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J Chin Med Assoc. 2004 Nov;67(11):571-4.
Effects of finasteride on prostate volume and prostate-specific antigen.
Chiu KY, Yong CR.
Department of Surgery, Taichung Veterans General Hospital, Taichung, ROC.
BACKGROUND: Finasteride was introduced to treat patients with benign prostatic hyperplasia (BPH) recently, and it has shown its effects in reduction of prostate volume and decrease of prostate-specific antigen (PSA). We want to know how and how much does finasteride affect prostate volume as well as PSA and prostate-specific antigen density (PSAD), since PSA and PSAD are widely used as screening tools for early detection of prostate cancers. METHODS: Among 166 men with the diagnosis of BPH who received finasteride (5 mg/day) for 6 months, the serum PSA levels were measured. The prostate volumes before and after medication for a subgroup of 86 patients were measured by transrectal ultrasonography (TRUS). Paired t-test was used for the statistical analysis. The median percentage change in PSA of total 166 men and the median percentage changes in prostate volumes and PSAD of 86 men were also calculated. RESULTS: Among 166 men, the average serum PSA level was 2.48+/-2.02 ng/mL at baseline and 1.57+/-1.47 ng/mL at 6 months later. The median percentage change of serum PSA level was -44.26%. For 86 patients who underwent TRUS evaluation the average prostate volume changed from 39.83+/-21.10 mL to 33.62+/-20.52 mL. The median percentage change of prostatic volume was -17.80%. Also, the median percentage change in PSAD for these 86 patients after medication was -38.67%. CONCLUSIONS: Finasteride does decrease the serum PSA level and PSAD as well as prostate volume in men with BPH treated with it for 6 months. Physicians prescribing finasteride for patients with symptomatic BPH should always keep in mind its effect on PSA and PSAD levels in order not to miss potential prostate cancers.


Expert Opin Pharmacother. 2004 Apr;5(4):933-40.
Finasteride in the treatment of alopecia.
Libecco JF, Bergfeld WF.
Cleveland Clinic Foundation, Department of Dermatology and Dermapathology, Cleveland, OH 44195, USA.
Finasteride is a 5alpha-reductase inhibitor approved for the treatment of male pattern hair loss. Originally approved for the treatment of benign prostatic hypertrophy in 1992, its approval was expanded in 1997 to include the treatment of androgenetic alopecia (AGA) in men at a dose of 1 mg/day. Finasteride inhibits 5alpha-reductase, thereby prohibiting the conversion of testosterone to dihydrotestosterone (DHT), which is implicated in the development of hairless in some men. Reduction in DHT results in a significant improvement in subjective and objective assessments of hair growth and density. Finasteride is well-tolerated with a favourable adverse event history. The most common adverse events include reduced libido, decreased ejaculate volume and gynaecomastia.


Gynecol Endocrinol. 2003 Oct;17(5):419-22.
Low-dose (2.5 mg/day) finasteride treatment in hirsutism.
Bayram F, Muderris I, Guven M, Ozcelik B, Kelestimur F.
Erciyes University Medical Faculty, Department of Endocrinology and Metabolism, 38039, Kayseri, Turkey.
This study was performed to confirm the therapeutic effects of low-dose, (2.5 mg/day) finasteride in hirsute women. Our study was a non-randomized prospective clinical trial. Twenty-nine patients with hirustism were included in the study. The patients received 2.5 mg finasteride once a day over a period of 12 months. Follicle stimulating hormone, luteinizing hormone, sex hormone binding globulin, 17 alpha-hydroxyprogesterone, estradiol, androstenedione, total and free testosterone, dehydroepiandrosterone sulfate levels and hirsutism scores were determined in all patients before treatment and at every 6 months during the therapy. The hirsutism score decreased from a mean of 18.4 +/- 4.6 to 8.4 +/- 4.2 during the study. The per cent reduction in hirsutism score (mean +/- SD) at 6 and 12 months was 29.2 +/- 14.5 and 55.7 +/- 14.9%, respectively. There were no significant differences in any of the hormone levels and no serious side-effects were observed during the treatment. In conclusion, low-dose finasteride (2.5 mg/day) is a cost-effective, well-tolerated therapeutic agent without significant abnormal biochemical findings and can be used in place of high-dose (5 mg/day) finasteride in the treatment of hirsutism.


Eur J Dermatol. 2003 Mar-Apr;13(2):150-60.
Efficacy and tolerability of finasteride 1 mg in men aged 41 to 60 years with male pattern hair loss.
Whiting DA, Olsen EA, Savin R, Halper L, Rodgers A, Wang L, Hustad C, Palmisano J; Male Pattern Hair Loss Study Group.
Dallas Associated Dermatologists, 3600 Gaston Avenue, #1051 LB76, TX 75246, USA.
A 24-month double-blind, randomized, placebo-controlled, parallel-group, multicenter study of 424 men was conducted to determine the efficacy and tolerability of finasteride 1 mg on hair growth/loss in men aged 41 to 60 years with mild-to-moderate, predominantly vertex male pattern hair loss. Efficacy was evaluated by review of global photographs of the vertex scalp taken at baseline and at Months 6, 12, 18, and 24 and by patient self-assessments and investigator clinical assessments of change from baseline in hair growth/loss collected at Months 6, 12, 18, and 24. Safety analyses included assessment of clinical and laboratory adverse experiences, including sexual adverse experiences. Analysis of global photographic assessment data showed significant improvement in hair growth for men in the finasteride group compared with those taking placebo beginning at Month 6 (p < 0.001) and maintained through Month 24 (p < 0.001). Results of the patient self-assessment and investigator assessments were consistent with those from the global photographic assessment. Finasteride 1 mg improved scalp hair growth in men aged 41 to 60 years with predominantly vertex male pattern hair loss compared with results seen with placebo. Improvement was evident by 6 months of treatment and continued through 24 months. Treatment with finasteride 1 mg was generally well tolerated.


Eur J Dermatol. 2002 Jan-Feb;12(1):32-7.
Finasteride improves male pattern hair loss in a randomized study in identical twins.
Stough DB, Rao NA, Kaufman KD, Mitchell C.
Burke Research, Hot Springs, Arkansas 71913, USA.
OBJECTIVES: This study compared the efficacy of finasteride with placebo in the treatment of male pattern hair loss (androgenetic alopecia) in nine pairs of male identical twins. METHODS: In this randomized, double-blind, placebo-controlled, single-center study, one twin from each identical twin pair received finasteride 1 mg/day for one year while the other received placebo. Hair growth was evaluated from standardized clinical photographs, hair counts and patient self-assessment questionnaires. Serum dihydrotestosterone and testosterone levels were analyzed and adverse events recorded. RESULTS: Finasteride significantly improved hair growth at one year compared to placebo (p < 0.05) based on analysis of photographs of the vertex and superior-frontal scalp. These results were consistent with the hair count change measured in the finasteride group, which was superior (p < 0.05) to the change measured in the placebo group. Patient self-assessment demonstrated that treatment with finasteride, in comparison to placebo, led to improvements in scalp hair growth and patients' satisfaction with appearance of hair. No drug-related adverse events were reported during the study. CONCLUSION: Through the use of identical twins, this study provides further evidence that finasteride significantly reduces hair loss progression and restores hair growth in men with male pattern hair loss.


Urologiia. 2002 Sep-Oct;(5):16-8.
Use of proscar in preoperative preparation of patients with benign prostatic hyperplasia before transureteral resection.
Kamalov AA, Riaboi AV, Ignashin NS, Karpov VK, Dorofeev SD.
Effects of proskar-MSD used before transurethral resection (TUR) of the prostate in patients with benign prostatic hyperplasia (BPH) were studied with specification of the drug action on hematuria during and after operation. Patients with histologically verified BPH received proskar for 3 and 6 months in a dose of 5 mg/day. Control patients did not receive preoperative proskar. Of patients who received proskar for 3 months, TUR with estimation of the intraoperative blood loss and changes in microcirculation and structure of prostatic tissue induced by proskar was made in 20 patients (mean age 68 years). A 3-month course of proskar reduced prostatic volume and its hyperplasia by 18-20 cm3, on the average. Mean blood loss was about 111 ml vs control 223 ml. Dopplerography revealed consolidation of adenomatous tissue and decline of volumic blood flow in the prostate after 3-month proskar course. Thus, preoperative proskar administration before TUR of prostatic adenoma results in sclerosing of prostatic tissue, decrease of microcirculation manifesting intraoperatively with diminished hematuria and less number of subsequent complications; promotes a favourable outcome of the operation; improves life quality.


J Urol. 2000 Jan;163(1):13-20.
Serum prostate specific antigen is a strong predictor of future prostate growth in men with benign prostatic hyperplasia. PROSCAR long-term efficacy and safety study.
Roehrborn CG, McConnell J, Bonilla J, Rosenblatt S, Hudson PB, Malek GH, Schellhammer PF, Bruskewitz R, Matsumoto AM, Harrison LH, Fuselier HA, Walsh P, Roy J, Andriole G, Resnick M, Waldstreicher J.University of Texas Southwestern Medical Center at Dallas, USA.
University of Texas Southwestern Medical Center at Dallas, USA.
PURPOSE: We analyze patterns of prostate growth in men diagnosed with benign prostatic hyperplasia (BPH) and treated with placebo during 4 years, and determine which baseline parameters were the strongest predictors of growth. MATERIALS AND METHODS: A total of 3,040 men were enrolled in the 4-year randomized, placebo controlled Proscar Long-Term Efficacy and Safety study. Of these men a subgroup of 10% underwent pelvic magnetic resonance imaging prostate volume measurement at baseline and yearly thereafter. Absolute and percent volume changes during 4 years were calculated in the 164 placebo treated men in the subgroup. The ability of age, baseline prostate volume and prostate specific antigen (PSA) to predict prostate growth in placebo treated patients was assessed by multiple linear regression analyses, receiver operator characteristics curves, and evaluations of growth stratified by tertiles of baseline serum PSA and decades of life. RESULTS: In placebo treated patients a steady increase in mean plus or minus standard deviation prostate volume from year to year was noted (2.5+/-6.1, 4.9+/-6.8, 6.4+/-8.5 and 7.2+/-8.8 ml. at years 1, 2, 3 and 4, respectively). Mean volume changes at 4 years ranged from -9 to +30 ml. Mean percent change from baseline ranged from 12.5% to 16.6% for men 50 to 59 years old to those 70 to 79 years old. Baseline serum PSA was a strong predictor of growth with 7.4% to 22.0% change at 4 years from the lowest to highest PSA tertiles. Annualized growth rates from baseline were 0.7 ml. per year for PSA 0.2 to 1.3, 2.1 for PSA 1.4 to 3.2 and 3.3 for PSA 3.3 to 9.9 ng./ml. Multiple linear regression analysis showed that serum PSA was a stronger predictor of prostate growth than age or baseline prostate volume. All but 1 man with baseline serum PSA greater than 2.0 ng./ml. had prostate growth during 4 years, and 32.6% of men with serum PSA less than 2.0 exhibited a decrease in volume. CONCLUSIONS: Serum PSA is a stronger predictor of growth of the prostate in placebo treated patients than age or baseline prostate volume. Since prostate volume is a risk factor for acute urinary retention and the need for BPH related surgery, the ability of PSA to predict prostate growth may be an important factor when considering individual treatment options for BPH. Such use of PSA represents a shift in paradigm away from focusing solely on symptoms of BPH toward a more comprehensive approach with consideration of predicting and preventing risk factors of BPH related outcomes.


J Am Acad Dermatol. 1999 Jun;40(6 Pt 1):930-7.
Finasteride in the treatment of men with frontal male pattern hair loss.
Leyden J, Dunlap F, Miller B, Winters P, Lebwohl M, Hecker D, Kraus S, Baldwin H, Shalita A, Draelos Z, Markou M, Thiboutot D, Rapaport M, Kang S, Kelly T, Pariser D, Webster G, Hordinsky M, Rietschel R, Katz HI, Terranella L, Best S, Round E, Waldstreicher J.
University of Pennsylvania School of Medicine, Philadelphia, USA.
BACKGROUND: Finasteride, a specific inhibitor of type II 5alpha-reductase, decreases serum and scalp dihydrotestosterone and has been shown to be effective in men with vertex male pattern hair loss. OBJECTIVE: This study evaluated the efficacy of finasteride 1 mg/day in men with frontal (anterior/mid) scalp hair thinning. METHODS: This was a 1-year, double-blind, placebo-controlled study followed by a 1-year open extension. Efficacy was assessed by hair counts (1 cm2 circular area), patient and investigator assessments, and global photographic review. RESULTS: There was a significant increase in hair count in the frontal scalp of finasteride-treated patients (P < .001), as well as significant improvements in patient, investigator, and global photographic assessments. Efficacy was maintained or improved throughout the second year of the study. Finasteride was generally well tolerated. CONCLUSION: In men with hair loss in the anterior/mid area of the scalp, finasteride 1 mg/day slowed hair loss and increased hair growth.


Urology. 1999 Apr;53(4):696-700.
Does long-term finasteride therapy affect the histologic features of benign prostatic tissue and prostate cancer on needle biopsy? PLESS Study Group. Proscar Long-Term Efficacy and Safety Study.
Yang XJ, Lecksell K, Short K, Gottesman J, Peterson L, Bannow J, Schellhammer PF, Fitch WP, Hodge GB, Parra R, Rouse S, Waldstreicher J, Epstein JI.
Department of Pathology, University of Chicago Medical Center, Illinois, USA.
OBJECTIVES: Finasteride, a common agent used to treat benign prostatic hyperplasia (BPH), inhibits 5-alpha-reductase. Testosterone is converted by 5-alpha-reductase to the more potent dihydrotestosterone, which is the primary androgen in the prostate. Leuprolide is a stronger antiandrogen that is used to downstage prostate cancer before radical prostatectomy. Leuprolide induces marked atrophy of prostate carcinoma cells, which sometimes makes pathologic diagnosis of cancer difficult, although evaluation at radical prostatectomy is easier than at biopsy. It is unknown whether finasteride produces similar changes, which would result in greater diagnostic difficulty because such changes would be seen on biopsy to rule out cancer in men with suspicious clinical findings treated for BPH. The current study investigated the histologic effects of finasteride therapy on human prostate cancer and benign prostatic tissue on needle biopsy. METHODS: In blinded manner, we reviewed 53 needle biopsy specimens showing prostate carcinoma (35 treated with finasteride, 18 with placebo). Also reviewed in blinded manner were 50 benign needle biopsy specimens (25 treated with finasteride, 25 with placebo). The Gleason score, number of cores involved, percentage cancer involvement in a core, percentage of atrophic changes in cancer cells, presence of mitoses, blue-tinged mucinous secretions, prominent nucleoli, and high-grade prostatic intraepithelial neoplasia were documented for each case in the cancer group. The percentage of atrophy, basal cell hyperplasia, transitional metaplasia, chronic inflammation, and stromal proliferation was documented for each case in the benign group. RESULTS: No significant histologic differences were present in either the benign or cancer group between cases treated with finasteride and placebo. CONCLUSIONS: We conclude that finasteride treatment for BPH does not cause difficulty in the diagnosis of cancer in prostate needle specimens. It is possible that there are severely atrophic areas resulting from finasteride treatment that are undersampled. However, the conclusion that cancer seen on needle biopsy in men treated with finasteride is unaltered and readily identified as cancer remains valid.


Urol Nefrol (Mosk). 1998 Jul-Aug;(4):37-9.
Long-term results of proscar (finasteride, MSD) treatment of patients with benign prostatic hyperplasia.
Tkachuk VN, Al-Shukri SKh, Kornienko VI, Kuzmin IV.
Patients with benign prostatic hyperplasia (BPH) received proscar (finasteride) in daily dose 5 mg for: at least 6 months (n = 206, 20.4%), 12 months (n = 513, 50.9%), 24 months (n = 164, 16.3%), 3-4 years (n = 125, 12.4%). Because the size of the prostatic gland reduced significantly (by 22%) only after one year of proscar treatment, the duration of this treatment should be continued for at least 12 months, in some patients as long as the whole life. The duration of the treatment should be decided for each individual patient. The improvement after the proscar treatment was observed in 95% of the patients treated for benign prostatic hyperplasia.
Patients with benign prostatic hyperplasia (BPH) received proscar (finasteride) in daily dose 5 mg for: at least 6 months (n = 206, 20.4%), 12 months (n = 513, 50.9%), 24 months (n = 164, 16.3%), 3-4 years (n = 125, 12.4%). Because the size of the prostatic gland reduced significantly (by 22%) only after one year of proscar treatment, the duration of this treatment should be continued for at least 12 months, in some patients as long as the whole life. The duration of the treatment should be decided for each individual patient. The improvement after the proscar treatment was observed in 95% of the patients treated for benign prostatic hyperplasia.


Tidsskr Nor Laegeforen. 1996 Nov 10;116(27):3226-30.
Treatment of benign prostatic hyperplasia with Proscar (finasteride). Results of a 10-year Scandinavian study.
Tveter KJ, Beisland HO, Andersen JT, Wolf H, Ekman P, Johansson JE, Kontturi M, Lehtonen T.
Urologisk avdeling, Ulleval sykehus, Oslo.
707 patients with moderate prostatic hyperplasia were recruited to a two-year Scandinavian multicenter study. The study was randomized, prospective and double-blind. Half of the patients were treated with finasteride (5 mg daily) and the controls were given placebo. The patients were monitored with regard to symptoms, urinary flow rate and prostate volume. In addition, various laboratory examinations were performed. A statistically significant difference was found between the groups with regard to symptom improvement and increase in urinary flow rate in favour of finasteride. Finasteride reduced prostate volume and stopped further growth, leading to a difference of 30% in prostate volume between the two groups after two years of treatment. Thus, finasteride was able to stop the continuous growth of the prostate in the elderly male. The proportion of patients with adverse clinical experiences was similar in both treatment groups. However, the finasteride-treated group contained more patients with sexual dysfunction. We conclude that finasteride is an alternative to vigilant waiting for patients with moderate symptoms of benign prostatic hyperplasia.


CMAJ. 1996 Nov 1;155(9):1251-9.
Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.
Nickel JC, Fradet Y, Boake RC, Pommerville PJ, Perreault JP, Afridi SK, Elhilali MM.
Queens University, Kingston, Ont.
OBJECTIVE: To evaluate the efficacy and safety of 2 years' treatment of moderate benign prostatic hyperplasia (BPH) with finasteride. DESIGN: Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study. SETTING: Outpatient care in 28 centres across Canada. PARTICIPANTS: Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment. INTERVENTION: After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years. OUTCOME MEASURES: Efficacy: changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume. Safety: onset, course and resolution of all adverse events during the treatment period. RESULTS: In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters). CONCLUSION: Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.


Khirurgiia (Sofiia). 1996;49(1):15-8.
Benign prostatic hyperplasia--its treatment with Proscar.
Panchev P, Neikov K, Simeonov P.
Benign prostate hyperplasia is a potentially serious condition affecting men in advanced age. The treatment is conservative and operative. Proskar of Msd is one of the drugs yielding encouraging results. It is a synthetic 4-azosteroid compound, and represents a new class of specific inhibitors of 5-alpha reductase, promoting stabilization of testosterone and the more active androgen dihydrotestosterone (DHT). A total of 35 patients undergo treatment with Proskar at 5 mg daily dose (one tablet) over a 6-month period. The study includes six patients with complete urinary retention. The results are assayed by the change in prostate gland volume, residual urine and maximal urinary flow, 6 PsA. Completely responsive to treatment are 71.44 per cent of patients, partial effect is recorded in 22.85 per cent, and no effect whatsoever--in 5.71 per cent.


Eur Urol. 1995;28(4):304-9.
Proscar: five-year experience.
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.



 
 
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