Naftopidil versus tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia with special reference to the storage symptom: A prospective randomized controlled study

Objectives: In order to compare the clinical efficacy of naftopidil (Naf) and tamsulosin hydrochloride (Tam), which differ in their selectivity to alpha receptor subtypes, we performed a multi‐center prospective randomized controlled study. Methods: Men complaining of lower urinary tract symptoms due to benign prostatic hypertrophy, were randomized into two treatment groups: one receiving 50 mg Naftopidil daily (Naf group, n = 31 pts), and one receiving 0.2 mg Tam once daily (Tam group, n = 28 pts). Baseline symptom scores were compared to those at 2 weeks and at the end of the observation period (6–8 weeks). Results: In the Naf group at 2 weeks, the score of the daytime frequency significantly improved from 3.5 to 2.2 (P = 0.03), and the score of nocturia improved significantly from 3.5 to 2.2 (P = 0.0004), respectively. In the Tam group at 2 weeks, however, no significant improvement was noted in the increased score of daytime frequency (P = 0.1) or nocturia (P = 0.2). At 2 weeks, the storage symptom score of the frequency to the combined score of daytime frequencies and the score of nocturia was better in the Naf group (improved from 7.0 to 4.4, P = 0.0017) than in the Tam group (from 6.8 to 4.9, P = 0.08) (P < 0.05). At 6–8 weeks, the effects of the two drugs on lower urinary tract symptoms were comparable. Conclusions: Naf demonstrated a significant early response to improve storage symptoms at 2 weeks, including daytime frequency and nocturia, compared with Tam.     

Usefulness of tamsulosin hydrochloride and naftopidil in patients with urinary disturbances caused by benign prostatic hyperplasia: A comparative, randomized, two-drug crossover study

BACKGROUND: The aim of the study presented here was to stratify drug therapy for patients with benign prostatic hyperplasia (BPH) displaying various voiding symptoms. METHODS: Two different alpha1-adrenoceptor antagonists; tamsulosin hydrochloride (Tam) and naftopidil (Naf ), were administered to 96 patients with BPH for 8 weeks in a crossover study. RESULTS: With the administration of both drugs, the International Prostate Symptom Score (I-PSS) significantly decreased and the maximum urinary flow significantly increased. Whereas Naf monotherapy decreased the I-PSS for storage symptoms, Tam monotherapy decreased the I-PSS for voiding symptoms. In both the Naf-to-Tam and Tam-to-Naf groups, crossover was effective when the initial drug was judged subjectively and objectively to have been ineffective. Compliance was acceptable with both drugs. CONCLUSION: Our results show that either Naf or Tam can be used to treat patients on the basis of objective and subjective assessment of voiding symptoms. Our findings should be helpful for patient guidance and treatment of BPH.     

Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Symptom Score

OBJECTIVE

To evaluate the efficacy of tolterodine extended‐release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials.

PATIENTS AND METHODS

Men aged ≥40 years with an IPSS of ≥12 and diary‐documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks.

RESULTS

Patients receiving tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points.

CONCLUSIONS

In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.     

Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial

OBJECTIVES: To compare the efficacy and safety of two alpha1a/alpha1d adrenoceptor (AR) antagonists with different affinity for the alpha1AR subtypes, tamsulosin and naftopidil, in the treatment of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Patients with BPH were randomized to receive either tamsulosin or naftopidil. The primary efficacy variables were the changes in the total International Prostate Symptom Score (IPSS), maximum flow rate on free uroflowmetry, and residual urine volume. The secondary efficacy variables were average flow rate, changes in the IPSS storage score, IPSS voiding score, and quality-of-life (QoL) Index score, from baseline to endpoint (12 weeks). Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure. RESULTS: Of the 185 patients enrolled data for 144 who were eligible for inclusion in the efficacy analysis were analysed (75 from the tamsulosin and 69 from the naftopidil group). There was no significant difference in any variable at baseline between the groups. There were statistically significant improvements for all primary and secondary variables in both groups, except for residual urine in the tamsulosin group. However, there was no significant intergroup difference in the improvement of any efficacy variable between the groups. The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups. CONCLUSIONS: This study suggests that naftopidil is as effective and safe as tamsulosin. Both drugs were effective in improving storage and voiding symptoms. However, there was no difference in clinical efficacy or adverse effects between the alpha1 AR antagonists with different affinity to alpha1 subtypes, alpha1a and alpha1d.     

Effects of three types of alpha‐1 adrenoceptor blocker on lower urinary tract symptoms and sexual function in males with benign prostatic hyperplasia

Objectives: The aim of the present study was to explore the effects of three different types of alpha‐1 adrenoceptor blockers (α1‐blocker) on lower urinary tract symptoms (LUTS), erectile dysfunction (ED) and ejaculatory dysfunction (EjD) in patients with benign prostatic hyperplasia. Methods: A total of 136 male LUTS patients aged 50–80 years with International Prostate Symptom Score (IPSS) ≥8 were enrolled. They were divided into three groups. Group S received silodosin at 4 mg twice a day; group T received tamsulosin at 0.2 mg once a day; and group N received naftopidil at 50 mg once a day. Assessment included IPSS, quality of life indexes (QOL), International Index of Erectile Function (IIEF‐5), an ejaculation questionnaire, Qmax and post‐void residual urine volume (PVR). These parameters were recorded at baseline, and at 1 and 3 months after treatment had ended. Results: Mean IPSS and Qmax significantly improved after treatment in all groups without any significant difference among them. As for the IIEF‐5 score, only group N significantly improved at 1 and 3 months. After treatment, 2.6 and 2.4% of patients complained of a de novo reduced volume of ejaculation in both groups T and N, respectively. Ten out of 41 patients (24.4%) complained of a total absence of antegrade ejaculation in group S after treatment. Conclusions: All three types of α1‐blockers provided an objective and subjective improvement of LUTS in the present study population. However, erectile function only improved in patients treated with naftopidil and a higher rate of EjD was observed in those receiving silodosin. Because of their variable effects, we should consider the sexual dimension when prescribing α1‐blockers for LUTS.     

Comparison of two alpha1-adrenoceptor antagonists, naftopidil and tamsulosin hydrochloride, in the treatment of lower urinary tract symptoms with benign prostatic hyperplasia: a randomized crossover study

OBJECTIVES: To compare the efficacy of two alpha(1)-adrenoceptor antagonists, alpha(1A)-adrenoceptor-selective tamsulosin hydrochloride and alpha(1D)-adrenoceptor-selective naftopidil, in the treatment of lower urinary tract symptoms (LUTS) with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Thirty-four patients (mean age 72.4 years, sd 4.3, range 66-79) with LUTS (International Prostate Symptom Score, IPSS >8) secondary to BPH were enrolled in a randomized crossover study. Seventeen patients were initially prescribed naftopidil 50 mg for 4 weeks, followed by tamsulosin 0.2 mg for 4 weeks (group A); another 17 were initially prescribed tamsulosin 0.2 mg, followed by naftopidil 50 mg (group B). Patients changed to the alternative treatment after a 1-week washout period. Efficacy criteria were improvement in LUTS (IPSS), quality of life (QoL), uroflowmetry, and pressure-flow study (PFS) values based on the treatment with each agent. RESULTS: At baseline there were no significant differences between the groups in IPSS, QoL, uroflowmetry values or PFS values, except for the volume at maximum desire to void. After treatment with each agent, the IPSS and QoL were significantly improved and the reduction in bladder outlet obstruction confirmed by PFS. Naftopidil was significantly more effective than tamsulosin in relieving nocturia. The increases from baseline (before treatment) to the endpoint (after treatment with each agent) in the volume at first desire and maximum desire to void were significantly higher with naftopidil than with tamsulosin. Involuntary contractions disappeared in two patients with relief of nocturia with naftopidil, but not with tamsulosin. The decrease in other symptoms of the IPSS, QoL, increase in uroflowmetry values and changes in other PFS values were similar for both agents. CONCLUSIONS: The two agents provided similar efficacy in the treatment of LUTS with BPH. However, naftopidil was better than tamsulosin for nocturia. The disappearance of involuntary contraction and the greater increase in first-desire volume with naftopidil may be associated with the relief of nocturia. The alpha(1D)-adrenoceptor antagonist is effective in alleviating both voiding and storage symptoms. The alpha(1D)-adrenoceptor antagonist may be more effective than the alpha(1A)-adrenoceptor antagonist in LUTS with BPH.     

坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的 探讨坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的有效性及安全性。 方法 本组良性前列腺增生伴膀胱过度活动症患者82例。年龄50～75岁,平均57岁。入选标准：平均每天排尿次数≥8次,夜间≥2次,每次尿量＜200 ml;膀胱过度活动症症状评分(OABSS)：第3项评分＞2分,总分＞3分。采用随机对照方法,分为对照组（38例）和实验组(44例)。2组临床指标比较差异无统计学意义(P＞0.05)。对照组口服坦索罗辛0.2 mg,每日1次,共12周;实验组口服坦索罗辛0.2 mg,每日1次,索利那新5 mg,每日1次,共12周。比较2组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、OABSS、尿常规检查、不良事件登记等。 结果 ①对照组治疗前后IPSS评分(19.5±2.2 vs 15.6±2.4)、排尿期症状评分(15.6±2.4 vs3.4±1.7)、Qmax(13.7±3.8 vs16.6±4.1),治疗前后比较差异有统计学意义（P值均＜0.05）。②实验组治疗前后IPSS评分(19.7±2.3 vs9.7±3.0)、储尿期症状评分（13.8±1.9 vs5.6±1.6）、OABSS( 10.3±1.8 vs5.3±1.3)、Qmax(14.1±4.1 vs 17.2±3.5),治疗前后比较差异有统计学意义（P值均＜0.05）。③治疗后实验组与对照组IPSS评分(9.7±3.0 vs15.6±2.4)、储尿期症状评分(5.6±1.6 vs 12.0±1.6,)、OABSS(5.3±1.3 vs9.7±2.7)比较差异有统计学意义（P值均＜0.05）。实验组与对照组排尿期症状评分(3.4±1.1 vs3.4±1.7)、Qmax (17.2±3.5 vs 16.6±4.1)、残余尿量(36.7±17.1 vs 35.7±12.5)比较差异无统计学意义(P值均＞0.05)。2组均无急性尿潴留发生,对照组总体不良反应发生率为7.9％( 3/38),实验组总体不良反应发生率为20.5％ (9/44)。 结论 坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症有效、安全,疗效优于单用坦索罗辛。     

Efficacy and safety of tamsulosin hydrochloride compared to doxazosin in the treatment of Indonesian patients with lower urinary tract symptoms due to benign prostatic hyperplasia

AIM: The objective of the study was to compare the efficacy and safety of tamsulosin hydrochloride and doxazosin in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). METHODS: The safety and efficacy of tamsulosin (0.2 mg) and doxazosin (2 mg) was determined after once daily administration for 6 weeks in an open-label, randomized, multicenter study of 101 men with BPH. The International Prostatic Symptom Score (IPSS), maximal urinary flow rates (Qmax), average urinary flow rates (Qave) and residual urine were determined at baseline and again at 6 weeks as efficacy parameters. The primary parameters used for safety evaluation were vital signs (blood pressure and heart rate) and adverse events. The number of patients with a clinically significant response to treatment with tamsulosin or doxazosin was determined and defined as those with >20% improvement from the baseline Qmax or >20% decrease in total IPSS. RESULTS: The total IPSS decreased significantly in both the tamsulosin and doxazosin groups compared to baseline. There was a significant difference in the decrease in total IPSS between two groups. Qmax, Qave and residual urine significantly improved only in the tamsulosin group. There were no significant differences in systolic blood pressure, diastolic blood pressure or heart rate profile in the tamsulosin group; however, doxazosin resulted in a significant difference in systolic and diastolic blood pressure. Tamsulosin was well tolerated; only three patients (6%) in the tamsulosin group reported an adverse event (dizziness) while 11 patients (22%) in the doxazosin group reported an adverse event (dizziness), one of whom withdrew from the study. CONCLUSIONS: Tamsulosin was shown to be more effective than doxazosin in the treatment of LUTS due to BPH.     

坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症的临床观察

目的:探讨坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症(OAB)患者的临床疗效及安全性。方法:2009年12月～2011年6月期间收集BPH伴有OAB患者262例,随机分成试验组(134例)和对照组(128例)。试验组患者口服坦索罗辛0.2mg,每天一次,同时口服索利那新5mg,每天一次;对照组患者仅口服坦索罗辛,用量用法同实验组。两组患者均药物治疗4周。观察两组患者治疗前后主观指标IPSS评分、OABSS评分及QOL评分和客观指标最大尿流率(Qmax)、24h排尿次数、尿急次数、急迫性尿失禁次数、夜尿次数、每次排尿量的变化,评估治疗后BPH患者OAB症状的改善情况及其安全性。结果:两组患者主观指标和客观指标治疗前后组内对比,差异均有统计学意义(P<0.05)。试验组治疗前后的主观指标和客观指标变化值与对照组相比,除Qmax和每次排尿量外,差异均有统计学意义(P<0.05)。两组患者的Qmax和每次排尿量治疗前后的变化值相比,差异均无统计学意义(P>0.05)。试验组和对照组不良事件总发生率较低,分别为4.58%和2.47%,无严重不良事件发生。结论:坦索罗辛联合索利那新治疗BPH伴有OAB患者的疗效,较单用坦索罗辛的疗效显著,且安全性好。     

Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia

OBJECTIVE: To evaluate the efficacy and safety of two doses (10 and 15 mg) of alfuzosin once daily and tamsulosin (0.4 mg) once daily, compared with placebo, in men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, multicentre study, 625 patients were randomized to receive alfuzosin 10 or 15 mg once daily, tamsulosin 0.4 mg once daily (active reference), or matching placebo for 12 weeks, with no initial dose titration. The study was designed to compare each of the three active treatments with the placebo group. Primary outcome measures were mean changes from baseline in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (Qmax) at 12 weeks, compared with placebo, using one-way analysis of variance. Because Qmax data were not normally distributed, median changes from baseline were also compared for Qmax. Pair-wise comparisons were conducted using the Dunnett correction for quantitative variables and Bonferroni-Holm correction for categorical variables, allowing for multiple treatment group comparisons. RESULTS: Alfuzosin 10 mg significantly improved urinary tract symptoms compared with placebo, with a mean (sd) change from baseline in the IPSS of -6.5 (5.2) vs -4.6 (5.8) for placebo (adjusted P = 0.007); there was a trend toward a difference between alfuzosin 15 mg, with a mean (sd) change from baseline in IPSS of -6.0 (5.6), and placebo (adjusted P = 0.050). The mean change from baseline in IPSS with tamsulosin 0.4 mg, at -6.5 (5.6), vs placebo was also significant (adjusted P = 0.014). The median change from baseline in Qmax was significantly increased with both alfuzosin doses and with tamsulosin (all adjusted P = 0.02 vs placebo). Both doses of alfuzosin were well tolerated, with dizziness the most frequent adverse event (placebo, 4%; alfuzosin 10 mg, 6%; 15 mg, 7%; tamsulosin, 2%); the respective incidence rates of sexual function adverse events were 0%, 3%, 1% and 8%. CONCLUSION: Treatment with alfuzosin 10 mg significantly improved urinary symptoms and Qmax compared with placebo and was well tolerated. There were also significant improvements over placebo with the active reference, tamsulosin 0.4 mg. The incidence of sexual function adverse events was higher with tamsulosin than with placebo. The benefit-to-risk profile of alfuzosin 10 mg once daily appeared to be reduced with a higher dose (15 mg).     

Outcomes and complications of naftopidil versus tamsulosin for elderly men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: A systematic review and meta-analysis

We conducted a systematic review and meta-analysis to assess the outcomes and complications of naftopidil in treating elderly men with lower urinary tract symptoms secondary to benign prostatic hyperplasia and compared them with those administered with tamsulosin. A literature review was performed to identify the available randomised controlled trials concerning the comparison between naftopidil and tamsulosin for men with LUTS/BPH. We searched the following databases: the Cochrane Library Database, PubMed, Embase and Web of Science. Eleven publications involving 1,114 men (557 in the naf group and 557 in the tam group) were pooled in our analysis. We found no significant differences in the total IPSS, IPSS storage score, IPSS voiding score, quality of life index, peak urinary flow rate, average flow rate and post-void residual volumes. We assessed cardiovascular and sexual adverse events, acute urinary retention, surgical intervention, withdrawals due to any reason and withdrawals due to adverse events. The incidence of adverse events was similar among patients in naf and tam groups. In conclusion, naftopidil shared comparable efficacy and similar incidence of adverse events with tamsulosin and appears to be a promising agent for and alternative to tam. However, more prospective trials with high quality and long-term treatment duration are needed to verify this observation.     

坦索罗辛联合索利那新在治疗轻中度良性前列腺增生合并膀胱过度活动症中的疗效分析

目的:探讨坦索罗辛联合索利那新在治疗轻中度BPH合并膀胱过度活动症(OAB)中的有效性及安全性。方法:选取在我院诊治的轻中度良性BPH合并OAB患者166例,分为轻度梗阻症状组(88例)(联合用药组48例及坦索罗辛组40例)和中度梗阻症状组(78例)(联合用药组36例及坦索罗辛组42例)。坦索罗辛组均服用坦索罗辛0.2mg,每日1次。联合用药组均口服坦索罗辛0.2mg,每日1次,索利那新5mg,每日1次,共12周。比较两组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、膀胱过度活动症症状评分(OABSS)、尿常规检查、不良事件等。结果:在轻度梗阻症状组中,联合用药组治疗后在IPSS、储尿期症状评分、Qmax、OABSS明显优于治疗前(P0.05),而残余尿无明显变化(P0.05),坦索罗辛组治疗后仅IPSS较治疗前有所改善,而其他方面无明显变化(P0.05);而治疗后联合用药组IPSS[(9.7±3.0)分vs(15.8±3.3)分]、储尿期症状评分[(8.1±1.7)分vs(12.3±3.1)分]、Qmax[(18.6±4.1)ml/s vs(14.2±2.3)ml/s]、OABSS[(5.3±1.3)分vs(9.7±2.7)分]等方面明显优于坦索罗辛组(P均0.05),而残余尿、尿常规检查及不良事件无明显差异(P0.05);在中度梗阻症状组,联合用药组治疗后IPSS、排尿期症状评分、Qmax、OABSS明显优于治疗前,而残余尿无明显差异;坦索罗辛组治疗后IPSS、排尿期症状评分、Qmax、OABSS及残余尿较治疗前改善明显;联合用药组的OABSS优于坦索罗辛组[(4.8±1.5)分vs(6.5±2.5)分,P0.05],而在IPSS、Qmax、排尿期症状评分、尿常规检查及不良事件等方面与坦索罗辛组无明显差异(P均0.05)。结论:坦索罗辛联合索利那新在治疗BPH轻中度梗阻症状合并OAB均有明显疗效,其疗效优于单用坦索罗辛,而不良反应无明显增加。     

Predictive factors for the effect of the α1-D/A adrenoceptor antagonist naftopidil on subjective and objective criteria in patients with neurogenic lower urinary tract dysfunction

Study Type – Therapy (RCT)
Level of Evidence 1b What's known on the subject? and What does the study add? α‐blockers may have little effect in the facilitation of storage and emptying in patients with neurogenic lower urinary tract dysfunction (NLUTD). Naftopidil is a novel α‐blocker, which is selective for the α1‐D/A adrenoceptor. This study showed the first objective evidence for the effect of naftopidil in treatment of NLUTD patients by pressure‐flow study.

OBJECTIVES

? To assess the effect of α1‐D/A adrenoceptor antagonist naftopidil on patients with neurogenic lower urinary tract dysfunction (NLUTD) and voiding difficulty. ? To explore the effectiveness of naftopidil in these patients by using urodynamic variables, including pressure flow study (PFS), and to find good and simple parameters (International Prostate Symptom Score (IPSS), Post‐void residual urine (PVR), and uroflowmetry (UFM) parameters) as substitution of PFS for predicting the effect of naftopidil.

PATIENTS AND METHODS

? The main inclusion and exclusion criteria were, IPSS ≥8, voiding symptoms with IPSS ≥5, IPSS‐quality of life (QOL) ≥2, PVR ≥50 mL, and without prostatic enlargement ≥20 mL. ? After initial assessment, patients were stepwisely administered for 12 weeks with the following: placebo for 2 weeks, naftopidil 25 mg/day for 2 weeks, naftopidil 50 mg/day for 2 weeks, and naftopidil 75 mg/day for 6 weeks. At the end of both placebo and 6 weeks’ naftopidil 75 mg/day, their IPSS, UFM, PVR, and PFS were assessed. ? A total of 82 Japanese patients (men 40, women 42) with lower urinary tract symptoms complicated by NLUTD, with a mean age of 63.9 years, were included from private or institutional clinics. ? The lesions were spinal cord 42, and peripheral nervous system 40. The spinal cord lesions were all lumbar spine (injury or lumbar canal stenosis).

RESULTS

? In all patients, pressure at maximum urinary flow rate (P_detQ_max) in PFS significantly decreased (P < 0.05), and maximum urinary flow rate in UFM significantly increased (P < 0.01). Analysis of data for men and for women also showed a significant decrease in PVR, %PVR, and total IPSS score. ? The degree of improvement of voided volume, PVR (%), and IPSS in patients with PVR <300 mL was significantly greater than those in patients with PVR ≥300 mL. ? The degree of improvement of P_detQ_max in PFS, and IPSS in patients with bladder contractility was significantly greater than that in patients without bladder contractility.

CONCLUSIONS

? α1‐D/A adrenoceptor antagonist naftopidil has a significant effect on both symptoms and urodynamic variables of patients of both genders with NLUTD in Japan. ? PVR <300 mL and bladder contractility are predictive factors for the efficacy of naftopidil on patients with NLUTD.     

The effectiveness of naftopidil in patients with benign prostatic hyperplasia evaluated by QOL index

We examined the effectiveness of naftopidil in 81 patients with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). We examined quality of life (QOL) and determined which symptoms improved as a result of naftopidil administration. The findings indicated that storage symptoms, voiding symptoms, total International Prostate Sympotom Score (IPSS), QOL index, Qmax and residual urine volume were significantly improved after treatment when compared to baseline. Improvement of nocturia and incomplete emptying by naftopidil contributed to improvement in QOL, odds ratio between the good response group and poor response group were 3.6 and 2.3, respectively. During naftopidil treatment, two of the 81 patients complained of adverse events. The results show that naftpidil is effective for LUTS caused by BPH, and that improvement of nocturia and incomplete emptying contributed to the improvement in QOL.     

Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia

Objectives:   To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).
Methods:   This was a randomized, 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 randomized 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.     

良性前列腺增生症规范化治疗方案的多中心临床研究

目的 比较不同种类药物治疗良性前列腺增生（BPH）的疗效与差异,确定不同药物对不同患者的最佳适应证。方法 采用随机平行对照、多中心临床研究方法,对2002年9月至2003年12月906例BPH患者,随机进入选择性α-受体阻滞剂特拉唑嗪、多沙唑嗪、坦索罗辛与萘哌地尔;50α-还原酶抑制剂非那雄胺与爱普列特以及植物制剂舍尼通等7种治疗药物组。每3个月随访一次,国际前列腺症状评分（IPSS）与生活质量评分（QOL）,最大尿流率（Qmax）与平均尿流率（Qave）,前列腺总体积（TPV）与前列腺移行带体积以及残余尿量为观察指标进行疗效评价。根据不同指标基线水平将患者进行分层,比较各治疗组患者主观指标IPSS和客观指标Qmax的改善情况。结果 基线指标分析显示,全组主观指标IPSS评分和客观指标Qmax水平与TPV以及移行带体积呈明显相关性（P〈0．01）。至随访6个月时各类药物均使BPH患者的主观指标IPSS与QOL评分及客观指标Qmax与残余尿量有明显改善。各种药物对主客观指标的影响程度的组间比较显示,对IPSS的改善无显著差异;5α-还原酶抑制剂类药物爱普列特与非那雄胺可以使TPV和移行带体积均明显缩小（P〈0．05）。将患者以前列腺体积〈35．5cm^3和≥35．5cm^3分为两层,在非那雄胺治疗的患者中Qmax平均增加5．7ml／s和2．2ml／s（P〈0．01）,在舍尼通、萘哌地尔及多沙唑嗪治疗组,≥35．5cm^3者症状改善更为明显（P〈0．05）。以IPSS〈20分和≥20分进行分层,各种药物的疗效均在≥20分时更为明显（P〈0．01）。结论 各种药物均可明显改善BPH患者的主、客观症状,各种药物的疗效均对基线IPSS评分较高的患者疗效更为明显。5α-还原酶抑制剂能明显减小前列腺体积,对于前列腺体积≥35．5cm^2者有更为明显的主客观疗效。     

A comparative study assessing clinical effects of naftopidil and tamsulosin hydrochloride on benign prostatic hyperplasia with overactive bladder

PURPOSE: We compared the efficacy of naftopidil with that of tamsulosin hydrochloride for 154 symptomatic benign prostatic hyperplasia (BPH) patients who also suffered from overactive bladder (OAB) symptoms. MATERIALS AND METHODS: Naftopidil and tamsulosin hydrochloride were administered for eight weeks. The international prostate symptom score (IPSS), QOL index, maximum flow rate (Q(max)), residual urine volume (RUV) and side effect profile were determined before the administration and after eight weeks of treatment. RESULTS: In the naftopidil group, seven parameters of IPSS and QOL index were improved significantly at the endpoint compared to the baseline. In the tamsulosin group, all parameters except frequency and straining were also improved. Both drugs improved the Q(max) at the endpoint, too. The RUV did not change in both groups. Naftopidil was also superior to tamsulosin hydrochloride regarding general treatment outcome by the Japanese clinical guideline of urinary disturbance. CONCLUSIONS: This study demonstrated that naftopidil was clinically efficacious in the treatment of BPH patients with OAB.     

Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men

OBJECTIVE: To verify the efficacy and safety of the new alpha1A-adrenoceptor-selective antagonist silodosin compared with tamsulosin and placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: This randomized, double-blind, placebo-controlled study was conducted at 88 centres in Japan. Men aged > or = 50 years with an International Prostate Symptom Score (IPSS) of > or = 8, a quality-of-life (QoL) score of > or = 3, a maximum urinary flow rate (Qmax) of < 15 mL/s, a prostate volume of > or = 20 mL and a postvoid residual urine volume of < 100 mL were eligible for enrolment. Patients were randomized to receive silodosin 4 mg twice daily, tamsulosin 0.2 mg once daily, or placebo, for 12 weeks. The primary endpoint was the change in IPSS from baseline. Safety was assessed by adverse events, physical examination, vital signs and laboratory tests. RESULTS: In all, 457 patients were randomized (silodosin 176, tamsulosin 192 and placebo 89). The change in the total IPSS from baseline in the silodosin, tamsulosin and placebo groups was -8.3, -6.8 and -5.3, respectively. There was a significant decrease in the IPSS vs placebo in the silodosin group from 1 week. In the early-stage comparison, silodosin showed a significant decrease in IPSS vs tamsulosin at 2 weeks. The change in QoL from baseline was -1.7, -1.4 and -1.1 in the silodosin, tamsulosin and placebo groups, respectively; silodosin showed a significant improvement in the QoL score vs placebo. In the subgroup of patients with severe symptoms (IPSS > or = 20) silodosin also gave a significantly better improvement than placebo (-12.4 vs -8.7). The incidence rates of adverse events and drug-related adverse events were, respectively, 88.6%, 82.3% and 71.6% and 69.7%, 47.4% and 36.4%, respectively. The most common adverse event in the silodosin group was abnormal ejaculation, which occurred more often in the silodosin than in the tamsulosin group (22.3% vs 1.6%). However, only five men (2.9%) discontinued treatment for abnormal ejaculation. CONCLUSION: Silodosin was generally effective in the absence of obtrusive side-effects. This study suggests that silodosin is clinically useful for treating LUTS associated with BPH.     

A randomized,double-blind crossover study of tamsulosin and controlled-release doxazosin in patients with benign prostatic hyperplasia

OBJECTIVE: To compare the effects of the doxazosin gastrointestinal therapeutic system, extended-release (doxazosin-GITS) formulation, and tamsulosin, another alpha1-antagonist, on total International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in treating patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Data were analysed from a prospective, randomized, double-blind, crossover study of men aged 50-80 years with concomitant BPH and hypertension as inclusion criteria. Fifty-two men were treated in four phases: phase I, placebo run-in for 2 weeks; phase II, first study drug doxazosin-GITS or tamsulosin for 8 weeks; phase III, washout with placebo for 2 weeks; and phase IV, second study drug tamsulosin or doxazosin-GITS for 8 weeks. Doxazosin-GITS was started at 4 mg/day and tamsulosin at 0.4 mg/day, and then titrated to 8 mg/day and 0.8 mg/day, respectively, after 4 weeks of therapy if the increase in Qmax was < 3 mL/s or the reduction in total IPSS was < 30%. Efficacy assessments included the IPSS and Qmax. Changes in blood pressure were not analysed, as most patients were actually not hypertensive. Endpoint efficacy data were analysed using an analysis of covariance model, with terms for sequence, phase, patients and sequence within patients, in addition to the baseline as covariate. Forty-seven men were treated in both efficacy arms of the study and were evaluable for analysis. RESULTS: Doxazosin-GITS and tamsulosin significantly relieved lower urinary tract symptoms and significantly increased Qmax from baseline (P = 0.001). Doxazosin-GITS produced significantly greater improvements than tamsulosin in total IPSS (P = 0.019) and obstructive subscores (P = 0.004) at the last treatment visit. The difference between doxazosin-GITS and tamsulosin in improving Qmax approached significance in favour of the former (mean change from baseline 2.6 vs 1.7 mL/s, respectively; between-group difference P = 0.089). Both treatments were well tolerated. CONCLUSIONS: Treatment with doxazosin-GITS was significantly more effective than tamsulosin in relieving lower urinary tract symptoms.     

萘哌地尔治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的:探讨α1A、α1D肾上腺素能受体阻滞剂萘哌地尔治疗良性前列腺增生(BPH)伴膀胱过度活动症(OAB)的有效性及安全性。方法:采用自身对照的临床试验方法,萘哌地尔25mg,每日1次口服,对50例BPH伴OAB患者进行了为期6周的治疗。于治疗前后,以国际前列腺症状评分(IPSS)、生活质量评估(QOL)及最大尿流率(Qmax)、平均尿流率(Qave)、尿量(VV),以及血压和心率为评估指标,观察其有效性及安全性。结果:服药6周后,可评价病例46例。IPSS平均降低9.75分(P<0.01),其中,排尿症状评分平均降低3.97分(P<0.01),储尿症状评分平均降低5.78分(P<0.01);QOL平均降低1.95分(P<0.01),Qmax平均增加4.29ml/s(P<0.01),Qave平均增加3.75ml/s(P<0.01),VV平均增加55.12ml(P<0.05)。血压及心律无明显变化(P>0.05)。治疗过程中不良事件发生率4.35%(1例患者出现头晕)。结论:萘哌地尔治疗BPH伴OAB有效,安全。