Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking the three PDE-5 inhibitors
Abstract
INTRODUCTION: We conducted a prospective, randomized, open-label, fixed-dose preference study, with a crossover design, using sildenafil, vardenafil, and tadalafil.
AIM: To assess patient preference for sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) for the treatment of erectile dysfunction. Secondary objectives included finding out whether patients would follow treatment with a second or third option, in the event that the preferred drug was not available, and to assess side effects.
MAIN OUTCOME MEASURES: Patient preference for any treatment, and evaluation of the elements that patients would assess when choosing one of these drugs.
MATERIAL AND METHODS: Sildenafil (100 mg), vardenafil (20 mg), and tadalafil (20 mg) were taken at least six times over a period of 45-60 days with a washout period of 7 days. A total of 132 patients were enrolled to achieve a valid sample of 90 cases (15 per randomized group, total of six groups). Enrolled patients had mild to moderate erectile function.
RESULTS: The International Index of Erectile Function (IIEF) score improved from baseline and was statistically significant in all cases (P < 0.0001). When we compared the IIEF scores, we found a statistically significant difference between tadalafil and vardenafil (P = 0.0002) favoring the former; similar results were obtained with the Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) Questionnaire (P = 0.000075). We also found a significant difference (P =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 132 participants or records.
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