A randomised, double-blind comparison of vardenafil and sildenafil: preference among men with erectile dysfunction and cardiovascular risk factors
Rubio-Aurioles, E(1); Porst, H(2); Eardley, I(3); Goldstein, I(4)
(1)Asociación Mexicana para la Salud Sexual AC, Tlalpan (2)Private Urological Practice, Hamburg (3)St James’s University Hospital, Leeds (4)Alvarado Hospital, San Diego
Introduction/Objective: Many patient preference studies have design flaws that hinder data interpretation. This prospective pooled analysis of data from two randomised, double-blind crossover studies compared patient preference for vardenafil and sildenafil among men with erectile dysfunction (ED) and cardiovascular risk factors. These studies employed a series of design features – including patient randomisation, treatment periods of equal length, and treatment-neutral preference assessment – to minimize bias.
Materials and Methods: The two studies (one in the USA and one in Europe/Mexico) included patients aged ≥18 years with ED for >6 months and concomitant diabetes mellitus, hypertension and/or hyperlipidaemia. Patients received vardenafil 20 mg or sildenafil 100 mg for 4 weeks. Following a 1-week washout period, patients switched to the other treatment for 4 weeks. The primary efficacy variable was the response to the question “Overall, which medication do you prefer?”. Responses to this question and further preference questions were assessed after both treatment periods.
Results: Overall 931 men were included in the intention-to-treat population. Reponses to the overall preference question demonstrated the non-inferiority of vardenafil: a higher percentage of men expressed an overall preference for vardenafil (38.9%) compared with sildenafil (34.5%); 26.6% indicated no preference. The percentage of patients who expressed a preference for vardenafil was consistently higher for further preference questions regarding side effects, ease of obtaining an erection, time to erection, duration of effectiveness, time to ejaculation, confidence that the medication worked every time, and hardness, duration and sensation of erection.
Conclusions: In this prospective analysis, overall more patients preferred vardenafil than sildenafil. Patients also preferred vardenafil when questioned about a number of factors related to the tolerability and effectiveness of treatment.
