Tadalafil for the Treatment of Lower Urinary Tract Symptoms in Japanese Men with Benign Prostatic Hyperplasia: Results from a 12‐week Placebo‐controlled Dose‐finding Study with a 42‐week Open‐label Extension

Takeda, Masayuki; Nishizawa, Osamu; Imaoka, Takeshi; Morisaki, Yoji; Viktrup, Lars

doi:10.1111/j.1757-5672.2012.00144.x

Cited by 36 publications

(109 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…12,13 Results from three pivotal studies of Japanese, Korean, and/or Taiwanese men with BPH/LUTS showed that tadalafil 5 mg once-daily improved LUTS while offering a favorable safety profile compared with alpha-blockers or 5-alpha reductase inhibitor. [14][15][16] The results from these three Asian studies were also comparable with pivotal clinical studies of tadalafil in American and European men with BPH/LUTS. [17][18][19][20][21][22] The incidence/severity of BPH/LUTS has been shown to increase with increasing age; additionally, LUTS patients experience varying degrees of symptom severity, have comorbid conditions, or have prior exposure to BPH treatments, all of which might impact the efficacy of new therapies.…”

supporting

confidence: 71%

“…[14][15][16] These studies were similar in design, participation criteria, and efficacy/safety measures. Individual study designs and results were previously published.…”

Section: Methodsmentioning

confidence: 99%

“…22 The potential limitations observed within each of the three individual studies were previously described. [14][15][16] One potential limitation of our integrated analyses was the duration of the studies that were utilized for our investigation. The treatment duration of all three studies was limited to 12 weeks; thus, no conclusions can be drawn from our integrated analyses on the efficacy and safety of longer-term treatment with tadalafil 5 mg once-daily in Asian men with BPH/LUTS.…”

Section: Discussionmentioning

confidence: 99%

“…Individual study designs and results were previously published. [14][15][16] In brief, studies included men aged !45 years, !6-month history of BPH/LUTS, IPSS total score !13 at study entry, intermediate bladder obstruction (characterized by Q max !4 mL/s), and prostate volume !20 mL (confirmed by ultrasound). Eligible patients who completed a washout period of 2-4 weeks and a single-blind, placebo lead-in period of 4 weeks before being randomly assigned to 12 weeks of double-blind treatment with tadalafil 5 mg or placebo once-daily were included in this integrated analysis.…”

Section: Methodsmentioning

confidence: 99%

“…[23][24][25] As individual studies, the three aforementioned trials were insufficiently powered to analyze patient subgroups. [14][15][16] However, such analyses can be carried out when the data are pooled.…”

mentioning

confidence: 99%

See 4 more Smart Citations

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies

Nishizawa¹,

Yoshida²,

Takeda

et al. 2015

Int J of Urology

Self Cite

View full text Add to dashboard Cite

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double-blind, placebo-controlled studies Objectives: Assess the efficacy and safety of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms by pooling data from three clinical studies. Methods: Data on 1199 Japanese, Korean, and Taiwanese men given tadalafil 5 mg (n = 601) or placebo (n = 598) were pooled from three double-blind, placebo-controlled, 12-week studies. Efficacy measures included International Prostate Symptom Score, and Patient and Clinician Global Impressions of Improvement. These measures were also assessed for patient subgroups (age categories, baseline disease severity and/or prostate volume, prior alpha-blocker treatment). Safety measures included adverse events, including those in selected body systems. Efficacy measure changes throughout treatment were assessed by mixed-effect model repeated-measures analysis; baseline to end-point changes for the total population and subgroups were evaluated by analysis of covariance. Results: Tadalafil 5 mg led to significant improvement (vs placebo) in all International Prostate Symptom Scores at all time-points (week 4 P 0.013 for all measures; week 8 P 0.005, week 12 P < 0.001). End-point results for both global impressions scales also favored tadalafil (both P < 0.001 vs placebo). Tadalafil efficacy was similar between patient subgroups of varied disease severity (interaction P = 0.097), prior alpha-blocker use (P = 0.580), and prostate volume (P = 0.921). The drug was slightly less effective in older men (interaction P = 0.042). No unexpected adverse events were reported, and no meaningful adverse effects were observed in visual, auditory, or cardiovascular systems. Conclusions: Tadalafil 5 mg once-daily for 12 weeks is efficacious and safe in Asian men with lower urinary tract symptoms. Tadalafil is also effective in men of different ages, disease severity, prior alpha-blocker exposure, and prostate volumes.

show abstract

supporting

confidence: 71%

“…[14][15][16] These studies were similar in design, participation criteria, and efficacy/safety measures. Individual study designs and results were previously published.…”

Section: Methodsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies

Nishizawa¹,

Yoshida²,

Takeda

et al. 2015

Int J of Urology

Self Cite

View full text Add to dashboard Cite

show abstract

Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia

Pattanaik

Mavuduru

Panda

et al. 2018

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

show abstract

Voiding behavior and chronic pelvic pain in two types of rat nonbacterial prostatitis models: Attenuation of chronic pelvic pain by repeated administration of tadalafil

et al. 2018

View full text Add to dashboard Cite

Background Experimental autoimmune prostatitis (EAP) and prostatitis induced by 17β‐estradiol treatment combined with castration (hormone/castration‐induced prostatitis; HCP) are the most commonly used rodent models of nonbacterial prostatitis. We studied the effect of the phosphodiesterase 5 inhibitor tadalafil on chronic pelvic pain in two such models in rats. Methods EAP was induced by intradermal injection of rat prostate antigen and complete Freund's adjuvant on Days 0 and 28. HCP was induced by castration followed by daily subcutaneous injection of 17β‐estradiol for 30 days. On Day 42 after antigen injection in the EAP model and Day 30 after castration in the HCP model, we investigated voiding behavior, pelvic pain (measured by applying von Frey filaments to the lower abdomen), and inflammatory changes, including changes in histopathology and IL‐1β, CCL2, and CCL3 mRNA levels. We investigated the effect of repeated administration of tadalafil on chronic pelvic pain in both models. Results In the EAP model, we observed inflammation in the ventral prostate, while in the HCP model, we observed inflammation in the lateral lobe of the prostate. Neither model showed any change in voiding behavior. As well as in the EAP model, in which chronic pelvic pain was observed, we found for the first time that HCP led to a significant increase in chronic pelvic pain. Repeated treatment with tadalafil attenuated the chronic pelvic pain in both models. Conclusions Chronic pelvic pain was induced in both EAP and HCP models. Tadalafil significantly attenuated the chronic pelvic pain in both models.

show abstract

Tadalafil for the Treatment of Lower Urinary Tract Symptoms in Japanese Men with Benign Prostatic Hyperplasia: Results from a 12‐week Placebo‐controlled Dose‐finding Study with a 42‐week Open‐label Extension

Abstract: Tadalafil (5.0 mg) had a favorable benefit-to-risk profile, supporting further investigation of tadalafil (5.0 mg) in Japanese men with BPH-LUTS.

Cited by 36 publications

References 22 publications

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies

Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia

Voiding behavior and chronic pelvic pain in two types of rat nonbacterial prostatitis models: Attenuation of chronic pelvic pain by repeated administration of tadalafil

Contact Info

Product

Resources

About