.png){kind=small}
EL FINASTERIDE
***********************************
****** DATA-MÉDICOS *********
*********************************
EL FINASTERIDE / THE FINASTERIDE
**************************************
***** DERMAGIC-EXPRESS No 5 ******
****** 20 OCTUBRE DE 1.998 *******
************************************
EDITORIAL ESPAÑOL:
================
Saludos colegas, Dermagic de nuevo con ustedes, el tema de hoy EL FINASTERIDE (PROSCAR, PROPECIA). El finasteride, molécula aprobada por la FDA en 1992 para el tratamiento de la hiperplasia prostática benigna, y que posteriormente se descubrió su efectividad en el tratamiento de la ALOPECIA ANDROGÉNICA.
Hoy 2024 te coloco otras 15 referencias sobre el FINASTERIDE y su uso en la HIPERPLASIA PROSTÁTICA BENIGNA, ALOPECIA ANDROGÉNICA, HIRSUTISMO en la mujer, y el SÍNDROME POST-FINASTERIDE (SPF), y un informe de la FDA actualizado al 2024 sobre esta molécula.
Aqui te dejo el enlace actualizado del FINASTERIDE II actualizado 2003-2024
Saludos,,,
Dr. José Lapenta R.
EDITORIAL ENGLISH
================
Greetings colleagues, Dermagic is with you again, today's topic is FINASTERIDE (PROSCAR, PROPECIA). Finasteride, a molecule approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia, and which was later discovered to be effective in the treatment of ANDROGENETIC ALOPECIA.
Today 2024, I will give you another 15 references about FINASTERIDE and its use in BENIGN PROSTATIC HYPERPLASIA, ANDROGENIC ALOPECIA, HIRSUTISM in women, the POST-FINASTERIDE SYNDROME (PFS), and an updated FDA report for 2024 on this molecule.
Here I leave you the updated link of FINASTERIDE II updated 2003-2024.
Greetings,,,
Dr. José Lapenta R.
====================================================================
DERMAGIC/EXPRESS(5)
=====================================================================
EL F I N A S T E R I D E /THE FINASTERIDE
=====================================================================
A.- PROSCAR. Label via DailyMed. FDA 2024
B.- Study Design of the Medical Therapy of Prostatic Symptoms (MTOPS) Trial.
D.- Finasteride Reduces the Risk of Incident Clinical Benign Prostatic Hyperplasia.
G.- Differential Gene Expression in Post-Finasteride Syndrome Patients 2021.
J.- The Post-Finasteride Syndrome: Possible Etiological Mechanisms and Symptoms 2023.
K.-Finasteride in the Treatment of Hirsutism: New Therapeutic Perspectives.
M.- Comparison of Finasteride and Flutamide in the Treatment of Idiopathic Hirsutism.
REFERENCIA 1: finasteride e hirsutismo
REFERENCIA 2: finasteride y esteroidogénesis
REFERENCIA 3: finasteride y desarrollo genital (monos)
REFERENCIA 4: finasteride y prostatismo
REFERENCIA 5: finasteride y vasculitis cutánea
REFERENCIA 6: finasteride e hirsutismo.
REFERENCIA 7: finasteride y espironolactona en hirsutismo (mujeres)
REFERENCIA 8: finasteride crecimiento del cabello (monos)
REFERENCIA 9: finasteride e hirsutismo (mujeres)
REFERENCIA 10: finasteride y ginecomastia
REFERENCIA 11: finasteride e hirsutismo (mujeres)
REFERENCIA 12: finasteride y miopatía
REFERENCIA 13: finasteride en la WEB: Results Of New Study Confirm Propecia Works Only In Men
=====================================================================
1.) TI: Predominant expression of 5 alpha-reductase type 1 in pubic skin from normal subjects and hirsute patients.
=====================================================================
AU: Mestayer-C; Berthaut-I; Portois-MC; Wright-F; Kuttenn-F; Mowszowicz-I; Mauvais-Jarvis-P
AD: Department of Endocrinology and Reproductive Medicine, Hopital Necker, Paris, France.
SO: J-Clin-Endocrinol-Metab. 1996 May; 81(5): 1989-93
ISSN: 0021-972X
PY: 1996
LA: ENGLISH
CP: UNITED-STATES
AB: Dihydrotestosterone (DHT), the 5 alpha-reduced metabolite of testosterone, is the active molecule triggering androgen action, and 5 alpha-reductase (5 alpha-R), the enzyme converting testosterone to DHT, is a key step in this mechanism. Skin, like prostate, is a DHT- dependent tissue. Our laboratory demonstrated, many years ago, that 5 alpha-R in external genitalia was not regulated by androgens, whereas it was androgen dependent in public skin. As two genes, 5 alpha-R types 1 and 2, encoding for 5 alpha-R enzymes have been recently cloned, we undertook the present study to determine whether the two enzymes we had postulated on the basis of regulation studies were coincident with the cloned isoforms. The expression of the two isoforms was studied in genital and pubic skin fibroblasts from normal men, normal women, and hirsute patients. Messenger ribonucleic acid analysis, using Northern blot and RT-PCR techniques, indicated that both 5 alpha-R1 and -2 messenger ribonucleic acids are expressed in genital skin as well as in public skin fibroblasts. In contrast, studies using specific inhibitors of 5 alpha-R1 (LY306089) and 5 alpha-R2 (finasteride) showed that 5 alpha-R2 is predominant in pubic skin of normal men, normal women, and hirsute patients. These data raise the question of the possible use of specific 5 alpha-R1 inhibitors in the treatment of idiopathic hirsutism.
========================================================================
2.) Effect of finasteride on human testicular steroidogenesis.
========================================================================
Castro-Magana M; Angulo M; Fuentes B; Canas A; Sarrantonio M; Arguello R; Vitollo P
Department of Pediatrics, Winthrop-University Hospital, Mineola, New York 11501,
USA.
J Androl (UNITED STATES) Sep-Oct 1996 17 (5) p516-21 ISSN: 0196-3635
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
We studied the testicular function and some androgen-mediated events in 22 males
(16-30 years of age) with male pattern baldness that was treated with finasteride (10
mg once daily) for 2 years. Patients were evaluated every 3 months. Prostatic
volume was determined in six subjects by endorectal ultrasound scans. Serum
gonadotropin, prostate-specific antigen (PSA), and sex hormone levels were determined
basally and periodically during the treatment period. Fourteen subjects underwent
gonadal stimulation with human chorionic gonadotropin (hCG), and the gonadotropin
response to gonadotropin releasing hormone (GnRH) was determined in eight subjects,
prior to and after 2 years of therapy. Finasteride treatment resulted in an
improvement in the male pattern baldness and prostatic shrinkage that was associated
with an increase in serum testosterone levels (17.2 +/- 2.5 vs. 26.3 +/- 1.7 nmol/L)
and a decrease in dihydrotestosterone (DHT) levels (1.45 +/- 0.41 vs. 0.38 +/- 0.10
nmol/L), causing a marked increase in that testosterone/DHT ratio. A significant
increase in the serum levels of androstenedione (3.67 +/- 0.49 vs. 7.05 +/- 0.70
nmol/L) and estradiol (132 +/- 44 vs. 187 +/- 26 pmol/L) was also noted, whereas
androstanediol glucoronide (33.3 +/- 6.4 vs. 10.7 +/- 4.5 pmol) and PSA (1.6 +/- 0.6
vs. 0.4 +/- 0.1 ng/ml) were significantly decreased. No changes in basal or
stimulated levels of gonadotropin were observed. There was a significant increase in
the testosterone response to hCG during finasteride therapy (delta: 16.7 vs. 35.5
nmol/L) that could be explained, at least in part, by the reduction of testosterone
metabolism resulting from the blockage induced by finasteride. The decrease in the
androstenedione to testosterone and estrone to estradiol ratios observed after hCG
treatment, however, strongly suggests increased activity of the 17-ketosteroid
reductase enzyme and an improvement of the testicular capacity for testosterone
production.
========================================================================
3.) Effects of finasteride, a type 2 5-alpha reductase inhibitor, on fetal development in the rhesus monkey (Macaca mulatta).
========================================================================
Prahalada S; Tarantal AF; Harris GS; Ellsworth KP; Clarke AP; Skiles GL; MacKenzie
KI; Kruk LF; Ablin DS; Cukierski MA; Peter CP; vanZwieten MJ; Hendrickx AG
Department of Safety Assessment, Merck Research Laboratory, West Point,
Pennsylvania 19486, USA.
Teratology (UNITED STATES) Feb 1997 55 (2) p119-31 ISSN: 0040-3709
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9709
Subfile: INDEX MEDICUS
In genetic male fetuses, dihydrotestosterone (DHT) plays an important role in
normal prostatic and external genital differentiation. The enzyme steroid 5-alpha
reductase (5 alpha R) catalyzes the conversion of testosterone (T) to DHT. The
importance of 5 alpha R in sexual differentiation is evident from the study of human
genetic males who congenitally lack this enzyme and consequently develop ambiguous
genitalia. These individuals are specifically deficient in the type 2 isozyme,
whereas the normal type 1 isozyme activity has been found. The purpose of this study
was to determine 1) the suitability of the rhesus monkey for testing the safety of 5
alpha R inhibitors when administered during pregnancy and 2) the potential risk of
administering a known type 2 5 alpha R inhibitor, finasteride, during the critical
period of internal and external genital differentiation in rhesus monkeys. In vitro
studies were also performed on selected rhesus monkey tissues to determine the
distribution of the 5 alpha R isozymes. Gravid monkeys were treated once daily from
gestational days (GD) 20 to 100. Sonographic monitoring was performed during the
course of gestation to monitor viability, growth, and organ system development.
Detailed fetal evaluations for developmental abnormalities were performed at term (GD
152 +/- 2). A group of 13 pregnant monkeys ("positive control") were given a high
oral dose (2 mg/kg/day) of finasteride to demonstrate that inhibiting type 2 5 alpha
R results in specific external genital abnormalities in male fetuses. Thirty-two
pregnant monkeys were administered an intravenous (i.v.) formulation of finasteride
at doses of 8, 80, or 800 ng/day. The highest i.v. dose selected was at least 60-750
times the semen levels of finasteride in man given orally 5 or 1 mg/day, respectively.
Seventeen vehicle-control pregnant monkeys were also included. Administration of a
high oral dose (2 mg/kg/day) of finasteride resulted in external genital
abnormalities characterized by hypospadias, preputial adhesions to the glans, a small
underdeveloped scrotum, a small penis, and a prominent midline raphe in male fetuses;
however, no developmental abnormalities were seen in female fetuses. Similarly, no
abnormalities were observed in either male or female fetuses of mothers given iv
doses (8, 80, or 800 ng/day) of finasteride during pregnancy. The in utero
sonographic findings in fetuses correlated with the gross findings at term. These
studies have shown that external genital abnormalities can be produced in male monkey
fetuses when exposed to a high oral dose (2 mg/kg/day) of finasteride, whereas no
abnormalities were observed in fetuses exposed to the i.v. formulation of finasteride.
Detailed in vitro studies demonstrated that the rhesus monkey also has two 5 alpha R
isozymes (types 1 and 2) with a tissue distribution similar to that seen in man and,
furthermore, that finasteride is a potent, mechanism-based inhibitor with selectivity
for both human and rhesus type 2 5 alpha R. These studies have demonstrated that the
monkey is a suitable model for assessing the safety of 5 alpha R inhibitors
administered during pregnancy.
========================================================================
4.) [Retrospective study of the treatment of 329 patients with prostatism syndrome and review of the literature]
Analisis retrospectivo del tratamiento de 329 pacientes con sindrome de prostatismo y revision de la bibliografia.
========================================================================
Fernandez Gomez JM; San Martin Blanco A; Sahagun Arguello JL; Rabade Rey CJ; Perez
Garcia FJ; Alonso Sainz F
Servicio de Urologia, Hospital Ntra, Hospital Universitario, Universidad de Oviedo,
Espana.
Arch Esp Urol (SPAIN) Nov 1996 49 (9) p929-43 ISSN: 0004-0614
Language: SPANISH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL English Abstract
Journal Announcement: 9707
Subfile: INDEX MEDICUS
OBJECTIVES: New drugs for the treatment of prostatism have been developed in recent
years; only surgery, however, has been demonstrated to achieve cure. Each modality
of drug therapy may afford symptomatic relief in those patients in whom surgery is
not indicated and a symptom-based stepwise indication could be established. METHODS:
329 patients with prostatism were treated by surgery, administration of finasteride,
alphablockers or plant extracts, according to the recommendations of the WHO.
Patient evaluation included abdominal US. PSA determination and uroflowmetry.
Patients with urodynamic or other derangements were excluded from the study.
RESULTS: Patients with a worse quality of life and important obstructive symptoms
underwent surgery. Patients with important obstructive symptoms and no complications
requiring surgery (infection, urinary retention, etc.) received finasteride, which
proved to be effective in these patients, although 16.6% required another type of
treatment and two presented impotence. Patients treated with plant extracts had
moderate prostatism; 17% of these patients required another type of treatment.
Patients treated with alphablockers presented symptoms that were similar to those
treated with plant extracts, but they had a more important irritative component; 24%
of these patients withdrew from the study due to the side effects or inefficacy of
their treatment regimen. CONCLUSIONS: Further studies and a longer follow-up are
warranted to determine whether these new drugs can replace or effectively delay
(avoiding the appearance of complications) surgery. We believe that the indications
for each treatment should be established according to the different stages of
prostatism. Moreover, further insight into the pathogenesis of BPH, appropriate
diagnostic methods and patient selection are essential to the development of new
therapeutical modalities and to achieving enhanced results. (36 References)
========================================================================
5.) Finasteride-related cutaneous vaculitis [letter]
Lear JT; Byrne JP
Postgrad Med J (ENGLAND) Feb 1996 72 (844) p127 ISSN: 0032-5473
========================================================================
========================================================================
6.) TI: Advances in the diagnosis and treatment of the hirsute patient.
========================================================================
AU: Knochenhauer-ES; Azziz-R
AD: Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA.
SO: Curr-Opin-Obstet-Gynecol. 1995 Oct; 7(5): 344-50
ISSN: 1040-872X
PY: 1995
LA: ENGLISH
CP: UNITED-STATES
AB: Most patients with hirsutism demonstrate hyperandrogenemia, which may be caused by polycystic ovary syndrome, nonclassic congenital adrenal hyperplasia, insulin resistance and, occasionally, neoplasms. In this review, current methods of diagnosis and recent advances in the medical treatment of hirsutism and hyperandrogenemia are discussed, including the use of gonadotropin-releasing hormone analogs, flutamide, spironolactone, finasteride, and ketoconazole.
========================================================================
7.) TI: Comparison of finasteride versus spironolactone in the treatment of idiopathic hirsutism.
========================================================================
AU: Erenus-M; Yucelten-D; Durmusoglu-F; Gurbuz-O
AD: Department of Obstetrics and Gynecology, Marmara University School of Medicine, Istanbul, Turkey.
SO: Fertil-Steril. 1997 Dec; 68(6): 1000-3
ISSN: 0015-0282
PY: 1997
LA: ENGLISH
CP: UNITED-STATES
AB: OBJECTIVE: To compare the efficacy of finasteride and spironolactone in the treatment of idiopathic hirsutism. DESIGN: Prospective, randomized, single-blind study. SETTING: A tertiary hirsutism clinic. PATIENT(S): Forty women with idiopathic hirsutism were selected. INTERVENTION(S): Patients were assigned randomly to receive either 5 mg of finasteride or 100 mg of spironolactone for 9 months. MAIN OUTCOME MEASURE(S): Hirsutism scores were measured according to the Ferriman-Gallwey scoring system, and side effects were monitored for 9 months of treatment. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters. RESULT(S): Hirsutism scores were decreased significantly in both groups at the end of 9 months. The mean percent change (+/- SD) in hirsutism scores in the finasteride and spironolactone groups was as follows: 5.91% +/- 7.18% and 20.60% +/- 12.59% at 3 months, 10.61% +/- 12.18% and 32.57% +/- 15.68% at 6 months, and 15.15% +/- 15.38% and 42.36% +/- 12.31% at 9 months, respectively. There was a significantly better response with spironolactone treatment at the end of 9 months. Eleven (55%) of 20 patients in the spironolactone group experienced side effects. However, none of them stopped treatment because of side effects. CONCLUSION(S): The present data suggest that both finasteride and spironolactone are effective in the treatment of idiopathic hirsutism. However, it appears that the spironolactone group responded significantly better.
========================================================================
8.) Ti: The effects of finasteride (Proscar) on hair growth, hair cycle
stage, and serum testosterone and dihydrotestosterone in adult
male and female stumptail macaques (Macaca arctoides).
========================================================================
Au: Rhodes L; Harper J; Uno H; Gaito G; Audette-Arruda J; Kurata S;
Berman C; Primka R; Pikounis B.
Ad: Merck Research Laboratories, Rahway, New Jersey 07065-0900.
So: J Clin Endocrinol Metab; 79(4):991-6, 1994 Oct.
Ab: Finasteride, a 5 alpha-reductase inhibitor, was administered
orally (1 mg/kg.day) for 6 months to six male and five female
stumptail macaques. Vehicle was given to five male and five
female animals over the same period of time. Hair weights in a
defined 1-in.2 area of frontal scalp were measured periodically
every 1-2 months, and serum was collected for measurement of
testosterone and dihydrotestosterone. In addition, scalp biopsies
were taken before and 6 months after treatment to evaluate the
micromorphometry of hair follicles. Results showed that both male
and female serum dihydrotestosterone levels were significantly
reduced (60-70%) by finasteride treatment. Both males and females
showed statistically significant increases in mean hair weight
over the treatment period compared to controls (P = 0.034). In
addition, there was a statistically significant increase in mean
follicle length (measured histologically in scalp biopsies)
compared to baseline in the finasteride-treated animals (P =
0.028). These data show that an inhibition of 5 alpha-reductase
in the stumptail macaque can reverse the balding seen with age in
both the male and female animals (Au).
========================================================================
9.) Ti: A prospective randomized trial comparing finasteride to
spironolactone in the treatment of hirsute women.
========================================================================
Au: Wong IL; Morris RS; Chang L; Spahn MA; Stanczyk FZ; Lobo RA.
Ad: Department of Obstetrics and Gynecology, University of Southern
California School of Medicine, Los Angeles 90033.
So: J Clin Endocrinol Metab; 80(1):233-8, 1995 Jan.
Ab: Enhanced 5 alpha-reductase activity has been found in the skin of
the majority of women with hirsutism. Finasteride is a specific
competitive inhibitor of 5 alpha-reductase, preferentially
inhibiting the type 2 isoenzyme. Therefore, we randomly assigned
14 hirsute women in a 2:1 ratio to 1 of 2 treatment arms: 1)
finasteride (F) treatment (n = 9; 5 mg, orally, daily), or 2)
spironolactone (S) treatment (n = 5; 100 mg, orally, daily). Each
group was treated for 6 months. Patients were evaluated at
baseline and after 3 and 6 months of treatment. The 2 groups were
similar in age, weight, hip/waist ratio, baseline
Ferriman-Gallwey score (F, 19 +/- 2; S, 19 +/- 2), and baseline
androgen levels. Finasteride treatment resulted in a significant
increase in testosterone (T; P < 0.01) and the
T/dihydrotestosterone ratio (P < 0.01). Finasteride caused a
significant decrease in 5 alpha-androstane-3 alpha,17 beta-diol
glucuronide (3 alpha-diolG; P < 0.05), the 3 alpha-diolG/T ratio
(P < 0.01), and the 3 alpha-diolG/androstenedione ratio (P <
0.05). All changes were consistent with 5 alpha-reductase
inhibition. In contrast, spironolactone treatment did not result
in significant changes in serum hormone levels. Both treatments
produced a significant decrease in anagen hair diameters [F,
-14.0 +/- 6.7% (P < 0.05); S, -13.4 +/- 3.8% (P < 0.05)] and
Ferriman-Gallwey scores [F, -2.1 +/- 0.4 (P < 0.05); S, -2.5 +/-
0.7 (P < 0.05)]. In conclusion, despite significantly different
effects on androgen levels, finasteride and spironolactone
treatment resulted in a similar clinical effect on hirsutism.
Both caused significant, but limited, improvement in hirsutism.
Although promising, further studies with finasteride are needed
to verify its effectiveness as a treatment for hirsutism. Such
studies will also provide a better understanding of the relative
contribution of 5 alpha-reductase isoenzymes to hirsutism (Au).
========================================================================
10.) Ti: Case report: finasteride-induced gynecomastia in a 62-year-old
man.
========================================================================
Au: Volpi R; Maccarini PA; Boni S; Chiodera P; Coiro V.
Ad: Department of Medicine, University of Parma, Italy.
So: Am J Med Sci; 309(6):322-5, 1995 Jun.
Ab: The authors describe a case of bilateral (with left prevalence)
gynecomastia in a 62-year-old man after finasteride treatment
because of benign prostatic hypertrophy. Finasteride is an
inhibitor of 5 alpha-reductase, the enzyme responsible for
testosterone metabolism to dihydrotestosterone. In this patient,
nonspecific endocrine alterations were found, except for a
significant decrease in dihydrotestosterone levels. In addition,
there were no pathologic conditions affecting other organs or
pharmacologic treatments that could be responsible for
gynecomastia. Drug withdrawal started a progressive reduction of
the lumps until complete their disappearance. It is possible that
gynecomastia was caused by alterations of estrogen/androgen ratio
because of a finasteride-induced decrease in circulating
dihydrotestosterone levels. In this article, the authors confirm
finasteride antiandrogenic activity and recommend a close
follow-up of long-term treatments with finasteride to find out
other possible side effects (Au).
========================================================================
11.) Ti: Clinical and endocrine effects of finasteride, a 5
alpha-reductase inhibitor, in women with idiopathic hirsutism.
========================================================================
Au: Ciotta L; Cianci A; Calogero AE; Palumbo MA; Marletta E; Sciuto
A; Palumbo G.
Ad: Department of Obstetrics and Gynaecology, University of Catania,
Italy.
So: Fertil Steril; 64(2):299-306, 1995 Aug.
Ab: OBJECTIVE: To evaluate the effects of long-term administration of
finasteride on hirsutism score, basal gonadotropin, and androgen
secretion in women with idiopathic hirsutism. DESIGN: Randomized
single-blinded study. PATIENTS: Eighteen patients with
moderate-severe hirsutism were recruited for the study.
INTERVENTIONS: Nine hirsute patients received 7.5 mg/d oral
finasteride for a period of 9 months whereas the other nine were
treated with placebo. Hirsutism score, serum basal gonadotropin,
androgens, estrogen, and sex hormone-binding globulin (SHBG)
levels were evaluated in all patients before treatment and every
3 months during treatment. RESULTS: After 6 and 9 months of
treatment, the hirsutism score improved significantly in the
patients receiving finasteride, whereas no significant
modifications were observed in patients treated with placebo. The
side effects observed were headache and depression of modest
entity during the 1st month of treatments, whereas libido did not
change. Serum levels of LH, FSH, androstenedione, unbound T,
DHEAS, E2, 17 alpha-hydroxyprogesterone, and SHBG did not change
during therapy. Hirsute patients treated with finasteride
exhibited a marked decrease of dihydrotestosterone and a
significant increase of T serum levels from the 3rd and 6th
months of treatment, respectively. CONCLUSION: Finasteride
decreased the hirsutism score of patients affected by idiopathic
hirsutism with few side effects during treatment. No modification
of libido was observed (Au).
========================================================================
12.) Reversible severe myopathy during treatment with finasteride.
Haan J; Hollander JM; van Duinen SG; Saxena PR; Wintzen AR
Department of Neurology, Leiden University Hospital, The Netherlands.
Muscle Nerve (UNITED STATES) Apr 1997 20 (4) p502-4 ISSN: 0148-639X
========================================================================
========================================================================
13.) Results Of New Study Confirm Propecia Works Only In Men
========================================================================
WEST POINT, PA -- May 4, 1998 -- New research presented this weekend
at an international hair loss workshop in Brussels, Belgium, has determined that
Merck & Co., Inc.'s Propecia(R) (finasteride 1 mg), the once-a-day pill to
treat certain types of men's hair loss, is not an effective treatment for women
with hair loss.
The results of a one-year study in 136 women showed that there was no
significant difference in the change in mean hair count at 12 months between
post-menopausal women treated with Propecia and those given a placebo.
The United States Food and Drug Administration cleared Propecia for
Marketing in December 1997 for men only. In clinical studies over 1,800 men,
18 to 41, with mild to moderate male pattern hair loss on the vertex (at the top
of the head) and anterior mid-scalp area were treated for up to two years. In
These studies, hair count increased during the first year and was maintained in
those men taking Propecia for 24 months. Men in the placebo group continued
to show progressive hair loss.
Although the differences in the factors that cause hair loss in men and women
are not fully understood, Joanne Waldstreicher, M.D., senior director of clinical
research, Merck Research Laboratories, said women normally have lower
levels of androgens (male sex hormones, such as testosterone and
dihydrotestosterone) than men. Propecia blocks the conversion of testosterone
to dihydrotestosterone and, by this mechanism, appears to interrupt a key
factor in the development of androgenetic alopecia in men who are genetically
predisposed.
Preliminary efficacy data from this new study are available on 65 women (mean
age 53.2) in the group treated with Propecia and 69 women (mean age 52.6) in
the group given a placebo, or sugar pill. Hair counts were obtained from a one
centimetre square area (approximately 0.155 square inch) in the anterior and
mid-area portion of the scalp at baseline, six months and 12 months. Of the
women in the trial, 73 were on hormone replacement therapy as well. The use
of hormone replacement therapy did not affect the outcome of the study.
Results of the study showed that:
-- the women treated with Propecia experienced an 8.4 percent decrease in
hair count (150.3 hairs at baseline to 141.0 at 12 months)
-- the women given placebo experienced a 6.5 percent decrease in hair count
(164.8 hairs at baseline to 157.8 at 12 months).
The difference between the treatment and placebo groups was not statistically
significant. In addition, global photographs of the scalp were reviewed by a
blinded panel of dermatologists. Analysis of these photographs revealed no
significant difference in results between the placebo group and the group
treated with Propecia.
"With no demonstrated efficacy and the known risks of Propecia in women
who are or may potentially be pregnant, this study establishes that Propecia
should be used in men only," Dr. Waldstreicher added.
Women who are or may potentially be pregnant must not use Propecia and
should not handle crushed or broken tablets because it may cause abnormalities
of the male baby's sex organs. Propecia tablets are coated and will prevent
contact with the active ingredient during normal handling, provided the tablets
have not been broken or crushed.
In an earlier analysis of 1,215 men with hair loss in the vertex area of the scalp
who were followed for up to two years, 83 percent had the same or higher hair
count versus 28 percent of the placebo group. Most men reported an increase
in the amount of their hair, a decrease in hair loss and improvement in
appearance. There is not sufficient evidence that Propecia works for recession
at the temporal areas. Men may need to take Propecia daily for three months
or more to see visible results.
In clinical studies in men, Propecia was generally well-tolerated and side effects
were uncommon. A very small number of men reported less desire for sex,
difficulty in achieving an erection and/or a decrease in the amount of semen.
Each of these side effects occurred in less than two percent of men. These side
effects went away in all men who discontinued therapy because of them and
also disappeared in 58 percent of men who chose to continue taking Propecia.
======================================================================
DATA-MEDICOS/DERMAGIC-EXPRESS No (5) 20/10/98 DR. JOSE LAPENTA R. DERMATOLOGO
======================================================================
Produced by Dr. José Lapenta R. Dermatologist
Venezuela
1.998-2.024
Producido por Dr. José Lapenta R. Dermatólogo Venezuela 1.998-2.0024
Tlf: 0414-2976087 - 04127766810
