Beste apotheek van Nederland

value was not reported). Even though the proportion of patients in one trial 226 was numerically
greater in the tadalafil arms (39.7–44.4 percent) than in the placebo arm (31.0 percent), this
difference was not statistically significant (p = 0.247). Most common adverse events reported
across all trials were headache, back pain, dyspepsia, dizziness, nasal congestion, flushing, and
myalgia. In general, the occurrence of these events tended to be numerically more frequent in
tadalafil arms than in placebo arms. Moreover, a statistically significant higher incidence of these
events was reported across several trials in tadalafil versus placebo arms. 215,220,222,223,225,226,239 The
majority of the trials reported that tadalafil was well tolerated and that patients had had adverse
events mostly of mild or moderate severity.
Eleven of the 23 trials did not report whether there had been any occurrence of serious
adverse events. 216,218,219,221,225-227,229,230,237,239
In the remaining 12 trials, 215,217,220,222-224,233-236,238,240 the incidence of serious adverse events
(i.e., the proportion of patients with at least one serious adverse event) was reported to have been
about 5.0 percent 222 or less, or 0, 238 , and to have been similar in tadalafil and placebo arms. 215,217,
220,222-224,233,235,240 In one trial, 217,243 three patients who received tadalafil developed carotid artery
bruit, esophageal spasm, and brain neoplasm (one case of each event). 217 Other specific serious
adverse events that were reported were single cases of pulmonary embolism and subarachnoid
hemorrhage, 223 two cases of chest pain requiring hospital admission, 224 and one case of
worsening CAD. 236 In one trial, 235 five patients experienced at least one of the following serious
adverse events in the tadalafil arm: acute myocardial infarction (AMI), benign lung neoplasm,
back pain, road traffic accident, and pancreatitis. Two trials 215,234 reported one death each which
had occurred due to AMI 215 and cardiac arrest. 234 Of the 12 trials that reported any occurrence of
serious adverse events, three trials 215,220,222 did not specify what these events were.
The proportion of patients who withdrew due to adverse events across trials was five–six
percent 217,222,224 215-220,222-227, 229,230,233-240
or less and similar across the tadalafil and placebo arms.
Efficacy. In general, the results of the 23 placebo-controlled trials showed that patients who
received tadalafil (10 or 20 mg) experienced greater improvement in erectile functioning (e.g.
outcomes based on responses to IIEF, SEP, and GAQ) compared with those who received
placebo. The observed between- or within-arm differences in the mean endpoint scores/mean
score changes for the IIEF “EF” domain 216,217,219,220,222-224,226, 227,229,234,236-240 and for the perpatient
proportion of “yes” answers to the SEP questions 2–3, were statistically significant (p
value < 0.05). 215-217,219,220,222-227,229,230,234,236-240 Similarly, the proportion of patients who
answered “yes” to the GAQ–Q1/2 was statistically significantly greater in tadalafil than in
216,217,220,222-224,226,227,229, 234,236-240
placebo arms.
For example, the mean within-arm IIEF “EF” domain absolute score change observed in
tadalafil arms (10 or 20 mg dose) across trials 216,217,219,220,222-224,226,227,229,234,236-240 ranged from
5.2 222 to 12.0, 219 whereas the corresponding treatment response observed in placebo arms ranged
from –1.6 216,242 to 2.9. 219 The mean change in the proportion who responded “yes” to SEP Q3
(i.e., per-patient percentage of successful intercourse attempts) in tadalafil arms (10 or 20 mg
dose) ranged from 23.0 percent 222 to 56.5 percent. 220,237 The corresponding mean treatment
response change in placebo arms ranged from 0.9 percent 216 to 18.3 percent. 237 The proportion of
patients who responded “yes” to GAQ–Q1 in tadalafil arms (10 or 20 mg) across trials 216,217,220,
222-224,226,227,229,234,236-240 ranged from 62.0 percent 222 to 92.3 percent. 229 For placebo arms this
proportion across the same trials ranged from 12.8 percent 216 to 54.5 percent. 229
In a parallel-arm trial of patients with LUTS (65 percent ED patients), 233 138 patients (n = 99
ED patients) received the dose-escalated tadalafil (5 mg for 6 weeks and the 5–20 mg dose­
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