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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.
Eur Urol. 2012 May; 61(5):917-25.EU

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<0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (-0.8; p<0.001) and tamsulosin (-0.9; p<0.001) and through 12 wk (tadalafil -0.8, 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<0.05) but not with tamsulosin (both p>0.1). The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil (4.0; p<0.001) but not tamsulosin (-0.4; 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.

Authors+Show Affiliations

Department of Urology, Hannover Medical School, Hannover, Germany. oelke.matthias@mh-hannover.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22297243

Citation

Oelke, Matthias, et al. "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, vol. 61, no. 5, 2012, pp. 917-25.
Oelke M, Giuliano F, Mirone V, et al. 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. Eur Urol. 2012;61(5):917-25.
Oelke, M., Giuliano, F., Mirone, V., Xu, L., Cox, D., & Viktrup, L. (2012). 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, 61(5), 917-25. https://doi.org/10.1016/j.eururo.2012.01.013
Oelke M, et al. 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. Eur Urol. 2012;61(5):917-25. PubMed PMID: 22297243.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Oelke,Matthias, AU - Giuliano,François, AU - Mirone,Vincenzo, AU - Xu,Lei, AU - Cox,David, AU - Viktrup,Lars, Y1 - 2012/01/20/ PY - 2011/11/22/received PY - 2012/01/09/accepted PY - 2012/2/3/entrez PY - 2012/2/3/pubmed PY - 2012/8/3/medline SP - 917 EP - 25 JF - European urology JO - Eur. Urol. VL - 61 IS - 5 N2 - 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<0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (-0.8; p<0.001) and tamsulosin (-0.9; p<0.001) and through 12 wk (tadalafil -0.8, 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<0.05) but not with tamsulosin (both p>0.1). The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil (4.0; p<0.001) but not tamsulosin (-0.4; 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. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/22297243/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(12)00015-2 DB - PRIME DP - Unbound Medicine ER -