A Primer on Anabolic A Primer on Anabolic Steroid Use in HIV Steroid Use in HIV

InfectionInfectionAntonio E. Urbina, M.D.Antonio E. Urbina, M.D.

Medical Director of HIV/AIDS Education and Medical Director of HIV/AIDS Education and TrainingTraining

St. Vincent Catholic Medical Center-ManhattanSt. Vincent Catholic Medical Center-Manhattan

A Local Performance Site of the New York/New A Local Performance Site of the New York/New Jersey AETCJersey AETC

Anabolic SteroidsAnabolic Steroids DefinitionsDefinitions Commonly Used AgentsCommonly Used Agents Indications/DiagnosisIndications/Diagnosis

HypogonadismHypogonadism HIV WastingHIV Wasting

Adverse EffectsAdverse Effects StudiesStudies ManagementManagement

DefinitionsDefinitions Androgens: all male sex hormones, usually Androgens: all male sex hormones, usually

testosterone, but also testosterone testosterone, but also testosterone derivativesderivatives

Androgenic: refers to masculinizing Androgenic: refers to masculinizing properties such as libido, aggression, acne, properties such as libido, aggression, acne, hair growth and losshair growth and loss

Anabolic: refers to assimilation of nitrogen Anabolic: refers to assimilation of nitrogen into tissue (muscle growth)into tissue (muscle growth)

Cannot completely separate one from the Cannot completely separate one from the otherother

Testosterone & Testosterone & DerivativesDerivatives

O

OH

19-Nor

A-RingModifications

5-Reduction

17-Esterification& 17-Alkylation

Target Organs and Physiological Target Organs and Physiological EffectsEffects

of Testosterone and Metabolitesof Testosterone and Metabolites Skin (Skin ( facial/ body facial/ body

hair, sebum hair, sebum production)production)

Bone (Bone ( BMD) BMD) Muscle (Muscle ( lean mass, lean mass,

strength)strength) Adipose Tissue (Adipose Tissue ( lipo- lipo-

lysis, lysis, abdominal fat) abdominal fat) Blood (Blood ( hematocrit) hematocrit) Immune system (Immune system (

auto-antibody auto-antibody production)production)

CNS (CNS ( libido, well-being, libido, well-being, aggression, spatial aggression, spatial cognition)cognition)

Hypothalamus/ Pituitary Hypothalamus/ Pituitary (( GnRH, LH, FSH; GnRH, LH, FSH; GH) GH)

Larynx (lowers voice)Larynx (lowers voice) Breast (EBreast (E22 size) size) Liver (Liver ( SHBG, HDL) SHBG, HDL) Kidney (Kidney ( erythropoietin) erythropoietin) Genitals (Genitals ( development, development,

spermatogenesis, spermatogenesis, erections)erections)

Prostate (Prostate ( size, secretions) size, secretions)

Androgenic vs AnabolicAndrogenic vs Anabolic AndrogenicAndrogenic

Testosterone (IM)Testosterone (IM) Androgel Androgel

(transdermal)(transdermal) Androderm Androderm

(transdermal)(transdermal)

AnabolicAnabolic Deca-Durabolin Deca-Durabolin

(IM)(IM) Oxandrin (oral)Oxandrin (oral) Anadrol (oral)Anadrol (oral)

Mean Steady-State Testosterone Concentrations in Patients Receiving AndroGel®

Day 90

Data on file. Unimed Pharmaceuticals, Inc.

Production and RegulationProduction and Regulationof Testosteroneof Testosterone

T = testosteroneT = testosteroneOnly 2% is free testosteroneOnly 2% is free testosteroneand 98% is boundand 98% is bound

Free TFree T2%2%

SHBG-bound TSHBG-bound T60%60%

Albumin-Albumin-bound Tbound T

38%38%

Adapted from Bagatell CJ, Bremner WJ. Adapted from Bagatell CJ, Bremner WJ. N Engl J MedN Engl J Med. . 1996;334:707-715.1996;334:707-715.

GnRHGnRH

LHLH FSHFSHTestosteroneTestosterone

TestosteroneTestosterone

SpermSperm

HypothalamusHypothalamus

PituitaryPituitary

TestisTestis

Adapted from Braunstein GD. In: Adapted from Braunstein GD. In: Basic & Clinical EndocrinologyBasic & Clinical Endocrinology. . 5th ed. Stamford, Conn: Appleton & Lange; 1997:403-433.5th ed. Stamford, Conn: Appleton & Lange; 1997:403-433.

Laboratory Diagnosis and Laboratory Diagnosis and Workup of Primary vs. Workup of Primary vs.

Secondary HypogonadismSecondary Hypogonadism Hypogonadism in adult male - presence of Hypogonadism in adult male - presence of

signs or symptoms of hypogonadism with signs or symptoms of hypogonadism with confirmation by laboratory testingconfirmation by laboratory testing

Laboratory TestingLaboratory Testing:: AM total testosterone x 2 AM total testosterone x 2

Normally diurnal rhythm with highest levels in AMNormally diurnal rhythm with highest levels in AM Free testosterone (2%) - (sometimes even if Free testosterone (2%) - (sometimes even if

total normal)total normal) Bioavailable testosterone - free (2%) plus Bioavailable testosterone - free (2%) plus

loosely bound to albumin (38%) - (total 40%)loosely bound to albumin (38%) - (total 40%) 60% tightly bound to SHBG60% tightly bound to SHBG

Diagnosis and Workup of Diagnosis and Workup of Primary vs. Secondary Primary vs. Secondary Hypogonadism (Cont.)Hypogonadism (Cont.)

LH and FSH - (if low T is established or as initial LH and FSH - (if low T is established or as initial workup); Repeat with 2 samples taken 20-30 min. workup); Repeat with 2 samples taken 20-30 min. apart and pooled apart and pooled FSH and LH secreted in short pulsesFSH and LH secreted in short pulses

Prolactin ; Estradiol (if gynecomastia or testicular or Prolactin ; Estradiol (if gynecomastia or testicular or adrenal tumor suspected)adrenal tumor suspected)

Definitive diagnosis of T deficiency on the basis of Definitive diagnosis of T deficiency on the basis of laboratory tests for the aging male has not been laboratory tests for the aging male has not been establishedestablished <200 ng/dL clearcut<200 ng/dL clearcut total T may not be an accurate measurement if there is total T may not be an accurate measurement if there is

increased or decreased SHBGincreased or decreased SHBG deficiency considered at 200-350 ng/dL (depending on assay) deficiency considered at 200-350 ng/dL (depending on assay)

or if the T or bioavailable T (or free T) is in the lower range of or if the T or bioavailable T (or free T) is in the lower range of normalnormal

Diagnosis and Workup of Diagnosis and Workup of Primary vs. Secondary Primary vs. Secondary Hypogonadism (Cont.)Hypogonadism (Cont.)

If studies indicate clear primary hypogonadismIf studies indicate clear primary hypogonadism Low T with reciprocal elevated FSH and LHLow T with reciprocal elevated FSH and LH Then pituitary workup not indicatedThen pituitary workup not indicated

If studies indicate secondary hypogonadism or If studies indicate secondary hypogonadism or combined:combined: Low T with low FSL/LH orLow T with low FSL/LH or Low T with normal or high-normal FSH/LH - not Low T with normal or high-normal FSH/LH - not

appropriately elevatedappropriately elevated Then MRI of pituitary indicatedThen MRI of pituitary indicated

MRI of pituitary always indicated if elevated prolactinMRI of pituitary always indicated if elevated prolactin Other pituitary testing may be necessaryOther pituitary testing may be necessary

Stimulation tests generally of limited clinical value to Stimulation tests generally of limited clinical value to distinguish 1º from 2º or pituitary from hypothalamic distinguish 1º from 2º or pituitary from hypothalamic defectdefect

AACE Guidelines, Endocrine Practice:8,439,2002

Medications (common) Medications (common) contribute to hypogonadismcontribute to hypogonadism

Glucocoticoids - testicular and Glucocoticoids - testicular and pituitary/hypothalamicpituitary/hypothalamic

ketoconazole - inhibitor of gonadal and adrenal ketoconazole - inhibitor of gonadal and adrenal steroidogenesissteroidogenesis

spironolactone - aldosterone antagonist; and spironolactone - aldosterone antagonist; and blocks androgen at receptor,inhibits androgen blocks androgen at receptor,inhibits androgen biosynthesis, interferes with binding T to SHBGbiosynthesis, interferes with binding T to SHBG

cimetidine - weak antiandrogencimetidine - weak antiandrogen finasteride (propecia) - inhibitor of typeII finasteride (propecia) - inhibitor of typeII

5alpha reductase, antiandrogen5alpha reductase, antiandrogen flutamide and other antiandrogensflutamide and other antiandrogens megastrol acatate (megace) - decreased megastrol acatate (megace) - decreased

androgen production and androgen mediated androgen production and androgen mediated actionaction

Testosterone Deficiency Testosterone Deficiency with Agingwith Aging

Decline in Testosterone with ageDecline in Testosterone with age Decrease in testosterone productionDecrease in testosterone production Decrease in testosterone clearanceDecrease in testosterone clearance Increase in SHBGIncrease in SHBG

may be due to higher serum estradiol levels from may be due to higher serum estradiol levels from increased adipose tissueincreased adipose tissue

Therefore, bioavailable T decreases more than Therefore, bioavailable T decreases more than total Ttotal T

Circadian rhythm (higher T values in AM) lost Circadian rhythm (higher T values in AM) lost with agingwith aging

Tenover,L.J. End.Metab.Clinics NA:27,969,1998

Dobs AS. Baillière’s Clin Endocrinol Metab. 1998;12:379-390.Grinspoon S, et al. J Clin Endocrinol Metab. 2000;85:60-65.

Wiley S, et al. AIDS. 2003; 17(2): 183-8. Habasque C, et al. Mol Hum Reprod 2002 8(5): 419-25.

Prevalence and Prevalence and Diagnosis ofDiagnosis of

Hypogonadism In HIVHypogonadism In HIV Approximately 30% of HIV+ men and 50% Approximately 30% of HIV+ men and 50% of men with AIDS are hypogonadalof men with AIDS are hypogonadal Correlated with stage of disease, lymphocyte Correlated with stage of disease, lymphocyte

depletion, weight loss, reduced muscle mass, depletion, weight loss, reduced muscle mass, and decreased functional statusand decreased functional status

Free testosterone is the preferred Free testosterone is the preferred measurementmeasurement

Sex hormone binding globulin (SHBG) Sex hormone binding globulin (SHBG) increases in men with HIV-infectionincreases in men with HIV-infection

Grinspoon S, et al. Ann Intern Med. 1998;129:18-26.

Effects of Testosterone in Effects of Testosterone in Hypogonadal Men With AIDS Hypogonadal Men With AIDS

WastingWastingStudy designStudy design 6-month, randomized, placebo-controlled trial 6-month, randomized, placebo-controlled trial 51 men with hypogonadism and AIDS wasting51 men with hypogonadism and AIDS wasting Randomly assigned to receive testosterone Randomly assigned to receive testosterone

enanthate 300 mg or placebo IM every 3 enanthate 300 mg or placebo IM every 3 weeks weeks

Testosterone

Fat-Free Mass (n=21)

Lean Body Mass (n=22)

Muscle Mass (n=21)

-1.5-1

-0.50

0.51

1.52

2.53

3.5

Cha

nges

, kg

No Testosterone

Fat-Free Mass (n=19)

Lean Body Mass (n=19)

Muscle Mass (n=18)

-1.5-1

-0.50

0.51

1.52

2.53

3.5

Cha

nges

, kg

Grinspoon S, et al. Ann Intern Med. 1998;129:18-26.

Effects of Testosterone in Effects of Testosterone in Hypogonadal Men With AIDS Hypogonadal Men With AIDS

WastingWasting

Bhasin S, et al. JAMA. 2000;283:763-770.

IM Testosterone Therapy and IM Testosterone Therapy and Resistance Exercise in Resistance Exercise in

Hypogonadal HIV+ MenHypogonadal HIV+ MenStudy designStudy design A 16-week, placebo-controlled, double-blind, A 16-week, placebo-controlled, double-blind,

randomized trialrandomized trial 61 HIV+ men, aged 18 to 50 years old61 HIV+ men, aged 18 to 50 years old Randomized to 1 of 4 groupsRandomized to 1 of 4 groups

Placebo, no exercise (n=14)Placebo, no exercise (n=14) Testosterone enanthate 100 mg/wk, Testosterone enanthate 100 mg/wk,

no exercise (n=17)no exercise (n=17) Placebo and exercise (n=15)Placebo and exercise (n=15) Testosterone and exercise (n=15)Testosterone and exercise (n=15)

Bhasin S, et al. JAMA. 2000;283:763-770.

IM Testosterone Therapy and IM Testosterone Therapy and Resistance Exercise in Resistance Exercise in

Hypogonadal HIV+ MenHypogonadal HIV+ Men

Study resultsStudy results weight in testosterone alone or weight in testosterone alone or

exercise aloneexercise alone maximum voluntary muscle strength maximum voluntary muscle strength

in all 4 treatment groupsin all 4 treatment groups Greater Greater in thigh muscle volume in thigh muscle volume

in T alone or PRE alonein T alone or PRE alone lean body mass with testosterone or T + PRElean body mass with testosterone or T + PRE hemoglobin in testosterone recipientshemoglobin in testosterone recipients

Grinspoon S, et al. Ann Intern Med. 2000;133:348-355.

IM Testosterone and/or IM Testosterone and/or Exercise in Exercise in

Eugonadal Men With AIDS Eugonadal Men With AIDS WastingWastingStudy design Study design

12-week randomized, controlled trial12-week randomized, controlled trial 54 eugonadal men with AIDS wasting 54 eugonadal men with AIDS wasting Randomized to testosterone enanthate Randomized to testosterone enanthate

200 mg/wk or placebo and progressive resistance 200 mg/wk or placebo and progressive resistance training (3x/wk) or no exercisetraining (3x/wk) or no exercise

0

200

400

600

800

1000

1200

1400

Arm Leg Arm Leg

Intervention Placebo

Cha

nge

in M

uscl

e M

ass,

mm

2

Progressive Exercise(3 times/wk)

IM Testosterone (200 mg/wk)

P=.004

P=.045

P=.001 P=.002

Grinspoon S, et al. Ann Intern Med. 2000;133:348-355.

IM Testosterone and/or Exercise IM Testosterone and/or Exercise in Eugonadal Men With AIDS in Eugonadal Men With AIDS

WastingWasting

BackgroundBackground Despite HAART, HIV-wasting is still very Despite HAART, HIV-wasting is still very

common, affecting up to 30% of patients common, affecting up to 30% of patients in the US and Europe (Wanke et al. 2000, in the US and Europe (Wanke et al. 2000, Balslef et al. 1997)Balslef et al. 1997)

Death due to wasting in patients with Death due to wasting in patients with AIDS is related to the magnitude of tissue AIDS is related to the magnitude of tissue depletion, independent of the underlying depletion, independent of the underlying cause (Kotler DP et al. cause (Kotler DP et al. Am J Clin NutrAm J Clin Nutr. . 1989)1989)

AIDS-Wasting Syndrome AIDS-Wasting Syndrome (AWS)(AWS)

10% involuntary weight loss in last 12 10% involuntary weight loss in last 12 monthsmonths

7.5% involuntary weight loss in last 6 7.5% involuntary weight loss in last 6 monthsmonths

5% loss of BCM in last 6 months5% loss of BCM in last 6 months Men: BCM <35% B.W. and BMI <27 kg/mMen: BCM <35% B.W. and BMI <27 kg/m22

Women: BCM <23% B.W. and BMI <27 Women: BCM <23% B.W. and BMI <27 kg/mkg/m22

Polsky, Kotler and Steinhart.

Major Causes of AWSMajor Causes of AWS Reduced food intakeReduced food intake Malabsorption/diarrheaMalabsorption/diarrhea Infections Infections HIV-enteropathy HIV-enteropathy Altered metabolismAltered metabolism MedicationsMedications

Treatment Strategies of Treatment Strategies of AWSAWS

Appetite stimulants (megestrol acetate, Appetite stimulants (megestrol acetate, dronabinol)dronabinol)

Nutritional supplements (beta-hydroxy-beta-Nutritional supplements (beta-hydroxy-beta-methyl-butyrate, glutamine, arginine, vitamins, methyl-butyrate, glutamine, arginine, vitamins, micronutrients, protein)micronutrients, protein)

Cytokine inhibitors (thalidomide, pentoxifyllin)Cytokine inhibitors (thalidomide, pentoxifyllin) Anabolic proteins (human growth hormone, Anabolic proteins (human growth hormone,

Insulin-like growth factor)Insulin-like growth factor) Anabolic steroidsAnabolic steroids Physical exercisePhysical exercise

Oxymetholone as Therapy to Maintain Oxymetholone as Therapy to Maintain Body Composition in HIV-Positive SubjectsBody Composition in HIV-Positive Subjects

(Urbina,A. 2003)(Urbina,A. 2003)

Open label, single center, Phase III study Open label, single center, Phase III study involving pts who have received at least 4 involving pts who have received at least 4 months of prior anabolic (nandrolone or months of prior anabolic (nandrolone or oxandrolone) for a past or current dx of oxandrolone) for a past or current dx of wastingwasting

Pts were then switched to oxymetholone Pts were then switched to oxymetholone 50 mg QD and followed for 6 months50 mg QD and followed for 6 months

Efficacy and safety evaluations performed Efficacy and safety evaluations performed at 4 week interval from baseline through at 4 week interval from baseline through week 12, then q6 weeks until week 24 week 12, then q6 weeks until week 24

Oxymetholone as Therapy Oxymetholone as Therapy to Maintainto Maintain

(Urbina, A 2003)(Urbina, A 2003) Study ObjectivesStudy Objectives

Maintenance (no change) or Maintenance (no change) or improvement (increase) in BCM as improvement (increase) in BCM as measured by BIAmeasured by BIA

Evaluate the effects on HIV replication as Evaluate the effects on HIV replication as measured by change in CD4 and viral measured by change in CD4 and viral load from baselineload from baseline

Evaluate clinical laboratory (hematology, Evaluate clinical laboratory (hematology, lipids, LFTs, testosterone, PSA) and vital lipids, LFTs, testosterone, PSA) and vital sign measurementssign measurements

Oxymetholone as Therapy Oxymetholone as Therapy to Maintainto Maintain

(Urbina, A 2003)(Urbina, A 2003) 16 HIV+ men were successfully 16 HIV+ men were successfully

switched to oxymetholoneswitched to oxymetholone BCM was maintained over the 24 BCM was maintained over the 24

week period with a mean increase of week period with a mean increase of 2.2 lbs (p=.091)2.2 lbs (p=.091)

Increase in FFM for all weeks with Increase in FFM for all weeks with significant increase at 24 weeks (3.1 significant increase at 24 weeks (3.1 lbs, p=0.027)lbs, p=0.027)

Oxymetholone to MaintainOxymetholone to Maintain(Urbina, A 2003)(Urbina, A 2003)

Lipids decreased over time Lipids decreased over time (especially HDL and LDL)(especially HDL and LDL)

Overall, no clinically significant Overall, no clinically significant effect on LFTseffect on LFTs

CD4 values increased over time CD4 values increased over time (mean of 21 cell increase)(mean of 21 cell increase)

Testosterone levels increased by Testosterone levels increased by week 18 and 24week 18 and 24

Oxymetholone to maintainOxymetholone to maintain(Urbina, A 2003)(Urbina, A 2003)

MeasureMeasure ResultResultBMIBMI Increased 0.8Increased 0.8±0.2 ±0.2

((p=0.006p=0.006))FFM (lbs)FFM (lbs) Increased 3.8Increased 3.8±1.5 ±1.5

((p=0.027p=0.027))Waist Waist circumference (cm)circumference (cm)

Decreased 0.4Decreased 0.4±0.9 ±0.9 (p=0.647)(p=0.647)

Triceps skinfold Triceps skinfold measure (cm)measure (cm)

Decreased 0.1Decreased 0.1±0.1 ±0.1 (p=0.424)(p=0.424)

Mid-arm muscle Mid-arm muscle (cm(cm22))

Increased 4.9Increased 4.9±2.0 ±2.0 ((p=.037p=.037))

No TestosteroneTestosterone

-3

-2

-1

0

1

2

3

4

5

Cha

nge

Lum

bar

Spi

ne R

egio

nal B

MD

, %

Fairfield WP, et al. J Clin Endocrinol Metab. 2001;86:2020-2026.

Effects of Testosterone on Effects of Testosterone on Bone Density in Eugonadal Bone Density in Eugonadal

Men With AIDS WastingMen With AIDS Wasting

Bone Density increased significantly in Bone Density increased significantly in response to testosterone (response to testosterone (PP=.02) =.02)

Anabolic Drugs: a Comparison of Clinical Studies

Drug (No of subjects)

Duration (weeks)

Control Arm Inclusion Criteria

Baseline Body Weight

Mean Gain of Weight

Body Composition

Comments

Oxymetholone (n=30) Hengge 1996 Nandrolone Decanoate (n=17) Gold 1996 Nandrolone Decanoate (n=10) Strawford 1999 Oxandrolone (n=10) Romeyn 2000 Oxandrolone (n=21) Berger 1996

12 16 12 12 16

Yes No open-label study No open-label study No pilot-study Yes

Loss of B.W. >10% last 4 mths. Loss of B.W. 5-15 % Loss of B.W. >5% reduced testosterone levels Loss of B.W. >5% reduction of muscle mass Loss of B.W. >10%

56.5 kg (Oxymetholone) 56 kg (Oxy + Ketotifen) 62 kg No data No data No data

5.7 kg (Oxymetholone) 4.4 kg (Oxy + Ketotifen) 2.3 kg 4.9 1.2 kg 2.7 kg Oxandrolone, 3.9 kg + PRE 1.7 kg

No Yes Yes No No

Significant increase of BMI in both groups Good tolerance No increased strength

Grinspoon S. et al. J Clin Endocrinol Metab. 2000;85:60-65.

Depression Indices in Depression Indices in Hypogonadal HIV-Hypogonadal HIV-

Infected MenInfected MenStudy designStudy design 6-month, randomized, placebo-controlled trial 6-month, randomized, placebo-controlled trial 51 men with hypogonadism and AIDS wasting51 men with hypogonadism and AIDS wasting Randomly assigned to receive testosterone Randomly assigned to receive testosterone

enanthate 300 mg or placebo IM every 3 weeks enanthate 300 mg or placebo IM every 3 weeks 10 age and weight matched men with AIDS 10 age and weight matched men with AIDS

wasting who were not hypogonadal were wasting who were not hypogonadal were recruited as a control group for baseline recruited as a control group for baseline comparison only and did not receive testosteronecomparison only and did not receive testosterone

Grinspoon S. et al. J Clin Endocrinol Metab. 2000;85:60-65.

Depression Indices in Depression Indices in Hypogonadal HIV-Hypogonadal HIV-

Infected MenInfected Men Beck Depression InventoryBeck Depression Inventory

Administered to all patients (hypogondal and Administered to all patients (hypogondal and eugonadal) at baseline and again after 6 eugonadal) at baseline and again after 6 months to the hypogonadal patients in the months to the hypogonadal patients in the randomized studyrandomized study

Normal range <10Normal range <10

N=5115.5 +1

N=1010.6 +1.4

*P=.02

Depression Indices in Depression Indices in Hypogonadal HIV-Hypogonadal HIV-

Infected MenInfected Men

Grinspoon S. et al. J Clin Endocrinol Metab. 2000;85:60-65.

P< 0.001 n.s.

Depression Indices in Depression Indices in Hypogonadal HIV-Hypogonadal HIV-

Infected MenInfected Men

Grinspoon S. et al. J Clin Endocrinol Metab. 2000;85:60-65.

ADVERSE EFFECTSADVERSE EFFECTS AcneAcne Hair lossHair loss Increased libido (supraphysiologic)Increased libido (supraphysiologic) InsomniaInsomnia Testicular atrophyTesticular atrophy Agressiveness (supraphysiologic)Agressiveness (supraphysiologic) HypertensionHypertension

ADVERSE EFFECTSADVERSE EFFECTS GynecomastiaGynecomastia VirilizationVirilization PolycythemiaPolycythemia Increase in transaminasesIncrease in transaminases

Hepatis peliosisHepatis peliosis Inceased risk with co-infectedInceased risk with co-infected

Hyperlipidemia (↓HDL)Hyperlipidemia (↓HDL) Prostatic enlargementProstatic enlargement

Algorithim for Use of Algorithim for Use of AnabolicsAnabolics

Select appropriate patientSelect appropriate patient Wasting, post-inpatient, after tx of OIWasting, post-inpatient, after tx of OI Hypogonadol vs eugonadolHypogonadol vs eugonadol

Free or bioavilableFree or bioavilable Prior to initiationPrior to initiation

Check LFTs, CBC, PSA and DRECheck LFTs, CBC, PSA and DRE

Algorithim for Use of Anabolic Algorithim for Use of Anabolic SteroidsSteroids

Treatment for short durationTreatment for short duration 3-6 months3-6 months

Monitoring of lab valuesMonitoring of lab values TestosteroneTestosterone LFT’sLFT’s CBCCBC Lipid panelLipid panel PSAPSA

Monitoring PSA during Monitoring PSA during Androgen TherapyAndrogen Therapy

Elevated serum PSA levels Elevated serum PSA levels before or during therapy must before or during therapy must be investigated.be investigated.

Measure PSA at baseline, 6 Measure PSA at baseline, 6 months, then annuallymonths, then annually

Interval increase of PSA of > Interval increase of PSA of > 0.75 ng/ml (even if still in 0.75 ng/ml (even if still in “normal” range) requires “normal” range) requires investigationinvestigation