Asian Journal of Andrology (2015) 17, 854 © 2015 AJA, SIMM & SJTU. All rights reserved 1008-682X www.asiaandro.com; www.ajandrology.com
Open Access
Erectile Function
LETTER TO THE EDITOR
Commentary on – "Comparison of the efficacy and safety of once‑daily dosing and on‑demand use of udenafil for type 2 diabetic patients with erectile dysfunction" De‑Hong Cao, Liang‑Ren Liu, Qiang Wei Asian Journal of Andrology (2015) 17, 854; doi: 10.4103/1008-682X.148069; published online: 16 January 2015
Dear Editor, We read with interest of the article written by Park et al.1 They performed a randomized controlled trial to compare efficacy and safety between 50 mg once‑daily and 200 mg on‑demand dosing use of udenafil for the treatment of type 2 diabetic patients with erectile dysfunction (ED). Their findings indicated that the most common drug‑related adverse events (AEs) were flushing (8.9% vs 2.5%) and headache (3.8% vs 1.3%) between the on‑demand group and the daily‑dosed group. Although the authors believed that the udenafil was well‑tolerated in both groups, unfortunately, they failed report the total incidence of AEs to assess the safety of the two groups. We agree with their view that both the 50 mg once‑daily group and 200 mg on‑demand group of udenafil for type 2 diabetic patients with ED were well tolerated. Furthermore, Moon du et al.2 performed a randomized, double‑blind controlled trial to assess the safety of udenafil for treatment of ED in patients with diabetes mellitus. They found that the total rate of AEs related to the 200 mg udenafil on‑demand was 22.4%, and the most frequent drug‑related AEs were flushing and headache with incidences of 10% and 5%, respectively. In addition, other major AEs were nausea and conjunctival hyperemia. Paick et al.3 performed a multicenter, double‑blind and parallel‑group trial to evaluate the efficacy and safety of 200 mg udenafil therapy in patients with ED. However, they found that the higher of incidence of treatment‑related AEs was 37.5%, and flushing rate was 23.2%, nasal congestion and ocular hyperemia rate were 7.1% independently, headache rate was 8.9%, chest discomfort rate 5.4%, withdrawal due
to AEs was 3.6%. Zhao et al.4 performed a multicenter, randomized, double‑blind, controlled trial to evaluate the efficacy and safety of once‑daily dosing of udenafil in the treatment of ED. They found the incidence of AEs using udenafil 50 mg once‑daily for ED patients was 10%. There are some differences in incidence rates of AEs among the studies.2–6 Thus, we believe that the AEs rate may be an important parameter to assess the drug safety. Meanwhile, we consider it is better to report the rate and classify of AEs contributed to objectively and fairly evaluate the safety between 50 mg once‑daily and 200 mg on‑demand dosing use of udenafil for the treatment of type 2 diabetic patients with ED, although most studies indicated AEs of udenafil for ED were safe.5,6 CONFLICTS OF INTEREST There are no conflicts of interest to declare. REFERENCES 1
2
3
4
5
Department of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. Correspondence: Dr. Q Wei ([email protected]) Received: 08 November 2014; Accepted: 09 December 2014
6
Park SH, Park SW, Cha BY, Park IB, Min KW, et al. Comparison of the efficacy and safety of once‑daily dosing and on‑demand use of udenafil for type 2 diabetic patients with erectile dysfunction. Asian J Androl 2015; 17: 143-8. Moon du G, Yang DY, Lee CH, Ahn TY, Min KS, et al. A therapeutic confirmatory study to assess the safety and efficacy of Zydena (udenafil) for the treatment of erectile dysfunction in male patients with diabetes mellitus. J Sex Med 2011; 8: 2048–61. Paick JS, Kim SW, Park YK, Hyun JS, Park NC, et al. The efficacy and safety of udenafil [Zydena] for the treatment of erectile dysfunction in hypertensive men taking concomitant antihypertensive agents. J Sex Med 2009; 6: 3166–76. Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, et al. Efficacy and safety of once‑daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double‑blind, placebo‑controlled trial. Eur Urol 2011; 60: 380–7. Cho MC, Paick JS. Udenafil for the treatment of erectile dysfunction. Ther Clin Risk Manag 2014; 10: 341–54. Ortaç M, Çayan S, Çaliskan MK, Yaman MÖ, Okutucu TM, et al. Efficacy and tolerability of udenafil in Turkish men with erectile dysfunction of psychogenic and organic aetiology: a randomized, double‑blind, placebo‑controlled study. Andrology 2013; 1: 549–55.
Open Access
Erectile Function
LETTER TO THE EDITOR
Commentary on – "Comparison of the efficacy and safety of once‑daily dosing and on‑demand use of udenafil for type 2 diabetic patients with erectile dysfunction" De‑Hong Cao, Liang‑Ren Liu, Qiang Wei Asian Journal of Andrology (2015) 17, 854; doi: 10.4103/1008-682X.148069; published online: 16 January 2015
Dear Editor, We read with interest of the article written by Park et al.1 They performed a randomized controlled trial to compare efficacy and safety between 50 mg once‑daily and 200 mg on‑demand dosing use of udenafil for the treatment of type 2 diabetic patients with erectile dysfunction (ED). Their findings indicated that the most common drug‑related adverse events (AEs) were flushing (8.9% vs 2.5%) and headache (3.8% vs 1.3%) between the on‑demand group and the daily‑dosed group. Although the authors believed that the udenafil was well‑tolerated in both groups, unfortunately, they failed report the total incidence of AEs to assess the safety of the two groups. We agree with their view that both the 50 mg once‑daily group and 200 mg on‑demand group of udenafil for type 2 diabetic patients with ED were well tolerated. Furthermore, Moon du et al.2 performed a randomized, double‑blind controlled trial to assess the safety of udenafil for treatment of ED in patients with diabetes mellitus. They found that the total rate of AEs related to the 200 mg udenafil on‑demand was 22.4%, and the most frequent drug‑related AEs were flushing and headache with incidences of 10% and 5%, respectively. In addition, other major AEs were nausea and conjunctival hyperemia. Paick et al.3 performed a multicenter, double‑blind and parallel‑group trial to evaluate the efficacy and safety of 200 mg udenafil therapy in patients with ED. However, they found that the higher of incidence of treatment‑related AEs was 37.5%, and flushing rate was 23.2%, nasal congestion and ocular hyperemia rate were 7.1% independently, headache rate was 8.9%, chest discomfort rate 5.4%, withdrawal due
to AEs was 3.6%. Zhao et al.4 performed a multicenter, randomized, double‑blind, controlled trial to evaluate the efficacy and safety of once‑daily dosing of udenafil in the treatment of ED. They found the incidence of AEs using udenafil 50 mg once‑daily for ED patients was 10%. There are some differences in incidence rates of AEs among the studies.2–6 Thus, we believe that the AEs rate may be an important parameter to assess the drug safety. Meanwhile, we consider it is better to report the rate and classify of AEs contributed to objectively and fairly evaluate the safety between 50 mg once‑daily and 200 mg on‑demand dosing use of udenafil for the treatment of type 2 diabetic patients with ED, although most studies indicated AEs of udenafil for ED were safe.5,6 CONFLICTS OF INTEREST There are no conflicts of interest to declare. REFERENCES 1
2
3
4
5
Department of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. Correspondence: Dr. Q Wei ([email protected]) Received: 08 November 2014; Accepted: 09 December 2014
6
Park SH, Park SW, Cha BY, Park IB, Min KW, et al. Comparison of the efficacy and safety of once‑daily dosing and on‑demand use of udenafil for type 2 diabetic patients with erectile dysfunction. Asian J Androl 2015; 17: 143-8. Moon du G, Yang DY, Lee CH, Ahn TY, Min KS, et al. A therapeutic confirmatory study to assess the safety and efficacy of Zydena (udenafil) for the treatment of erectile dysfunction in male patients with diabetes mellitus. J Sex Med 2011; 8: 2048–61. Paick JS, Kim SW, Park YK, Hyun JS, Park NC, et al. The efficacy and safety of udenafil [Zydena] for the treatment of erectile dysfunction in hypertensive men taking concomitant antihypertensive agents. J Sex Med 2009; 6: 3166–76. Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, et al. Efficacy and safety of once‑daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double‑blind, placebo‑controlled trial. Eur Urol 2011; 60: 380–7. Cho MC, Paick JS. Udenafil for the treatment of erectile dysfunction. Ther Clin Risk Manag 2014; 10: 341–54. Ortaç M, Çayan S, Çaliskan MK, Yaman MÖ, Okutucu TM, et al. Efficacy and tolerability of udenafil in Turkish men with erectile dysfunction of psychogenic and organic aetiology: a randomized, double‑blind, placebo‑controlled study. Andrology 2013; 1: 549–55.
