Volume 10, Issue 5 (September 2008) 10, 791–798; 10.1111/j.1745-7262.2008.00422.x
Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial
Jae-Seung Paick1, Hyung-Ki Choi2, Sae-Chul Kim3, Tai-Young Ahn4, Je-Jong Kim5, Jong-Kwan Park6, Kwang-Sung Park7, Sung-Won Lee8, Sae-Woong Kim9, Kwanjin Park10, Hyonggi Jung11 and Nam-Cheol Park12
1 Department of Urology, Seoul National University Hospital, Seoul 110-744, Korea
2 Department of Urology, Yonsei University Yongdong Severance Hospital, Seoul 135-720, Korea
3 Department of Urology, Chung-ang University Yongsan Hospital, Seoul 140-757, Korea
4 Department of Urology, University of Ulsan Asan Medical Center, Seoul 138-736, Korea
5 Department of Urology, Korea University Anam Hospital, Seoul 136-705, Korea
6 Department of Urology, Chonbuk National University Hospital, Jeonju 561-712, Korea
7 Department of Urology, Chonnam National University Hospital, Gwangju 501-757, Korea
8 Department of Urology, Sungkyunkwan University Samsung Medical Center, Seoul 135-710, Korea
9 Department of Urology, Catholic University St. Mary's Hospital, Seoul 150-713, Korea
10 Department of Urology, Korea Cancer Center Hospital, Seoul 139-706, Korea
11 Department of Biostatistics, Seokyeong University, Seoul 136-704, Korea
12 Department of Urology, Pusan National University Hospital, Busan 602-739, Korea
Correspondence: Prof. Jae-Seung Paick, MD, PhD, Department of Urology, Seoul National University, College of Medicine, Seoul 110-744, Korea. Fax: 82-2-762-2428. E-mail: firstname.lastname@example.org
Received 22 February 2008; Accepted 21 April 2008
Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE51), in Korean men with erectile dysfunction (ED).
Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs.
Results: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P < 0.05). Of the 89 patients in the treatment arm, 36 (42.3 %) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events.
Conclusion: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.
Keywords: erectile dysfunction, phosphodiesterase, sildenafil citrate
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