Beste apotheek van Nederland

Tadalafil (20 mg) versus tadalafil (10 mg) versus tadalafil (5 mg). The effects of both
tadalafil doses 20 mg and 10 mg were evaluated in eight trials. 215,226-230,237,238 In one of these
trials, 238 there was an additional randomized arm in which patients received 5 mg tadalafil.
Another trial 221 evaluated dose-response models for different doses of tadalafil (e.g. 5, 10, 25
mg).
Harms. The incidence of most reported adverse events (e.g. myalgia, nausea, back pain,
diarrhea, headache, dizziness, dyspepsia, nasal congestion, facial flushing, infection, flu
syndrome) across the eight trials was numerically comparable in patients receiving 20 mg versus
10 mg of tadalafil. In three trials, 228,230,238 the incidence of headache was slightly higher in
patients receiving 20 mg tadalafil as compared with those receiving 10 mg (or 5 mg) of tadalafil.
For example, in the first trial, 228 the proportions of patients with headache in 20 mg and 10 mg
tadalafil arms were 17.1 and 8.1 percent, respectively, with a statistically significant betweenarm
difference (p < 0.001).
In the same trial the incidence of serious adverse events (i.e., two cases of myocardial
infarction) was numerically similar in the 20 mg and 10 mg tadalafil groups (two patients in each
arm). In the second trial, 230 numerically more patients who received 20 mg tadalafil had
headache compared with those who received a 10 mg dose (8.0 versus 4.1 percent). In one
trial, 227 compared with those who received 10 mg of tadalafil, patients receiving a 20 mg dose
experienced numerically higher rates of dyspepsia (22.0 versus 9.7 percent), vasodilation (6.0
versus 3.9 percent), and accidental injury (5.0 versus 1.0 percent). The incidence of back pain
was numerically slightly higher in patients receiving 20 mg versus those receiving 10 mg of
tadalafil in one trial (4.0 versus 0.8 percent, respectively). 237 In another trial, 215 one patient died
from an AMI after being randomly assigned to receive 20 mg tadalafil. Of the eight trials
comparing the efficacy/safety profiles of 20 mg and 10 mg tadalafil, the absence or presence of
serious adverse events could not be ascertained for six trials. 221,226,227,229,230,237
Efficacy. In five trials, 226,227,229,237,238 the degree of improvement in the mean change for IIEF
“EF” domain and per-patient proportion of “yes” to SEP Q2–Q3 from baseline was numerically
similar between 20 mg, 10 mg, and 5 mg tadalafil arms. The proportions of patients with
improved erection (i.e., those who answered “yes” to GAQ) were also similar between the 10 mg
and 20 mg tadalafil dose arms. 226,227,229,237,238 In one trial, 215 the magnitude of improvement with
respect to the mean change in per-patient proportion of “yes” responses to SEP–Q3 from
baseline was numerically greater in the 20 mg than the 10 mg tadalafil arm 24 hours post-dose
(46.3 versus 25.5 percent). Similarly, in another trial, 230 the cumulative proportion of patients
with at least one successful intercourse attempt (“yes” to SEP–Q3) attempt 30 minutes post-dose
was numerically improved in patients who received 20 mg relative to those who received 10 mg
of tadalafil (34.0 versus 25.0 percent). In the same trial, patients on 20 mg tadalafil had a faster
erectogenic response (starting 16 minutes post-dose) than those on 10 mg of tadalafil (starting 26
minutes post-dose). 230
The results of one trial 228 were slightly inconsistent with those of others. 215,226,227,229, 230 More
specifically, patients on 10 mg (daily) of tadalafil experienced greater improvement in erectile
function (based on responses to SEP–Q3, IIEF, GAQ–Q1) compared with those receiving 20 mg
(on demand) of tadalafil. For example, there was a statistically significant higher mean perpatient
proportion of successful intercourse attempts (i.e., based on “yes” answers to SEP–Q3)
among patients receiving 10 mg tadalafil compared with those receiving 20 mg tadalafil (80
versus 67 percent, p <0.05). Similarly, the proportion of patients who answered “yes” to GAQ
Q1 was higher in the 10 mg arm compared with the 20 mg arm of tadalafil (88.0 versus 73
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