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Tadalafil (10 mg) versus placebo.
Efficacy. No meta-analysis was performed.
Harms.
Proportion of patients with any adverse events (all-cause). This meta-analysis included four
trials, 215,227,229,238 which compared 10 mg of tadalafil to placebo and also reported the proportion
of patients who experienced at least one adverse event. The pooled summary estimate of RR
indicated a statistically significant higher incidence of adverse events in patients treated with 10
mg tadalafil as compared with those treated with placebo (RR = 1.53, 95 percent CI: 1.11–2.11).
The test of heterogeneity was statistically significant (Chi2df=3 = 8.99, p = 0.03; I2 = 66.6
percent) (Figure 72).
After excluding a trial with a 6 week followup, 215 the pooled estimate of RR for the
remaining three trials with 12 weeks of followup 227,229,238 was RR = 1.31 (95 percent CI: 1.10–
1.57). The result indicated a statistically significant higher incidence of adverse events in patients
treated with 10 mg tadalafil compared with those treated with placebo. There was no statistically
significant heterogeneity present across the trials (Chi2df=2 = 0.01, p = 0.99; I2 = 0 percent)
(Figure 73).
Tadalafil versus sildenafil. No meta-analysis of the four crossover trials 103,118,121,163 that
compared tadalafil with sildenafil was performed because the sildenafil dose/dosage
varied, 103,118,121,163 and there was a lack of relevant efficacy outcome data such as the mean
absolute change in IIEF “EF” domain total score, 118,121,163 per-patient percentage of successful
attempts on SEP–Q2, 118,121,163 and the proportion of patients with improved erection on GAQ–
Q1). 118,121,163
Assessment of Publication Bias
Funnel plots were used to assess the extent of asymmetry (i.e., possible publication bias)
present in each meta-analysis. Visual inspection of these plots did not reveal any substantial
asymmetry. 53 (Funnel plots, Appendix G.)
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