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PubMed2003

Prevention of prostate cancer with finasteride: US/European perspective.

PURPOSE: Prostate cancer is the most common male cancer, affecting one man in six. Prevention of this disease, even in a subset of patients would have a significant impact on public health. The results of the National Cancer Institute-sponsored Prostate Cancer Prevention Trial demonstrate that finasteride causes a substantial risk reduction across all known risk groups. We herein amplify on the results of this trial to assist patients and physicians in reaching individualized decisions. MATERIALS AND METHODS: The results of the Prostate Cancer Prevention Trial were reviewed. RESULTS: The PCPT demonstrated a 24.8% reduction in prostate cancer risk with the administration of finasteride. High-grade cancers were noted in 6.4% of finasteride patients compared to 5.1% of men receiving placebo. The increase in high-grade tumors was seen within one year of finasteride exposure and did not increase over time. This observation, combined with previous evidence demonstrating an alteration in cytologic and architectural features of prostate cancer with hormonal therapy suggests that the differences in high-grade disease may be an artifact and that application of Gleason grading to these tumors may not be appropriate. DISCUSSION: Men should be presented the benefits and risks of taking finasteride and be assisted in integrating their sexual and urinary symptoms into their decision-making process. Blanket statements for or against the use of this medication ignore patient preferences and differential risk-benefit profiles from finasteride.

Aged↗
PubMed2006

Enhancement of follicular delivery of finasteride by liposomes and niosomes 1. In vitro permeation and in vivo deposition studies using hamster flank and ear models.

Finasteride is indicated orally in the treatment of androgenetic alopecia and some other pilosebaceous unit (PSU) disorders. We wished to investigate whether topical application of finasteride-containing vesicles (liposomes and niosomes) could enhance drug concentration at the PSU, as compared to finasteride hydroalcoholic solution (HA). Liposomes consisted of phospholipid (dimyristoyl phosphatidylcholine (DMPC) or egg lecithin):cholesterol:dicetylphosphate (8:2:1, mole ratio). Niosomes were comprising non-ionic surfactant (polyoxyethylene alkyl ethers (Brij series) or sorbitan monopalmitate):cholesterol:dicetylphosphate (7:3:1, mole ratio). Vesicles were prepared by the film hydration technique and characterized with regard to the size, drug entrapment efficiency and gel-liquid transition temperature (T(c)). In vitro permeation of (3)H-finasteride through hamster flank skin was faster from hydroalcoholic solution (0.13 microg/cm(2)h) compared to vesicles (0.025-0.058 microg/cm(2)h). In vivo deposition of (3)H-finasteride vesicles in hamster ear showed that liquid-state vesicle, i.e. those made of DMPC or Brij97:Brij76 (1:1), were able to deposit 2.1 or 2.3% of the applied dose to the PSU, respectively. This was significantly higher than drug deposition by gel-state vesicles (0.35-0.51%) or HA (0.76%). Both in vitro permeation and in vivo deposition studies, demonstrated the potentials of liquid-state liposomes and niosomes for successful delivery of finasteride to the PSU.

Administration, Cutaneous↗
PubMed2006

A rapid, simple, specific liquid chromatographic-electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study.

A fast, accurate, sensitive, selective and reliable method using reversed-phase high-performance liquid chromatography-mass spectrometry coupling with an electrospray ionization interface was developed and validated for the determination of finasteride in human plasma. After deprotienation with acetonitrile, centrifugation, evaporation to dryness and dissolving in mobile phase, satisfactory separation was achieved on a Hypersil-Keystone C(18) reversed-phase column using a mobile phase consisting of acetonitrile-water (46:54, v/v), 0.1% acetic acid and 0.1% trifluoracetic acid. Carbamazepine (IS) was used as internal standard. This method involved the use of the [M+H](+) ions of finasteride and IS at m/z 373 and 237 with the selective ion monitoring (SIM) mode. The calibration curve was linear in the range of 0.2-120 ng ml(-1). The limit of quantification for finasteride in plasma was 0.2 ng ml(-1) with good accuracy and precision. The intra-assay precision and accuracy were in the range of 2.1-11.2% and -1.3% to 8.5%, respectively. The inter-assay precision and accuracy were in the order of 3.4-12.1% and -1.5% to 11.5%, respectively. The mean sample extract recoveries of the method were higher than 85% and 74% for finasteride and internal standard (IS), respectively. The assay has been successfully used to estimate the pharmacokinetics of finasteride after oral administration of a 5mg tablet of finasteride to 24 healthy volunteers.

Administration, Oral↗
PubMed2006

Prostate cancer prevention and finasteride.

PURPOSE: 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. MATERIALS AND METHODS: A literature review was performed to obtain evidence to develop a hypothesis that may explain the results of the Prostate Cancer Prevention Trial. RESULTS: On average finasteride halved prostate specific antigen. As shown by the Medical Therapy of Prostatic Symptoms study and Prostate Cancer Prevention Trial, it also decreased the annual median increase in prostate specific antigen from benign prostatic hyperplasia. Therefore, despite doubling prostate specific antigen during the first 3 years of the Prostate Cancer Prevention Trial, to have prostate specific antigen exceed 4 ng/ml and have a prostate biopsy recommended men receiving finasteride vs placebo required greater increases in prostate specific antigen, which was shown in the Prostate Cancer Prevention Trial to be associated with high grade disease (p < 0.001). Also, the decrease of the contribution to prostate specific antigen from benign prostatic hyperplasia by finasteride improved the performance characteristics of prostate specific antigen to detect Gleason score 7 or higher prostate cancer. CONCLUSIONS: By decreasing the contribution to prostate specific antigen from benign prostatic hyperplasia finasteride makes changes in prostate specific antigen more cancer specific. This effect may explain the increased detection of high grade prostate cancer in men randomized to finasteride in the Prostate Cancer Prevention Trial. How to best use prostate specific antigen to recommend biopsy in men on 5alpha-reductase inhibitors requires further study.

Enzyme Inhibitors↗
PubMed2004

Interaction of chronic ethanol exposure and finasteride: sex and strain differences.

The neurosteroid allopregnanolone (ALLOP) is a very potent positive modulator of gamma-aminobutyric acidA (GABAA) receptors that can modulate ethanol (EtOH) withdrawal. The 5alpha-reductase inhibitor finasteride blocks the formation of ALLOP from progesterone and was recently found to reduce some effects of EtOH. Thus, the present studies were conducted to determine the effect of finasteride on chronic EtOH withdrawal severity in male and female C57BL/6 (B6) and DBA/2 (D2) mice. The animals were exposed to 72 h EtOH vapor or air and received four injections of finasteride (50 mg/kg ip) 24 h prior to, and each day of, the EtOH vapor exposure. Upon removal from the inhalation chambers, handling-induced convulsions (HICs) were measured hourly for the first 12 h and then again at 24 h. EtOH withdrawal severity was significantly greater in D2 than in B6 mice. Pretreatment with finasteride significantly decreased EtOH withdrawal severity only in the female D2 mice, produced a nonselective suppressive effect on HIC in male B6 and D2 mice, and did not significantly alter HIC in female B6 mice. Finasteride pretreatment significantly decreased blood EtOH concentration (BEC) upon initiation of withdrawal, suggesting that finasteride may affect withdrawal severity via an alteration in EtOH pharmacokinetics.

Animals↗
PubMed2001

Effects of the anti-androgen finasteride on the modulatory actions of oestradiol on androgen metabolism by human gingival fibroblasts.

5 alpha-Reduction of androgen substrates results in the formation of the biologically active androgen 5 alpha-dihydrotestosterone (DHT), while 17 beta-hydroxysteroid dehydrogenase metabolises androgen substrates to 4-androstenedione or testosterone. The aim here was to study the effect of the anti-androgen finasteride on 5 alpha-reduction of androgens by human gingival fibroblasts (HGF) and its modulation by oestradiol-17 beta. Duplicate cultures of HGF were incubated with [14C]testosterone/[14C]4-androstenedione in Eagle minimum essential medium (n=6) in the presence or absence of oestradiol-17 beta (O) or finasteride (F; 0.1-3 microg/ml) for 24 h. The steroid metabolites were analysed and quantified using a radioisotope scanner. With [14C]testosterone as substrate, oestradiol stimulated the formation of DHT by 63% (n=6; P<0.01). In contrast, finasteride inhibited this activity by 61% (n=6; P<0.01). The combination of O+F produced 43% less inhibition than finasteride alone (n=6; P<0.01). There were 200-300% increases in the formation of 4-androstenedione in response to O and F, being less pronounced in combination. Oestradiol stimulated the formation of DHT from [14C]4-androstenedione by 300-600% and finasteride reduced the yield of DHT by 40-64%; there was less inhibition in combination with O. There were 300-700% increases in the formation of testosterone in response to F and O alone and in combination (n=6; P<0.01). Oestradiol-induced stimulation of 5 alpha-reductase activity on androgen substrates by HGF is suggestive of hormone modulatory mechanisms in the healing periodontium of both sexes. Its inhibition by finasteride is suggestive of type 2 isoenzyme activity, confirming target-tissue functions in the gingiva.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMed1999

Comparison of finasteride and flutamide in the treatment of idiopathic hirsutism.

OBJECTIVE: To compare the effectiveness of finasteride and flutamide in the treatment of idiopathic hirsutism. DESIGN: Randomized study. SETTING: Department of Gynecological Endocrinology, University of Brescia, Italy. PATIENT(S): Forty-six women with idiopathic hirsutism were selected. INTERVENTION(S): Patients were assigned randomly to receive 5 mg of finasteride once daily or 250 mg of flutamide twice daily for 12 consecutive months. MAIN OUTCOME MEASURE(S): Hirsutism was evaluated at 6 and 12 months of therapy by measuring the Ferriman-Gallwey score and the terminal-hair diameters (microm) taken from different body areas. Blood samples were taken and side effects were monitored during the treatment. RESULT(S): Both finasteride and flutamide induced a statistically significant decrease in hirsutism scores and hair diameters at the end of 12 months. Finasteride reduced the Ferriman-Gallwey score by 20.5% at 6 months and by 34.2% at 12 months, and hair diameter by 18.9%-23.6% at 6 months and by 29.6%-37.9% at 12 months. Flutamide reduced the Ferriman-Gallwey score by 26.6% at 6 months and by 50.9% at 12 months, and hair diameter by 22.3%-28.2% at 6 months and by 47.7%-56.5% at 12 months. Flutamide did not induce hormonal variations, whereas finasteride increased T levels by 60% and decreased 3alpha-androstanediol glucuronide by 69.5% at 12 months. CONCLUSION(S): Both drugs were effective in the treatment of idiopathic hirsutism, but flutamide was more effective than finasteride.

Adolescent↗
PubMed2006

Intermittent use of testosterone inactivating pharmaceuticals using finasteride prolongs the time off period.

PURPOSE: Men with prostate cancer treated intermittently with TIP benefit from improved quality of life when TOP with recovered testosterone is prolonged. We examined factors influencing the duration of TOP. MATERIALS AND METHODS: We retrospectively reviewed the charts of 101 men treated with intermittent TIP in a 9-year period. Men with positive bone scan, men in whom a PSA nadir of less than 0.1 ng/ml on TIP failed to be achieved and maintained and men in whom testosterone failed to recover to greater than 150 ng/dl during the first 12 months of TOP were excluded. Potential factors predicting prolonged TOP or accelerated time to AIPC were studied with Cox regression analysis. RESULTS: Patient characteristics were clinical stage T1c-T2a in 51 and T2b-T3b in 11, PSA relapse in 29, and T3c, D0 or D1 in 10. Median PSA was 7.6 ng/ml, Gleason score was 3 + 4 = 7 and TIP duration was 15.8 months. The 60 group 1 patients received finasteride and the 41 in group 2 received no finasteride. Median TOP in groups 1 and 2 was 31 and 15 months, respectively, using Kaplan-Meier analysis. Cox regression analysis indicated that longer TIP, finasteride and increased age predicted longer TOP. A slow PSA decrease while on TIP, higher baseline PSA and increased Gleason score predicted shorter TOP. Cox regression analysis indicated that only higher clinical stage but not finasteride predicted the earlier onset of AIPC. CONCLUSIONS: Finasteride doubles the duration of TOP. AIPC was not increased by finasteride after almost 9 years of observation.

5-alpha Reductase Inhibitors↗
PubMed2002

Transurethral prostate resection and bleeding: a randomized, placebo controlled trial of role of finasteride for decreasing operative blood loss.

PURPOSE: Bleeding associated with transurethral prostate resection can often be significant and lead to increased morbidity and occasionally mortality. It has been shown that finasteride decreases bleeding in patients with hematuria of prostatic origin. We hypothesized that bleeding in patients undergoing transurethral prostate resection could be decreased by giving finasteride for 2 weeks before surgery. MATERIALS AND METHODS: A total 70 patients scheduled to undergo elective transurethral prostate resection were randomized to receive 5 mg. finasteride daily or placebo for 2 weeks before surgery. Serum hemoglobin was measured before and after surgery, and the following day. The volume of irrigation fluid used and its hemoglobin concentration as well as resected prostate weight were recorded. RESULTS: Of the 68 patients who underwent transurethral prostate resection 2 were withdrawn before surgery, and so 32 received finasteride and 36 received placebo. There was significantly less mean blood loss in irrigation fluid in the finasteride group than in the control group (43.6 versus 69.3 gm. hemoglobin, p = 0.011). The mean difference was more significant when blood loss per gm. resected prostate was calculated (2.65 versus 4.65 gm. hemoglobin per gm. prostate, p < 0.01). CONCLUSIONS: This study shows that finasteride given for 2 weeks preoperatively decreases bleeding in patients undergoing transurethral prostate resection. Further study is required to determine the optimal timing and dose duration to minimize blood loss and identify how relevant such a decrease in bleeding is in clinical practice.

Aged↗
PubMed1993

Urodynamic effects of finasteride in the treatment of bladder outlet obstruction due to benign prostatic hyperplasia.

Urodynamic effects of the 5-alpha-reductase inhibitor, finasteride, were studied in the treatment of patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH). A total of 36 patients was randomly assigned in a double-bind manner to receive either 5 mg. finasteride daily (19) or placebo (17) for 6 months. The possible relief of bladder outlet obstruction was monitored with uroflowmetry and repeated urodynamics. The mean flow rate, detrusor opening pressure, detrusor pressure at maximum flow and maximum detrusor pressure improved significantly in the patients treated with finasteride. There were no significant differences in the improvement of symptom score or peak flow rate, or in the reduction of residual urine between the finasteride and placebo groups. The treatment resulted in 30% average decrease in prostatic size and 46% decrease in prostate specific antigen concentration. The efficacy of finasteride in relief of bladder outlet obstruction caused by BPH seems to be of the same degree as that achieved by chemical castration therapy but without any significant side effects. There were wide variations among BPH patient response to finasteride treatment. Further studies are needed to define the responders who benefit from this treatment.

5-alpha Reductase Inhibitors↗
PubMed2000

Impact of baseline symptom severity on future risk of benign prostatic hyperplasia-related outcomes and long-term response to finasteride. The Pless Study Group.

OBJECTIVES: To evaluate the long-term effects of finasteride on symptoms, acute urinary retention (AUR), and the need for benign prostatic hyperplasia (BPH)-related surgery in relationship to baseline symptom severity. METHODS: A total of 3040 men with BPH were treated for 4 years with finasteride or placebo. The changes from baseline in symptoms and the incidence of BPH-related surgery and AUR were determined in men with mild (less than 8), low-moderate (8 to 12), high-moderate (13 to 19), and severe (greater than 19) baseline quasi-American Urological Association symptoms for all patients and for the subgroup with a baseline prostate-specific antigen (PSA) level of 1.4 ng/mL or greater. RESULTS: In patients who completed the 4-year study, the change in symptom score, stratified by baseline symptom severity, was +1.4 +/- 0.5 (mild), -0.8 +/- 0.3 (low-moderate), -3.6 +/- 0.3 (high-moderate), and -7.7 +/- 0.5 (severe) in finasteride-treated patients and, respectively, +3.4 +/- 0.5, +0.7 +/- 0.3, -1.4 +/- 0.3, and -5.3 +/- 0.6 in placebo-treated patients (between-group P <0.01). The between-group differences were greater in the subgroup of patients with a baseline PSA of 1.4 ng/mL or greater. The risk of BPH-related surgery increased among placebo patients with increasing baseline symptom severity to a greater extent than the risk of AUR. Finasteride reduced the risk of AUR or the need for BPH-related surgery in all subgroups (P <0.001), especially in men with a baseline PSA of 1.4 ng/mL or greater. CONCLUSIONS: Compared with placebo, finasteride had a beneficial effect on symptoms, AUR, and BPH-related surgery in all symptom categories. BPH-related surgery, but not AUR, occurred more commonly in placebo-treated men with more severe baseline symptoms. The greatest absolute benefit of finasteride on symptoms and the reduction in risk of AUR and surgery was in men with higher baseline symptom scores and a baseline PSA level of 1.4 ng/mL or greater.

Aged↗
PubMed2001

Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens.

OBJECTIVES: To determine the effects of a saw palmetto herbal blend (SPHB) compared with finasteride on prostatic tissue androgen levels and to evaluate needle biopsies as a source of tissue for such determinations. METHODS: Prostate levels of testosterone and dihydrotestosterone (DHT) were measured on 5 to 10-mg biopsy specimens (18-gauge needle cores) in three groups of men with symptomatic benign prostatic hyperplasia: 15 men receiving chronic finasteride therapy versus 7 untreated controls; 4 men undergoing prostate adenomectomy to determine sampling variability (10 specimens each); and 40 men participating in a 6-month randomized trial of SPHB versus placebo, before and after treatment. RESULTS: Prostatic tissue DHT levels were found to be several times higher than the levels of testosterone (5.01 versus 1.51 ng/g), that ratio becoming reversed (1.05 versus 3.63 ng/g) with chronic finasteride therapy. The finasteride effect was statistically significant for both androgens (P <0.01), and little overlap of individual values between finasteride-treated and control patients was seen. In the randomized trial, tissue DHT levels were reduced by 32% from 6.49 to 4.40 ng/g in the SPHB group (P <0.005), with no significant change in the placebo group. CONCLUSIONS: For control versus finasteride-treated men, the tissue androgen values obtained with needle biopsy specimens were similar-both for absolute values and the percentage of change-to those previously reported using surgically excised volumes of prostatic tissue. The quantification of prostatic androgens by assay of needle biopsies is thus feasible and offers the possibility of serial studies in individual patients. The SPHB-induced suppression of prostatic DHT levels, modest but significant in a randomized trial, lends an element of support to the hypothesis that inhibition of the enzyme 5-alpha reductase is a mechanism of action of this substance.

Aged↗
PubMed2003

Effects of finasteride on serum testosterone and body mass index in men with benign prostatic hyperplasia.

OBJECTIVES: To examine the effect of finasteride on serum testosterone in men with benign prostatic hyperplasia (BPH). METHODS: The Proscar Long-Term Efficacy and Safety Study (PLESS) was a 4-year trial comparing the safety and efficacy of finasteride 5 mg with placebo in 3040 men with moderate to severe symptomatic BPH and enlarged prostates. PLESS included the prospective measurement of annual serum testosterone in a randomly selected subset of patients comprising approximately 10% of the randomized population (n = 301). RESULTS: Finasteride treatment led to a modest, but significant (P <0.001), increase relative to placebo in serum testosterone, with this increase greatest in patients who had low baseline testosterone levels. The larger testosterone increases seen in finasteride-treated patients in the lower baseline testosterone tertiles were associated with significant mean reductions relative to placebo at year 4 in body mass index (BMI), ranging from 0.6 to 0.8 kg/m2. No statistically significant between-group difference was found in BMI in the upper testosterone tertile. The sexual adverse experience profiles for finasteride and placebo were similar across the baseline testosterone cohorts examined. CONCLUSIONS: Finasteride treatment led to a generally modest increase relative to placebo in serum testosterone, with the greatest increases occurring in men with low baseline testosterone levels. The physiologic significance of these changes in men with low baseline testosterone levels is unclear, but the associated reduction in BMI is intriguing and may be related, because BMI is known to be negatively correlated with serum testosterone levels in men.

5-alpha Reductase Inhibitors↗
PubMed1999

Effects of finasteride in patients with inflammatory chronic pelvic pain syndrome: a double-blind, placebo-controlled, pilot study.

OBJECTIVES: To investigate whether treatment of inflammatory chronic pelvic pain syndrome (ICPPS) with finasteride has any influence on symptoms associated with ICPPS. METHODS: Forty-one patients with ICPPS were randomized (1:3) to treatment with either placebo (25%, n = 10) or finasteride 5 mg daily (75%, n = 31 ) for 1 2 months. Efficacy was evaluated by analysis of symptomatic improvement through responses to symptom questionnaires, pain evaluation on an analytical visual scale, analgesic use as reported in patient diaries, urine flow and residual volume, and prostate volume. RESULTS: Prostatitis Symptom Severity Index and prostatism scores dropped significantly in patients in the finasteride group (P < 0.001 and P < 0.05, respectively). There were no statistically significant differences in pain between the groups. There were significant differences in the changes of prostate volume and in serum prostate-specific antigen concentrations between the finasteride and placebo groups (P < 0.03 and P < 0.02, respectively). The groups did not differ with regard to side effects. CONCLUSIONS: Our results indicate that finasteride has an effect in ICPPS. The mechanisms by which finasteride works in these patients are unclear and could not be solved in this pilot study, which had relatively few patients. A further trial with larger numbers is required to confirm these results.

Adult↗
PubMed1999

Effect of finasteride on bother and other health-related quality of life aspects associated with benign prostatic hyperplasia. PLESS Study Group. Proscar Long-term Efficacy and Safety Study.

OBJECTIVES: To investigate the long-term effects of finasteride on bother and health-related quality of life (HRQOL) in men with symptomatic benign prostatic hyperplasia. METHODS: A large prospective 4-year placebo-controlled trial (PLESS) of 3040 men with moderate to severe lower urinary tract symptoms and an enlarged prostate was performed that included self-administered questionnaires assessing HRQOL. RESULTS: Significantly greater reductions in bother score were seen for finasteride compared with placebo at every time point after 4 months. Analysis of bother scores by baseline serum prostate-specific antigen (PSA), as it is highly correlated with prostate volume, suggested greater differences from placebo for men with PSA 1.4 ng/mL or greater, primarily due to worsening after the first-year improvement in the placebo group. An activity interference domain score was significantly improved for finasteride over placebo at each time point (P<0.01), with greater treatment differences in men with higher baseline PSA levels. Comparable results were seen for worry at each time point and embarrassment due to urinary symptoms in the last 2 years of the trial. Mean changes in sexual interest and satisfaction were somewhat better for the placebo group overall, as has been previously reported, but little difference between treatments was found in sexual satisfaction measures for men with PSA 1.4 ng/mL or greater. CONCLUSIONS: Compared with placebo, men receiving finasteride had significantly less bother, activity interference, and worry due to urinary symptoms, with more pronounced differences for men with baseline PSA 1.4 ng/mL or greater. As expected, sexual satisfaction and sexual drive were slightly worse for finasteride overall, but little difference in sexual satisfaction measures was found for men with a higher baseline PSA. Thus, HRQOL was improved for finasteride compared with placebo, especially for men with a baseline PSA 1.4 ng/mL or greater.

Aged↗
PubMedDate not supplied

Patient satisfaction with finasteride in the treatment of symptomatic benign prostatic hyperplasia.

The type and magnitude of urinary symptoms, the behavioral adjustments necessitated by such symptoms, and the degree of patient satisfaction with treatment and current health were evaluated in 102 men with symptomatic benign prostatic hyperplasia (BPH) who had been receiving finasteride for 9 to 12 months. We also evaluated these variables in a group of 109 men who had undergone transurethral resection of the prostate (TURP) for symptomatic BPH 9 to 12 months before the study. A validated, patient-directed telephone questionnaire was used to solicit information. Men with BPH who continued to receive finasteride therapy for at least 9 months experienced considerable symptomatic relief during the first year of therapy, and reported a high degree of satisfaction with their urinary condition. Urinary symptoms either resolved or occurred only rarely in the majority of men treated with finasteride. Most of the BPH patients taking finasteride (78%) indicated that urinary symptoms did not restrict their participation in normal activities. Fifty-four percent of finasteride patients rated their current health as excellent or very good, and 87% indicated that their current condition represented an improvement over their pretreatment state. Responses in the men treated with TURP reinforced previous observations about the effectiveness of this treatment in men with symptomatic BPH. Thus in the appropriate patient group, finasteride represents an effective management option for symptomatic BPH.

Aged↗
PubMed2001

Finasteride and tamsulosin used in benign prostatic hypertrophy: a review of the prescription-event monitoring data.

OBJECTIVE: To review the results of non-interventional observational cohort studies of 14 772 patients treated with finasteride and 12 484 patients treated with tamsulosin, both studies being of national proportions and undertaken in general medical practice in England. METHODS: Both studies were undertaken by prescription-event monitoring (PEM), whereby the exposure data are derived from information provided in strict confidence by the Prescription Pricing Authority of the National Health Service. The outcome data are derived from 'green form' questionnaires completed by the prescribing general practitioners (GPs). Additional data are obtained by medical follow-up with the attending practitioners. Adverse experience was measured in three ways; as reports of events which the doctors considered to represent adverse drug reactions; as reports of reasons for stopping the drug; and by studying the incidence density of each reported event. For these purposes a computerized dictionary containing 1430 higher level terms was used. The duration of exposure in the finasteride study was approximately 1 year and was approximately 6 months in the tamsulosin study. RESULTS: The outcome data on the 14 772 and 12 484 patients treated in the finasteride and tamsulosin studies were derived from the 63% and 57.4% of the green forms sent out and returned, respectively. The finasteride cohort included two women and the tamsulosin cohort 70 women. The mean (SD) age of the men in the two cohorts was, respectively, 69.0 (9.2) and 66.2 (11.7) years. Both drugs were well tolerated on long-term therapy and 69.6% (10 274 patients) of the total finasteride and 62.0% (7739 patients) of the total tamsulosin cohort were still receiving the drug at the end of 6 months. In the finasteride study, impotence or ejaculatory failure was reported in 2.0% of the patients still receiving the drug; there were reports of decreased libido in 1.0% and gynaecomastia was reported whilst the drug was still being prescribed in 39 patients (0.3% of the cohort). With tamsulosin, uncommon cases of dizziness, headache, malaise and hypotension (89 reports in 12 484 patients, i.e. 0.7% of the cohort) were common to the findings of reported adverse reactions, reasons for stopping the drug and events of highest incidence density. None of the deaths which occurred in either of these large cohorts was attributed by either the reporting GPs or the PEM medical staff to the drugs examined. Conclusion The GPs rated the drugs effective in most patients; tolerance and adverse experience was consistent with the known pharmacology of the two drugs. No serious, unexpected adverse effects were identified.

Adrenergic alpha-Antagonists↗
PubMed2002

Changes in molecular forms of prostate-specific antigen during treatment with finasteride.

OBJECTIVE: To study the influence of finasteride treatment on the molecular forms of prostate-specific antigen (PSA) in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Total PSA, free PSA and PSA complexed to alpha1-antichymotrypsin (PSA-alpha1ACT) were measured in plasma and serum from 40 men with BPH and a total PSA of < 20 ng/mL, using in-house and commercial immunoassays, before and during treatment with finasteride (30 men) or placebo (10 men). RESULTS: The baseline values were not significantly different between the groups, with mean (sd) total plasma PSA levels of 3.6 (4.3) and 4.8 (5.9) ng/mL in the finasteride and placebo groups, respectively. Finasteride, but not placebo, induced a significant reduction in total PSA, free PSA and PSA-alpha1ACT levels in plasma and serum (P < 0.001). However, complexed-to-total (c/t) and free-to-total (f/t) PSA ratios remained constant in both groups, both in plasma and serum, during the follow-up. CONCLUSION: The decrease in total PSA after finasteride treatment results from a proportional reduction in its two major molecular forms, free PSA and PSA-alpha1ACT, which explains why the c/t and f/tPSA ratios do not change significantly despite treatment. This suggests that routine analysis of molecular forms of PSA could improve the utility of the change in total PSA associated with finasteride for the early diagnosis of prostate cancer. It also suggests that any subsequent change in both ratios, particularly an increase in c/tPSA or a decrease in f/tPSA ratio, could be considered an early sign of neoplastic degeneration rather than a therapeutic consequence.

Aged↗