Silodosin versus naftopidil in <scp>J</scp>apanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: A randomized multicenter study

Shirakawa, Toshiro; Haraguchi, Takahiro; Shigemura, Katsumi; Morishita, Shinichi; Minayoshi, Kohji; Miyazaki, Jiro; Yamada, Yuji; Tanaka, Kazushi; Fujisawa, Masato

doi:10.1111/iju.12055

Cited by 16 publications

(11 citation statements)

References 26 publications

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“…A clinical study in men with LUTS/BPH showed that silodosin more significantly improved the changes of storage symptom scores than those of naftopidil . In contrast, another clinical study reported that changes from the baseline of storage symptoms in the naftopidil‐treated group tended to be larger than those in the silodosin‐treated group .…”

Section: Discussionmentioning

confidence: 98%

Functional roles of bladder α1‐adrenoceptors in the activation of single‐unit primary bladder afferent activity in rats

et al. 2015

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ObjectivesTo clarify the involvement of bladder a1-adrenoceptors (a1-ARs) in afferent pathways by investigating the effects of silodosin and BMY7378, selective a1A-or a1D-AR antagonists, respectively, on single-unit afferent nerve fibre activity (SAA) of the primary bladder afferent nerves and their relationship with bladder microcontractions in rats. Materials and MethodsA total of 63 female Sprague-Dawley rats were anaesthetized with urethane. The SAA of Ad and C fibres generated from the left L6 dorsal roots was determined using electrical stimulation of the left pelvic nerve and bladder distension. After measuring baseline SAA during constant filling cystometry, the procedure was repeated with i.v. (0.3-30 lg/ kg) or intravesical (10 lM) administration of each antagonist. In separate rats, the bladder was filled with saline until the intravesical pressure reached 30 cmH 2 O, and was kept under isovolumetric conditions, then the recording was performed with i.v.-administered vehicle and silodosin (0.3 lg/kg). ResultsA total of Ad fibres and 33 C fibres were isolated from 63 rats. The SAA of Ad fibres, but not C fibres, were dosedependently decreased after both i.v. and intravesical administrations of each of the antagonists. In the experiments under bladder isovolumetric conditions, silodosin administration significantly decreased the SAA of Ad fibres, but not C fibres, compared with vehicle administration. There were no significant effects on either the mean basal bladder pressure or microcontractions. ConclusionThe present study suggests that both a1A-or a1D-ARs in the rat bladder are involved in the activation of the bladder mechanosensory Ad fibres during bladder filling, and that this activation may not be related to bladder microcontractions.

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Section: Discussionmentioning

confidence: 98%

Functional roles of bladder α1‐adrenoceptors in the activation of single‐unit primary bladder afferent activity in rats

et al. 2015

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“…Tamsulosin, naftopidil, silodosin, terazosin, urapidil and prazosin are approved in Japan, and are apparently of comparable efficacy. The former three have shown ample evidence for efficacy . Postural hypotension and asthenia can occur as rarely as a placebo (4–10%).…”

Section: Treatmentmentioning

confidence: 99%

Clinical guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia

et al. 2017

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The present article is the abbreviated English translation of the Japanese guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia updated as of the end of 2016. The target patients are men aged >50 years complaining of lower urinary tract symptoms, with or without benign prostatic hyperplasia, and the target readers are non-urological general physicians and urologists. Mandatory assessment for general physicians is medical history, physical examination, urinalysis and measurement of serum prostate-specific antigen. Additional mandatory assessment for urologists is symptoms and quality of life assessment by questionnaires, uroflowmetry, residual urine measurement, and prostate ultrasonography. Nocturia requires special attention, as it can result from nocturnal polyuria and/or sleep disturbance rather than lower urinary tract disorders. Functional lower urinary tract disorders with or without benign prostatic hyperplasia are primarily managed by conservative therapy and medications, such as a 1 -blockers and phosphodiesterase-type 5 inhibitors. Use of other medications or combination pharmacotherapy is to be reserved for urologists. 5a-Reductase inhibitors and anticholinergics or b3 agonists are indicated for men with enlarged prostates and overactive bladder symptoms, respectively. Surgical intervention for bladder outlet obstruction is considered for persistent symptoms or benign prostatic hyperplasia-related comorbidities. Surgical modalities should be optimized by the patient's characteristics, performance of equipment and the surgeon's experience.

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“…Consequently, it still remains largely untested whether the reported efficacy and safety of naftopidil in Japanese and Asian people are generally applicable to non-Asian populations. (4) In the comparative studies with tamsulosin [11][12][13][15][16][17][18]20 , the dose of tamsulosin was lower than the recommended dose in Western countries. This discrepancy makes all comparative studies with tamsulosin inconclusive.…”

Section: Resultsmentioning

confidence: 99%

“…This discrepancy makes all comparative studies with tamsulosin inconclusive. (5) Two recent comparative studies report a higher efficacy of silodosin 18,19 , administered as standard, in terms of improvement of both IPSS and QOL score, when compared to naftopidil. Based on these data, it may be postulated that the non-inferiority of naftopidil compared to tamsulosin in the management of LUTS may be due exclusively to the use of a nonstandard dose of tamsulosin.…”

Section: Resultsmentioning

confidence: 99%

“…In particular, six clinical trials out of fourteen compared naftopidil to low-dose (0.2 mg/day) tamsulosin, which is a dose approved by the Japanese Ministry of Health, Labor and Welfare but is lower than the tamsulosin dose generally administered in the United States and Europe [12][13][14][15][16][17] . Two studies compared naftopidil to silodosin (4 mg twice a day or 8 mg/day) 18,19 and one compared naftopidil to silodosin (4 mg twice a day) and tamsulosin (0.2 mg/day) 20 . Another report compared the naftopidil treatment to 6 tablets/day eviprostat, a phytotherapy product containing plant extracts from Phila umbellata, Populus tremula, Pulsatilla pratensis mill and wheat germ oil 21 .…”

Section: Randomized Clinical Trials (Rcts) In Bph-associated Lutsmentioning

confidence: 99%

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Naftopidil for the treatment of benign prostate hyperplasia: a systematic review

Castiglione

Benigni

Briganti

et al. 2013

Current Medical Research and Opinion

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It remains unknown whether the data reported on naftopidil in the Japanese population are applicable in symptomatic BPH patients from western countries given that: (1) no English-language clinical trials have compared naftopidil to placebo in Western countries; (2) all clinical trials available were carried out in Japan; (3) in the comparative studies with tamsulosin, the dose of this drug was lower than the recommended dose in Western countries; (4) no data from long-term clinical trials evaluating drug safety beyond 18 weeks.

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Silodosin versus naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: A randomized multicenter study

Abstract: Abbreviations & Acronyms AR = adrenoceptor BPH = benign prostatic hyperplasia IPSS = International Prostate Symptom Score LUTS = lower urinary tract symptoms Qmax = maximum urinary flow rate QOL = quality of life SAS = statistical analysis system Correspondence: Toshiro

Cited by 16 publications

References 26 publications

Functional roles of bladder α1‐adrenoceptors in the activation of single‐unit primary bladder afferent activity in rats

Functional roles of bladder α1‐adrenoceptors in the activation of single‐unit primary bladder afferent activity in rats

Clinical guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia

Naftopidil for the treatment of benign prostate hyperplasia: a systematic review

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