The objectives of this study were to
compare diary-recorded outcomes with vardenafil versus sildenafil, in
men with erectile dysfunction. This was a prospective pooled analysis of
two randomised, double-blind, crossover studies, one performed in the
USA and one in Europe and Mexico. Both studies comprised two 4-week
periods of treatment with either vardenafil 20 mg or sildenafil 100 mg,
separated by a 1-week washout period.
participants were men aged ?18 years with ED for >6 months according
to NIH criteria and risk factors for cardiovascular disease (diabetes
mellitus, hypertension and/or hyperlipidaemia). All participants also
had to be in a stable, heterosexual relationship (>6 months). The
primary endpoint of the study was treatment preference. Twelve diary
questions were also answered during the study, including the Sexual
Encounter Profile (SEP) questions 2 and 3.
A total of 1,057 men were randomised to treatment. Of 12 diary questions, 9 indicated a better response to vardenafil treatment versus sildenafil (nominal significance, p<0.05). These were: SEP2 (LS mean positive response with vardenafil: 83.9%, compared with 82.3% for sildenafil); SEP3 (74.4% vs 71.6%); ‘satisfied with hardness’ (55.7% vs 52.7%); ‘satisfied with sexual experience (64.9% vs 61.0%); ‘how hard was erection’ (LS mean score with vardenafil: 2.18, compared with 2.13 for sildenafil); ‘maintain erection’ (3.11 vs 3.02); ‘erection stayed hard’ (3.33 vs 3.24); ‘satisfied with length’ (3.37 vs 3.27); and ‘satisfied with girth’ (3.36 vs 3.27). The remaining 3 questions showed a trend in favour of vardenafil (‘some erection’, ‘ejaculate’, and ‘satisfied with sensitivity’).
Diary-recorded outcomes demonstrated that vardenafil was superior to sildenafil (nominal significance) in 9/12 questions, including SEP2 and SEP3, satisfaction with sexual experience, erection hardness and maintenance of erection.
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