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

Aug-28-2009

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.

The incidence of prior sildenafil and tadalafil use was similar between the treatment groups. In both treatment groups, 78% had used sildenafil previously, while 93% in the placebo group and 90% in the vardenafil group had not used tadalafil (generic cialis). Generally, insufficient effect was the most common reason patients reported for stopping either sildenafil (generic viagra) or tadalafil therapy before enrolment.

A total of 196 patients randomized to vardenafil (Generic Levitra) and 188 randomized to placebo completed the study. More patients in the placebo group (19%) than in the vardenafil group (15%) prematurely discontinued the study. This difference between the treatment groups was mainly due to patients withdrawing because of insufficient therapeutic effect (placebo group, 8%; vardenafil group, 2%). More patients in the vardenafil group (4%) than in the placebo group (1%) were withdrawn because of a protocol violation. In addition, 10 patients discontinued during the vardenafil challenge period: 5 withdrew their consent, 2 withdrew as a result of AEs, 2 withdrew because of the amended safety criteria, and 1 withdrew because of insufficient therapeutic effect (Fig. 1).

Efficacy
Of the 573 patients who received the 20-mg challenge of vardenafil (levitra professional), 464 (81%) achieved first-time success for penetration (SEP2) and 401 (70%) reported successful erection maintenance (SEP3). We stratified first-dose success data for vardenafil 20 mg according to specific comorbidities. For patients with comorbidities, respective first-dose SEP2 and SEP3 success rates were as follows: 76% and 64% with hypertension (n = 255), 75% and 63% with dyslipidemia (n = 177), 76% and 66% with BPH (n = 109), and 72% and 60% with diabetes mellitus (n = 149). For patients without comorbidities, respective first-dose SEP2 and SEP3 success rates were as follows: 85% and 75% for patients without hypertension (n = 318), 84% and 73% for patients without dyslipidemia (n = 396), 82% and 71% for patients without BPH (n = 463), and 84% and 74% for patients without diabetes mellitus (n = 424) (Fig. 2). Therefore, vardenafil 20 mg was effective in treating ED in patients with and without the aforementioned comorbidities.

Over the 12 weeks of treatment, patients receiving vardenafil had statistically and clinically superior reliability of insertion (85%), compared with patients receiving placebo (45%; p < 0.001). An increase in reliability was seen within the first 4 weeks of treatment. Subsequent SEP3 reliability rates were 78% with vardenafil 20 mg and 29% with placebo (p < 0.001) (Fig. 3).

Compared with placebo, patients treated with vardenafil (generic levitra) had a statistically and clinically significant superiority in the IIEF-EF domain score at each visit (p < 0.001). The increase in IIEF-EF domain score in placebo-treated patients between baseline and week 12 was not clinically significant. A significantly larger proportion of patients with an IIEF-EF domain score within the normal range (≥ 26) was observed in the vardenafil group (61%), compared with the placebo group (8%), at each visit (ITT, last observation carried forward; p < 0.001) (Fig. 4).

Safety
Vanadian Vardenafil was well tolerated, with most AEs having mild-to-moderate intensity. Headache, flushing and nasal congestion, each reported by about 5% of vardenafil-treated patients, were the most frequently reported AEs. An additional 52 patients (9.21%) reported at least a single AE during the 1-week challenge period. AEs occurring with an incidence 5% or higher in either treatment group are presented in Table 2. A total of 156 patients — 57 (24.5%) in the placebo group and 99 (43.0%) in the vardenafil group — reported at least 1 treatment-emergent AE.