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statistical test results for the observed between-treatment differences. In two trials, 85,93 the
number of participants with treatment-related adverse events did not differ across the 25 mg and
78,85,86, 93,96,137
50 mg sildenafil treatment groups. Of the events observed across the trials,
headache, myalgia, nausea, dyspepsia, and flushing were the most frequently experienced and
were mild to moderate or transient in nature.
A total of four serious adverse events were reported in two studies. 93,96 These trials compared
25 mg to 50 mg, 93 and 10 mg to 25 mg and 50 mg of sildenafil. 96 One participant (4.7 percent) in
the 25 mg sildenafil group discontinued the treatment because of pneumococcal pneumonia (the
authors did not consider this a serious adverse event). 93 There were three other instances of
serious adverse events (myocardial infarction, renal cell carcinoma, and epileptic crisis) in one
trial. 96 The group designation of the participants experiencing these events were not reported.
Withdrawals due to adverse events were reported in five trials. 85,86,93,96,137 The rate of
discontinuation ranged from 0 percent 85 to 3 percent 96 for the 10 mg dose of sildenafil, from 0
percent 137 to 4.7 percent 93,96 for the 25 mg dose, from 0 percent 85 a to 11 percent 96 for the 50 mg
dose, and from 2 percent 86 a to 4 percent 137 for the 100 mg dose.
Safety data was not reported for the trial that compared different timing of sildenafil (100
mg) administration in relation to food and sexual activity. 161 In the trial 157 comparing “nightly”
(50 mg) and “as needed” (50 mg to 100 mg) sildenafil dosing regimens, the proportion of
withdrawals due to adverse events was similar across the two groups (approximately 7 percent).
The authors of this trial did not report the incidence of any adverse events. Overall, more
participants experienced adverse events (headache, flushing, dyspepsia, and rhinitis) in the “as
needed” compared with the “nightly” group. Reportedly, none of the participants in this trial
developed a serious adverse event. 157
Efficacy. All six trials 78,85,86,93,96,137 assessing the efficacy of different doses of sildenafil
monotherapy (10 mg, 25 mg, 50 mg, and 100 mg), demonstrated a dose-response trend for
sildenafil toward improving erectile function. Although none of these trials provided a formal
statistical test for the observed between-arm (sildenafil versus placebo) differences, the degree of
improvement tended to increase numerically with a higher dose of sildenafil. For example, the
range for the mean IIEF Q–3 and Q–4 scores for three sildenafil dose arms in two trials 86,137 were
as follows: 25 mg (Q–3: 3.18–3.20, and Q–4: 2.99–3.10), 50 mg (Q–3: 3.50–3.65, and Q-4:
3.50–3.64), and 100 mg (Q-3: 3.79–4.00 and Q-4: 3.63–3.90). The proportion of participants
with an improved erection (based on GEQ–Q1) across four trials 86,93,96,137 ranged from 50 to 79
percent for 25 mg and from 52 to 88 percent for 50 mg sildenafil arms. In two trials, 86,137 the
corresponding proportion of participants who received 100 mg sildenafil ranged from 84 to 88
percent. The authors of two trials, 78,86 reported dose-response treatment effects associated with
administration of 25 mg, 78,86 50 mg, 78,86 and 100 mg 86 of sildenafil with respect to mean scores
for the IIEF “EF” domain (no numerical data provided; p <0.001) 86 and IIEF–Q1 (25 mg: 3.7,
versus 50 mg: 4.5). 78 In two other trials 85,93 the participants’ mean duration of penile rigidity
(>80 percent and >60 percent, respectively) in minutes at the base and the tip of the penis was
shown to increase numerically with higher doses of sildenafil (10 mg versus 25 mg versus 100
mg). In one trial, 85 the mean duration of penile rigidity at the base of the penis for participants
receiving 10 mg sildenafil was 3.5 minutes (95 percent CI: 1.6–7.3). The ranges for the mean
duration of penile rigidity (>60 percent or >80 percent) in two trials, 85,93 were 5.0 to 8.0 minutes
(in participants receiving 25 mg sildenafil) and 10.1 to 11.2 minutes (in participants receiving 50
mg sildenafil). The proportions of participants who achieved grades 3–4 erections in the 25 mg,
50 mg, and 100 mg sildenafil groups were 72, 80, and 85 percent, respectively. 86 The mean
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