Team 45 Presentation

7/31/2019 Team 45 Presentation

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Remember When You Had Energy ?


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Remember When You were happy?

Remember When You were Not Depressed?


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Remember When You Had Passion?

Remember When You were ConfidentAbout Your Sexual Performance?


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Remember When You were Leaner and

Stronger? Remember When You had Better Body


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You Can Make Those

Memories into a Reality!


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AndroGel


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Side Effects May Include:


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Testosterone


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History

Berthold in 1849 - castrated roosters In 1889 Charles-douard Brown-Sequard injected

testicular extracts from testicles of dogs and guinea pigson himself at the age of 72. He claimed a remarkablereturn of physical strength and endurance, a rejuvenatedbowel system, and enhanced mental capacity.

Butenandt in 1931 isolation of steroidal androgens Butenandt and Hanish in 1935 chemically synthesized

testosterone


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Background

Oral T (1930s) - Quickly eliminated by first passeffect

Oral versions were replaced by its alkylated form: 17alpha-methyl testosterone

Compressed into pellets and implanted SubQ

Injectable T esters (1950s)

Transdermal patches (1990s)

First gel (2000) Injectable form under clinical trials (2004-2009)


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Mechanism


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Objective: To determine the effects of a 12-weeklong-acting testosterone by measuring functionalcapacity and ventilatory efficiency in individuals

with chronic heart failure.


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Methods

- 70 elderly male patients with moderate to severeCHF

- At baseline and end of study, tests andmeasurements included: blood sample, ECG,muscle strength assessment, cardiopulmonaryexercise test, 6-minute walk test, BRS

- Patients received either IM long-actingtestosterone or IM saline


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Significant Change Insignificant Change

VO2 PSA levels

MVC Liver and renal function

VE/VCO2 slope Hemoglobin levels

6MWT Total cholesterol

Hematocrit Triglycerides

Body weight, BMI CRP

BRS

Changes from baseline after 3 months of TST


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Conclusions and Caveats

- Long-term testosterone supplementation DOESimprove functional capacity and baroreflex controlof heart rate, muscle strength, and glucosemetabolism in elderly patients with CHF

- Medications taken through study

- Short follow up, cannot generalize through clinicaloutcomes


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Purpose Determine the effects of 6 month treatment with

testosterone gel on intermediate-frail and frailelderly meno Muscle mass and Strength

o Physical Functiono Quality of life


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Criteria for Frailty1. Unintentional Weight Loss of More than 10lb in the

preceding year

2. Self reported exhaustion

3. Low physical activity

4. Slow walk time

5. Low handgrip strength

Intermediate-Frail = 1 to 2 criteria

Frail = 3 or more criteria


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Population 8260 community-dwelling men over the age of 65

were recruited

Exclusion criteria:o Not Frail

o Raised PSAo Prostate Pathology

o T>12nmol/l

o Moderate to severe peripheral vascular disease

274 were were candidates for the trialo 130 received testosterone gel

o 132 received placebo gel.


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Intervention Study Group Received T gel at a dose of 50mg/day

for 6 months

The dose was adjusted to 75mg/day or 25mg/dayaccording to serum T at day 10 and 3 months

Target Range of T levels 18-30nmol/l


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MethodsTook measurements at baseline and 6 months of: Muscle Strength

o Isokinetic knee extensiono Isometric knee extensiono Isokinetic knee flexiono Isometric knee flexiono Grip Strength

Physical Function

Body Compositiono LBMo FM

Quality of Life (The aging males' symptoms (AMS)rating scale)o Somatic Subscaleo Psychological Subscaleo Sexual Subscale


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Methods Monitoring:

o T, LH, FSH and SHBG

o Performed at baseline, 10days, 3 months, and 6 months


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Total Testosterone


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Luteinizing Hormone


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Adjusted Difference P-Value


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jT-Placebo

IME 8.6 Nm .04

LBM 1.1 lb


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Authors Conclusions increasing low or borderline-low testosterone

concentrations to the middle of the normal range inelderly men for 6 months improved lower limbmuscle strength compared with placebo.

Testosterone increased LBM and decreased FMalong with improvement of somatic and sexualsymptoms


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Study MethodsPatients: from Framingham study

Age range (51-70 yr)o Mobility (N=1111)

o Walking speed (N=693)

Study length: 6.6 years


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Mobility Limitation Using modified Roscow-Breslau questionaire

o Heavy works

o Half-mile walk, unassisted

o Walk up and down stairs

Responses:o No help

o Use device

o Human assistance

Minimal or maximalo Almost never


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Physical Performance Hand grip:

o Each hand

o Jamar hydraulic dynamometer

SPBB:o Standing balance

o Walking speed

o

Chair stand


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Cross-sectional analyses of

low FT association with SPBB

L it di l l f l


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Longitudinal analyses of lowFT association with mobility

limitation

They conclude:Low FT = 57% higher risk of mobility limitation

68% higher risk of worsening limitation no data


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Authors conclusion

Advantage Limitations

Wider age range

Included age, diseasehistory

Only in white men Some patients did not return

(possible, really sickpatients)

Can only considerassociation, not causalrelationship

Lower Free Testosterone (FT) = higher risk of mobility limitation (disability, institutionalized life, quality of life, death)

FT is associated with SPBB and walking speed Small but significant effect

No conclusion whether T therapy might work


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Patients Wave

Wave 1

Wave 2

Wave 3

12,2031996,1999

10,9402001,2004

3,2742008-2009


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Cross sectional association


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Cross-sectional associationof low FT and frailty

Longitudinal association


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Longitudinal associationof low FT and frailty


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Authors Conclusion Frailty is associated with:

o Lower FT

o Higher LH

From correlation of FT and weight loss, sarcopeniapatients may get benefit from therapy.

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Team 45 Presentation

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