Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Efficacy and Safety of Dutasteride in Chinese Adults with Symptomatic Benign Prostatic Hyperplasia : A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Extension. Efficacy and Safety of Dutasteride in Chinese Adults with Symptomatic Benign Prostatic Hyperplasia Effect of dutasteride on the symptoms of benign prostatic hyperplasia, and patient quality of life and discomfort, in clinical practice Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Dutasteride for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia: results of a phase III randomized open-label 3-year trial Effect of dutasteride on the risk of prostate cancer. The effect of dutasteride on the efficacy of photoselective vaporization of the prostate: results of a randomized, placebo-controlled, double-blind study (DOP trial). Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial Dutasteride reduces prostate size and prostate specific antigen in older hypogonadal men with benign prostatic hyperplasia undergoing testosterone replacement therapy. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: a randomized, double-blind, placebo-controlled, phase III study. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. Using a treatment satisfaction measure in an early trial to inform the evaluation of a new treatment for benign prostatic hyperplasia. Effect of Discontinuation of Tamsulosin in Korean Men with Benign Prostatic Hyperplasia Taking Tamsulosin and Dutasteride: An Open-Label, Prospective, Randomized Pilot Study. [Effect of dutasteride on reduction of intraoperative bleeding related to transurethral resection of the prostate].
OBJECTIVES To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia ( BPH ) . METHODS This was a r and omized , double-blind , placebo-controlled , parallel-group study . A total of 378 subjects with clinical BPH having an International Prostate Symptom Score ( IPSS ) of 8 points or greater , a prostate volume of 30 mL or greater , and a maximal urinary flow rate ( Qmax ) of 15 mL/s or less were r and omized to receive placebo or dutasteride once daily for 52 weeks . Subjects were stratified according to tamsulosin use at baseline . The numbers of subjects with and without tamsulosin  use were 242 and 136 , respectively . IPSS , Qmax , prostate volume and drug safety were evaluated . RESULTS Continued improvement in IPSS was noted in the dutasteride group , and dutasteride significantly decreased IPSS compared with placebo . At week 52 , dutasteride significantly improved Qmax and prostate volume compared with placebo . Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting . CONCLUSIONS Dutasteride improves urinary symptoms and flow rate and reduces prostate volume . In Japanese men with BPH , it is effective and generally well tolerated during the one-year treatment period BACKGROUND Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone , which plays a key role in the aetiology and development of benign prostatic hyperplasia ( BPH ) . Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian population s. OBJECTIVE This study aim ed to evaluate the efficacy and safety of dutasteride in Chinese adults with symptomatic BPH . METHODS This was a r and omized , double-blind , parallel-group , placebo-controlled study conducted over 6 months , followed by an open-label extension of 12 months . A total of 253 BPH subjects with a total prostate volume ( TPV ) of ≥30 cm3 , a maximal urinary flow rate ( Qmax ) between 5 and 15 mL/s , and an American Urology Association Symptom Index ( AUA-SI ) score of ≥12 units were r and omized to dutasteride 0.5 mg/day orally or matching placebo treatment in a 1 : 1 ratio . After 6 months , eligible subjects who volunteered to enter the open-label extension received dutasteride 0.5 mg/day orally . Changes in TPV , Qmax and AUA-SI as well as drug safety were evaluated . RESULTS Dutasteride significantly reduced mean TPV compared with placebo at 3 and 6 months ( both p<0.05 ) . At 6 months , mean TPV decreased by 17.14 % versus 3.71 % in the dutasteride and placebo groups , respectively . Numerically higher improvements in Qmax and AUA-SI were observed in the dutasteride group at 3 and 6 months , but there was no statistically significant difference between treatment groups . However , ad hoc analysis indicated that , at 6 months , significantly higher proportions of subjects in the dutasteride group experienced a Qmax improvement of ≥3 mL/s , or an AUA-SI improvement of ≥1 unit , compared with the placebo group ( both p<0.05 ) . According to these criteria , the Qmax responder rates were 33.63 % and 19.83 % in the dutasteride- and placebo-treated groups , respectively , and the AUA-SI responder rates were 87.61 % and 76.92 % , respectively . During the open-label extension , continuous improvements in TPV , Qmax and AUA-SI were noted in both groups . Dutasteride was well tolerated with a low incidence of treatment-related adverse events over 18 months . CONCLUSION Dutasteride was effective compared with placebo in the treatment of symptomatic BPH among Chinese patients . The efficacy data from trials involving subjects of different ethnic origins showed some similarities . Dutasteride was generally well tolerated during the study period Abstract Background : Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone , which plays a key role in the aetiology and development of benign prostatic hyperplasia ( BPH ) . Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian population s. Objective : This study aim ed to evaluate the efficacy and safety of dutasteride in Chinese adults with symptomatic BPH . Methods : This was a r and omized , double-blind , parallel-group , placebo-controlled study conducted over 6 months , followed by an open-label extension of 12 months . A total of 253 BPH subjects with a total prostate volume ( TPV ) of ≥30 cm3 , a maximal urinary flow rate ( Qmax ) between 5 and 15 mL/s , and an American Urology Association Symptom Index ( AUA-SI ) score of ≥12 units were r and omized to dutasteride 0.5 mg/day orally or matching placebo treatment in a 1 : 1 ratio . After 6 months , eligible subjects who volunteered to enter the open-label extension received dutasteride 0.5 mg/day orally . Changes in TPV , Qmax and AUA-SI as well as drug safety were evaluated . Results : Dutasteride significantly reduced mean TPV compared with placebo at 3 and 6 months ( both p<0.05 ) . At 6 months , mean TPV decreased by 17.14 % versus 3.71 % in the dutasteride and placebo groups , respectively . Numerically higher improvements in Qmax and AUA-SI were observed in the dutasteride group at 3 and 6 months , but there was no statistically significant difference between treatment groups . However , ad hoc analysis indicated that , at 6 months , significantly higher proportions of subjects in the dutasteride group experienced a Qmax improvement of ≥3 mL/s , or an AUA-SI improvement of ≥1 unit , compared with the placebo group ( both p<0.05 ) . According to these criteria , the Qmax responder rates were 33.63 % and 19.83 % in the dutasteride- and placebo-treated groups , respectively , and the AUA-SI responder rates were 87.61 % and 76.92 % , respectively . During the open-label extension , continuous improvements in TPV , Qmax and AUA-SI were noted in both groups . Dutasteride was well tolerated with a low incidence of treatment-related adverse events over 18 months . Conclusion : Dutasteride was effective compared with placebo in the treatment of symptomatic BPH among Chinese patients . The efficacy data from trials involving subjects of different ethnic origins showed some similarities . Dutasteride was generally well tolerated during the study period To assess the improvements in symptoms , quality of life ( QoL ) , discomfort and satisfaction in patients with symptomatic benign prostatic hyperplasia ( BPH ) treated with dutasteride in clinical practice OBJECTIVE To report additional analyses of efficacy over the initial 2 years and during a 2-year open-label extension of the three pivotal phase 3 studies in which dutasteride , a dual inhibitor of type 1 and 2 5alpha-reductase , was shown to be effective and well tolerated . PATIENTS AND METHODS All patients in the placebo and active groups were eligible for entry into the 2-year open-label extension , with all receiving dutasteride 0.5 mg daily . Mean changes from baseline were calculated for the American Urologic Association Symptom Index ( AUA-SI ) score at each scheduled time in the double-blind and open-label phase . The additional analyses included a breakdown of the AUA-SI score , including stratifying patients by symptom severity , assessment by baseline age and prostate volume , and the evaluation of symptoms responders . RESULTS There was a clinical ly meaningful improvement in AUA-SI in patients on dutasteride in the double-blind phase , but not in those on placebo . At 48 months , patients on dutasteride in both study phases had greater improvements in AUA-SI score and individual question scores than those on dutasteride in the open-label phase only . The proportion of patients with severe symptoms declined in both study groups , although these changes were more profound in those receiving dutasteride for the 4-year duration of the study . CONCLUSION In men with symptomatic benign prostatic hyperplasia , long-term ( 4-year ) treatment with the dual isozyme 5alpha-reductase inhibitor dutasteride result ed in sustained and continued improvements in symptoms and flow rate . For 4 vs 2 years , longer dutasteride therapy result ed in greater symptom improvement OBJECTIVES To study the efficacy and safety of dutasteride , a dual inhibitor of the 5-alpha-reductase isoenzymes types I and II . METHODS A total of 4325 men ( 2951 completed ) with clinical benign prostatic hyperplasia , moderate to severe symptoms ( American Urological Association-Symptom Index score of 12 points or greater ) , a peak flow rate of 15 mL/s or less , a prostate volume of 30 cm3 or greater ( as measured by transrectal ultrasonography ) , and a serum prostate-specific antigen level of 1.5 to 10.0 ng/mL ( inclusive ) were enrolled into three identical clinical trials and r and omized to 0.5 mg dutasteride daily or placebo . After a 1-month , single-blind , placebo lead-in , patients were followed up for 24 months in a double-blind trial with multiple interval assessment s. RESULTS At 24 months , serum dihydrotestosterone was reduced from baseline by a mean of 90.2 % ( median -93.7 % ; P < 0.001 ) , and the total prostate and transition zone volumes were reduced by a mean of 25.7 % and 20.4 % , respectively ( P < 0.001 ) . The symptom score was improved by as early as 3 months , with pooled significance from 6 months onward ( P < 0.001 ) and a reduction of 4.5 points ( 21.4 % ) at 24 months ( P < 0.001 ) . The maximal flow rate improved significantly from 1 month ( P < 0.01 ) , with an increase of 2.2 mL/s reported at 24 months ( P < 0.001 ) . Hence , the risk reduction of acute urinary retention was 57 % and the risk reduction of benign prostatic hyperplasia-related surgical intervention was 48 % compared with placebo . The drug was well tolerated . CONCLUSIONS Dutasteride is a potent inhibitor of dihydrotestosterone production that is safe and effective in terms of the reduction of prostate volume and symptoms , flow rate improvement , and the reduction of the risk of acute urinary retention and surgery during a 24-month study period Purpose High- grade prostatic intraepithelial neoplasia ( HGPIN ) is a potential precursor of prostate cancer ( PCa ) , and patients with HGPIN are at high risk for PCa development . Objective of our study was to evaluate the efficacy of dutasteride 0.5 mg in PCa prevention among men with isolated HGPIN on biopsy . Methods This prospect i ve , r and omized , phase III , open-label 3-year trial assessed dutasteride versus active surveillance in patients with HGPIN . Patients were r and omized to dutasteride 0.5 mg daily or active surveillance . Per- protocol prostate biopsies were performed at 6 , 12 , 24 , and 36 months until cancer detection or study end . The primary end point was cancer-free survival ( CFS ) . An intention-to-treat analysis was done for patients who underwent at least one per- protocol biopsy . An efficacy analysis was done for patients who completed the study . CFS was evaluated using Kaplan – Meier and log-rank analysis . Results In total , 220 men were r and omized ( dutasteride  , n = 107 ; surveillance , n = 113 ) . PCa was detected in 47.6 : 49.1 % in the surveillance group and 45.9 % in the treatment group ( p = 0.66 ) . The detected PCa differentiation by Gleason score ( GS ) was GS 6 in 76.9 % , GS 7 in 19.8 % , and GS ≥ 8 in 3.3 % , with no difference between groups . The 3-year PCa-free survival was 43.6 % in the surveillance and 49.6 % in the dutasteride group ( log rank p = 0.57 ) . Limitations include a relatively high non-adherence rate , open-label design , and baseline sextant biopsy scheme . Conclusions Dutasteride 0.5 mg for 3 years did not lower the PCa detection rate but did not worsen detected PCa characteristics in men with HGPIN BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo .  Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 . OBJECTIVES To study the effect of Dutasteride on the efficacy of GreenLight photoselective vaporization of the prostate ( PV ) . Some investigators have suggested that 5 alpha-reductase inhibitors may interfere with PV by reducing intraprostatic blood flow . Dutasteride offers the most complete blockade of the 5 alpha-reductase inhibitors , with minimal increase in side effects . METHODS This is a prospect i ve , placebo-controlled , r and omized , double-blind study . A total of 59 patients were r and omized to either dutasteride 0.5 mg or placebo  for 3 months before and 12 months after PV .  Surgical time , joules used , estimated blood loss , and ease of the procedure were compared . Other clinical end points investigated include postsurgical catheter time , hematuria , dysuria , urinary flow parameters , American Urological Association symptom score , benign prostatic hyperplasia quality of life score , prostate volume , and prostate-specific antigen level . RESULTS Average surgical time and joules used were 12 % ( P = .24 ) and 16 % ( P = .15 ) less , respectively , for dutasteride patients compared with placebo .  Estimated blood loss was also lower in the treatment group ( P = .14 ) . However , these results were not statistically significant . Surgeon-rated ease of the procedure was comparable between the 2 groups . There were no significant differences in catheter time , dysuria , quality of life scores , or urinary flow parameters . Quality of life and urinary parameters markedly improved after PV . CONCLUSIONS Compared with patients r and omized to placebo , patients r and omized to dutasteride experienced a trend toward decreased time , joules used , and blood loss during surgery . Although we could not convincingly prove an operative benefit of treatment with dutasteride before surgery , we have demonstrated the efficacy of PV in men receiving dutasteride BACKGROUND We aim ed to investigate the safety and efficacy of dutasteride , a 5α-reductase inhibitor , on prostate cancer progression in men with low-risk disease who chose to be followed up with active surveillance . METHODS In our 3 year , r and omised , double-blind , placebo-controlled study , undertaken at 65 academic medical centres or outpatient clinics in North America , we enrolled men aged 48 - 82 years who had low-volume , Gleason score 5 - 6 prostate cancer and had chosen to be followed up with active surveillance . We r and omly allocated participants in a one-to-one ratio , stratified by site and in block sizes of four , to receive once-daily dutasteride 0·5 mg or matching placebo . Participants were followed up for 3 years , with 12-core prostate biopsy sample s obtained after 18 months and 3 years . The primary endpoint was time to prostate cancer progression , defined as the number of days between the start of study treatment and the earlier of either pathological progression ( in patients with ≥1 biopsy assessment after baseline ) or therapeutic progression ( start of medical therapy ) . This trial is registered with Clinical Trials.gov , number NCT00363311 . FINDINGS Between Aug 10 , 2006 , and March 26 , 2007 , we r and omly allocated 302 participants , of whom 289 ( 96 % ) had at least one biopsy procedure after baseline and were included in the primary analysis . By 3 years , 54 ( 38 % ) of 144 men in the dutasteride group and 70 ( 48 % ) of 145 controls had prostate cancer progression ( pathological or therapeutic ; hazard ratio 0·62 , 95 % CI 0·43 - 0·89 ; p=0·009 ) . Incidence of adverse events was much the same between treatment groups . 35 ( 24 % ) men in the dutasteride group and 23 ( 15 % ) controls had sexual adverse events or breast enlargement or tenderness . Eight ( 5 % ) men in the dutasteride group and seven ( 5 % ) controls had cardiovascular adverse events , but there were no prostate cancer-related deaths or instances of metastatic disease . INTERPRETATION Dutasteride could provide a beneficial adjunct to active surveillance for men with low-risk prostate cancer . FUNDING GlaxoSmithKline PURPOSE Benign prostatic hyperplasia and hypogonadism are common disorders in aging men . There is concern that and rogen replacement in older men may increase prostate size and symptoms of benign prostatic hyperplasia . We examined whether combining dutasteride , which inhibits testosterone to dihydrotestosterone conversion , with testosterone treatment in older hypogonadal men with benign prostatic hyperplasia reduces and rogenic stimulation of the prostate compared to testosterone alone . MATERIAL S AND METHODS We conducted a double-blind , placebo controlled trial of 53 men 51 to 82 years old with symptomatic benign prostatic hyperplasia , prostate volume 30 cc or greater and serum total testosterone less than 280 ng/dl ( less than 9.7 nmol/l ) . Subjects were r and omized to daily transdermal 1 % T gel plus oral placebo or dutasteride for 6 months . Testosterone dosing was adjusted to a serum testosterone of 500 to 1,000 ng/dl . The primary outcomes were prostate volume measured by magnetic resonance imaging , serum prostate specific antigen and and rogen levels . RESULTS A total of 46 subjects completed all procedures . Serum testosterone increased similarly into the mid-normal range in both groups . Serum dihydrotestosterone increased in the testosterone only but decreased in the testosterone plus dutasteride group . In the testosterone plus dutasteride  group prostate volume and prostate specific antigen ( mean ± SEM ) decreased 12 % ± 2.5 % and 35 % ± 5 % , respectively , compared to the testosterone only group in which prostate volume and prostate specific antigen increased 7.5 % ± 3.3 % and 19 % ± 7 % ( p = 0.03 and p = 0.008 ) , respectively , after 6 months of treatment . Prostate symptom scores improved in both groups . CONCLUSIONS Combined treatment with testosterone plus dutasteride reduces prostate volume and prostate specific antigen compared to testosterone only . Coadministration of a 5α-reductase inhibitor with testosterone appears to spare the prostate from and rogenic stimulation during testosterone replacement in older , hypogonadal men with symptomatic benign prostatic hyperplasia BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) BACKGROUND Dutasteride ( Avodart ) is a dual inhibitor of both type I and type II 5 alpha reductases , and thus inhibits conversion of testosterone to dihydrotestosterone , a key mediator of male pattern hair loss . OBJECTIVES The aim of this r and omized double-blind phase III study was to compare the efficacy , safety , and tolerability of dutasteride ( 0.5 mg ) and placebo for 6 months of treatment in male patients with male pattern hair loss . METHODS A total of 153 men , 18 to 49 years old , were r and omized to receive 0.5 mg of dutasteride or placebo daily for 6 months . Efficacy was evaluated by the change of hair counts , subject assessment , and photographic assessment by investigators and panels . RESULTS Mean change of hair counts from baseline to 6 months after treatment start was an increase of 12.2/cm(2 ) in dutasteride group and 4.7/cm(2 ) in placebo group and this difference was statistically significant ( P = .0319 ) . Dutasteride showed significantly higher efficacy than placebo group by subject self- assessment and by investigator and panel photographic assessment . There was no major difference in adverse events between two groups . LIMITATIONS The study was limited to 6 months . CONCLUSIONS This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss PURPOSE We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement ( 30 cc or greater ) . We report preplanned 2-year analyses . MATERIAL S AND METHODS The CombAT study is an ongoing , multicenter , r and omized , double-blind , parallel group study . Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia , International Prostate Symptom Score 12 points or greater , prostate volume 30 cc or greater , total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were r and omized to 0.5 mg dutasteride , 0.4 mg tamsulosin or the combination once daily for 4 years . Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months . The primary end point at 2 years was the change in International Prostate Symptom Score from baseline . RESULTS Combination therapy result ed in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9 , and in benign prostatic hyperplasia related health status from months 3 and 12 , respectively . There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6 . There was a significant increase in drug related adverse events with combination therapy vs monotherapies , although most did not result in the cessation of therapy . CONCLUSIONS In men with moderate to severe lower urinary tract symptoms and prostate enlargement ( 30 cc or greater ) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy OBJECTIVE This article describes the results of an exploratory analysis of treatment satisfaction data from a phase 2 study to inform the evaluation of a new treatment for benign prostatic hyperplasia ( BPH ) . METHODS The study was a r and omized , placebo-controlled , double blind trial comparing three doses ( low , medium , and high ) of a new uro-selective alpha-blocker with an active comparator . A total of 536 men aged 40 years and older with lower urinary tract symptoms ( LUTS ) result ing from BPH were r and omized into the study . Patients ' perceptions of satisfaction with efficacy , dosing , and side effects were explored using a vali date d disease-specific instrument , the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ) . The TSS-BPH was administered at the end of the study or at withdrawal . RESULTS Compared with placebo , the medium and high doses showed the greatest efficacy on the primary endpoint , the International Prostate Symptom Score ( IPSS ) . Patient satisfaction with efficacy at these doses was significantly better than that for placebo . Nevertheless , adverse events were most frequent in the high dose group . Satisfaction with side effects was significantly worse than placebo for this group , and this was reflected in the total scores on the TSS-BPH , with patients being most satisfied overall with the medium dose . CONCLUSIONS Exploring patients ' treatment satisfaction with medication in early trials using multidimensional measures provides an overall evaluation of efficacy and side effects , and can be used to inform the selection of doses for later trials . This is especially useful for products that require adherence with medication over long periods of time OBJECTIVE This study was conducted to examine the effect of discontinuing tamsulosin in patients with benign prostatic hyperplasia who had been receiving combination therapy with tamsulosin and dutasteride . METHODS The study sample consisted of 108 men with benign prostatic hyperplasia and lower urinary tract symptoms who visited our urology clinics between April 2008 and December 2010 . All were assessed using the International Prostate Symptom Score ( IPSS ) .  The patients had IPSS of 8 - 19 and prostate volumes ≥25 mL by transrectal ultrasonography . They were put on tamsulosin and dutasteride , and the efficacy of this regimen was assessed every 12 weeks . After 48 weeks , patients were divided at r and om into a group continuing to take the same drug combination ( group 1 ) and a group taking only dutasteride 0.5 mg ( group 2 ) . RESULTS Sixty-nine of the original 108 patients completed the study , 36 ( 52 % ) in group 1 and 33 ( 48 % ) in group 2 . The mean age of all patients was 67.96 ± 7.88 years and mean prostatic volume was 40.45 ± 12.81 mL. Mean prostate-specific antigen was 3.31 ( 0.4 - 9.9 ) ng/mL at the outset . The IPSS scores of the two groups at first visit , 48 and 72 weeks were , respectively , 14.69 versus 15.85 ( P = 0.322 ) , 12.08 versus 12.85 ( P = 0.582 ) and 10.89 versus 11.06 ( P = 0.897 . ) There was a statistically significant difference between the baseline and 72-week IPSS scores in both groups ( group 1 : P < 0.001 , group 2 : P < 0.001 ) . CONCLUSION In patients with moderate IPSS , discontinuing tamsulosin after 48 weeks of combined tamsulosin and dutasteride therapy has no significant effect on outcome OBJECTIVE The pharmacological action of 5-alpha-reductase inhibitors ( 5-ARI ) would reduce angiogenesis associated with benign prostatic hyperplasia ( BPH ) , thereby decreasing peroperative bleeding during transurethral resection of the prostate ( TURP ) . Dutasteride , a double inhibitor of 5-alpha-reductase iso-enzymes types 1 and 2 , was not been previously studied in the context of reduction of peroperative bleeding related to TURP . MATERIAL AND METHODS We conducted a multicentre , r and omized , double-blind , placebo-controlled , parallel group study to evaluate the efficacy of dutasteride 0.5 mg per day , in peroperative bleeding related to TURP for BPH in patients over the age of 50 years with a prostatic volume greater than 30 cm3 . Treatment was administered for 4 weeks before the operation . The primary endpoint was haemoglobin , expressed in grams , and expressed in relation to the weight of prostate resected , also expressed in grams . RESULTS 59 patients were evaluated ( 32 treated with dutasteride and 27 treated with placebo ) . A significant difference in peroperative bleeding was observed between the dutasteride group ( 1.944 + /- 1.816 g of Hb/g of prostate resected ) and the placebo group ( 1.401 + /- 1.021 g of Hb/g of prostate resected ) . Preoperative treatment was well tolerated . CONCLUSION The working hypothesis of the study was not confirmed due to the low bleeding rate in the placebo group and the results suggest that a longer duration of treatment with dutasteride would reduce intraoperative and postoperative bleeding in TURP
When comparing dutasteride with finasteride , no significant differences in symptom improvement or the rate of adverse events were observed .
Conclusions Dutasteride can be used to improve urinary symptoms ( IPSS and Qmax ) and reduce TPV but with awareness of its potential adverse events .
Purpose To determine the efficacy and safety of dutasteride , alone or in combination , versus a placebo or control , used for the treatment of benign prostatic hyperplasia .