Beste apotheek van Nederland

number of erections per week (grades 3–4) was also shown to be numerically greater in two
trials. 93,96 For example, the mean number of erections per week in one trial among participants
who received 10 mg, 25 mg, and 50 mg sildenafil was 2.8, 3.0, and 3.6, respectively. 96
In two trials, 157,161 the efficacies of two different dosage regimens of sildenafil were
compared. In one trial, 157 participants received either a fixed dose (50 mg every night) or a
flexible dose (50 or 100 mg, as needed) of sildenafil for 12 months; in the other trial 161
participants were randomly assigned to receive 100 mg/d of sildenafil either 1 hour before/during
a meal or 30–60 minutes before sexual activity. In the first trial, 157 the effect of a fixed dose of
sildenafil given every night was maintained to a greater extent compared with that achieved with
a flexible dosage of sildenafil. Specifically, the proportion of patients with a normal IIEF score
(i.e., mean IIEF “EF” domain score ≥26) at 12 months in the two treatment groups (the “fixed 50
mg nightly” arm versus the “50–100 mg, as needed” arm), was similar (66.7 versus 67.3 percent,
respectively); however, the corresponding proportions for the two groups after 1 month of posttreatment
followup were 60.4 percent (95 percent CI: 45.3–74.2) versus 8.2 percent (95 percent
CI: 2.3–19.6) in favor of nightly dosage group. The 13-month (i.e., one month after the 12-month
treatment stopped) end-point mean peak systolic velocity (PSV) values for participants in the
“nightly” and “as needed” groups were 37.0 (SD = 10.4) cm/s versus 26.5 (SD = 8.9) cm/s,
respectively, favoring the “nightly” group. In the other trial, 161 the time between sildenafil
administration and intercourse attempt (0–0.5 to >10 hours) had no statistically significant effect
on the mean IIEF “EF” domain score and the proportion of intercourse attempts (based on SEP–
Q2; p = 0.56), however, a longer period of time between taking sildenafil and intercourse attempt
was associated with a statistically significant reduction in successful intercourse attempts (based
on SEP–Q3; 92.8 percent at 1.5–2 hours versus 81.6 percent at >10 hours; p = 0.003). No
statistically significant differences were observed for EDITS scores between the study arms (p
>0.80). 161
Sildenafil monotherapy versus sildenafil in combination. This review included nine
trials 104-106,112,150,158,162,169,173 in which the efficacy and harm of mono- versus combination
therapy of sildenafil were compared. In these trials, sildenafil was used in combination with PLC
and acetyl-L-carnitine (ALC), 104 intranasal PT–141, 105 psychotherapy, 106 propionyl-L-carnitine
(PLC), 112 dihydro-ergotamine (DHE), 150 cabergoline, 162 atorvastatin, 158,169 quinapril, 158 and
alfuzosin. 173
Harms. In general, harms were poorly reported in four trials. 106,150,158,169 The incidence of any
adverse events were reported in only one 162 of the nine trials. 104-106,112, 150,158,162,169,173 This study
reported a higher proportion of participants with one or more adverse events in the combination
arm (cabergoline and sildenafil) compared with the sildenafil monotherapy arm (12.2 versus 2.0
percent, p = 0.001). 162 In two trials no serious adverse events were reported during the trial
period. 112,173 104-106,150,158, 162,169
The remaining seven studies did not report serious adverse events.
Five studies reported information regarding withdrawals due to adverse events. 104,105,112,162,173
There were no withdrawals due to adverse events in three of these trials in any of the compared
treatment groups, 81,105,112 and two trials 162,173 reported higher rates of withdrawals in sildenafil
combination therapy than in sildenafil monotherapy. These rates were 5.8 percent with
sildenafil/cabergoline therapy compared with 1.0 percent in sildenafil monotherapy, 162 and 14.5
percent with sildenafil/alfuzosin therapy compared with 9.5 percent in sildenafil monotherapy. 173
Efficacy. In all nine trials, participants who received combination therapies, in comparison
with those who received sildenafil alone, were shown to have experienced numerical or
statistically significant improvements for mean IIEF (or IIEF–5) scores for the “EF domain” and
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