Beste apotheek van Nederland

Proportion of patients with improved erection (GAQ–Q1). This meta-analysis included eight
trials. 220,223,227,234,236-238,240 The pooled estimate of the relative proportion of patients with
improved erection (i.e., those who answered “yes” to GAQ–Q1) was 2.43 (95 percent CI: 2.06–
2.87), indicating a statistically significantly higher rate of improvement for patients who received
tadalafil (20 mg) relative to the placebo-treated patients (Figure 65).
Harms.
Proportion of patients with any adverse event (all- cause). This meta-analysis included five
trials 215,227,229,238,240 and yielded a RR of 1.95 (95 percent CI: 1.40–2.71) with a statistically
significant heterogeneity across trials (Chi 2 df=4 = 15.60, p = 0.004; I 2 = 74.4 percent) (Figure 66).
We explored potential sources of this heterogeneity by examining other trial characteristics
(e.g. populations, severity of ED, duration of ED, length of followup). Figure 67 presents the
results based on 4 trials 227,229,238,240 with a 12-week followup that yielded similar effect estimates
(RR range 1.45–2.08), whereas one trial 215 whose length of follow up was 6 weeks yielded a
more inflated estimate of RR (i.e., RR = 4). After excluding this trial, the pooled estimate of RR
was 1.61 (95 percent CI 1.37–1.89), indicating a statistically significantly greater rate of any
adverse events in patients who received tadalafil (20 mg) relative to placebo-treated patients.
There was no significant heterogeneity between the trials (Chi 2 df=3 = 2.88, p = 0.41; I 2 = 0
percent) (Figure 67). (Note that “favors” in forest plots refers to increased frequency of the event
for the respective treatment arm, regardless of the desirability of the event).
Tadalafil (20 mg) versus tadalafil (10 mg).
Efficacy.
Mean change from baseline in IIEF–EF score. Two trials 227,229 compared 10 mg and 20 mg
doses of tadalafil and also reported mean change in IIEF “EF” domain total score. The pooled
estimate of these trials indicated that the mean increase in IIEF “EF” domain total score was not
statistically different between the two dose-arms (mean difference 0.60, 95 percent CI:-0.92 to
2.11) (Figure 68)
Mean per-patient percentage absolute change (from baseline) on SEP–Q2. Two trials 227,229
compared 10 mg and 20 mg of tadalafil and also reported the mean per-patient percentage of
SEP–Q2. The meta-analysis of these trials indicated that the mean increase in per-patient
percentage of SEP–Q2 was not statistically different between the two dose-arms (mean
difference 0.32, 95 percent CI: 7.53–8.18) (Figure 69).
Proportion of patients with improved erection (GAQ–Q1). Four trials 227,229,237,238 compared
10 mg and 20 mg of tadalafil and also reported the proportion of patients with improved
erections as measured by GAQ–Q1. The meta-analysis incorporated three of these trials 227,237,238
and indicated that the difference observed between the rates of improvement in erection for
patients who received 10 mg and 20 mg of tadalafil was not statistically significant (RR = 1.07,
95 percent CI: 0.99–1.16) (Figure 70).
Harms.
Proportion of patients with any adverse events (all- cause). This meta-analysis included six
trials, 215,227,229,230,237,238 which compared 10 mg and 20 mg doses of tadalafil and also reported the
proportion of patients who developed at least one adverse event. The pooled summary estimate
of RR indicated a statistically significant higher incidence of adverse events in patients treated
with 20 mg tadalafil compared with those treated with 10 mg tadalafil (RR = 1.21, 95 percent CI:
1.05–1.38). There was no statistically significant heterogeneity across the trials (Chi 2 df=5 = 6.60,
p = 0.25; I 2 = 24.3 percent) (Figure 71).
64