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
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 s...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Korean Society for Sexual Medicine and Andrology
2018-05-01
|
| Series: | The World Journal of Men's Health |
| Subjects: | |
| Online Access: | https://www.wjmh.org/Synapse/Data/PDFData/2074WJMH/wjmh-36-161.pdf |
| _version_ | 1818497440257409024 |
|---|---|
| author | Ji Eon Won Ji Yeon Chu Hyunah Caroline Choi Yun Chen Hyun Jun Park Héctor José Dueñas |
| author_facet | Ji Eon Won Ji Yeon Chu Hyunah Caroline Choi Yun Chen Hyun Jun Park Héctor José Dueñas |
| author_sort | Ji Eon Won |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T18:45:48Z |
| format | Article |
| id | doaj.art-0ca7422b3218487d99f90950b8c8d815 |
| institution | Directory Open Access Journal |
| issn | 2287-4208 2287-4690 |
| language | English |
| last_indexed | 2024-12-10T18:45:48Z |
| publishDate | 2018-05-01 |
| publisher | Korean Society for Sexual Medicine and Andrology |
| record_format | Article |
| series | The World Journal of Men's Health |
| spelling | doaj.art-0ca7422b3218487d99f90950b8c8d8152022-12-22T01:37:30ZengKorean Society for Sexual Medicine and AndrologyThe World Journal of Men's Health2287-42082287-46902018-05-0136216117010.5534/wjmh.17017Safety 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 StudyJi Eon Won0Ji Yeon Chu1Hyunah Caroline Choi2Yun Chen3Hyun Jun Park4Héctor José Dueñas5Lilly KoreaLilly KoreaLilly KoreaLilly Suzhou Pharmaceutical CompanyPusan National University School of MedicineEli Lilly de MexicoPurpose: 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.https://www.wjmh.org/Synapse/Data/PDFData/2074WJMH/wjmh-36-161.pdfLower urinary tract symptomsPhosphodiesterase 5 InhibitorsProstatic hyperplasiaSafetyTadalafil |
| spellingShingle | Ji Eon Won Ji Yeon Chu Hyunah Caroline Choi Yun Chen Hyun Jun Park Héctor José Dueñas 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 Lower urinary tract symptoms Phosphodiesterase 5 Inhibitors Prostatic hyperplasia Safety Tadalafil |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Lower urinary tract symptoms Phosphodiesterase 5 Inhibitors Prostatic hyperplasia Safety Tadalafil |
| url | https://www.wjmh.org/Synapse/Data/PDFData/2074WJMH/wjmh-36-161.pdf |
| work_keys_str_mv | AT jieonwon safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy AT jiyeonchu safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy AT hyunahcarolinechoi safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy AT yunchen safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy AT hyunjunpark safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy AT hectorjoseduenas safetyandeffectivenessofoncedailytadalafil5mgtherapyinkoreanmenwithbenignprostatichyperplasialowerurinarytractsymptomsinarealworldclinicalsettingresultsfromapostmarketingsurveillancestudy |