FINPECIA

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    Finpecia

    Androgenic Alopecia(Male-pattern baldness Common baldness)

    Commonest type of hair loss. May be a

    physiological process.

    Prevalence rate is almost 100% in certain

    races.

    Mode of inheritance unknown.

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    Pathophysiology

    Normally; On the top: Androgen-sensitive follicles

    On the sides and back of the scalp: androgen-independent follicles

    In genetically predisposed individuals;(Under Influenceof Androgens)

    Terminal hair follicles are transformed into vellus.

    Shortened anagen and an increased telogen.

    Decreased growth of hair on the scalp as well asaxilla

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    Role of DHT

    T converted to DHT with the help of 5 -reductase.

    Persons with an inherited deficiency of type II5 -reductase & castrated prepubertal boys or eunuchsdo not develop androgenic alopecia

    Under the influence of DHT, the terminal follicle is

    converted to a vellus follicle

    High concentrations of DHT seen in the scalp ofpatients with androgenic alopecia.

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    Finasteride - Effects on semen production

    No effect since;

    Testosterone is responsible for

    spermatogenesis Men with an inherited deficiency

    of 5 -reductase still have

    normal sperm development.

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    Pharmacokinetic properties of oral finasteride afterrepeated administration of 1 mg/day or after singledose of 5 mg.

    1mg/day 5 mg(n=12) (n=6)

    Day 1 Day 17

    Cmax (g/L) 6.5 9.2 38.1

    tmax (h) 1.6 1.3 1.8

    t (h) 4.5 4.8 4.7

    AUC0-24(g/L/h) 38.2 53.2 180.6

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    Finasteride - 1mg

    Clinical Efficacy

    Evaluated in three phase III placebo-controlledstudies, each of 1 years duration

    Additionally, the two studies in men with mild to

    moderate vertex hair loss continued in a blindedmanner for a second year.

    A total of 1879 male patients aged between18 and 41 years were enrolled in the trials.

    A wide spectrum of patients (vertex and frontalhair loss) were enrolled in the study.

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    Finasteride 1 Mg:In Frontal Male Pattern Hair Loss

    Double-blind placebo-controlled trial (n = 326).

    End points included hair counts in the frontal scalp,patient self-assessment, investigator assessment andevaluation of global photographs.

    Finasteride 1 mg significantly increased scalp haircounts in the frontal area (P

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    Finasteride-1 Mg Tolerability

    Not significantly different from that of placebo except for sexual

    functional disorders Sexual adverse events were reported in (3.8%) finasteride compared

    with (2.1%) placebo recipients and comprised decreased libido(1.8 vs. 1.3%), ejaculation disorders (1.2 vs. 0.7%) and erectiledysfunction (1.3 vs. 0.7%)

    Resolved in many patients who reported them but remained ontherapy. It also resolved in those who stopped therapy.

    Small reductions (from 0.7 to 0.5 ng/ml) in serum prostate-specificantigen (PSA) may be seen. Hence double the reported PSA beforeinterpreting.

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    Finasteride 1mg - Indications

    Treatment of men with male

    pattern hair loss and to

    prevent further hair loss in

    these patients.

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    Finasteride-1mg - Dosage & Administration

    1mg/day taken with or without food. Continue for atleast 3 months before assessing. Effects are reversed

    within 12 months of stopping therapy

    Dosage adjustment unnecessary in elderly or in renalinsufficiency.

    Contraindicated in women.

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    Baseline Month 12 Month 24J Am Acad Dermatol 1998; 39:578-89

    Patient 1

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    Hair count mean change from baseline ( SE) from thecombined US and international studies for men who enteredthe extension studies.

    J Am Acad Dermatol 1998; 39:578-89

    BaselineMonth

    6 12 24

    Fin FinPbo Fin

    Fin Pbo

    Pbo PboMeanHairCountChan

    gefrom

    Baseline=1SE

    -60-40-20

    -80

    020406080

    100120

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    FinpeciaJ Am Acad Dermatol 1998; 39:578-89

    Investigator assessment mean rating score (+ 1 SE) from thecombined US and international studies for men who entered theextension studies.

    1.4Fin FinPbo FinFin Pbo

    Pbo Pbo

    1.2

    1.00.80.6

    MeanS

    core1SE

    +

    0.40.2

    -0.2-0.4-0.6

    Baseline 3 6 9 12Month

    15 18 21 24

    0.0

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    FinpeciaDrugs 1999; 57(1): 111-126

    Treatment-related sexual adverse events reported with finasteride.Men with male pattern hair loss were randomised to receive oralfinasteride 1 mg/day (n=945) or placebo (n=934) for 1 year.

    * p = 0.041 vs. placebo

    PlaceboFinasteride

    0

    1

    2

    3

    4

    Incidence(%o

    fpatients)

    Total

    Decreased

    libido Ejaculationdisorders Erectiledysfunction

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    Finasteride in frontal hair lossHair count mean change from baseline (+ 1 SE).

    12Month

    141210

    All patients 1 mg

    Mea

    nChangefromBaseline

    S.E

    (Hairs)

    +

    Baseline 24

    864

    20

    -2-4-6

    J Am Acad Dermatol 1999; 40: 930-7.