REVISTA DERMATOLÓGICA JUNIO 2003-2024, FINASTERIDE II-PROPECIA

La primera publicación sobre el FINASTERIDE la hice el año 1998, hace 26 años, luego la actualice en el año 2003, representada por este artículo, el cual contiene 10 publicaciones donde "saltaron las alarmas" de que esta medicina, podría desencadenar un cáncer agresivo de próstata, en aquellos que la estaban utilizando para la Hiperplasia prostática Benigna (HPB).

El mecanismo de acción del FINASTERIDE es inhibir la enzima 5-alfa reductasa (5ARI), la cual bloquea la conversión de la TESTOSTERONA en su metabolito DIHIDROTESTOSTERONA (DHT), tanto en la próstata como el cuero cabelludo. 

Hoy 2024 hice una revisión del tema en discusión, y efectivamente el FINASTERIDE disminuye la probabilidad de cancer de prostata en un 25-30%, en las lesiones prostáticas de bajo grado cancerígeno.

Pero también es cierto que el uso de la FINASTERIDA, ha provocado cáncer agresivo de próstata, cuando hay lesiones de mayor potencial maligno.

El tema hoy día 2024 es de gran debate, para ello solo hay dos teorías:

1.) Que el FINASTERIDE al disminuir el volumen prostático, enmascara el real potencial maligno de la lesión.

2.) El FINASTERIDE altera la histopatología del tejido del tejido prostático, lo que conlleva a una subestimación del grado de cáncer.

También en el año 2006 comenzó a describirse el llamado SÍNDROME POST FINASTERIDE (SPF), en pacientes que habían usado esta medicina para la hiperplasia prostática benigna (HPB), y lo tuvieron que abandonar al presentar una serie de síntomas, que incluyen:

1.) Síntomas Sexuales:

A.- Disminución y /o pérdida del deseo sexual: 6.4% en el primer año, luego disminuyó a 2.6% a partir del 2do año.

 B.- Disfunción eréctil e impotencia: 8.1%, disminuyendo a 5.4% en los años 2 al 4to.

C.-  Pérdida de erecciones matutinas y espontáneas.

D.-  pérdida del placer durante el orgasmo (Anhedonia sexual) .

 E.- Cambios en el volumen de semen al eyacular y fuerza: disminución de la cantidad de semen:3.7% en el primer año, luego disminuye a 1.5% en años subsiguientes.

2. Síntomas Físicos:

A.- Fatiga y debilidad muscular.

 B.-  Aumento del tejido mamario (Ginecomastia): 0.5% en el primer año, la cual aumentó a 1.8% en años posteriores.

C.- Sensibilidad Mamaria: 0.4% reportada en el primer año, y aumentó al 0.7% en años subsiguientes.

 D.- Cambios cutáneos: sequedad o lipoatrofia (pérdida de grasa).

3. Síntomas Neurológicos y Cognitivos:

A.-Dificultades para concentrarse y de memoria.

 B.-Depresión, ansiedad y cambios de estados de animo.

 C.-Insomnio.

4. Otros Síntomas incluyen: aumento de peso y /o cambios hormonales.

La incidencia de este SINDROME POST-FINASTERIDE, no esta bien establecida porque el numero de casos y síntomas reportados tiene una baja incidencia o prevalencia en la población que lo consume. Solo un pequeño porcentaje reporta efectos secundarios persistentes después de la suspensión del mismo.

Lo último que se dice como causal del este sindrome, es que en el organismo hay 3 tipos de 5-alfareducatsas (5ARI), las cuales están presentes en muchos órganos dentro y fuera del cerebro, entonces el FINASTERIDE, bloquea no solo las de la PRÓSTATA Y CUERO CABELLUDO, sino también en muchos otros tejidos. Las 5-alfa reductasas LIPOFÍLICAS pueden atravesar la barrera hematoencefálica y provocar bloqueo de neuroesteroides en el cerebro, ocasionando cambios en la NEUROQUÍMICA cerebral que explicaría los síntomas descritos. Este tema sigue debatiéndose hoy dia 2024.

Sin embargo esta medicina ha demostrado su efectividad en el tratamiento de la HIPERPLASIA PROSTÁTICA BENIGNA, ALOPECIA ANDROGÉNICA Y EL HIRSUTISMO en las mujeres.

Te dejo dos enlaces de interés:

1.) En este enlace encuentras información sobre el FINASTERIDE y EL HIRSUTISMO 2024  

2.) Aquí encuentras la primera publicación sobre  el FINASTERIDE ACTUALIZADA 2024

Saludos,,, 

Dr. José Lapenta.

ENGLISH

The first publication on FINASTERIDE was made in 1998, 26 years ago, then I updated it in 2003, represented by this article, which contains 10 publications where "alarms went off" that this medicine could trigger aggressive prostate cancer in those who were using it for Benign Prostatic Hyperplasia (BPH).

The mechanism of action of FINASTERIDE is to inhibit the enzyme 5-alpha reductase (5ARI), which blocks the conversion of TESTOSTERONE into its metabolite DIHYDROTESTOSTERONE (DHT), both in the prostate and the scalp.

Today 2024 I made a review of the topic under discussion, and indeed FINASTERIDE decreases the probability of prostate cancer by 25-30%, in low-grade cancerous prostate lesions.

But it is also true that the use of FINASTERIDE has caused aggressive prostate cancer, when there are lesions with a higher malignant potential.

The issue today, 2024, is a matter of great debate, and there are only two theories:

1.) That FINASTERIDE, by reducing prostate volume, masks the real malignant potential of the lesion.

2.) FINASTERIDE alters the histopathology of prostate tissue, which leads to an underestimation of the degree of cancer.

Also in 2006, the so-called POST-FINASTERIDE SYNDROME (PFS) began to be described in patients who had used this medicine for benign prostatic hyperplasia (BPH), and had to stop taking it after presenting a series of symptoms, including:

1.) Sexual Symptoms:

A.- Decreased and/or loss of sexual desire: 6.4% in the first year, then decreased to 2.6% from the 2nd year.

B.- Erectile dysfunction and impotence: 8.1%, decreasing to 5.4% in years 2-4.

C.- Loss of morning and spontaneous erections.

D.- Loss of pleasure during orgasm (Sexual anhedonia).

E.- Changes in ejaculation volume and strength: decreased semen quantity: 3.7% in the first year, then decreased to 1.5% in subsequent years.

2. Physical Symptoms:

A.- Fatigue and muscle weakness.

B.- Increase in breast tissue (Gynecomastia): 0.5% in the first year, which increased to 1.8% in subsequent years.

C.- Breast tenderness: 0.4% reported in the first year, and increased to 0.7% in subsequent years.

D.- Skin changes: dryness or lipoatrophy (fat loss).

3. Neurological and Cognitive Symptoms:

A.- Difficulty concentrating and remembering.

B.- Depression, anxiety and mood swings.

C.- Insomnia.

4. Other Symptoms include: weight gain and/or hormonal changes.

The incidence of this POST-FINASTERIDE SYNDROME is not well established because the number of reported cases and symptoms, has a low incidence or prevalence in the population that consumes it. Only a small percentage reports persistent side effects after discontinuing it.

The latest thing that is said to be the cause of this syndrome, is that there are 3 types of 5-alpha-reduced agonists (5ARI) in the body, which are present in many organs inside and outside the brain, so FINASTERIDE blocks not only those of the PROSTATE AND SCALP, but also in many other tissues. LIPOPHILIC 5-alpha reductases can cross the blood-brain barrier and cause neurosteroid blockage in the brain, causing changes in brain NEUROCHEMISTRY that would explain the symptoms described. This topic is still being debated today in 2024.

However, this medicine has proven its effectiveness in the treatment of BENIGN PROSTATIC HYPERPLASIA, ANDROGENIC ALOPECIA AND HIRSUTISM in women.

Here are two links of interest:

1.) In this link you will find more information about FINASTERIDE and HIRSUTISM

2.) Here you find the first post about FINASTERIDE UPDATED 2024

Greetings...

Dr. José Lapenta R. 

The Influence of Finasteride on the Development of Prostate Cancer
Source: http://www.nejm.org/

Ian M. Thompson, M.D., Phyllis J. Goodman, M.S., Catherine M. Tangen, Dr.P.H., M. Scott Lucia, M.D., Gary J. Miller, M.D., Ph.D., Leslie G. Ford, M.D., Michael M. Lieber, M.D., R. Duane Cespedes, M.D., James N. Atkins, M.D., Scott M. Lippman, M.D., Susie M. Carlin, B.A., Anne Ryan, R.N., Connie M. Szczepanek, R.N., B.S.N., John J. Crowley, Ph.D., and Charles A. Coltman, Jr., M.D.



ABSTRACT


Background Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer.

Methods In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study.

Results Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleason grade 7, 8, 9, or 10 were more common in the finasteride group (280 of 757 tumors [37.0 percent], or 6.4 percent of the 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], P<0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo.

Conclusions Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.

2.) Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial

Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial.
Control Clin Trials. 2003 Apr;24(2):224-43. Related Articles, Links

Bautista OM, Kusek JW, Nyberg LM, McConnell JD, Bain RP, Miller G, Crawford ED, Kaplan SA, Sihelnik SA, Brawer MK, Lepor H.

George Washington University, Rockville, MD, USA

Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of benign prostatic hyperplasia (BPH). Taken as monotherapy, alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms. Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery. Direct comparison of the alpha-blocker terazosin with finasteride has been done, but only for a period of 1 year. The Medical Therapy of Prostatic Symptoms (MTOPS) trial is a multicenter, randomized, placebo-controlled, double-masked clinical trial designed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride, whether taken as a monotherapy or in combination, in preventing or delaying the progression of BPH. We describe in this paper the design of the MTOPS trial, the concept of BPH progression, the definition and methods of determining the primary outcome events and the proposed statistical analysis methods. A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of randomized participants. Volunteers among randomized participants are to undergo a biopsy of the prostate at predetermined time points during the trial. Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH.

3.) The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group.

Source: N Engl J Med. 1998 Feb 26;338(9):557-63.

Comment in:
ACP J Club. 1998 Jul-Aug;129(1):11.
N Engl J Med. 1998 Feb 26;338(9):612-3.

McConnell JD, Bruskewitz R, Walsh P, Andriole G, Lieber M, Holtgrewe HL, Albertsen P, Roehrborn CG, Nickel JC, Wang DZ, Taylor AM, Waldstreicher J.

University of Texas Southwestern Medical Center, Dallas 75235-9110, USA.

BACKGROUND: Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, is not known. METHODS: In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men. RESULTS: During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001). CONCLUSIONS: Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the risk of surgery and acute urinary retention.

4.) 5 alpha-reductase inhibitors: what role should they play?

Urology. 2001 Dec;58(6 Suppl 1):65-70; discussion 70.
Kaplan SA.

Department of Urology, Columbia University, New York, New York, USA.

The development of finasteride (PROSCAR, Merck & Co., Whitehouse Station, NJ) for the treatment of benign prostatic hyperplasia (BPH) has had variable results. Numerous short-term and long-term studies comparing finasteride with placebo have been reported. The results suggest that, physiologically, treatment with finasteride significantly decreases levels of both serum and intraprostatic dihydrotestosterone about 70% to 80% from baseline. In addition, total gland size decreases significantly-about 15% to 25% from baseline-particularly in the area of the periurethral zone of the prostate after finasteride treatment. Baseline prostate size has been found to have a relation to efficacy of finasteride treatment. The larger the prostate at baseline, the greater the urinary flow rate increase and symptom score decrease compared with placebo. Health-related quality-of-life parameters improved in those taking finasteride. In studies evaluating combination therapy, no significant differences were noted between those treated with an alpha blocker, such as terazosin or doxazosin in combination with finasteride, and those receiving an alpha blocker alone. Long-term finasteride versus placebo studies, such as the PROSCAR Long-Term Efficacy and Safety Study (PLESS), suggest that long-term medical therapy with finasteride affects the natural history of the disease as manifested by the decrease in rates of acute urinary retention and surgery. In patients who are "therapeutic responders," the degree of symptomatic improvement in those treated with finasteride appears to be equal to that seen in patients receiving alpha blockers. Prostate cancer detection rates did not differ between those treated with finasteride and those receiving a placebo. The results of these studies suggest that physicians must evaluate what role finasteride plays in the spectrum of available options for the treatment of BPH and lower urinary tract symptoms. Baseline parameters, such as prostate volume, prostate-specific antigen values, and whether to administer finasteride in combination with alpha blockers, are among the factors that will determine the appropriateness of such therapy.

5.) Cytologic atypia in a 53-year-old man with finasteride-induced gynecomastia

Cytologic atypia in a 53-year-old man with finasteride-induced gynecomastia.
Arch Pathol Lab Med. 2000 Apr;124(4):625-7.

Zimmerman RL, Fogt F, Cronin D, Lynch R.

Departments of Pathology & Laboratory Medicine, Presbyterian Medical Center, University of Pennsylvania Health System, Philadelphia, PA 19104, USA.

Finasteride has been associated with the development of gynecomastia. Although cytoplasmic vacuolization has been noted in prostatic epithelium in men taking this drug, we found no documentation of the cytologic changes in finasteride-associated gynecomastia. We present the case of a 53-year-old man who developed unilateral gynecomastia following finasteride therapy for alopecia. A fine-needle aspiration biopsy of the mass was diagnosed as adenocarcinoma on the basis of nuclear atypia and particularly because of cytoplasmic vacuolization. Subsequent excisional biopsy revealed benign gynecomastia with no evidence of malignant change. The ductal epithelium did exhibit cytoplasmic vacuolization similar to that described in the prostate following finasteride therapy. We believe this is the first reported case documenting the cytologic changes seen in gynecomastia secondary to finasteride therapy. Cytoplasmic vacuolization in this setting should not be considered evidence of malignancy in men with gynecomastia. As with gynecomastia in general, extreme caution should be used before rendering a cytologic diagnosis of malignancy.

6.) Case report: finasteride-induced gynecomastia in a 62-year-old man.

Am J Med Sci. 1995 Jun;309(6):322-5.

Volpi R, Maccarini PA, Boni S, Chiodera P, Coiro V.

Department of Medicine, University of Parma, Italy.

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.

7.)Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia.

 
Urology. 2003 Mar;61(3):579-84.
Wessells H, Roy J, Bannow J, Grayhack J, Matsumoto AM, Tenover L, Herlihy R, Fitch W, Labasky R, Auerbach S, Parra R, Rajfer J, Culbertson J, Lee M, Bach MA, Waldstreicher J; PLESS Study Group.

University of Washington, Seattle, Washington, USA.

OBJECTIVES: To evaluate the incidence and resolution of sexual adverse experiences (AEs) in men with benign prostatic hyperplasia treated with finasteride 5 mg compared with placebo. METHODS: The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men, aged 45 to 78 years, with symptomatic benign prostatic hyperplasia, enlarged prostates, and no evidence of prostate cancer. Patients completed a questionnaire at screening regarding their history of sexual dysfunction. During treatment, spontaneously self-reported sexual AEs were recorded. RESULTS: At screening, 46% of patients in each treatment group reported some history of sexual dysfunction. During year 1 of the study, 15% of finasteride-treated patients and 7% of placebo-treated patients had sexual AEs that were considered drug related by the investigator (P <0.001). During years 2 to 4, no between-group difference was noted in the incidence of new sexual AEs (7% in each group). The drug-related sexual AE profile for finasteride was similar for men with or without a history of sexual dysfunction. Sexual AEs resolved while continuing therapy in 12% of finasteride patients and 19% of placebo patients. Only 4% of finasteride and 2% of placebo patients discontinued the study because of sexual AEs. In men who discontinued with a sexual AE, 50% and 41% experienced resolution of their sexual AE after discontinuing finasteride or placebo therapy, respectively. CONCLUSIONS: Compared with placebo, men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy.

8.) Droga para la calvicie (Finasteride) reduce riesgo de cáncer pero aconsejan cautela.

Source: http://www.cnnenespanol.com/

24 de junio, 2003

CNN) -- Un estudio difundido el martes indica que un medicamento para la calvicie reduce en 25 por ciento las posibilidades de sufrir de cáncer de próstata, pero también podría elevar el riesgo de sufrir formas más agresivas del cáncer en algunos casos.

"La finasterida es la primera droga de la que se tiene conocimiento que puede reducir el riesgo de cáncer de próstata", dijo el Ian Thompson, autor principal del estudio patrocinado por el Instituto Nacional del Cáncer de Estados Unidos y publicado en la edición online del New England Journal of Medicine.

"El medicamento funcionó en hombres que corrían alto riesgo de sufrir de cáncer de próstata y también en la franja de bajo riesgo", añadió.

Pero, los investigadores expresaron cautela ante el uso del medicamento como tratamiento preventivo y advirtieron que la finasterida parece aumentar las posibilidades de que el cáncer sea más agresivo en los casos en los que se contrae la enfermedad.

La droga se encuentra presente en bajas dosis en el medicamento contra la calvicie Propecia y también se comercializa bajo el nombre Proscar para el tratamiento de la próstata.

El Instituto Nacional del Cáncer en Estados Unidos calcula que si se realizara un seguimiento de mil hombres de 63 años a lo largo de siete años, 60 contraerían cáncer de próstata, entre ellos 18 que sufrirían tumores agresivos que se propagan rápidamente.

Si los mismos hombres tomaran finasterida durante siete años, sólo 45 contraerían el cáncer pero 22 presentarían tumores agresivos.

Calvicie y cautela

Pese a que el estudio representa un avance en el tratamiento del cáncer de próstata los pacientes deben sopesar bien las ventajas y los riesgos que conlleva, señaló el doctor Harmon J. Eyre, médico principal de la Sociedad del Cáncer de Estados Unidos.

En cuanto a los hombres que utilizan la droga para promover el crecimiento del cabello, el doctor John Wasson, director del Centro de Envejecimiento de la Facultad de Medicina Dartmouth, señaló:

" Ciertamente yo no quisiera tomar un medicamento que potencialmente puede promover un tipo agresivo de cáncer".

"Lo primero que hay que pensar sobre un medicamento o tratamiento es que no haga daño. Si uno es un hombre joven debería tener cuidado con la finasterida", añadió.

El especialista estima que los resultados del estudio podrían llevar a que la Agencia de Alimentos y Drogas de Estados Unidos revise la información disponible sobre la droga, producida por los laboratorios Merck y de venta bajo receta.

Ningún funcionario del organismo de salud se pronunció sobre el tema y el intento de CNN de obtener declaraciones del laboratorio fue infructuoso.

9.) Proscar: five-year experience

Eur Urol. 1995;28(4):304-9.

Erratum in:
Eur Urol 1996;29(2):234.

Moore E, Bracken B, Bremner W, Geller J, Imperato-McGinley J, McConnell J, Roy J, Tenover L, Vaughan D, Pappas F.

Merck Research Laboratories, Rahway, NJ 07065, USA.

We assessed the long-term safety and efficacy of finasteride, an orally active 5 alpha-reductase inhibitor, in 2 previously reported groups of patients with symptomatic benign prostatic hyperplasia (BPH). Prostate volume was measured by magnetic resonance imaging, and the maximum urinary flow rate was assessed noninvasively. Symptoms were scored utilizing a patient self-administered symptom score questionnaire. Total symptom scores ranged from 0 (or asymptomatic) to 35 (severely symptomatic). After an initial double-blind period, the patients in study 1 were treated with 10 mg finasteride for 1 year and then switched to 5 mg finasteride for an additional 4 years, whereas patients in study 2 were treated with 5 mg finasteride for the entire 5 years. A total of 190 patients were randomized in the double-blind studies, 156 entered year 1 of the open extension and 70 patients completed 5 years of finasteride therapy. In both studies prostate volume was reduced from baseline by 30%, dihydrotestosterone was reduced by 72%, and the maximum urinary flow rate improved by approximately 1.5 ml/s. Prostate-specific antigen was decreased by approximately 50%. Finasteride was well tolerated; approximately 10% of patients reported sexual adverse experiences during the 5-year study period, which were considered drug related by the investigators. The incidence in reporting sexual adverse experiences did not increase with the increased duration of treatment: findings consistent with previous reports. In summary treatment of BPH with finasteride for 5 years inhibits the progression of the disease with an excellent safety profile and represents a low-risk medical option for the treatment of symptomatic BPH.

10.) Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia.

Urology. 2002 Dec;60(6):1040-4.

Vaughan D, Imperato-McGinley J, McConnell J, Matsumoto AM, Bracken B, Roy J, Sullivan M, Pappas F, Cook T, Daurio C, Meehan A, Stoner E, Waldstreicher J.

Cornell University Medical Center, New York, New York, USA.

OBJECTIVES: To evaluate the effects of finasteride, a specific type II 5-alpha-reductase inhibitor, on symptoms of benign prostatic hyperplasia, prostate volume, and urinary flow during a 7 to 8-year period. METHODS: A total of 190 men with symptomatic benign prostatic hyperplasia and enlarged prostates entered one of two Phase II double-blind 3 to 6-month studies. Of these, 156 patients continued taking open-label finasteride, and more than 70 patients completed 7 to 8 years of treatment. The symptoms were scored using a patient self-administered modified Boyarsky symptom questionnaire. Prostate volume was measured by magnetic resonance imaging or ultrasonography, and the maximal urinary flow rate was assessed noninvasively. RESULTS: Treatment with finasteride for 7 to 8 years led to sustained improvement in symptoms, reduction in prostate volume (28% from baseline), and increased urinary flow (median 2.5 mL/s from baseline). Decreases in dihydrotestosterone (86%) and prostate-specific antigen (54%) levels were also maintained. Long-term finasteride treatment was safe and generally well tolerated. CONCLUSIONS: Long-term treatment with finasteride was well tolerated and resulted in durable symptom relief and improvement in prostate volume and urinary flow.

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Venezuela 1.998-2.024

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