A randomised, double-blind comparison of vardenafil and sildenafil: treatment satisfaction among men with erectile dysfunction and cardiovascular risk factors, and their partners
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, Germany (3)St James’s University Hospital, Leeds (4)Alvarado Hospital, San Diego
Introduction/Objective: This pooled analysis of two randomised, double-blind crossover studies compared treatment satisfaction with vardenafil and sildenafil among men with erectile dysfunction (ED) and cardiovascular risk factors, and their partners.
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 with diabetes mellitus, hypertension and/or hyperlipidaemia. All eligible patients were in a stable, heterosexual relationship for >6 months. Patients received vardenafil 20 mg or sildenafil 100 mg for 4 weeks. Following a 1-week washout period, patients received 4-weeks’ therapy with the second treatment. The Treatment Satisfaction Scale (TSS) was completed by patients and their partners at the end of each treatment period.
Results: Of 1,057 men randomised to treatment, 931 were included in the intention-to-treat population. For 12/19 patient TSS questions, patients reported nominally significant superior responses for vardenafil vs sildenafil (p<0.05). These superior responses were provided for questions regarding ease, duration and hardness of erection; time to erection; the ability to have sex when desired; confidence in initiating and completing sex; confidence that the medication worked; duration of effect; meeting expectations; overall satisfaction; and willingness to continue treatment. A numerical advantage was observed with vardenafil for six questions and with sildenafil for one question. Partners’ TSS results showed a numerical trend in favour of vardenafil vs sildenafil for 14/18 questions and equivalent scores for one question. Vardenafil was superior to sildenafil for three questions regarding duration and hardness of erection and the ability to have sex when desired (p<0.05, nominal significance).
Conclusions: Treatment satisfaction with vardenafil was higher than with sildenafil among men with ED and cardiovascular risk factors, and their partners.
