human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE We evaluated the long-term ( up to 6 years ) safety and efficacy of the selective alpha 1A-adrenoceptor antagonist tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 609 patients were enrolled in a 4-year multicenter open label extension study . Subjects entered the study after completion of a 1-year open label trial that included patients who previously completed up to 57 weeks of double-blind , placebo controlled studies . Maintenance doses ( 0.4 or 2 x 0.4 mg daily ) established in the 1-year study were continued . Efficacy and safety were assessed every 3 months . Primary efficacy evaluations were changes from baseline maximum urine flow rate and total American Urological Association symptom index , and the responder rates for those 2 end points . Secondary end points were changes in American Urological Association subset scores , Boyarsky symptom scores , average urine flow rate , post-void residual urine volume , quality of life index and investigator global assessment . RESULTS Of the 609 patients who entered the 4-year extension study 159 had a 2-year or greater prior experience with tamsulosin , yielding a potential 6-year experience on the medication . Of this 159 patient subset 109 completed the whole 6 years . Initial rapid improvements from baseline in primary and secondary end points were maintained each year throughout the duration of the study . Tamsulosin was well tolerated , confirming the safety profile demonstrated in earlier studies . Orthostatic hypotension was observed in 1.3 % of the patients . CONCLUSIONS This study demonstrates the sustained efficacy , safety and excellent long-term tolerability of tamsulosin for up to 6 years in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia AIMS To evaluate the efficacy and treatment satisfaction with low-dose ( 0.2 mg ) tamsulosin in patients with symptomatic benign prostatic hyperplasia ( BPH ) , and to investigate individual lower urinary tract symptoms according to treatment satisfaction . METHODS A cross-sectional study was conducted in a total sample of 2574 patients from multiple centres .  International Prostate Symptom Score ( IPSS ) , prostate volume , uroflowmetry and combined medications were review ed . Detailed question naires were used to assess treatment satisfaction and IPSS 8 weeks after treatment with low-dose tamsulosin . RESULTS After 8 weeks of treatment with low-dose tamsulosin , IPSS improved significantly . Among the 2574 patients , 1,630 ( 63.42 % ) were satisfied and 940 patients ( 36.50 % ) were dissatisfied with low-dose tamsulosin . The reasons for dissatisfaction included efficacy problems ( 84.66 % ) and side effects ( 3.72 % ) . Treatment satisfaction was affected by symptom duration , baseline IPSS , and prostate size ( p = 0.0441 , < 0.001 , < 0.009 , respectively ) . IPSS voiding ( IPSS-V ) and IPSS storage ( IPSS-S ) after treatment differed significantly depending on the degree of satisfaction ( p < 0.001 ) . IPSS-V after treatment did not improve in patients who were ' not satisfied ' or ' totally not satisfied ' ( p = 0.170 , 0.240 , respectively ) . All the individual IPSS items except urgency ( p = 0.1436 ) varied significantly with the degree of satisfaction ( p < 0.001 ) . CONCLUSIONS Treating symptomatic BPH with low-dose tamsulosin improved IPSS , but more than one-third of patients were dissatisfied with the treatment . The main reason for dissatisfaction was efficacy problems , and the degree of satisfaction was related to symptom duration , baseline IPSS , and prostate size , and also to IPSS-V. In patients with severe LUTS , the tamsulosin dose should be increased earlier BACKGROUND Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China OBJECTIVE To determine whether transrectal ultrasonography ( TRUS ) can predict the clinical response of patients with benign prostatic hypertrophy ( BPH ) to alpha 1-blocker and anti- and rogen therapy . PATIENTS AND METHODS From April 1994 to July 1995 , 128 patients with BPH were r and omized to treatment for 6 months with either tamsulosin ( a long-acting selective alpha 1-blocker ) or allylestrenol ( an anti- and rogen ) , with 64 patients receiving tamsulosin ( 0.2 mg/day ) and 64 receiving allylestrenol ( 50 mg/day ) . The results of TRUS , uroflowmetry and the American Urologic Association ( AUA ) symptom score were compared before and after treatment . TRUS was used to calculate the transition zone ( TZ ) volume , transition zone ratio ( TZ ratio = TZ volume/total prostate volume ) , total prostate volume and prostate-specific antigen density ( PSAD ) . RESULTS Both groups showed a statistically significant improvement in the AUA symptom score , quality -of-life ( QOL ) score and peak urinary flow rate ( Qmax ) at 6 months ( P < 0.001 ) . In the tamsulosin group , there was a significant negative correlation between the pretreatment PSAD and the percentage change in Qmax ( r = -0.640 , P < 0.001 ) , while there was a positive correlation between PSAD and the percentage change in the AUA symptom score ( r = 0.589 , P < 0.001 ) . On the other h and , the allylestrenol group showed a significant positive correlation between PSAD and the percentage change in Qmax ( r = 0.397 , P < 0.01 ) and a negative correlation between PSAD and the AUA symptom score ( r = -0.313 , P < 0.01 ) . CONCLUSION Patients with a high pretreatment PSAD responded well to anti- and rogen therapy , while those with a low PSAD responded better to alpha 1-blocker therapy Purpose To compare the efficacy and safety of Sulosin D ( PACIFICPHARMA , Korea ) and Harnal D ( ASTELLAS PHARMA KOREA , Korea ) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) . Material s and Methods This r and omized , controlled , open-label , multicenter non-inferiority study was conducted at four sites in Korea . We r and omly assigned 123 patients with an International Prostate Symptom Score ( IPSS ) ≥12 to receive either Sulosin D or Harnal D treatment for 8 weeks . The primary outcome was the mean change in IPSS from baseline to endpoint . Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores , maximum uroflowmetry ( Qmax ) , and post-voiding residuals ( PVR ) . Results In all , 123 patients were r and omly assigned ( 60 Sulosin D and 63 Harnal D ) . The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03 , respectively . There were significant decreases compared with baseline in both groups . The mean difference ( Sulosin D - Harnal D ) was -0.91 ( with a two-sided 90 % confidence interval ) , inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore , Qmax , and PVR from baseline were comparable between the groups ( both p>0.05 ) . During the treatment periods , the incidence of adverse events was 23.33 % and 34.92 % in the Sulosin D and Harnal D groups , respectively ( p=0.1580 ) . Conclusions We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH OBJECTIVES To evaluate the long-term efficacy and safety of once-daily tamsulosin ( 0.4 and 0.8 mg ) , a unique selective alpha1A-adrenoceptor antagonist in patients with benign prostatic hyperplasia ( BPH ) . METHODS This trial extended a 13-week , Phase III multicenter placebo-controlled , double-blind outpatient trial for an additional 40 weeks . Of 618 patients , 418 ( 68 % ) continued into the extension phase on the same double-blind medication and dose . The primary efficacy parameters were total American Urological Association ( AUA ) symptom score and maximum urinary flow ( Qmax ) . RESULTS The mean changes in AUA symptom score from baseline to end point were statistically significant in all groups ( P < 0.001 ) . Significant improvements were observed in Qmax for both tamsulosin groups but not for the placebo group . The statistically significant improvements from baseline in efficacy parameters observed for each tamsulosin group at the end of the 13-week Phase III trial were maintained during the long-term extension phase . Tamsulosin at both dosages was well tolerated as maintenance therapy . Clinical ly significant orthostatic hypotension was not observed . Vital sign changes in either hypertensive or normotensive patients were not clinical ly significantly different across the three groups . CONCLUSIONS Tamsulosin once-daily at 0.4 or 0.8 mg was shown to be effective , safe , and well tolerated in the target BPH population during long-term use To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists , we compared a selective ( tamsulosin ) and non-selective ( terazosin ) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia ( BPH ) . The study was a single-blind , r and omized , multicenter design to compare a fixed dose of tamsulosin ( 0.2 mg ) or terazosin ( 2 mg ) given once daily after breakfast for four weeks . A total of 212 patients were enrolled with 201 patients included in the analysis . The primary variables assessed were changes in total International Prostatic Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , and average urinary flow rate ( AFR ) four weeks after dosing . Adverse events were recorded through the treatment period . Both tamsulosin and terazosin produced significant improvements in total IPSS ( total score of 11.8 + /- 4.5 ; decrease in 45.1 % and total score of 13.3 + /- 5.3 ; decrease in 39.0 % , respectively ) ( p < 0.001 ) , Qmax ( 13.2 + /- 4.1 mL/s , 37.5 % increase and 13.6 + /- 3.6 mL/s , 30.8 % increase , respectively ) ( p < 0.001 ) and AFR ( 7.7 + /- 3.3 mL/s , 37.5 % increase and 7.8 + /- 3.1 mL/s , 25.8 % increase , respectively ) ( p < 0.001 ) at endpoint . Tamsulosin was superior to terazosin in improvement of total IPSS ( p < 0.05 ) and AFR ( p < 0.05 ) . The incidence of adverse events by administration of tamsulosin was less than that by terazosin ( 13 and 50 , respectively ; p < 0.01 ) . Among the adverse event , incidence of dizziness ( p < 0.001 ) and hypotension ( p < 0.01 ) by administration of terazosin were significantly greater than that by tamsulosin . Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin ( p < 0 
    Output:
    
agent
Although this study did not consider placebo effect and has high IPSS baseline scores , this study clarifies that low-dose tamsulosin has generally positive effect and safety in treatment of LUTS and could be a suitable option as an initial treatment , especially for patients with low body mass index , as is typical of Asian people
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE We evaluated the long-term ( up to 6 years ) safety and efficacy of the selective alpha 1A-adrenoceptor antagonist tamsulosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 609 patients were enrolled in a 4-year multicenter open label extension study . Subjects entered the study after completion of a 1-year open label trial that included patients who previously completed up to 57 weeks of double-blind , placebo controlled studies . Maintenance doses ( 0.4 or 2 x 0.4 mg daily ) established in the 1-year study were continued . Efficacy and safety were assessed every 3 months . Primary efficacy evaluations were changes from baseline maximum urine flow rate and total American Urological Association symptom index , and the responder rates for those 2 end points . Secondary end points were changes in American Urological Association subset scores , Boyarsky symptom scores , average urine flow rate , post-void residual urine volume , quality of life index and investigator global assessment . RESULTS Of the 609 patients who entered the 4-year extension study 159 had a 2-year or greater prior experience with tamsulosin , yielding a potential 6-year experience on the medication . Of this 159 patient subset 109 completed the whole 6 years . Initial rapid improvements from baseline in primary and secondary end points were maintained each year throughout the duration of the study . Tamsulosin was well tolerated , confirming the safety profile demonstrated in earlier studies . Orthostatic hypotension was observed in 1.3 % of the patients . CONCLUSIONS This study demonstrates the sustained efficacy , safety and excellent long-term tolerability of tamsulosin for up to 6 years in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia AIMS To evaluate the efficacy and treatment satisfaction with low-dose ( 0.2 mg ) tamsulosin in patients with symptomatic benign prostatic hyperplasia ( BPH ) , and to investigate individual lower urinary tract symptoms according to treatment satisfaction . METHODS A cross-sectional study was conducted in a total sample of 2574 patients from multiple centres .  International Prostate Symptom Score ( IPSS ) , prostate volume , uroflowmetry and combined medications were review ed . Detailed question naires were used to assess treatment satisfaction and IPSS 8 weeks after treatment with low-dose tamsulosin . RESULTS After 8 weeks of treatment with low-dose tamsulosin , IPSS improved significantly . Among the 2574 patients , 1,630 ( 63.42 % ) were satisfied and 940 patients ( 36.50 % ) were dissatisfied with low-dose tamsulosin . The reasons for dissatisfaction included efficacy problems ( 84.66 % ) and side effects ( 3.72 % ) . Treatment satisfaction was affected by symptom duration , baseline IPSS , and prostate size ( p = 0.0441 , < 0.001 , < 0.009 , respectively ) . IPSS voiding ( IPSS-V ) and IPSS storage ( IPSS-S ) after treatment differed significantly depending on the degree of satisfaction ( p < 0.001 ) . IPSS-V after treatment did not improve in patients who were ' not satisfied ' or ' totally not satisfied ' ( p = 0.170 , 0.240 , respectively ) . All the individual IPSS items except urgency ( p = 0.1436 ) varied significantly with the degree of satisfaction ( p < 0.001 ) . CONCLUSIONS Treating symptomatic BPH with low-dose tamsulosin improved IPSS , but more than one-third of patients were dissatisfied with the treatment . The main reason for dissatisfaction was efficacy problems , and the degree of satisfaction was related to symptom duration , baseline IPSS , and prostate size , and also to IPSS-V. In patients with severe LUTS , the tamsulosin dose should be increased earlier BACKGROUND Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia ( BPH ) symptoms after the first dose and achieve long-term efficacy in European and American population s ; however , the corresponding studies from China are rarely seen . The purpose of this study was to evaluate the long-term efficacy and safety of tamsulosin hydrochloride 0.2 mg once daily in patients with lower urinary tract symptoms ( LUTS ) suggestive of BPH in China . METHODS Chinese patients with LUTS suggestive of BPH were enrolled in a 4-week placebo run-in period and subsequent 60-week open-label study . Tamsulosin hydrochloride 0.2 mg was administered daily during the period of the study . The efficacy and safety parameters were evaluated at the end of treatment period I ( 0 - 12 weeks ) and period II ( 13 - 60 weeks ) . The BPH patients were divided into tamsulosin monotherapy group and combination therapy group which received concomitant medication of finasteride 5 mg once daily after the evaluation at the end of treatment period I. RESULTS A total of 113 patients were recruited to the study . Eighty-two patients received tamsulosin monotherapy and twenty-nine received combination therapy during the treatment period II . Tamsulosin hydrochloride produced a great improvement in mean maximum urinary flow rate ( Q(max ) ) ( 1.7 ml/s , 3 ml/s ) and a significant decrease in mean international prostate symptom score ( IPSS ) ( 4.1 , 6.4 ) after 12-week and 60-week treatments , respectively . At the end of treatment period II , there were significant improvement in IPSS , quality of life ( QOL ) score , Q(max ) and average flow rate ( Q(ave ) ) for combination therapy group compared with the treatment period I ( all P < 0.05 ) . No serious adverse events ( SAE ) were recorded during the study . CONCLUSION Long-term tamsulosin hydrochloride therapy is a safe , effective and well-tolerated method for the treatment for LUTS suggestive of BPH in China OBJECTIVE To determine whether transrectal ultrasonography ( TRUS ) can predict the clinical response of patients with benign prostatic hypertrophy ( BPH ) to alpha 1-blocker and anti- and rogen therapy . PATIENTS AND METHODS From April 1994 to July 1995 , 128 patients with BPH were r and omized to treatment for 6 months with either tamsulosin ( a long-acting selective alpha 1-blocker ) or allylestrenol ( an anti- and rogen ) , with 64 patients receiving tamsulosin ( 0.2 mg/day ) and 64 receiving allylestrenol ( 50 mg/day ) . The results of TRUS , uroflowmetry and the American Urologic Association ( AUA ) symptom score were compared before and after treatment . TRUS was used to calculate the transition zone ( TZ ) volume , transition zone ratio ( TZ ratio = TZ volume/total prostate volume ) , total prostate volume and prostate-specific antigen density ( PSAD ) . RESULTS Both groups showed a statistically significant improvement in the AUA symptom score , quality -of-life ( QOL ) score and peak urinary flow rate ( Qmax ) at 6 months ( P < 0.001 ) . In the tamsulosin group , there was a significant negative correlation between the pretreatment PSAD and the percentage change in Qmax ( r = -0.640 , P < 0.001 ) , while there was a positive correlation between PSAD and the percentage change in the AUA symptom score ( r = 0.589 , P < 0.001 ) . On the other h and , the allylestrenol group showed a significant positive correlation between PSAD and the percentage change in Qmax ( r = 0.397 , P < 0.01 ) and a negative correlation between PSAD and the AUA symptom score ( r = -0.313 , P < 0.01 ) . CONCLUSION Patients with a high pretreatment PSAD responded well to anti- and rogen therapy , while those with a low PSAD responded better to alpha 1-blocker therapy Purpose To compare the efficacy and safety of Sulosin D ( PACIFICPHARMA , Korea ) and Harnal D ( ASTELLAS PHARMA KOREA , Korea ) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia ( BPH ) . Material s and Methods This r and omized , controlled , open-label , multicenter non-inferiority study was conducted at four sites in Korea . We r and omly assigned 123 patients with an International Prostate Symptom Score ( IPSS ) ≥12 to receive either Sulosin D or Harnal D treatment for 8 weeks . The primary outcome was the mean change in IPSS from baseline to endpoint . Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores , maximum uroflowmetry ( Qmax ) , and post-voiding residuals ( PVR ) . Results In all , 123 patients were r and omly assigned ( 60 Sulosin D and 63 Harnal D ) . The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03 , respectively . There were significant decreases compared with baseline in both groups . The mean difference ( Sulosin D - Harnal D ) was -0.91 ( with a two-sided 90 % confidence interval ) , inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore , Qmax , and PVR from baseline were comparable between the groups ( both p>0.05 ) . During the treatment periods , the incidence of adverse events was 23.33 % and 34.92 % in the Sulosin D and Harnal D groups , respectively ( p=0.1580 ) . Conclusions We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH OBJECTIVES To evaluate the long-term efficacy and safety of once-daily tamsulosin ( 0.4 and 0.8 mg ) , a unique selective alpha1A-adrenoceptor antagonist in patients with benign prostatic hyperplasia ( BPH ) . METHODS This trial extended a 13-week , Phase III multicenter placebo-controlled , double-blind outpatient trial for an additional 40 weeks . Of 618 patients , 418 ( 68 % ) continued into the extension phase on the same double-blind medication and dose . The primary efficacy parameters were total American Urological Association ( AUA ) symptom score and maximum urinary flow ( Qmax ) . RESULTS The mean changes in AUA symptom score from baseline to end point were statistically significant in all groups ( P < 0.001 ) . Significant improvements were observed in Qmax for both tamsulosin groups but not for the placebo group . The statistically significant improvements from baseline in efficacy parameters observed for each tamsulosin group at the end of the 13-week Phase III trial were maintained during the long-term extension phase . Tamsulosin at both dosages was well tolerated as maintenance therapy . Clinical ly significant orthostatic hypotension was not observed . Vital sign changes in either hypertensive or normotensive patients were not clinical ly significantly different across the three groups . CONCLUSIONS Tamsulosin once-daily at 0.4 or 0.8 mg was shown to be effective , safe , and well tolerated in the target BPH population during long-term use To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists , we compared a selective ( tamsulosin ) and non-selective ( terazosin ) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia ( BPH ) . The study was a single-blind , r and omized , multicenter design to compare a fixed dose of tamsulosin ( 0.2 mg ) or terazosin ( 2 mg ) given once daily after breakfast for four weeks . A total of 212 patients were enrolled with 201 patients included in the analysis . The primary variables assessed were changes in total International Prostatic Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , and average urinary flow rate ( AFR ) four weeks after dosing . Adverse events were recorded through the treatment period . Both tamsulosin and terazosin produced significant improvements in total IPSS ( total score of 11.8 + /- 4.5 ; decrease in 45.1 % and total score of 13.3 + /- 5.3 ; decrease in 39.0 % , respectively ) ( p < 0.001 ) , Qmax ( 13.2 + /- 4.1 mL/s , 37.5 % increase and 13.6 + /- 3.6 mL/s , 30.8 % increase , respectively ) ( p < 0.001 ) and AFR ( 7.7 + /- 3.3 mL/s , 37.5 % increase and 7.8 + /- 3.1 mL/s , 25.8 % increase , respectively ) ( p < 0.001 ) at endpoint . Tamsulosin was superior to terazosin in improvement of total IPSS ( p < 0.05 ) and AFR ( p < 0.05 ) . The incidence of adverse events by administration of tamsulosin was less than that by terazosin ( 13 and 50 , respectively ; p < 0.01 ) . Among the adverse event , incidence of dizziness ( p < 0.001 ) and hypotension ( p < 0.01 ) by administration of terazosin were significantly greater than that by tamsulosin . Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin ( p < 0 
    Output:
    