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

Sae Chul Kim, Jong Kwan Park, Sae Woong Kim, Sung Won Lee, Tai Young Ahn, Je-Jong Kim, Jae Seung Paick, Nam Cheol Park, Kwangsung Park, Kweon Sik Min, Stephen R. Kraus, Roberta J. Secrest, Albert Elion-Mboussa, Lars Viktrup

Research output: Contribution to journalArticle

28 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)86-93
Number of pages8
JournalLUTS: Lower Urinary Tract Symptoms
Volume3
Issue number2
DOIs
Publication statusPublished - 2011 Sep 1

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tamsulosin
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Placebos
Prostate
Therapeutics
Tadalafil
Phosphodiesterase 5 Inhibitors

Keywords

  • Benign prostatic hyperplasia
  • International Prostate Symptom Score
  • Lower urinary tract symptoms
  • Tadalafil
  • Tamsulosin

ASJC Scopus subject areas

  • Neurology
  • Urology

Cite this

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. / Kim, Sae Chul; Park, Jong Kwan; Kim, Sae Woong; Lee, Sung Won; Ahn, Tai Young; Kim, Je-Jong; Paick, Jae Seung; Park, Nam Cheol; Park, Kwangsung; Min, Kweon Sik; Kraus, Stephen R.; Secrest, Roberta J.; Elion-Mboussa, Albert; Viktrup, Lars.

In: LUTS: Lower Urinary Tract Symptoms, Vol. 3, No. 2, 01.09.2011, p. 86-93.

Research output: Contribution to journalArticle

Kim, Sae Chul ; Park, Jong Kwan ; Kim, Sae Woong ; Lee, Sung Won ; Ahn, Tai Young ; Kim, Je-Jong ; Paick, Jae Seung ; Park, Nam Cheol ; Park, Kwangsung ; Min, Kweon Sik ; Kraus, Stephen R. ; Secrest, Roberta J. ; Elion-Mboussa, Albert ; Viktrup, Lars. / 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. In: LUTS: Lower Urinary Tract Symptoms. 2011 ; Vol. 3, No. 2. pp. 86-93.
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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.",
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