Levitra (vardenafil) Info

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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Study 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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