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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