World J Mens Health.  2018 May;36(2):161-170. 10.5534/wjmh.17017.

Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study

• Won JE
• Chu JY
• Choi HC
• Chen Y
• Park HJ
• Dueñas HJ

• KMID: 2419315
• DOI: http://doi.org/10.5534/wjmh.17017

Abstract

PURPOSE
The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting.
MATERIALS AND METHODS
This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint.
RESULTS
All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001), with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score.
CONCLUSIONS
Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.

Keyword

Lower urinary tract symptoms; Phosphodiesterase 5 Inhibitors; Prostatic hyperplasia; Safety; Tadalafil

MeSH Terms

Cohort Studies
Humans
Lower Urinary Tract Symptoms
Male
Phosphodiesterase 5 Inhibitors
Prospective Studies
Prostate
Prostatic Hyperplasia
Quality of Life
Tadalafil*
Urinary Tract*
Phosphodiesterase 5 Inhibitors
Tadalafil

Figure

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  Fig. 1 Patient populations for the safety and effectiveness analyses. CRF: case report form.

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  Fig. 2 Change in IPSS scores as a measure of treatment effectiveness. (A) Mean IPSS total score and subscores for the 12-week (N=265) and 24-week surveillance groups (N=44). Mean±SD is shown. (B) Mean change from baseline on all IPSS scores. Error bars represent±SE. ***p<0.0001. IPSS: International Prostate Symptom Score, SD: standard deviation, QoL: quality of life, SE: standard error.

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