An open, multicenter flexible dose escalation study to evaluate the efficacy and safety of sildenafil administered as required to male patients with erectile dysfunction
Journal Title: Progress in Health Sciences - Year 2012, Vol 2, Issue 2
Abstract
Objective: To evaluate the efficacy, satisfaction, safety and tolerability of sildenafil taken as prescribed prior to anticipated sexual activity in male outpatients with erectile dysfunction (ED). Materials and methods: Two hundred and three adult male with ED participated in a 2-week, no treatment, run-in period followed by a 6-week open treatment period. In the present trial, they received 50 mg of Viagra. The primary efficacy variable was the change from baseline in response to item 3 and 4 of the International Index of Erectile Function (IIEF). The secondary efficacy variables were as follows: response to the other questions of the IIEF, the IIEF domain scores, response to the Global Efficacy Assessment Question (GAQ), the Event Logs of Erectile Function and Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. Results: A total of 203 subjects were screened and 175 subjects received the study drug. A total of 168 subjects completed the study. The percent of improved erection based on the (GAQ) was 84.5%. The mean rate of successful intercourse was 0.6. Almost thirty-seven percent of patients were satisfied with the effect of treatment in their erections at week 2. The treatment satisfaction increased to 83.3 % at the end of the study, after 62.6 % of patients increased dose to 100 mg of Viagra. A total of 7 (4%) subject discontinued the study prior to the final visit. The reasons of discontinuation were: adverse events - 1.1%, lost to follow-up - 1.1%, subject no longer willing to participate - 3. Of the 175 subjects who received Viagra, 34 subjects experienced at least one adverse event. Conclusions: The results of the analyses of the responses to the primary variable were highly statistically significantly in favour of sildenafil, as well as the results of the analyses of all the secondary efficacy variables. These findings support effectiveness of sildenafil. The adverse event profile of sildenafil in this study was consistent with the labeled adverse events for this product.
Authors and Affiliations
B. Darewicz, T. Werel, M. Chlabicz, J. Kudelski, Skrodzka
Keywords
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