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PubMed2000

Comparison of Diane 35 and Diane 35 plus finasteride in the treatment of hirsutism.

OBJECTIVE: To compare the clinical efficacy of an original combined therapy with cyproterone acetate, 2 mg, and ethinylestradiol, 35 microgram (Diane 35), plus finasteride (5 mg) for 2 weeks per month with that of Diane 35 alone in hirsute women. DESIGN: Prospective randomized, single-blinded study. SETTING: Outpatients in an academic research environment. PATIENT(S): Fifty women with idiopathic hirsutism (IH) or the polycystic ovary syndrome (PCOS). INTERVENTION(S): Group 1 (n = 25) received Diane 35 alone and group 2 (n = 25) received Diane 35 plus finasteride. The latter drug was administered using a new therapeutic scheme: 14 consecutive days for each therapeutic cycle. MAIN OUTCOME MEASURE(S): Hormonal evaluation was done before beginning treatment and after 3 and 6 months of therapy. Hirsutism was graded at 3-month intervals. RESULT(S): The combination of Diane 35 plus finasteride for 14 days significantly decreased the hirsutism score after 3 months of therapy, while Diane 35 alone induced this effect after 6 months. CONCLUSION(S): Finasteride in combination with Diane 35 for 14 days is effective, well accepted, and safe in hirsute patients, as the amount of antiandrogenic drugs administered is much lower than that in conventional treatment.

Adolescent↗
PubMed2006

Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater.

PURPOSE: We examined data from the Medical Therapy of Prostatic Symptoms trial to determine the relationship between baseline TPV and the effect of medical therapy in men with LUTS secondary to BPH. MATERIALS AND METHODS: A total of 3,047 patients with LUTS were randomized to placebo, 4 to 8 mg doxazosin, 5 mg finasteride or the combination of doxazosin and finasteride. Average treatment duration was 4.5 years The primary outcome was time to overall clinical progression of BPH, defined as a confirmed 4 point or greater increase in AUA SS, acute urinary retention, incontinence, renal insufficiency or recurrent urinary tract infection. Secondary outcomes were the need for invasive therapy for BPH, and changes in AUA SS and the maximum urinary flow rate with time. TPV was measured by transrectal ultrasound at baseline and study end. RESULTS: In patients with a small prostate (baseline TPV less than 25 ml) combination therapy was no better than doxazosin alone for decreasing the risk of clinical progression of BPH and need for invasive therapy as well as improving AUA SS and the maximum urinary flow rate. However, in patients with moderate size (25 to less than 40 ml) or enlarged (40 ml or greater) glands combination therapy led to a clinical benefit in these outcomes that was superior to that of doxazosin or finasteride. CONCLUSIONS: Combination therapy with doxazosin and finasteride led to a greater decrease in the risk of clinical progression of BPH than either drug alone in patients with LUTS with a baseline TPV of 25 ml or greater.

Aged↗
PubMed2002

Effect of nonsteroidal anti-inflammatory agents and finasteride on prostate cancer risk.

PURPOSE: We examine the relationship of nonsteroidal anti-inflammatory drugs and finasteride on the risk of prostate cancer. MATERIALS AND METHODS: Participants in this case control study using a prospective collection of data were drawn from consecutive patients who underwent prostate biopsy at 12 different departments of urology from January 1999 to June 2000. Medication use was assessed by self-questionnaire as well as questions about dietary and lifestyle factors that might be relevant for prostate cancer risk. RESULTS: The study included 639 patients with prostate cancer and 659 cancer-free controls. Univariate analysis showed no significant impact of aspirin and finasteride on prostate cancer risk while the nonaspirin nonsteroidal anti-inflammatory drug users had a lower risk (OR 0.80, 95% CI 0.64-0.99). After adjusting for potential confounders, the protective effect of nonaspirin nonsteroidal anti-inflammatory drugs was no longer significant (OR, 0.84, 95% CI 0.66-1.07), while finasteride showed a significant protective effect (OR 0.58, 95% CI 0.37-0.92). CONCLUSIONS: The results suggest that finasteride could have a chemopreventive role in prostate cancer. While aspirin did not show any impact on prostate cancer risk, the role of nonaspirin nonsteroidal anti-inflammatory drugs warrants further studies.

Aged↗
PubMed2001

Discontinuation of alpha-blockade after initial treatment with finasteride and doxazosin in men with lower urinary tract symptoms and clinical evidence of benign prostatic hyperplasia.

OBJECTIVES: To determine the effect of discontinuation of alpha-blockade and continuation of finasteride in men with lower urinary tract symptoms and enlarged prostates receiving combination treatment and to determine whether the alpha-blocker dose influences the ability to discontinue it. METHODS: We treated 272 consecutive men with a prostate size greater than 40 g and American Urological Association symptom score greater than 20 with 5 mg finasteride and 2 mg doxazosin daily. Two hundred forty men reported a favorable response to therapy, defined as any reduction in symptom score and toleration of the medications. The dose was maintained at 2 mg doxazosin in 100 men and was titrated to 4 mg doxazosin in 80 patients and to 8 mg doxazosin in an additional 60 patients. We discontinued doxazosin at 3, 6, 9, or 12 months, while continuing finasteride, and then re-evaluated the patients 1 month later to determine whether any worsening of symptoms had resulted. RESULTS: In patients discontinuing doxazosin at 3 months, success (defined as no increase in symptom score and no desire to resume doxazosin) was reported by 20%, 15%, and 13% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 6 months, success was reported by 48%, 45%, and 40% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 9 months, success was reported by 84%, 80%, and 73% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 12 months, success was reported by 84%, 85%, and 87% of those taking 2, 4, and 8 mg, respectively. CONCLUSIONS: Patients with lower urinary tract symptoms and moderately enlarged prostates initially receiving combination therapy using finasteride and an alpha-blocker are likely to experience no significant symptom deterioration after discontinuing the alpha-blocker after 9 to 12 months of combination therapy regardless of the dose of alpha-blocker chosen.

Adrenergic alpha-Antagonists↗
PubMed1994

Effect of finasteride on prostate-specific antigen density.

OBJECTIVE: Prostate-specific antigen density (PSAD) has been proposed as a diagnostic marker for prostate cancer. Because treatment with finasteride may affect PSAD differently in men with BPH compared with men with BPH plus prostate cancer, we evaluated the diagnostic utility of PSAD in men treated with finasteride for twelve months. METHODS: Data for this analysis were obtained from 895 men with BPH enrolled in a twelve-month placebo-controlled North American study. Prostate volume was measured by magnetic resonance imaging and PSA was measured by the Hybritech immunoradiometric assay. RESULTS: Treatment with finasteride for twelve months increased the positive predictive value of PSAD for identifying the presence of prostate cancer from 14 percent to 30 percent. Using PSA values alone with a cutoff of 10 ng/mL at baseline and 5 ng/mL after twelve months of treatment, similar specificity and sensitivity could be achieved. CONCLUSION: The data suggest that adjustment of PSA values during treatment with finasteride can be used to maintain the diagnostic accuracy for prostate cancer while PSAD can be used to provide additional reassurance without requiring adjustment for treatment.

Adult↗
PubMed1998

Meta-analysis of randomized clinical trials of finasteride.

A meta-analysis was recently published based on six randomized clinical trials of at least one year duration involving finasteride 5 mg and placebo in the treatment of men with clinical benign prostatic hyperplasia (BPH). In a pooled analysis, mean improvement in symptoms and urinary flow rate with finasteride were found to increase with increasing prostate size. This article reviews the previous publication of this meta-analysis, which indicated prostate volume is a key predictor of outcomes with finasteride treatment and suggested that finasteride is most effective in men with large prostates.

Finasteride↗
PubMed1995

Economic modeling to assess the costs of treatment with finasteride, terazosin, and transurethral resection of the prostate for men with moderate to severe symptoms of benign prostatic hyperplasia.

OBJECTIVES: We developed a decision analytic model to compare the costs of treatment for an initial 2-year period with finasteride, terazosin, and transurethral resection of the prostate (TURP) in men with at least moderate symptoms of benign prostatic hyperplasia (BPH). Outcome measures were BPH treatment costs, duration of symptomatic improvement, and lost productivity days (work or other customary activity). METHODS: Patterns of health care resource use associated with the treatment of moderate to severe BPH and BPH-related complications were evaluated by a survey of urologists and validated by a urology consensus panel. BPH safety and efficacy studies in the published literature were used to provide probabilities of treatment success. Both a national health care resource database (Systemetrics) and Medicare data were used to estimate the costs of specific health care services (such as physician services and laboratory tests). RESULTS: The probabilities of first-year success (defined as symptomatic improvement) for surgery, finasteride, and terazosin were 88%, 67%, and 74%, respectively. The most expensive intervention was surgery, followed by finasteride and terazosin, at estimated 24-month costs of $6411, $2860, and $2422 for private insurance and $3874, $2161, and $1820 for Medicare, respectively. Duration of symptom improvement was comparable for the three treatments. Estimates of usual activity days lost (work or other customary activity) were 22, 8, and 8 days for surgery, finasteride, and terazosin, respectively. CONCLUSIONS: As a primary intervention for patients considering conventional clinical approaches to BPH treatment, pharmacotherapy is expected to be less expensive than TURP over the initial 2 years of therapy.

Adrenergic alpha-Antagonists↗
PubMed2003

Finasteride inhibits the progesterone-induced spike-wave discharges in a genetic model of absence epilepsy.

Previously, it was found that progesterone aggravates spike-wave discharges (SWD) in WAG/Rij rats in a nongenomic way. In order to elucidate whether the regulatory effect of progesterone depends on its conversion to allopregnanolone, the effect of finasteride, a 5alpha-reductase inhibitor, on progesterone-induced increase in SWD was studied in the same model for absence epilepsy. Progesterone (10 and 20 mg/kg ip) dose-dependently increased the number of SWD (by 54% and 97%, respectively) during the first hour postinjection. Pretreatment of rats with finasteride (50 mg/kg sc) blocked the progesterone-induced enhancement of SWD. Finasteride alone had no effect on the number of SWD, up to 24 h following its administration. It is concluded that finasteride blocked the progesterone-induced increase in SWD, which indicates that this action of progesterone is mediated by its neuroactive metabolite allopregnanolone.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMed1997

Finasteride in biological fluids: extraction and separation by a graphitized carbon black cartridge and quantification by high-performance liquid chromatography.

A simple, specific and sensitive high-performance liquid chromatographic method has been developed and validated for the determination of finasteride in human plasma. A solid-phase extraction procedure was used to isolate finasteride from the biological matrix before quantitative analysis. The analyte was separated on a Symmetry reversed-phase column using acetonitrile-0.04 M orthophosphoric acid (pH 4.0) as mobile phase and quantified by measuring its UV absorbance at 215 nm. The limit of detection for the analyte was 0.005 microg/ml. 4-Androstene-3,17-dione was used as internal standard. The calibration graph of the method was linear from 0.01 to 3.0 microg/ml of finasteride in human plasma, and the coefficient of variation less than 4.5%. This HPLC procedure is simple, precise and accurate for the determination of finasteride in human plasma.

Carbon↗
PubMed1998

Proscar (Finasteride) inhibits 5 alpha-reductase activity in the ovaries and testes of Lytechinus variegatus Lamarck (Echinodermata: Echinoidea).

Recent investigations into the steroid metabolic pathway in the echinoid Lytechinus variegatus demonstrated the capacity of the gonads to convert androstenedione, the classical mammalian precursor to bioactive androgens, into testosterone and a variety of 5 alpha-reduced androgens including 5 alpha-androstane-3 beta, 17 beta-diol and 5 alpha-androstane-3 alpha, 17 beta-diol. The synthesis of these steroids, which requires 5 alpha-reductase activity, varies with sex and reproductive state in L. variegatus, suggesting that these steroids may be involved in reproductive processes. The classical method of castration followed by steroid replacement therapy to determine the biological role of steroids in the gonads of higher vertebrates is not possible in echinoids. Therefore, this study was designed to determine the efficacy of finasteride, a selective 5 alpha-reductase inhibitor in the mammalian prostate gland, on 5 alpha-reductase activity in the gonads of L. variegatus. Finasteride inhibits echinoid 5 alpha-reductase in a dose-dependent manner with IC50 approximately 2.7 microM for both ovaries and testes. These echinoid IC50s are significantly higher than those reported for humans and rats. In addition, oral administration of finasteride to the echinoids appeared to inhibit 5 alpha-reductase with no apparent stress (no spine loss) to the animals. These data suggest that finasteride may be used to selectively and chemically ablate 5 alpha-reduced androgen synthesis in the gonads of L. variegatus.

Animals↗
PubMed1996

In vivo time-dependent inhibition of human steroid 5 alpha-reductase by finasteride.

Finasteride (17 beta-(N-t-butylcarbamoyl)-4-aza-5 alpha-androstan-1-en-3- one), a time-dependent, irreversible inhibitor of human steroid 5 alpha-reductase (5AR), may only reduce dihydrotestosterone levels in humans by approximately 60% at the doses used clinically. A theoretical model was developed to aid in understanding the in vivo efficacy data of finasteride. According to the theory, whether an enzyme can be inhibited in vivo by an irreversible inhibitor is dependent on the value of a ratio of the observed rate of enzyme inhibition over the rate constant for inhibitor elimination. As shown, this ratio should be in excess of 3 for > 95% inhibition of the target in vivo. Subsequent application of the theory to evaluate the in vivo efficacy data of finasteride indicates low effective concentration of finasteride at the inhibition sites and suggests complete inhibition of 5AR 2, but insufficient suppression of 5AR 1 at the clinical doses.

5-alpha Reductase Inhibitors↗
PubMed2006

Finasteride as a chemopreventive agent in prostate cancer: impact of the PCPT on urologic practice.

Prostate cancer chemoprevention involves the use of natural and/or synthetic agents that inhibit or reverse the development of precancerous lesions or delay progression of these lesions to invasive disease. The recent completion of the first Phase III trial for prostate cancer prevention, the Prostate Cancer Prevention Trial (PCPT) using the drug finasteride, has provided the urologic community with the first evidence that a chemopreventive agent can reduce the risk of developing prostate cancer. The enthusiasm for the clear relative risk reduction in the finasteride arm of the trial has been tempered by the observation that the incidence of high-grade tumors was higher in men receiving finasteride compared to those on placebo. A question remains about whether the observed higher incidence in high-grade tumors is real or whether it is related to a pathologic or sampling artifact. The PCPT has instigated a great deal of debate, resulting in the larger urologic community being reluctant to recommend the widespread use of finasteride as a chemopreventive agent. This review summarizes the PCPT, analyzes its controversial results, and describes future prostate cancer chemoprevention studies.

Clinical Trials, Phase III as Topic↗
PubMed2005

GABRA2 alleles moderate the subjective effects of alcohol, which are attenuated by finasteride.

GABA(A) receptors are involved in the subjective effects of alcohol. Endogenous neuroactive steroids interact with GABA(A) receptors to mediate several behavioral effects of alcohol in rodents. Based on a haplotypic association of alcohol dependence with the gene encoding the GABA(A) receptor alpha-2 subunit (GABRA2), we examined whether GABRA2 alleles are associated with the subjective response to alcohol. We also examined whether finasteride (a 5-alpha steroid reductase inhibitor), which blocks the synthesis of some neuroactive steroids, reduces the subjective response to alcohol. In all, 27 healthy social drinkers (15 males) completed a randomized, double-blind, placebo-controlled study of high-dose finasteride. After being pretreated with study drug, subjects consumed three alcoholic drinks. Subjective effects were measured repeatedly over the ascending blood alcohol curve. To examine the moderating role of genetic variation in GABRA2, a single-nucleotide polymorphism that was informative in association studies was included as a factor in the analysis. Subjects homozygous for the more common A-allele (n=7) showed more subjective effects of alcohol than did individuals with one or two copies of the alcohol dependence-associated G-allele (n=20, including two homozygotes). Among the A-allele homozygotes, there was a greater reduction in several subjective effects during the finasteride session compared to the placebo session. These findings provide preliminary evidence that the risk of alcoholism associated with GABRA2 alleles may be related to differences in the subjective response to alcohol. The effects of finasteride provide indirect evidence for a mediating role of neuroactive steroids in some of the subjective effects of alcohol.

5-alpha Reductase Inhibitors↗
PubMed1996

Effect of finasteride on free and total serum prostate-specific antigen in men with benign prostatic hyperplasia.

OBJECTIVE: To examine changes in the free-to-total (f/t) serum prostate-specific antigen (PSA) ratio among men treated with finasteride for benign prostatic hypertrophy. PATIENTS AND METHODS: Blood samples were taken from 20 men (mean age 71 years, range 61-87) before and after a minimum of 9 months of treatment with finasteride and the f/tPSA ratio determined using the Immulite assay system. RESULTS: Although mean total and free PSA levels decreased significantly, the mean f/tPSA ratio increased only slightly and not significantly; the ratios remained unchanged in men with an initially low or high (< > 10%) ratio. CONCLUSIONS: Concern has been expressed over the loss of the discriminatory power of serum PSA in a patient receiving treatment with finasteride. The f/tPSA ratio, currently used to help differentiate benign from malignant processes in the prostate, remains valid during treatment with finasteride; it does not affect the f/tPSA ratio.

Aged↗
PubMed1999

Anaemia in men receiving combined finasteride and flutamide therapy for advanced prostate cancer.

OBJECTIVE: To determine the effect of combined finasteride and flutamide therapy on haemoglobin and haematocrit values in men with advanced prostate cancer. PATIENTS AND METHODS: Nineteen men, previously untreated by hormone therapy, with histologically confirmed adenocarcinoma of the prostate and clinical evidence of advanced disease, were treated with combined finasteride (5 mg/day) and flutamide (750 mg/day) for at least 6 months. Complete blood counts were performed before initiation and after 6 months of therapy. RESULTS: After 6 months of finasteride and flutamide therapy both haemoglobin levels and haematocrit decreased in all men, with a mean (sd, range) decrease of 16 (10, 3-42) g/L and 4.6 (2.7, 0.8-9.9)%, respectively. CONCLUSION: Combined finasteride and flutamide therapy significantly lowers haemoglobin and haematocrit levels in men with advanced prostate cancer, and further study of this effect is warranted.

Aged↗
PubMed2000

Effects of finasteride and bicalutamide on prostatic blood flow in the rat.

OBJECTIVE: To determine whether finasteride and bicalutamide, both currently used in the clinical management of patients with prostate diseases because they have anti-androgenic properties, have any effects on prostatic blood flow in a rat prostate model, as androgens are known to be involved in the regulation of prostatic blood flow and angiogenesis. MATERIALS AND METHODS: Both finasteride and bicalutamide were supplied as oral suspensions in water and given daily to rats for 7 days by tube feeding. Blood flows to the ventral and dorsal prostates, and to the kidneys, were measured using the radioactive microsphere technique. In the bicalutamide experiments, some rats were treated with the Leydig cell toxin ethane dimethane sulphonate (EDS), to obtain a castration-like effect, and one group of these rats received testosterone. RESULTS: Finasteride induced a clear decrease in blood flow to the ventral and dorsal prostates after 7 days of treatment, with no significant changes in blood pressure or kidney blood flow. Bicalutamide inhibited the testosterone-induced increment of prostatic blood flow observed in EDS-treated animals. CONCLUSIONS: Finasteride, a blocker of 5alpha-reductase, decreases prostate blood flow after 7 days of administration. The response was slower than that after castration, but was of similar magnitude. Blood flow was also decreased after treatment with the androgen-receptor inhibitor bicalutamide. These observations suggest that prostatic blood flow is increased by dihydrotestosterone, and that the androgen receptor is responsible for mediating this effect.

Androgen Antagonists↗
PubMed2002

Effects of the chronic use of finasteride on testicular weight and spermatogenesis in Wistar rats.

OBJECTIVE: To evaluate spermatogenesis in rats chronically exposed to finasteride, as the recent use of finasteride in young men to prevent hair loss has raised concerns about chronic use and fertility. MATERIALS AND METHODS: Male Wistar rats (4 months old) were selected and divided into two groups. Group 1 (17 rats) received a finasteride suspension of 2 mg/kg/day in saline solution, 5 days/week for 10 months; group 2 (eight rats of the same age) were treated with placebo for the same period. At the end of the exposure the testes were weighed and processed for histological analysis. Spermatogenesis was evaluated as the mean number of seminiferous tubules with and without spermatozoids in their lumen, in five random fields on the same slide. Student's t-test was used to assess differences in the groups. RESULTS: In group 1, the mean (sd) weight of the testes was 1.55 (0.29) g and in group 2 1.58 (0.34) g (P>0.05). The histological analysis showed a mean of 13.35 (1.66) seminiferous tubules per field and 1.20 (3.30) tubules with no spermatozoids in group 1; in group 2 the respective values were 13.53 (1.46) and 0.06 (0.14) (P>0.05). CONCLUSION: Finasteride had no detectable effects on the quantitative and qualitative analysis of spermatogenesis in rats.

Animals↗
PubMed2001

Evaluation of sexual function in subjects taking finasteride for the treatment of androgenetic alopecia.

BACKGROUND: Our practical experience indicates that sexual side-effects in subjects taking finasteride 1 mg (Propecia) for androgenetic alopecia are much less common than reported in the literature. OBJECTIVE: To evaluate the sexual function in subjects taking finasteride (1 mg) compared with age-matched controls using the International Index of Erectile Function (IIEF). METHODS: The IIEF, a brief, reliable questionnaire, was self-administered to 236 patients taking Propecia and 236 age-matched males attending the Department of Dermatology of the University of Bologna. RESULTS: Statistical analysis showed no differences between scores obtained with the IIEF in subjects taking finasteride and controls. CONCLUSIONS: The sexual and erectile function of subjects taking finasteride does not significantly differ from that of age-matched controls. This is consistent with the experience of many dermatologists who do not see sexual or erectile dysfunction in patients taking Propecia.

Adolescent↗