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    THE LINK BETWEENERECTI LE DYSFUNCTION,

    TESTOSTERONE AND METABOLICSYNDROME

    PIT I II MK N, PERHIM PUNAN DOKTER UMUM INDONESIA9-11 Maret 2012, Ballroom Pullman HotelNugroho Setiawan, RSUP FATMAWATI

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    Testosterone deficiencysyndrome is a proven riskfactor for all the metabolicsyndrome components

    All components of metabolicsyndrome are underlying

    conditions for erectiledysfunction and T deficiency

    Erectiledysfunction

    Abdominal obesity represents a vicious circle:abdominal fat tissue reduces testosterone andtestosterone reduces the fat tissues.

    Testosteronedeficiencysyndrome

    Metabolicsyndrome(abdominal fat, diabetes,obesity, hypertension,dyslipidemia....)

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    Metabolic

    syndrome

    Erectile

    dysfunction

    Testosteronedeficiency

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    Disfungsi Ereksi

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    Disfungsi Ereksi (DE) adalahketidakmampuan seorang pria yangmenetap untuk mencapai dan / atau

    mempertahankan ereksi untuk sanggama yang memuaskan

    Disfungsi Ereksi

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    Erection Hardness Score (EHS)

    Penis islarger but

    not hard

    Penis is hardbut not hardenough forpenetration

    Penis is hardenough forpenetration

    but notcompletelyhard

    Penis iscompletely

    hard andfully rigid

    Severe ED

    IIEF 6 - 10

    Moderate ED

    IIEF 11 - 16

    Mild ED

    IIEF 17 - 25

    No ED

    IIEF 26 - 30

    Adapted from: Goldstein I , et al. N Engl J Med . 1998;338:1397-140Mullhall J P, et al. Validation of the erection hardness score . J Sex Med. 2007 Nov;4(6):1626-3

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    Age and Sexual problem

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    Source: MMAS, Decision Resources, Scott-Levin PDDA

    Disfungsi Ereksi merupakan

    masalah kita bersama

    PrevalensiTotal

    Pada pria 40-70 th

    48% 8% Diagnosa52%

    DEDE

    92%60%

    Diterapi

    40%

    Tidak

    Ya

    Tidakterdiagnosa

    48% Sedang

    19% Berat

    33% Ring an

    TIDAK

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    Psychological Factors Influencing Male Erectile Function

    Vascular Male

    ErectileFunction

    Neural

    EndocrineHormones

    Structural

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    TREATMENT OPTIONS TREATMENT OPTIONS

    FIRST LINE : ORAL DRUGS(sildenafil , vardenafil , tadalafil)SEX Therapy

    SECOND LINE : VACUM PUMPIntra UrethaINTRACAVERNOSUM INJECTION

    THIRD LINE : Prostesis Penis

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    cGMP-specific protein kinase

    Endothelial

    cell

    Guanylatecyclase

    GTP cGMP

    K +

    Ca 2+

    Decreased Ca 2+

    Smooth

    musclerelaxation& erection

    Nitric

    oxide

    Smooth muscle cell

    PDE5 Inhibitors: Mechanism of Action

    5'GMP

    PDE5

    Cavernousnerve

    Sexual st imulation

    PDE5 Inhibitor

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    Maleable penile prosthesis

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    Inflatable penile prosthesis

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    New PDE-5 inhibitors

    Palit, V. & Eardley, I. Nat. Rev. Urol. 2010

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    New Preparation of PDE-5i

    Levitra ODT (orodispersible tablet)

    Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. J Sex Med. 2010

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    A NEW APPROACH TO MENS

    HEALTHCAREIn this Event we will introduce a new approach to menshealthcare:

    Treat ED and check for T

    1.Men presenting with ED often require an immediatesolution to their ED

    2. However, men with ED frequently have underlyingconditions which are also linked to testosteronedeficiency

    3. In these men, checking testosterone levels may uncovera treatable deficiency

    4. This approach has considerable benefits for mensoverall health

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    SEKS HORMON ENDOGEN YANG SANGAT PENTING PADAPRIA DAN WANITA

    MERUPAKAN HORMON STEROID TERBENTUK DARIKOLESTEROL

    BERSIFAT LIPOFILIK DAN MUDAH BERDIFUSI

    PADA PRIA 90-95 % DIHASILKAN LEYDIG SEL

    DIPRODUKSI 5-7 MG/ HARI PADA PRIA

    BERPENGARUH PADA: SEKS ORGAN, TULANG, OTOT,DARAH, J ARINGAN TISSUE, OTAK, KULIT, RAMBUT DANFUNGSI MENTAL

    PADA WANITA SANGAT PENTING UNTUK FUNGSI SEKSUALDAN LIBIDO, SERTA PERAN PSIKOLOGIKAL WELL BEING

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    ORGAN TUJUAN TESTOSTERON DAN METABOLISMENYA

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    TDS

    Bone mineral density Muscle mass and strengthObesity

    LibidoErectile functionHematopoiesisDepressed mood Cognitive functionGeneral well-being

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    Low testosterone

    is associated withatherosclerosis

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    Svartberg J et al. J Int Med 259: 576-582 (2006)

    Cross-Sectional:

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    TDS

    IN ADULT MEN

    Typicaltds

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    (Visceral) fat suppressestestosterone production

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    Obese men have lower testosterone

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    Wu FCW et al. J Clin Endocrin Metab 93(7): 2737-2745 (2008)

    European Male Aging Study (EMAS)Relationship between Age, BMI, and Hormones

    40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79

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    Central obesity: waist circumference in Europids 94 cmAsians: > 90 cm

    PLUS any 2 of the following:

    raised triglycerides: 1.7 mmol/L ( 150 mg/dL)reduced HDL cholesterol < 1.03 mmol/L ( < 40 mg/dL)raised blood pressure: systolic 130 mm Hg

    diastolic 85 mm Hg (or treatment)raised fasting plasma glucose: 5.6 mmol/L ( 100 mg/dL)

    (or type 2 diabetes)

    The Metabolic Syndrome - A New World Wide Definition: IDF Consensus Group, Berlin 2005

    http://www.idf.org/webdata/docs/MetSyndrome_FINAL.pdf

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    Prevalence of Metabolic Syndrome in an Urban KoreanPopulation According to Modified NCP ATPI II Criteria

    19.7

    25.9

    34.9

    45.5

    0

    10

    20

    30

    40

    50

    %

    < 40 yr 40-59 yr 50-59 yr 60 and older

    Oh J-Y et al. Diabetes Care 27: 2027-2032 (2004)

    19.7

    25.9

    34.9

    45.5

    0

    10

    20

    30

    40

    50

    %

    < 40 yr 40-59 yr 50-59 yr 60 and older

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    Fat distributionWAIST CIRCUMFERENCE (WC)

    Lowest rib

    Iliac crest

    Mid axillary line

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    BMI and BMI are not the same...waist circumference is more accurate189 cm, 93 kg =BMI 26 190 cm, 94 kg =BMI 26

    Waist circumference Waist circumference Testosterone Testosterone

    > pembunuh yg tak disadari

    Penumpukan lemak di sekitar perut

    Kadar lemak yg >Tekanan darah >Gula darah >

    Resiko penyakit jantung koroner & DM

    Penumpukan lemak di sekitar perut

    Kadar lemak yg >Tekanan darah >Gula darah >

    Resiko penyakit jantung koroner & DM

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    Indikasi untuk Penggantian Testosteron

    -TDS-Kadar testosteron pada pagi hari di bawah

    normal menengah- TI DAK ADA KONTRA INDIKASI

    Nieschlag and Behre, Andrology, 2000, Springer

    0

    5

    10

    15

    20

    25

    30

    35

    40

    Hours 8 10 12 14 16 20 24 8

    Acc. to Behre et al. 1992 J CEM

    n m o l

    / l

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    Nugroho Setiawan

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    T estosteron

    Testosteron total terdiri: T terikat globulin (SHBG) 60% T terikat albumin 38% T bebas 2%

    Yang dapat aktif T terikat albumin dan T bebas

    Yang aktif oleh enzim dapat dirubahEstradiol (aromatase)Dehidrotestosteron (5 a reduktase)

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    Testosterone physiology and aging

    Free T

    SHBG + T SHBG + T

    Free T

    aging

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    Perubahan hormonal terkait usia

    www.get-back-on-track.comNugroho Setiawan

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    Mengembalikan kadar testosteron

    ke dalam kisaran normal menengah

    WHO 1992, Geneva

    Target Terapi Testosteron

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    Contraindicatedtestosterone treatment:

    carcinoma of the prostateor male mammary gland.

    Nugroho Setiawan

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    40-49 50-59 60-69 70-79

    %CaP

    Total T

    CaP Prevalence Increases as T Levels De

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    Morgentaler A and Rhoden, Urology (2006)

    Lower levels of total testosterone or free testosteroneare associated with an increased risk of cancer.

    Risk of cancer doubled for men with TT < 250 ng/dl

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    Pemeriksaan fisik

    Tensi, nadi, berat badan, lingkar pinggang

    Pemeriksaan colok dubur

    Pertumbuhan organ seks dan tanda sekssekunder

    Nugroho Setiawan

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    Laboratory examination

    TESTOSTERONEPSA

    Optional:Hemoglobin, hematokrit

    HbA1CLipid profilSHBG, estradiol, LH

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    Testosterone preparations

    1940

    1954

    1977

    1992

    1995

    1998

    20042004

    2002

    2004

    Testosterone

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    Sediaan Testosteron diIndonesia yang disetujui POMTestosterone Undecanoat capsul 40mgMesterolone tablet 25 mgTestosterone Propionat 30mg,

    Testosterone Phenylpropionat 60mg,Testosterone isocaproate 60 mg,Testosterone decanoat 100mg AmpulTestosterone Undecanoat 1000 mg

    ampulTestosterone gel

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    Pemilihan preparat Testosteron- Sudah di setujui BPOM RI- Aman, minimal side effects , tidak toxic

    tidak melalui liver / portal systemLevels within the normal range of physiological

    - Comfortable ?????- Pemilihan diserahkan pada pasien dengan

    menerangkan effectifitas, keamanan, carapemberian , perkiraan harga obat, resiko sideeffect, dll.

    - Pemberian testosteron harus dibawah tanggung jawab dokter

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    403530

    25201510

    5

    0

    6055

    5045

    0 2 4 6 8 10 12 14Weeks

    T o t a l t e s

    t o s t e r o n e n m o l

    / l

    Nieschla and Behre, Androlo , 2000, S rin er

    Normal range

    Testosterone enanthate Testosterone undecanoate (Nebido)

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    h b l d d

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    Men with metabolic syndrome and testosterone deficiency receive testosterone

    treatment

    Improves every single factor of the metabolicsyndromeNormalisation of testosterone level about 8-9 months:

    - Reduced fat mass(viseral/abdomen>> than subcutaneous / WC )

    - Improves muscle mass (glucose metabolised)

    Improves every single factor of the metabolicsyndromeNormalisation of testosterone level about 8-9 months:

    - Reduced fat mass(viseral/abdomen>> than subcutaneous / WC )

    - Improves muscle mass (glucose metabolised)

    M i h b li d d

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    Men with metabolic syndrome and testosterone deficiency receive testosterone

    treatment Normalisation of testosterone level about

    8-9 months:- Reduced glucose, insulin, HbA1c, improved

    insulin sensitivity (with diet and exercisereduced HbA1c 1,2% without any anti diabeticmedication)

    - Improves lipid patern (inhibit lipoprotein lipase),LDL cholesterol and triglycerides are reduced,HDL cholesterol increases.

    - Reduction in both systoic and diastolic bloodressure.

    Normalisation of testosterone level about8-9 months:- Reduced glucose, insulin, HbA1c, improved

    insulin sensitivity (with diet and exercisereduced HbA1c 1,2% without any anti diabeticmedication)

    - Improves lipid patern (inhibit lipoprotein lipase),LDL cholesterol and triglycerides are reduced,HDL cholesterol increases.

    - Reduction in both systoic and diastolic bloodressure.

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    TestosteroneAs a vasodilator by

    Increase of endothelial nitric oxideproduction and decrese of endothelin 1.As anticoagulatory effects by

    Reducing fibrinogen andplasminogen activator inhibitor 1PAI-1

    As a vasodilator byIncrease of endothelial nitric oxideproduction and decrese of endothelin 1.As anticoagulatory effects by

    Reducing fibrinogen andplasminogen activator inhibitor 1PAI-1

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    International multicenter Post

    Authorization Surveillance Study on theuse of Nebido to assess tolerability andtreatment outcomes in daily clinical

    practice

    IPASS-NEBIDO

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    IPASS

    Patients received up to 5 TU injduring an observation parameters of:

    - Erectile function- Libido- Vigour/ vitality- Mood and- Ability to concentrate

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    NEBIDOContaining 4 ml solution for injectioncontains 1000 mg Testosterone undecanoate

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    Tracking statusCountry N Australia 164Austria 120Bulgaria 22Colombia 123Czech Republic 5Germany 68Hong Kong 14Indonesia 20Italy 148Kazakhstan 12Republic of Korea 95Macedonia 55Malaysia 21

    Mexico 8Moldova 48Philippines 19Romania 80Russian Federation 122Saudi Arabia 40Singapore 31

    Taiwan 15 Thailand 38UK 66Ukraine 20

    Total 1354

    164

    120 22

    123

    5 68

    14

    20

    148

    12

    95 55

    21

    8

    48

    19

    80

    122

    40

    31

    15

    38

    66 20

    N is equal to either n=enrolled or n=returned, whichever is greater.In this status, the n of CRFs considers that all enrolled patients started therapy and are being documented. L ikely, the truen of cases is smaller.

    circle areas proportional to n patients in center/country

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    Recommended treatment regimen for TU 1000 mg

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    Patient demographics and baseline characteristics

    Parameter

    Age (years ) 49.2 13.9

    Weight (kg) 86.8 17.6

    Waist circumference (cm) 99.5 15.25

    Previous androgen therapy n=641 (54%)injections: 37.4%, gels: 44.9%, capsules: 17.5%

    Comorbidities Diabetes: 14.0%

    Hypertension: 26.1%

    Dyslipidemia: 22.2%

    ED: 64.7%

    Zitzmann M et al. Mens Health World Congress 2010.

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    Summary of key safety data

    Adverse events

    Most common ADRs: hematocrit increased, PSAincreased and injection site pain (all

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    Summary of key results of final analysis

    1493 Patients enrolled (1500 planned)

    1438 valid patients (safety population) 55 patients excluded due to retrospective documentation or

    violation of study entry criteria

    1123 (78.1%) patients completed study

    First patient first visit: 30 October 2006Last patient last visit: 14 July 2010Data base lock: 1 September 2010Report final: 24 September 2010

    6333 injections documented

    Mean age: 49.2 years

    54 % of patients were previously treated with androgens

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    Change from Baseline in Sexual Desire after 90 days of Testosterone Treatment in 274 Hypogonadal Men According to Achieved Testosterone Levels (Threshold 600 ng/dL?)

    Seftel AD et al. J Androl 25(6): 963-972 (2004)

    0

    0.5

    1

    1.5

    2

    0-300 (n=121) 300-599 (n=125) 600+ (n=28)

    Chang e in daily desire score

    p=0.25

    p=0.0003

    p

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    Body Mass Index in 183 Hypogonadal Men after a total of 2,135 Injections of Nebido (maximal Treatment Duration 11 years)

    k g x m - 2

    p = 0.03

    15

    20

    25

    30

    35

    40

    Baseline Nadir levelsat 5th injection(40 - 44 th week)

    Mean nadir levelsafter 572 th injection

    Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)

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    Waist Circumference in 130 Hypogonadal Men after at least 8 Injections (total of 923 Injections) of Nebido

    c m

    p = 0.001

    80

    85

    90

    95

    100

    105

    110

    115

    120

    Baseline Nadir levelsat 5th injection(40 - 44 th week)

    Mean nadir levelsafter 8 th injection

    Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)

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    LDL-Cholesterol in 183 Hypogonadal Men after a total of 2,135 Injections of Nebido (maximal Treatment Duration 11 years)

    m

    g / d L

    p < 0.001

    100

    110120130140

    150160170180

    190

    Baseline Nadir levelsat 5th injection(40 - 44 th week)

    Mean nadir levelsafter 8th injection(max. 572 th week)

    Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)

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    HDL-Cholesterol in 183 Hypogonadal Men after a total o f 2,135 Injections of Nebido (maximal Treatment Duration 11 years)

    m g /

    d L

    20

    253035404550556065

    70

    p = 0.003

    Baseline Nadir levelsat 5th injection(40 - 44 th week)

    Mean nadir levelsafter 8th injection(max. 572 th week)

    Zitzmann M and Saad F,Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)

    R i S li d Di li Bl d P ( H ) i 183

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    Resting Systolic and Diastolic Blood Pressure (mm Hg) in 183Hypogonadal Men after a total of 2,135 Injections of

    Nebido (maximal Treatment Duration 11 years)

    Baseline 5th injection(40 - 44th week)

    8th injection(max. 572 thweek)

    m m / H g

    p =0.003

    100,0

    110,0

    120,0

    130,0

    140,0

    150,0

    160,0

    Baseline 5th injection(40 - 44th week)

    8th injection(max. 572 thweek)

    p =0.001

    60,0

    70,0

    80,0

    90,0

    100,0

    110,0

    Zitzmann M and Saad F, Abstract Book of the 3rd Japan-Asean Mens Health & Aging Conference: 41 (2008)

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    Double-Blind Study by Svartberg:Reduction of fat mass by 5.7 kg, increase of muscle mass by 4.2 kg after 1 year treatmentwith Nebido

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    Observational Study by Haider:Improvement of metabolic syndrome and liver

    function (non-alcoholic liver steatosis) after1 year treatment with Nebido

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    Median Value of Blood Glucose and Mean Total Cholesterol, LDL,HDL, and Triglycerides over the Study Period

    54

    56

    58

    60

    62

    H D L ( m m o l

    / L )

    H D L ( m m o l

    / L )

    200

    220

    240

    260

    280

    300

    T r i g l y c e r i d e a n

    d C

    h o l e s t e r o l

    ( m m o l

    / L )

    T r i g l y c e r i d e a n

    d C

    h o l e s t e r o l

    ( m m o l

    / L )

    100

    110

    120

    130

    140

    G l u c o s e a n

    d L D L ( m m o l

    / L )

    G l u c o s e a n

    d L D L ( m m o l

    / L )

    begin 3 mths 6 mths 9 mths 12 mths Time

    GlucoseLDL

    TriglycerideCholesterolHDL

    Haider A et al. Experimental Clin Endocrinol Diab, accepted (2009)

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    Study by Kurbatov:Improvement of erectile function in

    hypogonadal ED patients after treatment withNebido for an average of 30 weeks.9 out of 17 patients with venous leakage fullyrecovered their erectile function.

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    Pilot Study by Kalinchenko:Improvement of the diabetic foot after a single

    injection of Nebido

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    77-year-old man, type 2 diabetes, phlegmon of left foot,osteomyelitis of the left calcaneus, critical ischemia of the leftleg before and 25 days after a single injection of Nebido

    Kalinchenko S et al. Cardiovasc Diabetol 8: 19: 1-6 (2009)

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    Study by Corona:Increased arterial stiffness is associated with

    arteriogenic ED and hypogonadism.

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    ED patients who did not respond to PDE

    5 inhibitors alone, experiencedsignificant improvement in erectilefunction when treated with testosteroneand PDE 5 inhibitor.

    Testosterone and Erectile Function:

    Aversa A, et al. Clin Endocrinol (Oxf )2000;53:517522.Aversa A, et al., Clin Endo 2003;58:632638.Shabsigh R, et al., J Urol 004;172:658663.Shabsigh R. J Sex Med 2005;2:785792.Hwang TI-S, et al., Intl. J . Impotence. Res.2006; 18: 400-404. Yassin AA et al., J Sex Med 2006;3:727735 Yassin A Saad F Diede H. Andrologia38:61-68 (2006)

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    Clinical Outcomes

    www.get-back-on-track.comNugroho Setiawan

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    MENINGKATKAN KUALITAS HIDUP

    Nugroho Setiawan

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    Clinical Symptomatology

    Usual appearance of young men

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