Tadalafil

14,000,000 Leading Edge Experts on the ideXlab platform

Scan Science and Technology

Contact Leading Edge Experts & Companies

Scan Science and Technology

Contact Leading Edge Experts & Companies

The Experts below are selected from a list of 7584 Experts worldwide ranked by ideXlab platform

Lars Viktrup - One of the best experts on this subject based on the ideXlab platform.

  • Tadalafil 5 mg once daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia results from a randomized double blind placebo controlled trial carried out in japan and korea
    International Journal of Urology, 2014
    Co-Authors: Masayuki Takeda, Osamu Yokoyama, Yoji Morisaki, Masahiro Murakami, Lars Viktrup
    Abstract:

    Objectives To gain further evidence on the efficacy, safety and tolerability of Tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily Tadalafil 5 mg (n = 306) or placebo (n = 304) for 12 weeks. Results A significantly greater improvement (P < 0.001) in total International Prostate Symptom Score for the change from baseline (week 0) to study end-point (week 12) was observed for Tadalafil (−6.0) versus placebo (−4.5). Significantly greater improvements (P < 0.01) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for Tadalafil versus placebo. Significantly greater improvements (P < 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for Tadalafil versus placebo. Significantly greater improvements (P < 0.001) in urinary symptoms were observed for Tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified. Conclusions These findings confirm the efficacy and safety profile of Tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

  • Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia a randomized placebo and tamsulosin controlled 12 week study in asian men
    International Journal of Urology, 2013
    Co-Authors: Osamu Yokoyama, Masaki Yoshida, Chiijye Wang, Takeshi Imaoka, Yoji Morisaki, Lars Viktrup
    Abstract:

    Objectives To examine the efficacy and safety of Tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n = 154), Tadalafil 2.5 mg (n = 151), Tadalafil 5.0 mg (n = 155) or tamsulosin 0.2 mg (active control, n = 152) for 12 weeks. Results Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with Tadalafil 2.5 mg (−4.8, P = 0.003) and 5 mg (−4.7, P = 0.004) versus placebo (−3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for Tadalafil 5.0 mg than for Tadalafil 2.5 mg (week 8). Significant improvements (P < 0.05) in both Tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for Tadalafil 5.0 mg (−1.7, P = 0.021), but not Tadalafil 2.5 mg (−1.5, P = 0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with Tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known Tadalafil and tamsulosin safety profiles. Conclusions Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

  • monotherapy with Tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international randomised parallel placebo controlled clinical trial
    European Urology, 2012
    Co-Authors: Matthias Oelke, Francois Giuliano, Vincenzo Mirone, Lei Xu, Lars Viktrup
    Abstract:

    Abstract Background Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study. Objective Assess Tadalafil or tamsulosin versus placebo for LUTS/BPH. Design, setting, and participants A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q max ) ≥4 to ≤15ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo ( n =172), Tadalafil 5mg ( n =171), or tamsulosin 0.4mg ( n =168) once daily for 12 wk. Measurements Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables). Results and limitations IPSS significantly improved versus placebo through 12 wk with Tadalafil (−2.1; p =0.001; primary efficacy outcome) and tamsulosin (−1.5; p =0.023) and as early as 1 wk (Tadalafil and tamsulosin both −1.5; p p p p =0.003; tamsulosin −0.6, p =0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale–BPH improved significantly versus placebo with Tadalafil (both p p >0.1). The International Index of Erectile Function–Erectile Function domain improved versus placebo with Tadalafil (4.0; p p =0.699). Q max increased significantly versus placebo with both Tadalafil (2.4ml/s; p =0.009) and tamsulosin (2.2ml/s; p =0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare Tadalafil versus tamsulosin. Conclusions Monotherapy with Tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q max . However, only Tadalafil improved erectile dysfunction. Trial registration Clinicaltrials.gov ID NCT00970632

  • efficacy and safety of Tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia results of an international randomized double blind placebo controlled trial
    European Urology, 2011
    Co-Authors: Hartmut Porst, A Casabe, Vincenzo Mirone, Lei Xu, David P Sundin, Roberta J Secrest, Lars Viktrup
    Abstract:

    Abstract Background Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS). Objective To assess efficacy, including onset, and safety of Tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms. Design, setting, and participants This randomized, double-blind, placebo-controlled, 12-week trial enrolled men ≥45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) ≥13, and maximum urine flow rate (Q max ) ≥4 to ≤15ml/s. Intervention Tadalafil 5mg ( n =161) or placebo ( n =164), once daily. Measurements Analysis of covariance (ANCOVA) modeling evaluated change from baseline in continuous efficacy variables. Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test, and between-group differences in treatment-emergent adverse events (TEAEs) were assessed using the Fisher exact test. Results and limitation Tadalafil significantly improved IPSS results, from baseline to endpoint, compared to placebo (−5.6 vs −3.6; p =0.004). Reduction in IPSS results was apparent after 1 wk and significant after 4 wk (Tadalafil −5.3 vs placebo −3.5; p =0.003). The BPH Impact Index (BII) was not assessed at week 1; however, BII improvement was apparent at 4 wk (Tadalafil −1.8 vs placebo −1.2; p =0.029) and continued at 12 wk (Tadalafil −1.8 vs placebo −1.3; p =0.057). Tadalafil significantly improved the International Index of Erectile Function–Erectile Function score in sexually active men with erectile dysfunction (ED; 6.7 vs 2.0; p p =0.44). For Tadalafil, the most common TEAEs were headache (3.7%) and back pain (3.1%). Tadalafil did not significantly improve Q max or reduce postvoid residual volume. Conclusions Tadalafil 5mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED. Trial registration This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242.

  • Tadalafil administered once daily for treatment of lower urinary tract symptoms in korean men with benign prostatic hyperplasia results from a placebo controlled pilot study using tamsulosin as an active control
    Luts: Lower Urinary Tract Symptoms, 2011
    Co-Authors: Jong Kwan Park, Albert Elionmboussa, Roberta J Secrest, Jae Seung Paick, Nam Cheol Park, Kwangsung Park, Stephen R Kraus, Lars Viktrup
    Abstract:

    Objectives: Assess the efficacy and safety of once-daily Tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms (LUTS) in Korean men with benign prostatic hyperplasia (BPH). Methods: Following a 4-week placebo run-in period, 151 Korean men were randomly assigned to receive once-daily Tadalafil 5 mg, tamsulosin 0.2 mg, or placebo for 12 weeks. Results: The International Prostate Symptom Score (IPSS) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the Tadalafil (−5.8) and tamsulosin (−5.4) groups compared with placebo (−4.2, P > 0.05). Decreases in IPSS obstructive and irritative subscores, IPSS Quality of Life score, and BPH Impact Index from baseline to endpoint were largest in the Tadalafil group followed by tamsulosin, though none separated significantly from placebo. Increases in maximum urinary flow rate were small and not significantly different than placebo; the increase was largest in the Tadalafil group (2.5 mL/sec), followed by the placebo (2.3 mL/sec) and tamsulosin (2.1 mL/sec) groups. The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5, 13.7 and 3.9% in the tamsulosin, Tadalafil and placebo groups, respectively. Conclusions: In this pilot study in Korean men, those with BPH and treated with Tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS, which was numerically (but not statistically) significant compared with the placebo. Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events. Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed.

Francesco Montorsi - One of the best experts on this subject based on the ideXlab platform.

  • effect of Tadalafil once daily on penile length loss and morning erections in patients after bilateral nerve sparing radical prostatectomy results from a randomized controlled trial
    Urology, 2015
    Co-Authors: Gerald B Brock, Francesco Montorsi, P Costa, Nimish Shah, J M Martinezjabaloyas, Peter Hammerer, Giuseppe Ludovico, Carsten Henneges, Karim Hamidi, Andrea Rossi
    Abstract:

    Objective To report penile integrity measures, including stretched penile length (SPL), from a randomized, double-blind, double-dummy, placebo-controlled trial evaluating treatment with Tadalafil initiated after nerve-sparing radical prostatectomy (nsRP). Methods Patients aged ≤68 years were randomized after nsRP 1:1:1 to 9-month double-blind treatment (DBT) with Tadalafil 5 mg once daily (OaD), 20-mg Tadalafil on-demand (“pro-re-nata”; PRN), or placebo, followed by 6-week drug-free washout and 3-month open-label OaD treatment. Secondary outcome measures included the change in SPL from pre-nsRP to the end of DBT (analysis of covariance adjusting for treatment, country, baseline, age, and nerve-sparing score), responses to Sexual Encounter Profile (SEP) questions 1-3 (mixed models for repeated measures adjusting for treatment, country, visit, visit-treatment-interaction, age), and Standardized Morning Erection Question (Cochran-Mantel-Haenszel test adjusted for age and country). Results Four hundred twenty-three patients were randomized to Tadalafil OaD (N = 139), Tadalafil PRN (N = 143), and placebo (N = 141). Greater retainment of SPL was observed with Tadalafil OaD vs placebo at the end of DBT (least-square mean [95% confidence interval] difference OaD vs placebo, 4.1 mm [0.4 to 7.8 mm]; P  = .032). No significant effects on SPL were found for Tadalafil PRN vs placebo, or for the nerve-sparing score. Penile tumescence (SEP1) and ability for vaginal insertion (SEP2) significantly improved vs placebo at the end of double-blind and open-label treatment for patients randomized to Tadalafil OaD only. The ability for successful sexual intercourse (SEP3) significantly improved with Tadalafil OaD vs placebo only during DBT. The distribution of Standardized Morning Erection Question responses was different at the end of DBT ( P  = .045); 34.2% of patients on Tadalafil OaD, 50.0% on Tadalafil PRN, and 56.5% on placebo reported absence of morning erections. Conclusion These data suggest the early initiation of Tadalafil OaD protects from penile length loss and may contribute to protection from structural cavernosal changes after nsRP.

  • effects of Tadalafil treatment on erectile function recovery following bilateral nerve sparing radical prostatectomy a randomised placebo controlled study reactt
    European Urology, 2014
    Co-Authors: Francesco Montorsi, Carsten Henneges, Ignacio Moncada, Gerald Brock, Jensuwe Stolzenburg, John P Mulhall, Hitendra R H Patel, Daniel Chevallier, Kazimierz Krajka, Ruth Dickson
    Abstract:

    Background The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors (PDE5-Is) on penile function after nerve-sparing radical prostatectomy (NSRP) remains unclear. Objective The primary objective was to compare the efficacy of Tadalafil 5mg once daily and Tadalafil 20mg on demand versus placebo taken over 9 mo in improving unassisted erectile function (EF) following NSRP, as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score ≥ 22 after 6-wk drug-free washout (DFW). Secondary measures included IIEF-EF, Sexual Encounter Profile question 3 (SEP-3), and penile length. Design, setting, and participants Randomised, double-blind, double-dummy, placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate (Gleason ≤ 7) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada. Interventions 1:1:1 randomisation to 9 mo of treatment with Tadalafil 5mg once daily, Tadalafil 20mg on demand, or placebo followed by a 6-wk DFW and 3-mo open-label Tadalafil once daily (all patients). Outcome measurements and statistical analysis Logistic regression, mixed-effects model for repeated measures, and analysis of covariance, adjusting for treatment, age, and country, were applied to IIEF-EF scores ≥ 22, SEP-3, and penile length. Results and limitations Four hundred twenty-three patients were randomised to Tadalafil once daily (n=139), on demand (n=143), and placebo (n=141). The mean age was 57.9 yr of age (standard deviation: 5.58 yr); 20.9%, 16.9%, and 19.1% of patients in the Tadalafil once daily, on demand, and placebo groups, respectively, achieved IIEF EF scores ≥ 22 after DFW; odds ratios for Tadalafil once daily and on demand versus placebo were 1.1 (95% confidence interval [CI], 0.6-2.1; p=0.675) and 0.9 (95% CI, 0.5-1.7; p=0.704). At the end of double-blind treatment (EDT), least squares (LS) mean IIEF-EF score improvement significantly exceeded the minimally clinically important difference (MCID: ΔIIEF-EF ≥ 4) in both Tadalafil groups; for SEP-3 (MCID ≥ 23%), this was the case for Tadalafil once daily only. Treatment effects versus placebo were significant for Tadalafil once daily only (IIEF-EF: p=0.016; SEP-3: p=0.019). In all groups, IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment. At month 9 (EDT), penile length loss was significantly reduced versus placebo in the Tadalafil once daily group only (LS mean difference 4.1mm; 95% CI, 0.4-7.8; p=0.032). Conclusions Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP, and data suggest a potential role for Tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes. Unassisted EF was not improved after cessation of active therapy for 9 mo. Trial registration ClinicalTrials.gov identifier NCT01026818.

  • effects of once daily Tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia
    European Urology, 2009
    Co-Authors: Hartmut Porst, Albert Elionmboussa, Francesco Montorsi, Kevin T Mcvary, Peter Sutherland, Anne M Wolka, Lars Viktrup
    Abstract:

    Abstract Background Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED). Objective To evaluate the effects of once-daily Tadalafil on erectile function in men with ED and BPH-LUTS. Design, setting, and participants Post hoc analysis of a phase 2–3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate. Interventions Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or Tadalafil 2.5, 5, 10, or 20mg for 12 wk. Measurements International Index of Erectile Function–Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max ), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior α-blocker use, and prior ED therapy. Results and limitations Overall, 581 men were included (placebo, n =115; Tadalafil 2.5mg, n =113; Tadalafil 5mg, n =117; Tadalafil 10mg, n =120; Tadalafil 20mg, n =116). IIEF-EF domain score improvements from baseline to end point with Tadalafil were 5.4 (2.5mg), 6.8 (5mg), 7.9 (10mg), and 8.2 (20mg) versus 2.0 with placebo (least-squares means; all p values p values max and PVR were small and not clinically meaningful. Conclusions These data support the use of once-daily Tadalafil in men with ED and BPH-LUTS. Trial registration http://www.clinicaltrials.gov: NCT00384930.

  • an open label multicentre randomized crossover study comparing sildenafil citrate and Tadalafil for treating erectile dysfunction in men naive to phosphodiesterase 5 inhibitor therapy
    BJUI, 2005
    Co-Authors: Ian Eardley, David J Ralph, Vincenzo Mirone, Francesco Montorsi, Philip Kell, Margaret R Warner, Yanli Zhao, Anthony Beardsworth
    Abstract:

    Associate Editor Michael G. Wylie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands OBJECTIVES To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and Tadalafil for treating erectile dysfunction (ED) in men naive to phosphodiesterase 5 (PDE5) inhibitor therapy. PATIENTS AND METHODS This was an open-label, crossover study of sildenafil and Tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by Tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg Tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg Tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary. RESULTS Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose Tadalafil (P  5% of men were headache and flushing. CONCLUSIONS In men with ED who were naive to PDE5 inhibitor therapy, sildenafil and Tadalafil were both effective and well tolerated. After treatment with sildenafil and Tadalafil, 29% of men chose sildenafil and 71% chose Tadalafil for ED therapy during an 8-week extension.

Kevin T Mcvary - One of the best experts on this subject based on the ideXlab platform.

  • effects of once daily Tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia
    European Urology, 2009
    Co-Authors: Hartmut Porst, Albert Elionmboussa, Francesco Montorsi, Kevin T Mcvary, Peter Sutherland, Anne M Wolka, Lars Viktrup
    Abstract:

    Abstract Background Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED). Objective To evaluate the effects of once-daily Tadalafil on erectile function in men with ED and BPH-LUTS. Design, setting, and participants Post hoc analysis of a phase 2–3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate. Interventions Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or Tadalafil 2.5, 5, 10, or 20mg for 12 wk. Measurements International Index of Erectile Function–Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max ), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior α-blocker use, and prior ED therapy. Results and limitations Overall, 581 men were included (placebo, n =115; Tadalafil 2.5mg, n =113; Tadalafil 5mg, n =117; Tadalafil 10mg, n =120; Tadalafil 20mg, n =116). IIEF-EF domain score improvements from baseline to end point with Tadalafil were 5.4 (2.5mg), 6.8 (5mg), 7.9 (10mg), and 8.2 (20mg) versus 2.0 with placebo (least-squares means; all p values p values max and PVR were small and not clinically meaningful. Conclusions These data support the use of once-daily Tadalafil in men with ED and BPH-LUTS. Trial registration http://www.clinicaltrials.gov: NCT00384930.

  • Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia a dose finding study
    The Journal of Urology, 2008
    Co-Authors: Claus G Roehrborn, Albert Elionmboussa, Kevin T Mcvary, Lars Viktrup
    Abstract:

    Purpose: Phosphodiesterase type 5 inhibitors are widely used to treat erectile dysfunction. Preliminary data have suggested phosphodiesterase type 5 inhibitor efficacy in men with lower urinary tract symptoms associated with clinical benign prostatic hyperplasia.Materials and Methods: After a 4-week placebo run-in period 1,058 men with benign prostatic hyperplasia lower urinary tract symptoms were randomly allocated to receive 12-week, once daily treatment with placebo or Tadalafil (2.5, 5, 10 or 20 mg).Results: The International Prostate Symptom Score least squares mean change from baseline to end point was significantly improved for 2.5 (−3.9, p = 0.015), 5 (−4.9, p <0.001), 10 (−5.2, p <0.001) and 20 mg (−5.2, p <0.001) Tadalafil compared to placebo (−2.3). International Prostate Symptom Score improvements at 4, 8 and 12 weeks were significant for all Tadalafil doses and they demonstrated a dose-response relationship. Tadalafil (2.5 mg) significantly improved the International Prostate Symptom Score ob...

  • Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia
    The Journal of Urology, 2007
    Co-Authors: Kevin T Mcvary, Claus G Roehrborn, Jed Kaminetsky, Stephen Auerbach, B Wachs, Jay M Young, Anne Esler, Gregory D Sides, Bela S Denes
    Abstract:

    Purpose: We assessed the efficacy and safety of Tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia.Materials and Methods: Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg Tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo.Results: Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg Tadalafil −2.8 vs placebo −1.2) and at 12 weeks (5/20 mg Tadalafil −3.8 vs placebo −1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg Tadalafil −7.1 vs placebo −4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. In...

Albert Elionmboussa - One of the best experts on this subject based on the ideXlab platform.

  • Tadalafil administered once daily for treatment of lower urinary tract symptoms in korean men with benign prostatic hyperplasia results from a placebo controlled pilot study using tamsulosin as an active control
    Luts: Lower Urinary Tract Symptoms, 2011
    Co-Authors: Jong Kwan Park, Albert Elionmboussa, Roberta J Secrest, Jae Seung Paick, Nam Cheol Park, Kwangsung Park, Stephen R Kraus, Lars Viktrup
    Abstract:

    Objectives: Assess the efficacy and safety of once-daily Tadalafil or tamsulosin versus placebo during 12 weeks on lower urinary tract symptoms (LUTS) in Korean men with benign prostatic hyperplasia (BPH). Methods: Following a 4-week placebo run-in period, 151 Korean men were randomly assigned to receive once-daily Tadalafil 5 mg, tamsulosin 0.2 mg, or placebo for 12 weeks. Results: The International Prostate Symptom Score (IPSS) least squares mean changes from baseline to endpoint were numerically but not significantly improved in the Tadalafil (−5.8) and tamsulosin (−5.4) groups compared with placebo (−4.2, P > 0.05). Decreases in IPSS obstructive and irritative subscores, IPSS Quality of Life score, and BPH Impact Index from baseline to endpoint were largest in the Tadalafil group followed by tamsulosin, though none separated significantly from placebo. Increases in maximum urinary flow rate were small and not significantly different than placebo; the increase was largest in the Tadalafil group (2.5 mL/sec), followed by the placebo (2.3 mL/sec) and tamsulosin (2.1 mL/sec) groups. The percentage of subjects reporting at least one treatment-emergent adverse event was 26.5, 13.7 and 3.9% in the tamsulosin, Tadalafil and placebo groups, respectively. Conclusions: In this pilot study in Korean men, those with BPH and treated with Tadalafil 5 mg or tamsulosin 0.2 mg once daily experienced a reduction in LUTS, which was numerically (but not statistically) significant compared with the placebo. Tadalafil was well tolerated and few subjects discontinued the study due to treatment-emergent adverse events. Larger studies in Asian men with BPH and LUTS treated with phosphodiesterase type 5 inhibitors are needed.

  • changes in peak urinary flow and voiding efficiency in men with signs and symptoms of benign prostatic hyperplasia during once daily Tadalafil treatment
    BJUI, 2010
    Co-Authors: Claus G Roehrborn, Albert Elionmboussa, Jed Kaminetsky, Stephen Auerbach, Rafael Martinez Montelongo, Lars Viktrup
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To determine, by post hoc analysis, the effects of Tadalafil (a long-acting phosphodiesterase 5 inhibitor) on peak urinary flow (Qmax), bladder capacity, voiding efficiency and the obstructive symptoms of benign prostatic hyperplasia (BPH) in men with lower urinary tract symptoms secondary to BPH (BPH-LUTS), compared with placebo. PATIENTS AND METHODS After a 4-week placebo run-in period, 1058 men with BPH-LUTS were randomly allocated to receive once daily treatment with placebo or Tadalafil (2.5, 5, 10, or 20 mg) for 12 weeks. Uroflowmetry, postvoid residual volume (PVR), and BPH symptom score measurements were assessed throughout the trial. RESULTS Increases in Qmax were numerically greater for Tadalafil (2.5, 5, 10, and 20 mg with percentage changes of 15%, 16%, 17%, 22%, respectively) vs placebo (12%), but did not reach statistical significance. Age, baseline Qmax, erectile dysfunction history, sexual activity, and previous α-blocker therapy significantly influenced the Qmax response. Tadalafil was not associated with significant changes in PVR. Tadalafil had its greatest effects on bladder capacity and voiding efficiency in men with a Qmax of <10 mL/s at baseline, but these changes were not significantly different from placebo responses. Tadalafil treatment significantly improved the IPSS obstructive subscores (Tadalafil 2.5, 5, 10, 20 mg with percentage changes of 24%, 31%, 33%, 33%, respectively) vs placebo (13%). CONCLUSIONS Once daily Tadalafil did not significantly change Qmax or voiding efficiency compared with placebo in men with BPH-LUTS, although there were dose-dependent improvements. No subgroups were identified where Tadalafil or placebo treatment had a deleterious effect on Qmax. Despite these minimal changes in uroflowmetric measures, Tadalafil was associated with clinically meaningful and statistically significant improvements in the obstructive symptoms of BPH.

  • effects of once daily Tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia
    European Urology, 2009
    Co-Authors: Hartmut Porst, Albert Elionmboussa, Francesco Montorsi, Kevin T Mcvary, Peter Sutherland, Anne M Wolka, Lars Viktrup
    Abstract:

    Abstract Background Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED). Objective To evaluate the effects of once-daily Tadalafil on erectile function in men with ED and BPH-LUTS. Design, setting, and participants Post hoc analysis of a phase 2–3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate. Interventions Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or Tadalafil 2.5, 5, 10, or 20mg for 12 wk. Measurements International Index of Erectile Function–Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max ), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior α-blocker use, and prior ED therapy. Results and limitations Overall, 581 men were included (placebo, n =115; Tadalafil 2.5mg, n =113; Tadalafil 5mg, n =117; Tadalafil 10mg, n =120; Tadalafil 20mg, n =116). IIEF-EF domain score improvements from baseline to end point with Tadalafil were 5.4 (2.5mg), 6.8 (5mg), 7.9 (10mg), and 8.2 (20mg) versus 2.0 with placebo (least-squares means; all p values p values max and PVR were small and not clinically meaningful. Conclusions These data support the use of once-daily Tadalafil in men with ED and BPH-LUTS. Trial registration http://www.clinicaltrials.gov: NCT00384930.

  • Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia a dose finding study
    The Journal of Urology, 2008
    Co-Authors: Claus G Roehrborn, Albert Elionmboussa, Kevin T Mcvary, Lars Viktrup
    Abstract:

    Purpose: Phosphodiesterase type 5 inhibitors are widely used to treat erectile dysfunction. Preliminary data have suggested phosphodiesterase type 5 inhibitor efficacy in men with lower urinary tract symptoms associated with clinical benign prostatic hyperplasia.Materials and Methods: After a 4-week placebo run-in period 1,058 men with benign prostatic hyperplasia lower urinary tract symptoms were randomly allocated to receive 12-week, once daily treatment with placebo or Tadalafil (2.5, 5, 10 or 20 mg).Results: The International Prostate Symptom Score least squares mean change from baseline to end point was significantly improved for 2.5 (−3.9, p = 0.015), 5 (−4.9, p <0.001), 10 (−5.2, p <0.001) and 20 mg (−5.2, p <0.001) Tadalafil compared to placebo (−2.3). International Prostate Symptom Score improvements at 4, 8 and 12 weeks were significant for all Tadalafil doses and they demonstrated a dose-response relationship. Tadalafil (2.5 mg) significantly improved the International Prostate Symptom Score ob...

  • evaluation of the efficacy and safety of once a day dosing of Tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction results of a multicenter randomized double blind placebo controlled trial
    European Urology, 2006
    Co-Authors: Hartmut Porst, Francois Giuliano, Sidney Glina, David J Ralph, A Casabe, Albert Elionmboussa, Wei Shen, Steve J Whitaker
    Abstract:

    Abstract Background Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like Tadalafil. Because the 17.5-h half-life of Tadalafil enables therapeutic plasma levels to be sustained with daily administration, Tadalafil is a good candidate for once daily dosing therapy. Methods This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, Tadalafil 5mg, and Tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26–30). Results For patients who took placebo, Tadalafil 5mg, and Tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between Tadalafil and placebo were significant ( p Conclusions Once-a-day Tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

Robert A Kloner - One of the best experts on this subject based on the ideXlab platform.

  • The cardiovascular safety of Tadalafil
    Expert Opinion on Drug Safety, 2008
    Co-Authors: Thorsten Reffelmann, Arne Kieback, Robert A Kloner
    Abstract:

    Tadalafil is an inhibitor of phosphodiesterase 5, approved for the treatment of erectile dysfunction. Blood pressure-lowering effects of Tadalafil in healthy volunteers are minimal. In patients on a broad spectrum of antihypertensive medication, severe hypotension did not occur in combination with Tadalafil; however, a combination of Tadalafil with any nitric oxide donor can lead to life-threatening hypotension and is, therefore, absolutely contraindicated (at least 48 h interval after last dose of Tadalafil). Combination with α-blocking agents, such as doxazosin, may only be considered when patients are hemodynamically stable for a longer period using the lowest dose of Tadalafil and with close blood pressure monitoring. In placebo-controlled trials, severe adverse cardiovascular events were rare in Tadalafil users and similar in frequency in comparison to placebo. However, as cardiovascular disease is highly prevalent in patients with erectile dysfunction, a complete diagnostic work up of these patients...

  • the phosphodiesterase 5 inhibitor Tadalafil reduces myocardial infarct size
    International Journal of Impotence Research, 2007
    Co-Authors: C Sesti, V Florio, E G Johnson, Robert A Kloner
    Abstract:

    The aim of this study was to determine, in an animal model, the effects of Tadalafil on myocardial infarct size (IS), hemodynamics and regional myocardial blood flow after myocardial ischemia and reperfusion. Patients with erectile dysfunction (ED) often have risk factors for coronary artery disease. Tadalafil, a long-acting inhibitor of the enzyme phosphodiesterase-5 (PDE5), is used for the treatment of ED; there are no previous data regarding Tadalafil in the setting of coronary artery occlusion (CAO). Sprague–Dawley male rats were treated with Tadalafil or vehicle (10 mg/kg, by gastric gavage), 2 h before a 30 min CAO. Heart rate was comparable between Tadalafil and control groups. Tadalafil reduced mean arterial pressure (P=0.009), systolic (P=0.035) and diastolic (P=0.009) blood pressures during ischemia/reperfusion. Tadalafil significantly reduced IS (42±2%) versus controls (54±3%) (P=0.006). For the first time, we showed that the PDE5 inhibitor, Tadalafil, was well tolerated and cardioprotective in the setting of an experimental myocardial infarction, by substantially reducing ischemic cell death.

  • interaction between the phosphodiesterase 5 inhibitor Tadalafil and 2 α blockers doxazosin and tamsulosin in healthy normotensive men
    The Journal of Urology, 2004
    Co-Authors: Robert A Kloner, Jeffrey T Emmick, Malcolm I Mitchell, Alun Bedding, Margaret R Warner, Graham Jackson, Alvaro Pereira
    Abstract:

    ABSTRACT Purpose: Tadalafil, a phosphodiesterase type 5 inhibitor, is effective therapy for erectile dysfunction (ED). Men with ED have a high incidence of comorbid conditions including cardiovascular disease, diabetes mellitus and benign prostatic hyperplasia. Although phosphodiesterase type 5 inhibitors are safe when administered with most medications, sildenafil given with doxazosin and vardenafil given with terazosin evoke orthostatic hypotension in some patients. We examined the hemodynamic interactions of Tadalafil with the α-blockers doxazosin and tamsulosin. Materials and Methods: In separate double-blind, placebo controlled, randomized crossover studies (18 patients in each study) we evaluated the hemodynamic effects of doxazosin 8 mg with Tadalafil 20 mg, and tamsulosin 0.4 mg with Tadalafil 10 and 20 mg. Blood pressure (BP) and heart rate were recorded before dosing and for 24 hours after dosing. Results: Tadalafil 20 mg augmented the hypotensive effect of doxazosin by producing a mean maximal decrease in standing systolic BP (SBP) that was significantly greater than placebo (a mean difference of 9.8 mm Hg). Analysis of BP outliers showed that the number of subjects with a standing SBP of less than 85 mm Hg was greater after doxazosin plus Tadalafil (28%) versus doxazosin plus placebo (6%). In subjects on tamsulosin, Tadalafil 10 and 20 mg produced mean maximal decreases in standing SBP that were similar to placebo (mean difference of 1.7 and 2.3 mm Hg, respectively). No subject taking tamsulosin had a decrease in standing SBP less than 85 mm Hg. Conclusions: Tadalafil augmented the hypotensive effects of doxazosin but had little hemodynamic interaction with tamsulosin. In patients taking Tadalafil for ED, tamsulosin 0.4 mg may be given for the treatment of benign prostatic hyperplasia.

  • time course of the interaction between Tadalafil and nitrates
    Journal of the American College of Cardiology, 2003
    Co-Authors: Robert A Kloner, Jonathan Denne, Jeffrey T Emmick, Malcolm I Mitchell, Adolph M Hutter, Graham Jackson
    Abstract:

    Abstract Objectives This study was designed to determine the time course of nitrate interaction with Tadalafil, a phosphodiesterase 5 (PDE5) inhibitor with a half-life (t1/2) of 17.5 h. Background The PDE5 inhibitors augment the blood pressure (BP)-lowering effects of nitrates, yet the time course of this interaction is unclear. Recent guidelines from the American College of Cardiology/American Heart Association recommend that nitrates be withheld for 24 h after taking sildenafil (t1/2= 4 h). Methods Male subjects (n = 150) received seven consecutive daily doses of placebo or Tadalafil (20 mg). On day 7 and beyond, subjects received repeated doses of sublingual nitroglycerin (0.4 mg) after the last dose of placebo or Tadalafil. After a 10- to 21-day washout period, subjects crossed over to either placebo or Tadalafil, and nitrate dosing was repeated. Results In response to nitroglycerin at 4, 8, and 24 h, standing systolic BP fell below 85 mm Hg in more subjects on Tadalafil compared with placebo (p 0.2). Similar observations were made for standing diastolic BP 30 mm Hg, and decrease in diastolic BP >20 mm Hg. Nitroglycerin also evoked greater mean maximal decreases in standing systolic BP at 8 and 24 h after taking Tadalafil versus placebo (p 0.49). Conclusions The hemodynamic interaction between Tadalafil and sublingual nitroglycerin lasted 24 h, but was not seen at 48 h and beyond. Similar to other PDE5 inhibitors, Tadalafil should not be administered in combination with organic nitrates.

  • cardiovascular effects of Tadalafil
    American Journal of Cardiology, 2003
    Co-Authors: Malcolm Mitchell, Robert A Kloner, Jeffrey T Emmick
    Abstract:

    Abstract To determine the effects of Tadalafil on the cardiovascular system, safety assessments were performed on a database of >4,000 subjects who received Tadalafil in >60 clinical pharmacology, phase 2, phase 3, and open-label studies. In healthy subjects, Tadalafil resulted in small changes in blood pressure, which are not believed to be clinically relevant. Daily administration of Tadalafil 20 mg for 26 weeks in healthy male subjects or patients with mild erectile dysfunction resulted in blood pressure changes similar to those observed after placebo administration. In patients with coronary artery disease (CAD), Tadalafil administration before nitrate administration resulted in small decreases in blood pressure. The resulting mean maximal change in standing systolic blood pressure (SBP) after coadministration of sublingual nitroglycerin in patients with chronic stable angina was −36 mm Hg for Tadalafil 5 mg, −31 mm Hg for Tadalafil 10 mg, and −28 mm Hg for placebo. In addition, a larger number of men had a standing SBP