Archive for the ‘Erectile Dysfunction’ Category

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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

Optical Series - ThumbsupThe 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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Patient demographics

Patient demographics
The study enrolled a relatively higher percentage of patients having comorbidities associated with endothelial dysfunction than the RELY-I study that had a similar design.  Of the 573 men who received a single 20-mg dose of vardenafil in the challenge phase, 41% had hypertension, 28% had dyslipidemia, and 24% had diabetes mellitus. Of these patients, 230 were randomized to receive vardenafil 20 mg, and 233 were randomized to placebo. The ITT population consisted of 223 patients randomized to vardenafil 20 mg and 226 to placebo. The baseline demographic characteristics were similar between the treatment groups. Overall, patients had a mean age of 56 years, mean weight of 85 kg and mean body mass index of 28. Most patients were of European (63%) or Asian (23%) ethnicity. Of all patients enrolled in the study, 83% either abstained or had light alcohol use; there were slightly more smokers or former smokers (56%) than nonsmokers (44%). The baseline disease characteristics were similar between the treatment groups. The mean baseline IIEF-EF domain score was similar between the placebo (12.9) and vardenafil (13.1) groups, indicative of moderately severe ED. Most patients had a baseline ED severity category of moderate (placebo group, 32%; vardenafil group, 39%) or severe (placebo group, 37%; vardenafil group, 31%). A majority of patients in both treatment groups had ED of either organic (placebo group, 57%; vardenafil group, 53%) or mixed (placebo group, 36%; vardenafil group, 41%) causes. Overall, the mean duration of ED was 5.9 years. Of the patients, 90% on placebo and 89% on vardenafil had at least a single comorbidity at baseline. Specific comorbidity histories were similar between the treatment groups for all conditions except that back pain, headache and dyspepsia were common in the vardenafil group, whereas benign prostatic hyperplasia (BPH), dyslipidemia, hypermetropia and drug hypersensitivity were common in the placebo group. Table 1 shows baseline demographic and disease characteristics.

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MethodsStudy objectives
The primary objective of this study was to assess first-dose success and reliability of vardenafil 20 mg in men with ED through 12 weeks of treatment in a placebo-controlled clinical trial. The secondary objective was to evaluate the safety and tolerability of vardenafil 20 mg compared with placebo.

Study design
RELY-II was a 12-week, multicentre, randomized, double-blind, parallel-group, placebo-controlled trial in vardenafil-naive patients. At screening, patients were entered into a 4-week, treatment-free, run-in phase and instructed to make at least 4 attempts at sexual intercourse on 4 separate days. A diary was provided for patients to record all attempts made at sexual intercourse. The patients who failed at 50% or more of their attempts at intercourse were entered into a 1-week challenge phase. Patients were then instructed to make at least 1 attempt at sexual intercourse 1 hour after administration of a single 20-mg dose of vardenafil. Medication was to be taken without regard to meals. Patients with a positive response to question 2 of the Sexual Encounter Profile (SEP2) (“Were you able to insert your penis into your partner’s vagina?”) in regard to attempts made 0.5 to 6 hours after ingestion of the study medication were randomized to receive either vardenafil 20 mg or placebo for 12 weeks. Patients were instructed to take each dose of medication without regard to meals, on an as-needed basis 1 hour before attempting sexual intercourse, with only 1 dose permitted per day. Patients recorded the date and time at which they took the study medication, the time at which they attempted sexual intercourse and their responses to questions regarding success at penetration (SEP2) and maintenance of erection sufficient enough for completion of intercourse (SEP3: “Did your erection last long enough for you to have successful intercourse?”). During the 12-week treatment period, patients were scheduled for study visits at weeks 4, 8 and 12 for assessment of efficacy, safety, tolerability and compliance.

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Erectile dysfunction

Erectile dysfunction (ED) is a highly prevalent condition that has a major impact on the lives of millions of men and their partners, affecting sexual and psychological health and quality of life (QOL). Depending on the etiology, ED may indicate underlying systemic vascular or neurogenic disease that is often associated with the impairment of neurogenic and/or endothelium-dependent vasodilatory mechanisms, which in turn contribute to circulatory and structural changes in penile tissues. The resulting arterial insufficiency and defective smooth muscle relaxation in men with vascular comorbidities lead to an increased prevalence of ED in this patient population, which complicates disease management.

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