A randomised, double-blind comparison of vardenafil and sildenafil: efficacy in 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: Data from head-to-head clinical trials of phosphodiesterase type-5 (PDE5) inhibitors are scare. This prospective pooled analysis of data from two randomised, double-blind crossover studies compared the efficacy of vardenafil and sildenafil in men with erectile dysfunction (ED) and cardiovascular risk factors.
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 diabetes mellitus, hypertension and/or hyperlipidaemia. Patients received either 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. Efficacy assessments after each treatment period included the five domains of the International Index of Erectile Function (IIEF), and responses to the Sexual Encounter Profile (SEP) diary questions SEP2 (Were you able to insert your penis into your partner’s vagina?) and SEP3 (Did your erection last long enough for you to have successful intercourse?).
Results: A total of 1057 men were randomised to treatment; 931 were included in the intention-to-treat population. The LS mean change from baseline in IIEF erectile function domain scores was nominally significant in favour of vardenafil vs sildenafil (10.00 vs 9.40 respectively; p=0.0052). Vardenafil-associated improvements in the IIEF intercourse satisfaction (4.41 vs 4.17, p=0.0127) and overall satisfaction (2.80 vs 2.65, p=0.0400) domain scores were also nominally significant. There were no significant differences in the IIEF orgasmic function (1.61 vs 1.51) and sexual desire (0.67 vs 0.64) domain scores between treatment groups. SEP2 and SEP3 positive-response rates were higher in the vardenafil group (p<0.05, nominal significance).
Conclusions: In this randomised, double-blind comparison of two PDE5 inhibitors, vardenafil achieved nominal statistical superiority over sildenafil for several commonly used measures of efficacy.
