Levitra (vardenafil) Info

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.

Table 1.

The objective of this study was to evaluate the 12-week reliability, efficacy and safety of vardenafil 20 mg in men with ED who reported a first-dose success of vaginal penetration. This placebo-controlled trial was conducted after the similarly designed RELY-I study that evaluated vardenafil 10 mg in patients with less severe ED and fewer associated comorbidities. Study limitations included the lack of investigator and patient blinding during the open-label challenge phase and the potential bias toward positive efficacy effects on patients in the placebo group at randomization. These are similar to the limitations found in the RELY-I study (owing to the shared study design) and should be considered when the results of this study are reviewed. Results from our study demonstrated 12-week reliability with vardenafil 20 mg and showed that this treatment regimen was highly successful, compared with placebo, as first-dose therapy for ED patients both with and without comorbidities. This also confirms earlier results reported by the RELY-I study. At the end of the RELY-I trial, the least squares mean reliability rate by dose in terms of SEP2 was 83.4% and in terms of SEP3, 76.5%. Rates at the end of the RELY-II trial (SEP2, 85.0%; SEP3, 78.5%) were comparable and slightly higher than those in the RELY-I trial, despite the more severely ill patient population and corresponding lower baseline values. First-dose success rates were slightly lower overall in this study, compared with the RELY-I trial, which can be explained by the more severely ill patient population. However, considering the improved reliability rates discussed earlier, these lower first-dose success values with vardenafil 20 mg have no impact on the reliability profile of this dose. It is important to remember when comparing data from clinical trials having the same or similar study designs that differences in baseline characteristics of patients enrolled in the trials may often produce clinical outcomes that are not expected or the same as those seen earlier. Therefore, evaluation of baseline patient characteristics is an essential facet and should be done while data from such studies are reviewed. Vardenafil 20 mg was safe and well tolerated in patients with and without comorbidities. The AEs reported during the study were consistent with those seen in the RELY-I study.

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