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PDE-5 Inhibitors Versus Placebo




Efficacy. Overall, the evidence consistently indicated that patients with ED who received these agents (i.e., sildenafil, vardenafil, ortadalafil), compared with those on placebo, experienced greater improvements in the clinical measures of erectile function such as the mean scores for the International Index of Erectile Function (IIEF) “Erectile Function domain” (i.e., erection frequency, erection firmness, penetration ability, and erection confidence), IIEF-Q3/Q4 (i.e., penetration ability and maintenance frequency), and Sexual Encounter Profile (SEP)-Q2/Q3 (i.e., the per-patient proportion of successful intercourse attempts). The evidence was also consistent in favor of PDE-5 inhibitors over placebo in showing the clinical benefit with respect to the proportion of patients with improved erection (GAQ-Q1). Sildenafil, vardenafil, and tadalafil also demonstrated consistent statistically significant clinical benefits over placebo with regard to mean total scores for the specific IIEF domains such as “Intercourse Satisfaction” (i.e., intercourse frequency, satisfaction, and enjoyment) and “Overall Satisfaction” (i.e., overall satisfaction and relationship satisfaction). Results obtained from the same trials suggested that the effects of sildenafil and tadalafil did not differ from that of placebo for the IIEF domains of “Sexual Desire” (i.e., desire frequency and desire level) and “Orgasmic Function” (ejaculation and orgasm frequency). In a few trials, patients treated with vardenafil had improved in the domains of “Sexual Desire” and/or “Orgasmic Function” compared with placebo-treated patients.183, 194, 199, 204 Furthermore, all trials that reported patient satisfaction with a medication (i.e., mean Erectile Dysfunction Index of Treatment Satisfaction scores) showed statistically significant improved scores for patients who received sildenafil or tadalafil compared with those who received placebo. None of the vardenafil trials reported scores for the Erectile Dysfunction Index of Treatment Satisfaction (EDITS). The results of meta-analyses conducted in this review were consistent with those of qualitative assessments in that they indicate statistically significant improvements in PDE-5 inhibitor-treated (regardless of dose/dosing regimen) patients versus placebo-treated patients with respect to the mean change/endpoint scores of IIEF “EF domain, ” IIEF-Q3/Q4, SEP-Q2/Q3, as well as with respect to the proportion of patients with improved erection (GAQ-Q1).

Harms. In general, all three PDE-5 inhibitors were described as well-tolerated drugs whose use was associated with adverse events mainly of a mild or moderate nature. Overall, the occurrence of any all-cause adverse events tended to be higher either numerically or with a statistical significance in patients treated with PDE-5 inhibitors as compared with those treated with placebo. The most commonly observed all-cause adverse events for all three PDE-5 inhibitors were headache, flushing, dyspepsia, and rhinitis. The incidence of serious adverse events was poorly reported. Numerically, there was no obvious imbalance with respect to the occurrence of serious adverse events between patients who received PDE-5 inhibitors and those who received placebo. The result of meta-analysis agreed with those for the qualitative assessment of harms in their indication of an increased risk of any adverse events in patients who received PDE-5 inhibitors (regardless of dose/dosing regimen) compared with those who received placebo.

Two meta-analyses also showed that there were no statistically significant differences with respect to the occurrence of serious adverse events or withdrawals due to adverse events between vardenafil- and placebo-treated groups. Compared with placebo, the use of either sildenafil or vardenafil was associated with an increased risk of either headache or flushing. In addition, patients treated with vardenafil or sildenafil, in comparison with those treated with placebo, were at increased risk of dyspepsia and visual disturbances, respectively.


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