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patients who answered “yes” to the Global Assessment Question 1 or 2 (i.e. GAQ–Q1: “Has the
treatment you have been taking improved your erections?” and GAQ–Q2: “If yes, has the
treatment improved your ability to engage in sexual activity?”). 216,217,220,222-224,226-229,234, 236-240 Of
the 16 trials that reported outcomes based on GAQs, nine trials 216,217,224,226-229, 237,238 evaluated the
proportion of patients who answered “yes” to GAQ–Q1 only, whereas the remaining seven
trials 220,222,223,234,236,239,240 evaluated this parameter for both GAQ–Q1 and GAQ–Q2.
Eight trials additionally evaluated the efficacy (i.e., the mean per-patient percentage of
successful intercourse attempts based on “yes” responses to SEP Q3) for different time-periods
after dosing of tadalafil. 216,217,219,220,224,225,227,230
The authors of one trial, 221 derived logistic regression models based on the patient data
obtained from a randomized placebo-controlled trial. These dose-response models assessed the
relationship between the dose of tadalafil (2, 5, 10, or 25 mg) and the probability of getting an
outcome (SEP questions 2 and 3 and/or on IIEF questions 3 and 4). The models included such
covariates as baseline severity of ED and IIEF–EF domain score.
In five trials, 103,163,217,222,223,241,243 treatment satisfaction was measured using the Erectile
Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire.
The patients’ treatment preference (e.g. percentage of patients who preferred the use of
tadalafil to that of sildenafil) was evaluated and reported in six trials, all of which were of a
crossover design in which the patients received both tadalafil and sildenafil 103,118,121, 163,241 or
alternating dosing regimens of tadalafil (i.e., on demand versus fixed). 214,228,244-247
Endothelial function using percentage change (compared with baseline) in the mean flow
mediated dilation (FMD) of brachial and cavernous arteries was measured in two trials. 218,232
Study Quality and Reporting
The mean Jadad total score for the 30 included trials was 3.2. The individual Jadad total
score for 30 trials ranged from 1 163 to 5. 216,222,225 All 30 trials but six 103,163,214, 219,228, 232 were
double-blind. Three trials could not have been double blinded because patients received either
on-demand or fixed dosing regimens of tadalafil. 214,228,232 Of the 24 double-blind trials, only nine
trials 118,216,218,221,222,224,225,227,239 reported some description of the blinding method(s) used. Only
three trials 219,238,239 reported some information on the allocation concealment, which was deemed
to be adequate. The adequacy of allocation concealment for the remaining 27 trials could not be
ascertained (i.e., was unclear).
Of the eight crossover trials, 103,118,121,163,214,228,232,239 only one 239 failed to report whether a
washout period had been applied between the treatment periods. The length of washout period
for the seven remaining crossover trials ranged from 4 days 118 to 14 days. 121,228,232
Qualitative Synthesis
Tadalafil (any dose: fixed or flexible) versus placebo.
Harms. The occurrence of total and serious adverse events across the 23 placebo-controlled
trials was reported poorly. 215-227,229,230,233-240
In the majority of these trials, the frequency of any adverse events (i.e., the proportion of
patients with at least one adverse event) was greater either numerically or with statistical
215,220,222,223,225-227,229, 230,236-240
significance in the tadalafil arms than in the placebo arms.
For example, in one trial, the proportion of patients who experienced at least one adverse
event in the tadalafil and placebo arms were 51.7 versus 26.5 percent, respectively (p < 0.001). 222
In another trial, 225 the corresponding numbers were 40 (22.5 percent) versus two (1.3 percent) (p
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