publication . Article . 2018

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

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; ...
Open Access
  • Published: 01 Jul 2018 Journal: Asian Journal of Andrology, volume 20, page 587 (issn: 1008-682X, Copyright policy)
  • Publisher: Medknow
Abstract
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) ...
Subjects
free text keywords: Urology, General Medicine, Adverse effect, Endocrinology, medicine.medical_specialty, medicine, Tadalafil, medicine.drug, Clinical endpoint, Nasopharyngitis, Erectile dysfunction, medicine.disease, Confidence interval, Upper respiratory tract infection, Population, education.field_of_study, education, business.industry, business, Internal medicine, Original Article, long-term safety, once-daily dosing, erectile dysfunction; long-term safety; once-daily dosing; tadalafil, Diseases of the genitourinary system. Urology, RC870-923
Related Organizations
20 references, page 1 of 2

Australian Government Therapeutic Goods Administration. AusPAR: Tadalafil. 2013

China Food and Drug Administration. Database of approved Active Pharmaceutical Ingredients (APIs) and API manufacturers in China. Tadalafil.

U.S. Food & Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. Product details for NDA 021368.

European Medicines Agency. Assessment Report: Cialis. 2013

Bai, WJ, Li, HJ, Dai, YT, He, XY, Huang, YR. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy. Asian J Androl. 2015; 17: 61-7 [OpenAIRE] [PubMed]

Govier, F, Potempa, AJ, Kaufman, J, Denne, J, Kovalenko, P. A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20mg or sildenafil citrate 50mg during initiation of treatment for erectile dysfunction. Clin Ther. 2003; 25: 2709-23 [OpenAIRE] [PubMed]

Rosen, RC, Padma-Nathan, H, Shabsigh, R, Saikali, K, Watkins, V. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med. 2004; 1: 193-200 [PubMed]

Yip, WC, Chiang, HS, Mendoza, JB, Tan, HM, Li, MK. Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study. Asian J Androl. 2006; 8: 685-92 [PubMed]

Costa, P, Grivel, T, Gehchan, N. Tadalafil once daily in the management of erectile dysfunction: patient and partner perspectives. Patient Prefer Adherence. 2009; 3: 105-11 [OpenAIRE] [PubMed]

Hatzimouratidis, K, Hatzichristou, DG. A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?. Drugs. 2005; 65: 1621-50 [OpenAIRE] [PubMed]

Forgue, ST, Patterson, BE, Bedding, AW, Payne, CD, Phillips, DL. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006; 61: 280-8 [OpenAIRE] [PubMed]

Rubio-Aurioles, E, Porst, H, Kim, ED, Montorsi, F, Hackett, G. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med. 2012; 9: 1418-29 [PubMed]

Burns, PR, Rosen, RC, Dunn, M, Baygani, SK, Perelman, MA. Treatment satisfaction of men and partners following switch from on-demand phosphodiesterase type 5 inhibitor therapy to tadalafil 5mg once daily. J Sex Med. 2015; 12: 720-7 [PubMed]

Donatucci, CF, Wong, DG, Giuliano, F, Glina, S, Dowsett, SA. Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option. Curr Med Res Opin. 2008; 24: 3383-92 [OpenAIRE] [PubMed]

Porst, H, Giuliano, F, Glina, S, Ralph, D, Casabé, AR. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol. 2006; 50: 351-9 [PubMed]

20 references, page 1 of 2
Abstract
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) ...
Subjects
free text keywords: Urology, General Medicine, Adverse effect, Endocrinology, medicine.medical_specialty, medicine, Tadalafil, medicine.drug, Clinical endpoint, Nasopharyngitis, Erectile dysfunction, medicine.disease, Confidence interval, Upper respiratory tract infection, Population, education.field_of_study, education, business.industry, business, Internal medicine, Original Article, long-term safety, once-daily dosing, erectile dysfunction; long-term safety; once-daily dosing; tadalafil, Diseases of the genitourinary system. Urology, RC870-923
Related Organizations
20 references, page 1 of 2

Australian Government Therapeutic Goods Administration. AusPAR: Tadalafil. 2013

China Food and Drug Administration. Database of approved Active Pharmaceutical Ingredients (APIs) and API manufacturers in China. Tadalafil.

U.S. Food & Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. Product details for NDA 021368.

European Medicines Agency. Assessment Report: Cialis. 2013

Bai, WJ, Li, HJ, Dai, YT, He, XY, Huang, YR. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy. Asian J Androl. 2015; 17: 61-7 [OpenAIRE] [PubMed]

Govier, F, Potempa, AJ, Kaufman, J, Denne, J, Kovalenko, P. A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20mg or sildenafil citrate 50mg during initiation of treatment for erectile dysfunction. Clin Ther. 2003; 25: 2709-23 [OpenAIRE] [PubMed]

Rosen, RC, Padma-Nathan, H, Shabsigh, R, Saikali, K, Watkins, V. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med. 2004; 1: 193-200 [PubMed]

Yip, WC, Chiang, HS, Mendoza, JB, Tan, HM, Li, MK. Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study. Asian J Androl. 2006; 8: 685-92 [PubMed]

Costa, P, Grivel, T, Gehchan, N. Tadalafil once daily in the management of erectile dysfunction: patient and partner perspectives. Patient Prefer Adherence. 2009; 3: 105-11 [OpenAIRE] [PubMed]

Hatzimouratidis, K, Hatzichristou, DG. A comparative review of the options for treatment of erectile dysfunction: which treatment for which patient?. Drugs. 2005; 65: 1621-50 [OpenAIRE] [PubMed]

Forgue, ST, Patterson, BE, Bedding, AW, Payne, CD, Phillips, DL. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006; 61: 280-8 [OpenAIRE] [PubMed]

Rubio-Aurioles, E, Porst, H, Kim, ED, Montorsi, F, Hackett, G. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med. 2012; 9: 1418-29 [PubMed]

Burns, PR, Rosen, RC, Dunn, M, Baygani, SK, Perelman, MA. Treatment satisfaction of men and partners following switch from on-demand phosphodiesterase type 5 inhibitor therapy to tadalafil 5mg once daily. J Sex Med. 2015; 12: 720-7 [PubMed]

Donatucci, CF, Wong, DG, Giuliano, F, Glina, S, Dowsett, SA. Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option. Curr Med Res Opin. 2008; 24: 3383-92 [OpenAIRE] [PubMed]

Porst, H, Giuliano, F, Glina, S, Ralph, D, Casabé, AR. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol. 2006; 50: 351-9 [PubMed]

20 references, page 1 of 2
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publication . Article . 2018

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

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; ...