Beste apotheek van Nederland

The approximate proportion of smokers was ascertained for 17 trials, 103,118,121,214,215,217-221,225,
227-229,232,234,238 and ranged from 15-16 percent 215,217 to 37–40 percent. 229,238 The authors of 13
trials 163,216,222-224,226,230,233,235-237,239,240 did not report the proportion of smokers.
The majority of the trials included patients with ED of all three etiologic groups (i.e.,
organic, psychogenic, and mixed. 103,118,121,163,214-217,219,220,223-225,227-229,232,234-238,240 In eight trials 118,
215-217,227,229,234,235 the proportion of patients with ED of psychogenic origin was below 10
percent, whereas in 13 other trials 103,121,214,219,220,223-225,228,236-238,240 this proportion ranged from
about 10 percent 224 to 29 percent. 238
The approximate proportion of patients with severe ED (IIEF “EF” domain score: 1–10)
across 24 trials 103,118,121,214-217,219-225,227-230,234-238,240 ranged from 18–23 percent 223,228,240 to 50–52
percent. 217,222 In 14 trials, 103,214-216,219-221,224,225,227,230,235,237,238 the approximate proportion of
patients with severe ED ranged from 30–32 percent 103,237,241 to 40–42 percent. 220,224,235 In seven
trials, 118,121,223,228,229,234,236 this proportion was from 20 to 30 percent. The proportion of patients
by ED severity groups was not reported in six trials. 163,218,226,232,233,239
Interventions
Patients across the 30 trials that were reviewed received oral tadalafil monotherapy in either
experimental or active control arms. In most of the trials, tadalafil was given in 10 mg 215,221,226­
230,237,238 and 20 mg doses. 118,121,163,214-220,222-230,232,234,236-240 One trial 221 included three additional
randomized arms in which patients received 2 mg, 5 mg or 25 mg of tadalafil. In another trial, 238
one additional arm of randomly assigned patients received 5 mg of tadalafil. In one placebocontrolled
trial, 235 patients were randomly assigned to receive either 2.5 mg or 5 mg of tadalafil.
Dose escalations were used in two trials: 10–20 mg 103 and 5–20 mg. 233
In three trials, 214,228,232 20 mg tadalafil on demand was compared with 20 mg three times per
week, 214 20 mg on alternate days, 232 or 10 mg daily. 228 In addition to these three trials, 214,228,232 a
fixed dose of tadalafil was used in nine others. 118,121,163,217-220,225,235 “On demand” (i.e., “as
103,215,216,221-224,226,229, 230,234,236-240
needed”) dosing of tadalafil was used in 17 trials.
The duration of tadalafil treatment across the trials ranged from about 4–6
weeks 214,215,218,230,232,233,239 to 24–26 weeks. 216 In half of the trials, tadalafil was administered for
about 12 weeks. 103,118,217,219,220,222-224,226-229,234,236-238
Tadalafil was compared with placebo, 215-227,229,230,233-240 , sildenafil 103,118,121,163 , tadalafil
(control dose/dosing regimen), 214,215,221,226-230,232,235,237,238 , and vardenafil. 163
Outcomes
In total, all 30 trials reported some information on the absence and/or occurrence of either
total or serious adverse events. In four trials, the incidence of any adverse events was not
reported. 121,217,221,224,232 Authors of 14 trials failed to report the absence or occurrence of serious
adverse events. 118,121,163,216,218,219,221,225-227,229,230,232,237 The number of patients who withdrew as a
result of adverse events was reported in all but two trials. 221,232
Efficacy. The efficacy outcomes measured in the 30 included trials varied to some degree.
The most commonly measured and reported outcomes across the trials were the mean or median
endpoint score/mean score change on IIEF domains and/or individual questions, 103,163,214,216,217,
219,220,222-224,226-229,233,234,236-240,242,243 the mean endpoint/ mean change in the per-patient proportion
of “yes” answers to the Sexual Encounter Profile questions 2 and 3 (i.e., SEP–2/3, “Were you
able to insert your penis into your partner’s vagina?” and “Did your erection last long enough
for you to have successful intercourse?”), 103,214-217,219,220,222-230,234,236-240,243 and the proportion of
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