Table 1—

Demographic and baseline characteristics (safety population)

Placebo10 mg vardenafil20 mg vardenafil
n143152144
Age (mean in years)56.858.056.9
Race
 Caucasian113 (79)124 (82)113 (78)
 Black15 (10)14 (9)12 (8)
 Hispanic10 (7)10 (7)15 (10)
 Other*5 (3)4 (3)4 (3)
BMI (mean in kg/m2)31.530.630.2
Duration of ED since first diagnosis (mean in years)3.73.43.3
Etiology
 Organic118 (83)125 (83)115 (80)
 Psychogenic0 (0)2 (1)0 (0)
 Mixed25 (17)24 (16)28 (20)
Severity of ED
 Severe (<11)82 (57)88 (58)70 (49)
 Moderate (11–16)35 (24)30 (20)37 (26)
 Mild to moderate (17–21)19 (13)26 (17)23 (16)
 Mild (22–25)5 (3)8 (5)13 (9)
 Normal (≥26)2 (1)— (—)1 (1)
Duration of diabetes (mean in years)12.010.010.5
Type of diabetes
 Type 114 (10)17 (11)20 (14)
 Type 2128 (90)135 (89)124 (86)
 With neural manifestation10 (7)8 (5)7 (5)
 With eye manifestation8 (6)7 (5)7 (5)
 With another manifestation1 (<1)3 (2)4 (3)
HbA1c levels
 ≤6.03 (2)5 (3)4 (3)
 >6.0 to <8.060 (42)66 (43)66 (46)
 ≥8.079 (55)80 (53)73 (51)
Medical history
 Hypertension82 (57)83 (55)66 (46)
 Depressive disorder11 (8)14 (9)20 (14)
Concomitant medication
 β-Blockers14 (10)16 (11)22 (15)
 Renin-angiotensin system acting agents76 (53)70 (46)64 (44)
 Calcium-channel blockers22 (15)24 (16)20 (14)
 Serum lipid–reducing agents50 (35)49 (32)47 (33)
 Diuretics25 (17)27 (18)19 (13)
 Other antihypertensive agents10 (7)20 (13)10 (7)
 Insulin51 (36)54 (36)47 (33)
 Glucose-lowering drugs108 (76)110 (72)100 (69)
Prior sildenafil use78 (55)91 (60)87 (60)
  • Data are n (%) unless otherwise indicated.

  • *

    * Asian, Native American, or unknown,

  • renal or ketoacidosis;

  • patients using a medication any time after the start of dosing with the study drug and up to 30 days after the last dose of the study drug, regardless of their use before starting the study drug, except for rates of insulin and glucose-lowering drug use, which were measured at randomization; patients could be on more than one medication.