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
The World Journal of Men's Health
;
: 161-170, 2018.
Article
in English
| WPRIM
| ID: wpr-714389
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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Prostate
/
Prostatic Hyperplasia
/
Quality of Life
/
Urinary Tract
/
Prospective Studies
/
Cohort Studies
/
Phosphodiesterase 5 Inhibitors
/
Lower Urinary Tract Symptoms
/
Tadalafil
Type of study:
Diagnostic study
/
Etiology study
/
Incidence study
/
Observational study
/
Risk factors
/
Screening study
Limits:
Humans
/
Male
Language:
English
Journal:
The World Journal of Men's Health
Year:
2018
Type:
Article
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