHS D. Start niacin E. Check TSH and UA

2013 ACC/AHA Management of Blood Cholesterol

Major Changes Treatment decisions now based on 10-year risk assessment only. Treatment no longer targets a specific LDL.

Counting risk factors = Out

2013 ACC/AHA Cardiovascular Risk

Use Pooled Cohort Equation for calculation of 10Y risk Available at ACC/AHA website within 2013 guidelines (spreadsheet) Overwhelming drive to identify the low-risk guy who drops dead of CVD Getting lots of criticism…

For primary prevention, 40 – 79 YO. Assess traditional Risk Factors and calculate 10Y risk Q 4-6 Y

Traditional Risk Factors = age, sex, T. chol, HDL-c, SBP, anti-HTN Rx, DM, smoking

Available at: http://www.cardiosource.org/science-and-quality/practice-guidelines-and-quality-standards/2013-prevention-guideline-tools.aspx

This is the Pooled Cohort Equation Calculator with an example: 68 y/o woman who has HTN and total cholesterol of 210

GROUP RECOMMENDATION DRUG

Secondary Prevention High Intensity Statin

Atorva- 40 – 80 mg Rosuva- 20 mg

Primary Prevention

≥ 21 YO, LDL > 190 High Intensity Statin

Atorva- 40 – 80 mg Rosuva- 20 mg

40 – 75 YO, LDL 70-189, 10Y risk ≥ (5.0% - ) 7.5%

Moderate or

High Intensity Statin

Simva- 20 – 40 mg Prava- 40 mg Lova- 40 mg Atorva- 20 – 80 mg Rosuva- 10 – 20 mg

40 – 75 YO, LDL 70 – 189, Diabetic,

10Y risk ≥ 7.5%

High Intensity Statin

Atorva- 40 – 80 mg Rosuva- 20 mg

40-75 YO, LDL 70-189, Diabetic,

10Y risk < 7.5%

Moderate Intensity Statin

Simva- 20-40 mg Prava- 40 mg Lova- 40 mg Atorva- 20 mg Rosuva- 10 mg

2014: What Do We Actually DO?

If > 75 YO, for both primary and secondary prevention: Consider comorbidities, drug-drug interactions, and patient preferences Options:

Con’t current statin, if doing okay. Prescribe moderate intensity statin. Do not prescribe any statin.

Trouble with Statins

Hepatitis Myalgias/myopathy (even rhabdomyolysis) Impaired cognition Diabetes Proportional to intensity of statin “Adverse outcome of incident diabetes must be weighed in context of potentially fatal

or debilitating occurrence of MI or stroke that could be prevented by statin.” “It’s worth it!” point of view. “Occurrence of major CVD event represents a much greater harm than an increase in blood

glucose”

Interesting Assessment

“Here’s one bright spot with the near simultaneous publication of these new guidelines: They will clearly wreak havoc on the quality indicator mafia. Pay for performance? Try calculating the individualized LDL target now and dinging me on that basis. It won’t be easy.” December 30, 2013 By: PAUL J. HAUPTMAN Family Practice News

Hypertension JNC VIII Guidelines

Poll Question #3

Based on JNC VIII, which of the following values on the next slide is correct in regards to when someone ≥ 60 years of age should be started on pharmacologic therapy?

Poll Answer Choice #3--Which of the following is most appropriate?

A. When their BP is ≥ 140/90? B. When their BP is ≥ 140/90 after lifestyle modifications have been

implemented? C. When their BP is ≥ 150/90? D. When their BP is ≥ 150/90 after lifestyle modifications have been

implemented?

VOTE NOW 15 Seconds…

CLOSE POLL

Poll Answer Review #3--Which of the following is most appropriate?

A. When their BP is ≥ 140/90? B. When their BP is ≥ 140/90 after lifestyle modifications have been

implemented? C. When their BP is ≥ 150/90? D. When their BP is ≥ 150/90 after lifestyle modifications have been

implemented?

Hypertension JNC VIII (2013)

Recommendation 1 (Note ages here!) In the general population aged ≥ 60 years, initiate pharmacologic treatment to

lower blood pressure (BP) at systolic blood pressure (SBP) ≥ 150 mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg and treat to a goal SBP < 150 mm Hg and goal DBP < 90 mm Hg. (Strong Recommendation – Grade A)

Corollary Recommendation In the general population aged ≥ 60 years, if pharmacologic treatment for high BP

results in lower achieved SBP (eg, < 140 mm Hg) and treatment is well tolerated and without adverse effects on health or quality of life, treatment does not need to be adjusted. (Expert Opinion – Grade E)

Note that in this patient population, no evidence that going lower than a DBP of 80-85 makes any difference! And we know if you go too low it is harmful!

Poll Question #4 - Hypertension JNC VIII Treatment

A 68 year-old Caucasian woman with diabetes presents with a BP of 166/98.

Poll Question #4 – Answer Choices

Which of the following anti-hypertensives should she start?

A. Thiazide-like diuretic B. ACE-inhibitor C. Angiotensin receptor blocker (ARB) D. Calcium-channel blocker E. Any of the above choices is acceptable according to JNC VIII

VOTE NOW 15 Seconds…

CLOSE POLL

Poll Question Review #4 - Hypertension JNC VIII Treatment

A 68 year-old Caucasian woman with diabetes presents with a BP of 166/98.

Poll Answer Review #4

Which of the following anti-hypertensives should she start?

A. Thiazide-like diuretic B. ACE-inhibitor C. Angiotensin receptor blocker (ARB) D. Calcium-channel blocker E. Any of the above choices is acceptable according to JNC VIII

What to Start With?

Non-Blacks: including those with diabetes, start a thiazide diuretic, calcium channel blocker (CCB), angiotensin-converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB).

Blacks: including those with diabetes, start a thiazide diuretic or CCB.

The panel did NOT recommend β-blockers for the initial treatment of hypertension because of higher rate of the primary composite outcome of cardiovascular death, myocardial infarction, or stroke compared to use of an ARB, a finding that was driven largely by an increase in stroke.

NOW WAIT A MINUTE

What about diabetics and use of ACE-inhibitors???

What about patients ≥ 75 years old with CKD?….there is no data on ACE-inhibitors being better for these patients…therefore a diuretic or CCB may be better…(Especially in light of good data with thiazides being protective for stroke in this patient population).

Testosterone Clinical Guidelines

Testosterone therapy in men with androgen deficiency syndromes Endocrine Society, 2011

Medical guidelines for clinical practice for evaluation and treatment of hypogonadism American Association of Clinical Endocrinology, Update 2002

Hypogonadism

Consider diagnosis only if: Consistent symptoms and signs

And Unequivocally low serum testosterone levels

Morning total testosterone level; reliable assay Confirm low values with repeat test Evaluate using normal ranges for your lab

Do not measure during acute or subacute illness Do not screen the general population Definitely screen certain populations

Testosterone Levels

Levels are very controversial, especially in the elderly! “Panelists disagreed on serum T levels below which therapy should be offered to older

men with symptoms.” Treat T < 280 – 300 ng/dL (healthy, young men levels) Observational studies show symptoms may be attributable to low T

Treat T < 200 ng/dL RCTs show lack of treatment effects with pretreatment T > 300

Everybody agrees that levels ~ 150 ng/dL are pathologic.

Clinical Manifestations

SPECIFIC SIGNS AND SYMPTOMS Incomplete or delayed sexual development: Clinical

history Low libido and sexual activity

Decreased spontaneous erections Sore breasts, gynecomastia

Alopecia and reduced shaving habits < 5 mL testicles (or shrinking ones . . .)

Infertility or low/zero sperm count Low-trauma fractures, osteopenia, loss of height

Hot flashes, sweats

Clinical Manifestations

OTHER SIGNS AND SYMPTOMS Low energy, motivation, confidence

Melancholy, depressed mood Difficulty concentrating and poor memory

Sleep disturbances Anemia (normochromic, normocytic; mild)

Lack of strength; reduced muscle Increased fat

What Do I Order?

Total testosterone (early a.m.) + FSH and LH Secondary: ↓ T, low or low-nl FSH and LH

Assess etiology, so consider: Serum Fe, TIBC, ferritin Prolactin, other studies of pituitary function, MRI (headaches, VF defects, T < 150, other

symptoms of hypopituitarism) Polysomnogram ROS-based assessment for infiltrative diseases (e.g., sarcoidosis, HIV, tuberculosis)

Primary: ↓ T, ↑ FSH and LH Karyotype +/- seminal fluid analyses

Major Options for Treatment

FORMULATION DOSING NOTES

Injections 150 – 200 mg Q 2 W or 75 – 100 mg Q week

Quick, high (supraphysiologic) peaks (“high”) (hypogonadal) troughs Controlled substance

1% gel Sachets, tubes, and pumps 50 – 100 mg T QD

Less peaks/troughs Less “high” with dosing More physiologic dosing Ease of application Potential for transfer

Transdermal patch 5 – 10 mg T QD Less peaks/troughs Less “high” with dosing More physiologic dosing Ease of application Some patients need two patches

“Recommend against a general policy of offering T therapy to all older men with low T levels.”

Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events

Recent Issue: January, 2014

RECOMMENDATION: At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death

Erectile Dysfunction

Erectile Dysfunction (ED) - Etiology

Vascular (MOST COMMON!): Diabetes, other PVD

Neurogenic: Diabetes, peripheral neuropathy Hypogonadism (low testosterone): Low libido along with ED Medications: Beta-blockers, diuretics Psychogenic: Associated with

acute onset, may be partner-specific, depression

Erectile Dysfunction Therapy

Sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®), and avanafil (Stendra™) are phosphodiesterase-5 inhibitors (PDE-5) All contraindicated with nitrates and alpha-adrenergic blockers

Except tamsulosin, OK with tadalafil Blue vision (3%): Sildenafil (cross-reacts with PDE-6

in the retina) Back pain (6%): Tadalafil Tadalafil now approved for daily use Recent warnings show risk of hearing loss

Penile injections: Alprostadil, papaverine, phentolamine Vacuum device: Safe but time-consuming Intraurethral alprostadil (MUSE®): Safe Penile implants: Use only after other therapy

Poll Question #5

A 67-year-old man presents for treatment of erectile dysfunction. He has had problems sustaining erections for the past year. He has a normal libido. Meds: Simvastatin, omeprazole, isosorbide mononitrate, lisinopril, aspirin.

Poll Answer Choice #5- What would you recommend?

1. An intraurethral med such as alprostadil (MUSE®) 2. An oral med such as Sildenafil (Viagra®) 3. Testosterone patch (Androderm®, Testoderm® TTS) 4. Referral for penile implant 5. Psychotherapy

VOTE NOW 15 Seconds…

CLOSE POLL

Poll Question Review #5

A 67-year-old man presents for treatment of erectile dysfunction. He has had problems sustaining erections for the past year. He has a normal libido. Meds: Simvastatin, omeprazole, isosorbide mononitrate, lisinopril, aspirin.

Poll Answer Review #5- What would you recommend?

1. An intraurethral med such as alprostadil (MUSE®) 2. An oral med such as Sildenafil (Viagra®) 3. Testosterone patch (Androderm®, Testoderm® TTS) 4. Referral for penile implant 5. Psychotherapy

Time for Q & A

Before we start, let’s review how you can ask a question! Dr. Cross – next slide please!

GoToWebinar Housekeeping: Time for Questions

Question # 1

Moderator conclusion: Thank You – Dr. Cross, Tracey Coletta, and AAP Reminders: Webinar Evaluation Questionnaire (hyperlink) will come

via email. Please respond. Future Topics??? Webinar On Demand plus presentation and

resources available on SOSM website at www.aap.org/seniors in 24-72 hours. Tell your colleagues! SOSM “new look “website at www.aap.org/seniors

Thank you and Good Bye Tommy Cross MD