Vardenafil demonstrates first-dose success and reliability of penetration and maintenance of erection in men with erectile dysfunction. Conclusion
Compared with placebo, vardenafil 20 mg showed clinical and statistical superiority in continued successful penetration reliability over a 12-week study period. RELY-II results confirm and expand the retrospective analysis findings of Montorsi and colleagues, as well as the reliability findings of the RELY-I study.Despite a high proportion of patients with severe ED and with concomitant comorbidities, the RELY-II study demonstrated that most patients who respond initially to vardenafil 20 mg are likely to experience successful intercourse (penetration and maintenance of erection to completion) on their subsequent attempts at a probability similar to their first-dose success.
Figure 1. Disposition of patients from study enrolment through endpoint.
Figure 2. First-dose SEP2 and SEP3 success rates in specific comorbidity subgroups during the open-label challenge phase. Presence or absence of a specific comorbidity did not preclude patients from having other associated comorbidities. DL = dyslipidemia; DM = diabetes mellitus; HTN = hypertension; SEP2 = Sexual Encounter Profile, question 2; SEP3 = Sexual Encounter Profile, question 3.
Figure 3. Reliability of insertion (SEP2) and maintenance through intercourse (SEP3). LS = least squares; SEP2 = Sexual Encounter Profile, question 2; SEP3 = Sexual Encounter Profile, question 3.
Figure 4. Return to normal rates for IIEF-EF domain score, p < 0.001 for all visits. IIEF-EF = International Index of Erectile Function-Erectile Function; LOCF = last observation carried forward.