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The profound decrease in serum dihydrotestosterone observed with the dual 5alpha-reductase inhibitor dutasteride makes it an attractive agent for prostate cancer therapy. To our knowledge we compared for the first time the antitumor effect of dutasteride with that of the specific 5alpha-reductase-1 inhibitor MK386 and the specific 5alpha-reductase-2 inhibitor finasteride in human prostate primary cultures.
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Influence of adrenergic and serotonergic stimulation on glial fibrillary acidic protein (GFAP) gene expression in rat C6 glioma cells was first examined as an in vitro model experiment for investigating the neuronal regulation of glial cell differentiation. Stimulation of these cells with isoproterenol and serotonin elevated GFAP mRNA levels followed by an increase in its protein contents, thus suggesting that both adrenergic and serotonergic stimulation might induce the differentiation of the glioma cells. In addition, progesterone and its 5alpha-reduced metabolite dihydroprogesterone also elevated GFAP mRNA levels in rat C6 glioma cells, consistent with their stimulatory actions on GFAP gene expression observed in rat astrocytes. Further studies showed that the elevation of GFAP mRNA levels induced by isoproterenol and serotonin as well as progesterone was abolished by pretreatment of the glioma cells with finasteride, an inhibitor of 5alpha-reduced steroid production. Moreover, the stimulatory actions of isoproterenol and serotonin on GFAP gene expression were inhibited by pretreatment with a GABA(A) receptor antagonist bicuculline and a progesterone receptor antagonist RU486. These findings suggest that both adrenergic and serotonergic stimulation may indirectly activate GFAP gene expression probably through the production of 5alpha-reduced steroid metabolites in rat C6 glioma cells, proposing the possibility that 5alpha-reduced neurosteroids may play a potential role in the neuronal regulation of glial cell differentiation.
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Data for our decision tree model came from men in the two arms (finasteride or placebo) of the Prostate Cancer Prevention Trial (PCPT) and from clinically localized prostate cancer patients studied for long-term survival outcomes. Our model compared survival outcomes for men treated with finasteride or placebo. Prostate cancer rates were based on the 7-year period prevalence of prostate cancer detected in the PCPT; survival probabilities were abstracted from the long-term outcome studies. We assessed variability in the PCPT and long-term survival studies to test the variability of our model.
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By concentration-dependent inhibition of 5α-reductase type II in vitro (half-maximal inhibitory concentration 3.58±0.05 μg/mL), SPSE demonstrated competitive binding toward the active site of the enzyme. Finasteride, the approved 5α-reductase inhibitor tested as positive control, led to 63%-75% inhibition of 5α-reductase type II.
Testosterone (T) plays a crucial role in prostate growth. In androgen-dependent tissues T is reduced to dihydrotestosterone (DHT) because of the presence of the 5α-reductase enzyme. This androgen is more active than T, since it has a higher affinity for the androgen receptor (AR). When this mechanism is altered, androgen-dependent diseases, including prostate cancer, could result. The aim of this study was to synthesize several 16-dehydropregnenolone acetate derivatives containing a triazole ring at C-21 and a linear or alicyclic ester moiety at C-3 of the steroidal skeleton. These steroids were designed as potential inhibitors of the activity of both types (1 and 2) of 5α-reductase. The cytotoxic activity of these compounds was also evaluated on a panel of PC-3, MCF7, and SK-LU-1 human cancer cell lines. The results from this study showed that with the exception of steroids 20-oxo-21-(1H-1,2,4-triazole-1-yl)pregna-5,16-dien-3β-yl-propionate and 20-oxo-21-(1H-1,2,4-triazole-1-yl)pregna-5,16-dien-3β-yl-pentanoate, the compounds exhibit a lower inhibitory activity for both isoenzymes of 5α-reductase than finasteride. Furthermore the 3β-hydroxy-21-(1H-1,2,4-triazole-1-yl)pregna-5,16-dien-20-one and 20-oxo-21-(1H-1,2,4-triazole-1-yl)pregna-5,16-dien-3β-yl-acetate derivatives display 80% cytotoxic activity on the SK-LU-1 cell line. These results also indicated that the triazole derivatives, which have a hydroxyl or acetoxy group at C-3, could have an anticancer effect, whereas the derivatives with a alicyclic ester group at C-3 do not show biological activity.
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The novel finasteride 0.25% solution applied o.d. at the doses of 100 and 200 μL results in an appropriate inhibition of scalp DHT potentially minimizing the untoward sexual side-effects linked to a systemic DHT reduction.
The objective of this study was to further investigate the metabolism of the 5alpha-reductase inhibitor, finasteride, and to identify previously unknown phase I and phase II metabolites in vitro and in vivo in human bile and urine. Healthy volunteers were given 5 mg of finasteride, directly to the intestine, and bile and urine were collected for 3 and 24 h, respectively. A single-pass perfusion technique, Loc-I-Gut, was used for drug administration and bile collection from the proximal jejunum, distal to papilla of Vater. Incubations with human liver microsomes/S9 fractions and different cofactors were performed with finasteride and the previously known metabolites, omega-hydroxy finasteride (M1) and finasteride-omega-oic acid (M3). Liquid chromatography coupled to triple quadrupole mass spectrometry (MS) with positive/negative electrospray ionization and ion trap with MS(n) measurements were used for structural investigations and identification of metabolites. Two hydroxy metabolites of finasteride, other than M1, and one intact hydroxy finasteride glucuronide were identified in vitro and in bile and urine. The glucuronide and at least one of the hydroxy metabolites were previously unidentified. M1 and M3 were glucuronidated in vitro by specific human UDP-glucuronosyltransferases, UGT1A4 and UGT1A3, respectively. M1 glucuronide was not identified in vivo, and M3 glucuronide, an acyl glucuronide, was present in low amounts in bile from a few individuals. In conclusion, previously undescribed metabolites were identified, in vitro and in human urine and bile. Bile collection using the Loc-I-Gut technique followed by sensitive mass spectrometry analysis led to the discovery of novel, both phase I and phase II, finasteride metabolites in human bile.
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Finasteride consistently improved urinary symptom scores more than placebo in trials of > 1 year duration, and significantly lowered the risk of BPH progression (acute urinary retention, risk of surgical intervention, ≥ 4 point increase in the AUASI/IPSS). In comparison to alpha-blocker monotherapy, finasteride was less effective than either doxazosin or terazosin, but equally effective compared to tamsulosin. Both doxazosin and terazosin were significantly more likely than finasteride to improve peak urine flow and nocturia, versus finasteride. Versus tamsulosin, peak urine flow and QoL improved equally well versus finasteride. However, finasteride was associated with a lower risk of surgical intervention compared to doxazosin, but not to terazosin, while finasteride and doxazosin were no different for risk of acute urinary retention. Two small trials reported no difference in urinary symptom scores between finasteride and tamsulosin. Finasteride + doxazosin and doxazosin monotherapy improved urinary symptoms equally well (≥ 4 point improvement).For finasteride, there was an increased risk of ejaculation disorder, impotence, and lowered libido, versus placebo. Versus doxazosin, finasteride had a lower risk of asthenia, dizziness, and postural hypotension, and versus terazosin, finasteride had a significant, lower risk of asthenia, dizziness, and postural hypotension.
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In men with mild to moderate BPH, pharmacotherapy is a safe and effective alternative to surgery. The primary care physician should be able to manage the treatment without referral to a urologist, provided he has undertaken appropriate steps to assure himself, and the patient, that there is no evidence of cancer of the prostate.
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A prospective, randomized, open label, 1-year study was designed to assess the safety and efficacy of saw palmetto and finasteride in the treatment of men diagnosed with CP/CPPS. Patients were randomized to finasteride (5 mg once daily) or saw palmetto (325 mg daily) for 1 year. Patients were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index, individual domains (pain, urinary symptoms, quality of life and mean pain score) and the American Urological Association Symptom Score at baseline, 3, 6 and 12 months.
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Between March 13, 1998, and Jan 12, 2000, 355 men aged 40-60 years with male-pattern hair loss were stratified by age decade (40-49 years and 50-60 years), and randomised in a ratio of four to one to 1 mg/day finasteride or placebo. The primary endpoint was the effect of this treatment for 48 weeks on serum PSA concentration compared with placebo. This trial is in the process of being registered on the US National Institutes of Health website . Analyses were according to protocol.
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Flutamide resulted in a reduction of 21% in Ludwig scores (2.3 +/- 0.2 to 1.8 +/- 0.1). The other treatment effects were not statistically significant. Patient and investigator assessments showed a similar trend.
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The prevalence of symptomatic BPH in France is relatively high. About 15-20% of men over 50-60 years of age report moderate to severe lower urinary tract symptoms (LUTS: total I-PSS >7). If this is applied to the 5.7 million men aged 60 or over living in France, it seems that 855,000-1,140,000 men have symptomatic BPH. In the AFU-Synthélabo community-based survey, around half of these men (more than 10%) visited a physician because they were bothered by these symptoms interfering with performing daily life activities. This suggests that approximately 600,000 patients have a diagnosis of symptomatic BPH in France. These patients can contact both general practitioners (GPs) and urologists for the management of symptomatic BPH. Approximately one in every four to one in every three men with LUTS visits directly a urologist whereas the other 65-75% initially contacts a GP in France. GPs very often prescribe medical treatment for LUTS related to BPH. Of all medical prescriptions in France, 80% are made by GPs and only 12.5% by urologists. The total market for medical therapy increased substantially since 1994. Since 1998, it grew with 2-3%/year. A total of 640,000 patients received medical therapy for BPH in 1998. The growth in the medical treatment market was mainly due to an increase in the number of patients receiving alpha(1)-adrenoceptor antagonists. Today, this is the most frequently prescribed class of medical therapy (45.3%) followed by plant extracts (37.5%) who's market share decreased slightly since 1996. The market share of finasteride is also still decreasing and represents today 17.2% of all prescriptions. The growth in the alpha(1)-adrenoceptor antagonist segment can mainly be attributed to the introduction of tamsulosin in 1996. The price for medical therapy in France is around 1 Euro/day and is estimated to be around 229 million Euro in 1998. All drugs are reimbursed for 35% by the Social Insurance. The number of prostatectomies has declined in France in the 1990s. A national database includes information from events taking place in all hospitals in France. It appears that a total of 66,431 surgical procedures for the prostate were done in 1997 of which 81% were performed transurethrally and 14% open. Total direct costs involved with these surgical procedures were 229 million Euro.
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The efficacy of a multimodality protocol using neoadjuvant and concomitant hormonal therapy, brachytherapy, and three-dimensional conformal external beam radiotherapy (RT) in high-risk prostate cancer was evaluated using biochemical outcomes and posttreatment biopsy results.
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Luteinizing hormone-releasing hormone agonist plus antiandrogen is more successful for reducing prostate volume before prostate brachytherapy than luteinizing hormone-releasing hormone agonist or flutamide plus finasteride. Hormonal therapy offered no advantage over implantation alone for post-implantation prostate volume reduction. 103Pd appears to reduce prostate volume more rapidly than 125I but this advantage is lost by year 2. No rebound in prostate volume was noted at longer followup.
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Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia (BPH).
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Between March 1997 and November 2002, 194 men with clinical Stage T1A-T3N0M0 prostate carcinoma (according to the 1992 International Union Against Cancer/American Joint Committee on Cancer TNM classification system) were treated with interstitial palladium (103Pd3) BT and androgen ablation therapy with or without external beam radiotherapy (EBRT). Based on tumor characteristics, 127 patients received an antiandrogen, finasteride, and BT whereas 67 received an antiandrogen, leuprolide, and EBRT followed by a BT boost. Hormonal therapy was initiated 2-3 months before any radiotherapy for a total duration of 8-9 months. Follow-up included physical examination and determining the PSA level at 3-month intervals. Postoperative serum testosterone was evaluated in preoperatively potent patients with erectile dysfunction > 6 months after therapy. A PSA level < or = 0.06 ng/mL or < or = 0.20 ng/mL detected during a 6-12-month window after the implant were evaluated as predictors of biochemically disease-free survival (DFS), defined as the time to a PSA level > or = 1.0 ng/mL.
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To review the contemporary management of symptomatic benign prostatic hyperplasia (BPH) in North America.
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The quality of life of men treated with doxazosin, finasteride, and the drugs combined generally improved when assessed with the BII and the I-PSS-QoL compared with those treated with placebo. Quality of life did not show improvement when measured by the MOS-SF-36.
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The aim of this work was to evaluate the efficacy of two new antiandrogen drugs, finasteride and flutamide, in 80 hirsute patients: 44 with Polycystic Ovary Syndrome (PCOS) and 36 with Idiopathic Hirsutism (IH).
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We assessed whether the association between the larger changes in prostate specific antigen and high grade prostate cancer observed in the Prostate Cancer Prevention Trial can explain the increased detection of high grade prostate cancer in men randomized to finasteride vs placebo.
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The treatment of hirsutes includes cosmetic measures, such as bleaching, plucking, electrical epilation and, more recently, laser epilation. Pharmacological therapy consists of anti-androgens and includes the androgen receptor blockers spironolactone and cyproterone acetate. Other drugs reducing androgen expression include oral contraceptives and corticosteroids. A new follicular 5 alpha reductase inhibitor, finasteride, is currently under evaluation, as is the anti-androgen flutamide. Gonadotrophin-releasing hormone agonists reduce androgen expression and show early promise in the treatment of hirsutes.
Androgenetic alopecia (AGA) is the most frequent cause of hair loss affecting up to 50% of men and 40% of women by the age of 50.
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The method developed based on controlled pH extraction method and HPLC-mass spectrometry analysis allowed better identification and confirmation of glucocorticosteroids and a few other drugs in different categories. The validated method has been used successfully for testing of 1000 In-competition samples. The method helped in detection of chemically and pharmacologically different banned drugs in urine in a single short run at a minimum required performance limit set by WADA.
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To investigate differences in the risk of benign prostatic hyperplasia (BPH)-related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients using finasteride or dutasteride.
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To evaluate the efficacy, safety and tolerability of finasteride administered for 24 months following successful balloon dilatation in patients with benign prostatic hyperplasia (BPH).
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Finasteride is standard medical treatment for androgenetic alopecia; however, no large studies with 5 years or more of follow up have been performed in Japan. The authors followed Japanese men with androgenetic alopecia treated with finasteride for 5 years to evaluate long-term treatment efficacy. Of 903 men treated with finasteride (1 mg/day), 801 patients were evaluated over 5 years by modified global photographic assessment. Although the proportion of improvement was high (99.4%), modified global photographic assessment scores after 5 years of treatment were lower in patients with more advanced disease as measured by the modified Norwood-Hamilton scale. After separating patients into "sufficient" and "insufficient" efficacy groups according to the modified global photographic assessment score after 5 years (scores ≥6 and <6, respectively), multivariate analysis showed that independent risk factors of insufficient efficacy were age at start of treatment of 40 years or more (P = 0.021) and classification on the modified Norwood-Hamilton scale (P < 0.001), whereas presence of stress at start of treatment was a negative predictor (P = 0.025). In conclusion, continuous finasteride treatment for 5 years improved androgenetic alopecia with sustained effect among Japanese. Younger age and less advanced disease at start of treatment were the key predictors of higher finasteride efficacy.
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The combination therapy is effective in decreasing the irritative and obstructive symptoms in patients with BPE than monotherapy.
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Two populations of men free of risk factors for erectile dysfunction and other sexual dysfunction or its treatment: men aged 40 or more with benign prostatic hyperplasia who received a prescription for a 5-α reductase inhibitor (finasteride or dutasteride) or α blocker, or both, and men aged 18-59 with alopecia.
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The lethal dose of kolaviron was 3050mg/kg body weight. Body weights, relative heart weight (RHW), relative liver weight (RLW), serum levels of prostate specific antigen, prolactin, estradiol, testosterone, testosterone/estradiol ratio, aspartate transaminase (AST), alanine transaminase (ALT), urea, creatinine and prostatic levels of total proteins in the normal rats administered finasteride (standard drug) or kolaviron were not different (P>0.05) from normal control whereas most of these parameters were altered in the disease control except RHW, RLW, AST and ALT. Finasteride (5mg/70kg) or kolaviron (100 and 200mg/kg) ameliorated most of these parameters compared with disease control except RHW, RLW, prolactin, AST, ALT, urea and creatinine (for kolaviron at 100mg/kg). The normal rats administered finasteride or kolaviron had decreased prostate weights (P<0.05) compared with the normal control which results were corroborated by histological assay that also showed that treatment with kolaviron (200mg/kg) or finasteride reversed the histoarchitecture of the prostates of the BPH rats.
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Hirsutism is the presence of excess terminal hairs in females in a male-like pattern. The most accepted hypothesis for the development of hirsutism is increased 5α-reductase activity in hair follicles of hirsute women. Finasteride partially blocks the conversion of testosterone to dihydrotestosterone through inhibition of 5α-reductase in hair follicles. This study was designed to determine the efficacy of finasteride gel 0.25% in management of idiopathic hirsutism and treatment of hirsutism with topical finasteride to lessen the side-effects.
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The 5alpha-reductase inhibitors improve urinary symptoms related to benign prostatic hyperplasia, deter benign prostatic hyperplasia progression and provide prostate cancer chemoprevention. Currently there are a number of 5alpha-reductase inhibitor formularies, including Proscar, generic finasteride and dutasteride. While all formularies decrease serum prostate specific antigen (a proxy for prostate volume), they may not accomplish this to the same degree, which may have dramatic effects on prostate specific antigen kinetics in men changing 5alpha-reductase inhibitor formularies. We examined prostate specific antigen velocity after changes in 5alpha-reductase inhibitor formularies.
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In addition to clinical data, biopsies and laboratory tests (antinuclear antibodies, sex hormones, thyroid hormones) were performed in order to rule out other causes of scarring alopecia. Patients were treated with intralesional corticosteroids, finasteride, and minoxidil, depending on the stage of the disease and association to androgenetic alopecia.