Finasteride in the treatment of benign prostatic hyperplasia. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study Group. 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. Therapeutic effects of finasteride in benign prostatic hyperplasia: a randomized double-blind controlled trial. Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia. Endocrine therapy for benign prostatic hyperplasia in the 90's. Combined analysis of two multicenter studies of finasteride 5 mg in the treatment of symptomatic benign prostatic hyperplasia Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. Finasteride (MK-906) in the treatment of benign prostatic hyperplasia. The Finasteride Study Group. Finasteride in the treatment of benign prostatic hyperplasia. A urodynamic evaluation. Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Proscar: five-year experience. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. Effect of discontinuation of 5alpha-reductase inhibitors on prostate volume and symptoms in men with BPH: a prospective study. Pharmacotherapy of benign prostatic hyperplasia: Inhibitor of 5 alpha-reductase The effect of finasteride on prostate volume, urinary flow rate and symptom score in men with benign prostatic hyperplasia. Urodynamic effects of finasteride in the treatment of bladder outlet obstruction due to benign prostatic hyperplasia. Prostate tissue composition and response to finasteride in men with symptomatic benign prostatic hyperplasia. Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.
Finasteride is an enzyme inhibitor which blocks the conversion of testosterone by 5 alpha-reductase to dihydrotestosterone , the active and rogenic metabolite in the prostate . In a double-blind , placebo-controlled study , 707 patients with moderately symptomatic BPH were treated for 2 years . The study confirmed that treatment significantly improved symptoms , reduced prostate size and increased urine flow rate . Side effects were usually mild . The authors find that finasteride can reverse the natural progression of BPH Benign prostatic hyperplasia ( BPH ) is a highly prevalent condition in aging men , which can be progressive and lead to acute urinary retention ( AUR ) and the need for surgery . It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors ( 5ARIs ) , both of which improve the symptoms of BPH . Long-term treatment with 5ARIs can also reduce the risk of developing AUR and the need for surgery . The l and mark Medical Therapy of Prostatic Symptoms ( MTOPS ) trial demonstrated that over 4 years the combination of the type 2-specific 5ARI , finasteride and the alpha-blocker doxazosin was more effective than either agent alone in reducing overall clinical progression . Since the initiation of MTOPS , it has been shown that patients with larger prostates and higher prostate-specific antigen ( PSA ) levels are at greater risk of BPH progression , and are therefore arguably more likely to benefit from combination therapy . The Combination of Avodart and Tamsulosin ( CombAT ) trial is a 4-year , global , multicenter , r and omized , double-blind , parallel-group study design ed to investigate the benefits of combination therapy with the dual 5ARI dutasteride and the alpha-blocker tamsulosin compared with each monotherapy in improving symptoms and long-term outcomes in men with moderate-to-severe symptoms of BPH and prostate enlargement .  Symptoms and long-term outcomes ( AUR and surgery ) will be assessed as separate primary endpoints at 2 and 4 years , respectively . Eligible patients were at least 50 years old with prostate volume > or = 30 cm(3 ) and PSA level > or = 1.5 ng/mL. A total of 4838 subjects have been enrolled . This paper describes the rationale , design and baseline data of the CombAT study BACKGROUND Benign prostatic hyperplasia is a progressive , and rogen-dependent disease result ing in enlargement of the prostate gl and and urinary obstruction . Preventing the conversion of testosterone to its tissue-active form , dihydrotestosterone , by inhibiting the enzyme 5 alpha-reductase could decrease the action of and rogens in their target tissues ; in the prostate the result might be a decrease in prostatic hyperplasia and therefore in symptoms of urinary obstruction . METHODS In a double-blind study , we evaluated the effect of two doses of finasteride ( 1 mg and 5 mg ) and placebo , each given once daily for 12 months , in 895 men with prostatic hyperplasia .  Urinary symptoms , urinary flow , prostatic volume , and serum concentrations of dihydrotestosterone and prostate-specific antigen were determined periodically during the treatment period . RESULTS As compared with the men in the placebo group , the men treated with 5 mg of finasteride per day had a significant decrease in total urinary-symptom scores ( P less than 0.001 ) , an increase of 1.6 ml per second ( 22 percent , P less than 0.001 ) in the maximal urinary-flow rate , and a 19 percent decrease in prostatic volume ( P less than 0.001 ) . The men treated with 1 mg of finasteride per day did not have a significant decrease in total urinary-symptom scores , but had an increase of 1.4 ml per second ( 23 percent ) in the maximal urinary-flow rate , and an 18 percent decrease in prostatic volume . The men given placebo had no changes in total urinary-symptom scores , an increase of 0.2 ml per second ( 8 percent ) in the maximal urinary-flow rate , and a 3 percent decrease in prostatic volume . The frequency of adverse effects in the three groups was similar , except for a higher incidence of decreased libido , impotence , and ejaculatory disorders in the finasteride-treated groups . CONCLUSIONS The treatment of benign prostatic hyperplasia with 5 mg of finasteride per day results in a significant decrease in symptoms of obstruction , an increase in urinary flow , and a decrease in prostatic volume , but at a slightly increased risk of sexual dysfunction 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 . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized 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 ) gl and s 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 The clinical effects of finasteride , a 5 alpha-reductase inhibitor , in patients with benign prostatic hyperplasia ( BPH ) were evaluated in a double-blind , placebo-controlled study . Forty-six patients with symptomatic BPH were r and omly assigned to 2 groups , the finasteride group and the placebo group . The finasteride group received 5 mg of finasteride daily for 6 months . Prostate volume , urinary flow , urinary symptoms , serum prostate-specific antigen ( PSA ) and adverse events were determined before and after treatment . After 6 months of treatment the patients treated with 5 mg of finasteride per day had a 30 % decrease in their total urinary symptom score , a 14 % decrease in prostate volume and a 0.9 ng/dL decrease of PSA . Their maximal urinary flow rate increased by 1.42 mL per second and the mean urinary flow rate increased by 0.64 mL per second . The patients given placebo showed no significant changes in their prostate volume , serum PSA and maximal and mean urinary flow rate . However , the symptom scores in the placebo group also decreased significantly . When compared with the placebo group , those in the finasteride group had significantly lower prostate volume , serum PSA , maximal urinary flow rate and urinary symptoms , but not mean urinary flow rate . The frequency of adverse events was low in both the finasteride and placebo groups . These results show that finasteride may be an effective and safe alternative for the treatment of patients with BPH Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of  benign prostatic hyperplasia ( BPH )  . Taken as monotherapy , alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms . Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery . Direct comparison of the alpha-blocker terazosin with finasteride has been done , but only for a period of 1 year . The Medical Therapy of Prostatic Symptoms ( MTOPS ) trial is a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride , whether taken as a monotherapy or in combination , in preventing or delaying the progression of BPH . We describe in this paper the design of the MTOPS trial , the concept of BPH progression , the definition and methods of determining the primary outcome events and the proposed statistical analysis methods . A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of r and omized participants . Volunteers among r and omized participants are to undergo a biopsy of the prostate at predetermined time points during the trial . Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH OBJECTIVES To compare the efficacy and safety of finasteride 5 mg in older ( 65 years old or older ) versus younger ( 45 to younger than 65 years old ) men with benign prostatic hyperplasia ( BPH ) . METHODS The Proscar Long-Term Efficacy and Safety Study ( PLESS ) was a 4-year , r and omized , double-blind , placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH , enlarged prostates , and no evidence of prostate cancer . The endpoints included urinary symptoms , prostate volume , occurrence of acute urinary retention and /or BPH-related surgery , and safety . RESULTS In both age cohorts , finasteride treatment led to a 51 % reduction ( P < 0.001 ) in the relative risk for acute urinary retention and /or BPH-related surgery , a significant ( P < 0.001 ) and durable improvement in symptom score , and a significant ( P < 0.001 ) and sustained reduction in prostate volume . Within each age cohort , no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events . Significant differences were evident between the placebo and finasteride groups in the incidence of the typical , known , drug-related adverse events , but no specific differences were associated with age . No drug interactions of clinical importance were observed in the finasteride-treated patients . CONCLUSIONS The present analysis from PLESS demonstrates that in both older ( 65 years old or older ) and younger men with symptomatic BPH and enlarged prostates , finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery . In addition , the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed Endocrine therapy by means of castration for benign prostatic hyperplasia was introduced already in the middle of the 19th century . The technique was never popularized and was ab and oned following the introduction of safe surgical techniques . In the second half of this century , small series of various endocrine treatments have been reported , mainly using progestational agents . The hormone dependency of the prostate is unique , since testosterone itself is not very active on the prostate cells but has to be converted to 5 alpha-dihydrotestosterone , which is almost ten times as effective an and rogen in the prostate cell . By blocking this conversion , highly specific anti and rogenic effect will be obtained in the prostate but not in other organs of the body . The first 5 alpha-reductase inhibitor , finasteride , has proven effective in reducing prostate DHT . In large clinical trials , it has shown to reduce prostate size , improve urinary flow and reduce symptom score , statistically significantly better than placebo . The effect is sustained over at least 3 years . In a double-blind , r and omized , placebo-controlled study over 2 years , patients were similarly improved in the finasteride group , whereas they deteriorated in the placebo group . This indicates that finasteride is able to halt the progression of the natural course of benign prostatic hyperplasia . Benign prostatic hyperplasia , generally believed to be a stromal disease , is potentially dependent on estrogens for its development . By blocking aromatization of testosterone to estrogen in the prostate cells , a hypothetical beneficial effect on the disease process should be gained . Results from phase II- studies have been promising . However , in placebo-controlled studies , aromatase inhibitors did not perform better than placebo . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of this paper is to examine effects of finasteride 5 mg across different age groups in an ethnically diverse population of men with symptomatic benign prostatic hyperplasia ( BPH ) seen in community urology and primary care practice s. Data were combined from two previous placebo-controlled r and omised trials of finasteride that evaluated changes in urinary symptoms , blinded global assessment s of urologic status , adverse experiences , and effects on dihydrotestosterone ( DHT ) and prostate-specific antigen ( PSA ) in over 4500 men .  Finasteride showed a favourable efficacy and tolerability profile in this large ethnically diverse population and was similarly effective in middle-aged and older men with BPH and prostate gl and enlargement PURPOSE Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker . We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms . MATERIAL S AND METHODS In an international , r and omized , double-blind , parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS ( International Prostate Symptom Score ) of 13 or greater and prostate volume 30 ml or greater , 350 were treated with placebo/finasteride  and 345 received tadalafil/finasteride for 26 weeks . Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS , erectile dysfunction improvements were assessed with the IIEF-EF ( International Index of Erectile Function-Erectile Function ) in sexually active men and safety was assessed by evaluating adverse events . RESULTS Least squares mean changes from baseline in I-PSS after 4 , 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0 , -5.2 and -5.5 , respectively . Corresponding values for placebo/finasteride coadministration were -2.3 , -3.8 and -4.5 ( p ≤ 0.022 at all visits favoring tadalafil/finasteride  coadministration ) . I-PSS subscores ( storage and voiding ) and quality of life index were also numerically improved with tadalafil/finasteride coadministration . Least squares mean changes from baseline in IIEF-EF  with tadalafil/finasteride coadministration were 3.7 after 4 weeks , and 4.7 after 12 and 26 weeks . Corresponding values for placebo/finasteride coadministration were -1.1 , 0.6 and -0.0 ( p < 0.001 at all visits favoring tadalafil/finasteride coadministration ) . Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate . CONCLUSIONS The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement . Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction The effects of finasteride , a potent 5 alpha-reductase inhibitor , were assessed in 750 patients with benign prostatic hyperplasia ( BPH ) in a multicenter , double-blind , placebo-controlled study . Patients were r and omized to finasteride , 1 or 5 mg , or placebo , daily for 12 months . The following changes were seen with finasteride 5 mg after 12 months : ( 1 ) Serum dihydrotestosterone decreased by 62 % compared to no change with placebo ( P < 0.001 ) ; ( 2 ) serum prostate-specific antigen ( PSA ) decreased by 46 % compared to no change with placebo ( P < 0.001 ) ; ( 3 ) prostate volume was reduced by 22 % compared to a 5 % decrease with placebo ( P < 0.001 ) ; ( 4 ) maximum urinary flow rate increased by 1.7 ml/sec compared to a 0.4 ml/sec increase with placebo ( P < 0.025 ) ; ( 5 ) total urinary symptom scores decreased by 3.3 points compared to a 2.0 point decrease with placebo ( P = 0.005 ) , and ( 6 ) obstructive symptom scores decreased by 2.1 points compared to a 1.4 point decrease with placebo ( P = 0.017 ) . The effects of finasteride 1 mg were similar to 5 mg , except in urinary symptoms , where no significant differences between 1 mg and placebo were seen . Patients treated with 5 mg finasteride demonstrated significantly greater improvements in urological status ( assessed by the investigator ) and the troublesome symptom score , compared to placebo . Treatment with finasteride was well tolerated . We conclude that finasteride is an effective medical therapy for a significant proportion of patients with BPH A group of 69 men with bladder outflow obstruction due to benign prostatic hyperplasia ( BPH ) were treated in a double-blind , placebo-controlled study with finasteride ( Proscar , MK-906 ) , a 5-alpha reductase inhibitor , 5 mg or 10 mg/day or placebo for 3 months ; subsequently , 20 patients received finasteride 5 mg/day for a further 9 months in an open extension study . In treated patients dihydrotestosterone declined by over 60 % , remaining unchanged with placebo . Symptom scores fell significantly in all 3 groups . Mean maximum flow rates fell slightly in placebo-treated patients but improved by 1.5 ml/s in the 10 mg group and by 3.3 ml/s in the 5 mg group . After 1 year 's treatment , the reduction in symptom score and increase in flow rate were well maintained ; the mean prostate volume was reduced by 14 % and prostatic specific antigen declined by 28 % . It was concluded that finasteride shows some efficacy in the treatment of BPH , with minimal toxicity , but 12 months of therapy or longer may be necessary to achieve maximal effect OBJECTIVES To evaluate the effects of finasteride , a specific type II 5-alpha-reductase inhibitor , on symptoms of benign prostatic hyperplasia , prostate volume , and urinary flow during a 7 to 8-year period . METHODS A total of 190 men with symptomatic benign prostatic hyperplasia and enlarged prostates entered one of two Phase II double-blind 3 to 6-month studies . Of these , 156 patients continued taking open-label finasteride  , and more than 70 patients completed 7 to 8 years of treatment . The symptoms were scored using a patient self-administered modified Boyarsky symptom question naire . Prostate volume was measured by magnetic resonance imaging or ultrasonography , and the maximal urinary flow rate was assessed noninvasively . RESULTS Treatment with finasteride for 7 to 8 years led to sustained improvement in symptoms , reduction in prostate volume ( 28 % from baseline ) , and increased urinary flow ( median 2.5 mL/s from baseline ) . Decreases in dihydrotestosterone ( 86 % ) and prostate-specific antigen ( 54 % ) levels were also maintained . Long-term finasteride treatment was safe and generally well tolerated . CONCLUSIONS Long-term treatment with finasteride was well tolerated and result ed in durable symptom relief and improvement in prostate volume and urinary flow 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 question naire . 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 r and omized 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 BACKGROUND Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia ( BPH ) . METHODS This was a 6-month double-blind r and omized equivalence study that compared the effects of a plant extract ( 320 mg Permixon ) with those of a 5 alpha-reductase inhibitor ( 5 mg finasteride ) in 1,098 men with moderate BPH using the International Prostate Symptom Score ( IPSS ) as the primary end-point . RESULTS Both Permixon and finasteride decreased the IPSS ( -37 % and -39 % , respectively ) , improved quality of life ( by 38 and 41 % ) , and increased peak urinary flow rate ( + 25 % and + 30 % , P = 0.035 ) , with no statistical difference in the percent of responders with a 3 ml/sec improvement . Finasteride markedly decreased prostate volume ( -18 % ) and serum PSA levels ( -41 % ) ; Permixon improved symptoms with little effect on volume ( -6 % ) and no change in PSA levels . Permixon fared better than finasteride in a sexual function question naire and gave rise to less complaints of decreased libido and impotence . CONCLUSIONS Both treatments relieve the symptoms of BPH in about two-thirds of patients but , unlike finasteride , Permixon has little effect on so-called and rogen-dependent parameters . This suggests that other pathways might also be involved in the symptomatology of BPH INTRODUCTION Tadalafil ( TAD ) 5 mg coadministered with finasteride ( FIN ) 5 mg significantly improves lower urinary tract symptoms ( LUTS ) in men with benign prostatic hyperplasia ( BPH ) and prostatic enlargement . However , its effects on erectile/sexual function have yet to be fully described . AIM Assess the effects of TAD/FIN coadministration ( compared with placebo [PBO]/FIN ) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction ( ED ) . METHODS A r and omized , double-blind , PBO-controlled study of 695 men ( 610 sexually active ; 450 with baseline ED ; 404 sexually active with baseline ED ) conducted at 70 sites in 13 countries .  TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks . MAIN OUTCOME MEASURES International Index of Erectile Function ( IIEF ) domain and single-item scores ; proportions of patients who demonstrated minimal clinical ly important differences ( MCIDs ) in IIEF-Erectile Function domain scores ( IIEF-EF ; MCID defined as ≥4-point improvement ) ; and sexual dysfunction adverse events ( AEs ) . RESULTS Compared with PBO/FIN , TAD/FIN result ed in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED ( P ≤ 0.002 for all measures ) and among patients without baseline ED ( P ≤ 0.041 for all measures ) . Compared with PBO/FIN , significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4 , 12 , and 26 weeks of therapy ( P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints ) . The incidence of sexual AEs was low : five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs , including ED , decreased/lost libido , and ejaculation disorders . CONCLUSIONS TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated , regardless of the presence/absence of ED at treatment initiation OBJECTIVES To investigate the change in prostate volume and symptoms after discontinuation of 5alpha-reductase inhibitors ( 5ARIs ) in men with moderate to severe symptoms due to benign prostatic hyperplasia ( BPH ) . METHODS A total of 120 patients with BPH were enrolled from December 2004 to May 2008 . The patients were r and omized into 2 groups : group 1 received finasteride 5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily , and group 2 received dutasteride 0.5 mg plus alfuzocin 10 mg or tamsulosin 0.2 mg daily . All the patients received combination therapy for 1 year , followed by 1 year of alpha-blocker monotherapy . The prostate volume , International Prostate Symptom Score , and serum prostate-specific antigen level were determined at baseline and at 12 and 24 months after treatment . RESULTS At 1 year after treatment , the prostate volume was reduced by 24.5 % + /- 10.01 % ( P < .001 ) in group 1 and by 26.1 % + /- 5.06 % ( P < .001 ) in group 2 . One year after withdrawal of the 5ARIs , the prostate volume had increased by 20.7 % + /- 14.1 % ( P < .001 ) and 18.6 % + /- 7.4 % ( P < .001 ) in groups 1 and 2 , respectively , compared with at the end of 1 year of treatment . Furthermore , the International Prostate Symptom Score had significantly deteriorated at 1 year after cessation of the 5ARIs in both groups compared with the values at the end of 1 year of combination therapy . CONCLUSIONS Our data demonstrate that the discontinuation of 5ARIs during combination therapy induces prostate regrowth , as well as aggravation of symptoms in men with BPH . This result , therefore , suggests that the life-long use of 5ARIs should be considered for the prevention of BPH progression We studied the effects of 5 alpha-reductase inhibitor ( finasteride ) in the treatment of benign prostatic hyperplasia ( BPH ) . This study is a r and omized controlled trial . Sixty-two patients were treated with 5 alpha-reductase ( finasteride 5 mg/day ) and 61 patients  ( control group )  with placebo for one year . Prostatic volume , maximal urine flow rate , AUA symptom scoring , residual urine volume and prostate-specific antigen ( PSA ) levels were evaluated at 3 , 6 , 9 and 12 months . In the first 6 months prostatic volume decreased rapidly ( 20.5 % ) , in the second 6 months it decreased slowly and reached the maximal rate ( 23.3 % ) . Maximal urine flow rate increased in the second 6 months . AUA symptom scores decreased first at 3 months and were 4.6 points lower at the end of the 12th month . There were no significant changes in residual volume . The 5 alpha-reductase inhibitor caused a 50 % decrease in PSA levels , like in other studies .Becuase of the prolonged use of the drug , treatment with 5 alpha-reductase inhibitor is not tolerated by many patients and being expensive its future in the pharmacotherapy of BPH is unclear This study was design ed to determine the efficacy of the 5 alpha-reductase inhibitor finasteride ( Proscar , MK-906 ) in men with reduced urinary flow rates and symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia . Forty-five men were r and omized to one of three groups receiving either placebo , 1 mg/day or 5 mg/day finasteride for the first 12 months of the study period . At the end of this period all men received 5 mg/day finasteride for a further 2 years . Efficacy was determined by measurement of prostate volume , maximum urinary flow rate , and symptom score using a modified Boyarsky assessment . Prostate volume reduced by 20 and 27 % , respectively , for those on 1 and 5 mg after the first year . At 3 years the volume had reduced by 43 % . This reduction in prostate volume was associated with an improvement in maximum urinary flow rate by 50 % ( 1 mg ) , and 35 % ( 5 mg ) at 1 year , and 36 % at 3 years . The total , obstructive and non-obstructive symptom scores decreased ( improved ) for patients on 1 and 5 mg finasteride , with the total score reducing by 33 % from baseline at year 3 . The results demonstrate that finasteride causes a modest but significant clinical improvement in men with urinary outflow obstruction secondary 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 r and omly 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 result ed 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 PURPOSE We sought to quantify prostate tissue changes induced by finasteride and to identify a predictor of finasteride response in men with symptomatic benign prostatic hyperplasia ( BPH ) via a r and omized , placebo controlled , double-blind clinical trial . MATERIAL S AND METHODS Men with symptomatic BPH ( 52 to 78 years old ) were r and omly assigned to 6 months of treatment with finasteride ( 26 ) or placebo ( 15 ) . Outcome measures were clinical ( urinary symptom score and flow rate ) , chemical ( serum prostate specific antigen and dihydrotestosterone levels ) , volumetric ( transrectal ultrasound , and magnetic resonance imaging for whole and zonal prostate volumes ) and histological ( morphometry of prostate sextant biopsies , separated into inner and outer gl and segments , to measure the percent epithelium , stroma and gl and ular lumen ) . RESULTS In the finasteride group we found a suggestion of decreasing symptom scores and increasing flow rates ( not significant ) with significant decreases ( p < 0.01 ) in prostate specific antigen ( 48 % ) , dihydrotestosterone ( 74 % ) and prostate volume ( 21 % ) . Finasteride treatment induced a 55 % decrease in inner gl and epithelium ( p < 0.01 ) with little effect on stroma or lumina . We also found a linear correlation between pretreatment inner gl and epithelial content and prostate volume decrease induced by the drug ( tau = 0.58 , p = 0.01 ) . CONCLUSIONS Finasteride treatment results in a major suppression of prostate epithelium , which is most pronounced in the inner gl and . Moreover , a finasteride induced prostate volume decrease was predictable by quantification of epithelial tissues of the inner gl and . These data lend additional support to the emerging concept of transition zone primacy in symptomatic BPH BACKGROUND Finasteride , a 5 alpha-reductase inhibitor , has been shown to have beneficial effects in the treatment of benign prostatic hyperplasia . The long-term safety and efficacy of finasteride in the treatment of benign prostatic hyperplasia was assessed . METHODS In two multicenter , double-blind , placebo-controlled studies ( North American and international ) , patients with symptomatic benign prostatic hyperplasia were r and omly assigned to receive finasteride , 1 or 5 mg , or placebo for 1 year followed by an open-extension study in which all patients were treated with finasteride , 5 mg , regardless of original therapy . Men aged 40 to 80 years , in good physical and mental health , were eligible to enter the study . All patients were to have a maximum urinary flow rate of 15 mL/s or less with a voided volume of 150 mL or more , an enlarged prostate , and symptoms of urinary obstruction . Patients with a prostate-specific antigen level of 40 mg/mL or more or any finding suggestive of prostate cancer were excluded . RESULTS Two hundred ninety-eight patients received finasteride , 5 mg , continuously for 24 months . At the end of 24 months of finasteride therapy , the median prostate volume was reduced by 25 % , and 60 % of patients had a 20 % or greater reduction in prostate volume . Maximum urinary flow rate was improved by at least 2 mL/s , and symptoms were improved by approximately 3.5 points . Decreased libido and ejaculation disorders were the only drug-related adverse experiences reported in more than 1 % of patients . CONCLUSION These studies support the long-term safety and tolerability of finasteride , while demonstrating its continuing clinical efficacy in the treatment of patients with symptomatic benign prostatic hyperplasia BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0.001 ) was significantly greater than that associated with doxazosin ( P<0.001 ) or finasteride ( P<0.001 ) alone . The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy ( P<0.001 ) and finasteride ( P<0.001 ) but not by doxazosin . Doxazosin ( P<0.001 ) , finasteride ( P=0.001 ) , and combination therapy ( P<0.001 ) each result ed in significant improvement in symptom scores , with combination therapy being superior to both doxazosin ( P=0.006 ) and finasteride ( P<0.001 ) alone . CONCLUSIONS Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone . Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy
MAIN RESULTS 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 .
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 .
Finasteride improves long-term urinary symptoms versus placebo , but is less effective than doxazosin .
Long-term combination therapy with alpha blockers ( doxazosin , terazosin ) improves symptoms significantly better than finasteride monotherapy .
Finasteride + doxazosin improves symptoms equally - and clinical ly - to doxazosin alone .
Finasteride + doxazosin versus doxazosin  improves scores equally for short and long term .
Drug-related adverse effects for finasteride are rare ; nevertheless , men  taking  finasteride are at increased risk for impotence , erectile dysfunction , decreased libido , and ejaculation disorder , versus placebo .
Versus doxazosin , which has higher rates of dizziness , postural hypotension , and asthenia , men taking finasteride are at increased risk for impotence , erectile dysfunction , decreased libido , and ejaculation disorder .
Finasteride significantly reduces asthenia , postural hypotension , and dizziness versus terazosin .
Finasteride significantly lowers the risk of asthenia , dizziness , ejaculation disorder , and postural hypotension , versus finasteride + terazosin
BACKGROUND Benign prostatic hyperplasia ( BPH ) , a non-malignant enlargement of the prostate in aging men , can cause bothersome urinary symptoms ( intermittency , weak stream , straining , urgency , frequency , incomplete emptying ) .
Finasteride , a five-alpha reductase inhibitor ( 5ARI ) , blocks the conversion of testosterone to dihydrotestosterone , reduces prostate size , and is commonly used to treat symptoms associated with BPH .
OBJECTIVES To compare the clinical effectiveness and harms of finasteride versus placebo and active controls in the treatment of lower urinary tract symptoms ( LUTS ) .