Vardenafil demonstrates first-dose success and reliability of penetration and maintenance of erection in men with erectile dysfunction. Conclusion

Sep-15-2009

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.
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.

First-dose SEP2 and SEP3

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.

Reliability of insertion (SEP2)

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.

rates for IIEF-EF

Table 1.

Baseline demographics and disease characteristics