Tags

Type your tag names separated by a space and hit enter

A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea.
Int J Impot Res. 2003 Apr; 15(2):80-6.IJ

Abstract

The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an 'as needed' basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P&<0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.

Authors+Show Affiliations

Department of Urology, Yonsei University Hospital, Korea. ssclinic@yumc.yonsei.ac.krNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12789384

Citation

Choi, H K., et al. "A Double-blind, Randomised- Placebo, Controlled, Parallel Group, Multicentre, Flexible-dose Escalation Study to Assess the Efficacy and Safety of Sildenafil Administered as Required to Male Outpatients With Erectile Dysfunction in Korea." International Journal of Impotence Research, vol. 15, no. 2, 2003, pp. 80-6.
Choi HK, Ahn TY, Kim JJ, et al. A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. Int J Impot Res. 2003;15(2):80-6.
Choi, H. K., Ahn, T. Y., Kim, J. J., Kim, S. C., Paick, J. S., Suh, J. K., Kim, H. S., Kim, Y. K., Lee, W. H., Oh, B. H., Park, C. H., Ryu, W. S., Chung, T. G., Kim, S. W., Lee, W. H., Moon, D. G., Ryu, D. S., Seo, K. K., Kim, D. K., & Lee, D. S. (2003). A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. International Journal of Impotence Research, 15(2), 80-6.
Choi HK, et al. A Double-blind, Randomised- Placebo, Controlled, Parallel Group, Multicentre, Flexible-dose Escalation Study to Assess the Efficacy and Safety of Sildenafil Administered as Required to Male Outpatients With Erectile Dysfunction in Korea. Int J Impot Res. 2003;15(2):80-6. PubMed PMID: 12789384.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. AU - Choi,H K, AU - Ahn,T Y, AU - Kim,J J, AU - Kim,S C, AU - Paick,J S, AU - Suh,J K, AU - Kim,H S, AU - Kim,Y K, AU - Lee,W H, AU - Oh,B H, AU - Park,C H, AU - Ryu,W S, AU - Chung,T G, AU - Kim,S W, AU - Lee,W H, AU - Moon,D G, AU - Ryu,D S, AU - Seo,K K, AU - Kim,D K, AU - Lee,D S, PY - 2003/6/6/pubmed PY - 2004/1/16/medline PY - 2003/6/6/entrez SP - 80 EP - 6 JF - International journal of impotence research JO - Int. J. Impot. Res. VL - 15 IS - 2 N2 - The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an 'as needed' basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P&<0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations. SN - 0955-9930 UR - https://www.unboundmedicine.com/medline/citation/12789384/A_double_blind_randomised__placebo_controlled_parallel_group_multicentre_flexible_dose_escalation_study_to_assess_the_efficacy_and_safety_of_sildenafil_administered_as_required_to_male_outpatients_with_erectile_dysfunction_in_Korea_ L2 - http://dx.doi.org/10.1038/sj.ijir.3900944 DB - PRIME DP - Unbound Medicine ER -