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Long-term tadalafil once daily in Chinese men with erectile dysfunction:a 2-year final analysis of a post-marketing,multicenter,randomized,open-label trial

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Asian Journal of Andrology 2024年第3期26卷 282-287页

作者： Hui Jiang Lian-Ming Zhao Su Yan Ji-Hong Liu Zhao-Hui Zhu Jin-Dan Luo Yu-Tian Dai Fu-Biao Li Hao-Cheng Lin Zhi-Chao Zhang Department of Urology Peking University First HospitalBeijing 100000China Department of Urology Peking University Third HospitalBeijing 100191China Department of Urology Peking Union Medical College HospitalBeijing 100730China Department of Urology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Department of Urology Union Hospital of Tongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430022China Department of Urology The First Affiliated HospitalZhejiang University School of MedicineHangzhou 310003China Departmentof Andrology Nanjing Drum Tower HospitalNanjing 210008China Department of Andrology The First Hospital of Jilin UniversityChangchun 130021China Andrology Center Department of UrologyPeking University First HospitalBeijing 100034China

The long-term safety and effectiveness of once-daily tadalafil is crucial,but limited data are available in Chinese patients witherectile dysfunction(ED).In this post-marketing,multicenter,randomized,open-label trial with 2-year follow-up,635 ED caseswere randomized to receive daily oral tadalafil 2.5 mg or 5 mg for 3 months,of whom 580 continued once-daily tadalafil 5 mg for21 ***-emergent adverse events in the 12-month and 24-month period were similar,with the most common beingviral upper respiratory tract infection,upper respiratory tract infection,and *** improvement from baseline inthe International Index of Erectile Function-Erectile Function(IIEF-EF)score was detected at month 12(least squares mean[LSM]change:7.9,95%confidence interval[CI]:7.5–8.4,Pdaily application of tadalafil 5mg in Chinese men with ED showed a favorable safety profile and durable improvement in sexual performance and satisfaction.

关键词： clinical trial erectile dysfunction long-term safety once-daily dosing tadalafil

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每日一次与按需使用乌地那非对治疗2型糖尿病患者勃起功能障碍的有效性和安全性比较

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Asian Journal of Andrology 2015年第1期17卷 143-148,I0011,I0012页

作者： Soon Hyun Park Sung Woo Park Bong Yun Cha Ie Byung Park Kyung Wan Min Yeon Ah Sung Tae Hwa Kim Jae Min Lee Kang Seo Park Department of Internal Medicine Eulji University School of Medicine Daejeon 302-799 South Korea Department of Endocrinology and Metabolism Kangbuk Samsung Hospital Sungkyunkwan University School of Medicine Seou1110-746 South Korea Department of Endocrinology and Metabolism College of Medicine the Catholic University of Korea Seou1137-701 South Korea Department of Internal Medicine Gachon University of Medicine and Science Graduate School of Medicine Incheon 405-760 South Korea Department of Internal Medicine Eulji University School of Medicine Seou1139-872 South Korea Department of Endocrinology Ewha Woman's University School of Medicine Seoul 158-710 South Korea Department of Internal Medicine College of Medicine Hanyang University Seoul 133-792 South Korea.

We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction （ED）. A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile （SEP） diary Question 2 and 3 （Q2 and Q3） were randomized into 200 mg on-demand （n = 80） or 50 mg once-daily （n = 81） dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function （IIEF） erectile function domain （EFD） score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate （EFD 〉 26）. Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment （P 〈 0.0001）. There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.

关键词： erectile dysfunction International Index of Erectile Function once-daily dosing ptiosphodiesterase type 5 inhibitor type 2 diabetes mellitus udenafil

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Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction： interim results of a multicenter, randomized, open-label trial

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Asian Journal of Andrology 2018年第6期20卷 587-592页

作者： Hui Jiang Lian-Ming Zhao Hao-Cheng Lin Su Yan Ji-Hong Liu Zhao-Hui Zhu Jin-Dan Luo Yu-Tian Dai Fu-Biao Li Ying Lou Zhi-Chao Zhang Department of Urology Peking University Third Hospital Beijing 100191 China Department of Urology Peking Union Medical College Hospital Beijing 100730 China Department of Urology Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan 430030 China Department of Urology Union Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan 430022 China Department of Urology The First Affiliated Hospital Zhejiang University Hangzhou 310003 China Department of Andrology Nanjing Drum Tower Hospital Nanjing 210008 China Department of Andrology The First Hospital of Jilin University Changchun 130021 China Lilly Suzhou Pharmaceutical Co Ltd Shanghai Branch Shanghai 200041 China Peking University First Hospital Institute of Urology Peking University Beijing 100034 China

once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction （n = 635）. The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event （serious or nonserious）. The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function （IIEF-EF） domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg （least squares [LS] mean change： 6.3; 95% confidence interval [CI]： 5.4-7.1; P 〈 0.001） and 5.0-mg （LS mean change： 7.4; 95% CI： 6.8-7.9; P 〈 0.001） tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function （IIEF-EF 〉26） following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

关键词： erectile dysfunction long-term safety once-daily dosing tadalafil

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