Beste apotheek van Nederland

Interventions
In the 73 reviewed trials, participants were randomly assigned to receive either mono and/or
combined therapy of oral sildenafil citrate (as experimental or control intervention) with a dose
(at randomization) ranging from 10 mg 85,96 to 100 mg. 101,104,122,130,134,137,146,150,155,158,161,169
Depending on the observed efficacy and tolerability of sildenafil, the daily dose was flexible
(upward or downward titrations: 50 mg – 25 mg – 100 mg) in more than half of the included
79-84,87-91,94,95,97-99,107-109,115, 124-126,128,131,133,135,138,142,143,147,150,151,156,157,160,162,164-168,171
trials.
In eight trials, participants were randomized to receive different dosages (e.g. with respect to
dose, dose escalation, fixed/on demand, time of administration) of sildenafil monotherapy. 78,85,86,
93,96,137,157,161 Of these, six trials 78,85,86,93,96,137 assessed a dose-response effect of sildenafil given at
a fixed dose (dose range 10 mg/d to 100 mg/d). In one 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. Participants in another trial were randomly assigned to receive either fixed
dosing (50 mg every night) or flexible dosing (50 mg or 100 mg, as needed) of sildenafil. 157
In nine trials, oral sildenafil was administered in combination with propionyl-L-carnitine
(PLC), 112 PLC and acetyl-L-carnitine (ALC), 104 intranasal PT-141, 105 psychotherapy, 106
alfuzosin, 173 dihydro-ergotamine (DHE), 150 atorvastatin, 158,169 quinapril, 158 and cabergoline. 162
In five trials, patients received either mono (or combined) therapy of sildenafil or
monotherapy of another active treatment. 106,124,132,155,173 These therapies were psychotherapy, 106
continuous positive air pressure (CPAP), 155 phentolamine, 124 Ro70–0004 (i.e., α 1A -adrenoceptor
antagonist), 132 or alfuzosin. 173
Of the 73 trials, 66 (91 percent) were placebo-controlled (with or without an active treatment
78-91,93-99,101,102,104,105,107-111,115,122,123,125,126,128,130-135,137,138,142,143,146,147,149,151, 156,158,160-162,164-169,
arm), 171,175 and the remaining seven trials had no placebo arm. 106,112,124,150,155,157,173
79-81,83,84, 87,94,97,98,
In most of the trials, the duration of sildenafil treatment was about 12 weeks 102,107,109,115,125,126,131,133,135,137,138,142,151,155,156,158,160,166,169,171,173,175 and ranged from 1–2 weeks 93,168
to 48 weeks. 157
Outcomes
Harms. The presence or absence of any all-cause adverse events (i.e., the proportion of
patients with ≥ 1 adverse event) was reported in 29 trials. 79-83,85-87,90,94,96-98,107-109,115,124-126,132,137,
142,143,147,151,160 The presence or absence of withdrawals due to adverse events was reported in 62
78-91,94-99,101,104,105,107-109,112,115,122-126,128,130,131,133-135,137,138,142,143,146, 147,149,151,155-157,160,162,165-168,
trials. 171,173,175 The absence or presence of serious adverse events was reported in 52 trials. 78,80-85,87-91,
93,95-99,101,105,107-112,123-126,128,131,133-135,138,143,146,147,149,151, 155-157,160,166-168,171,173
Efficacy. The efficacy outcomes measuring the degree of ED reported in the 73 trials were
79-84,86-88,90,91,97,98,102, 104,107-109,112,115,
total mean scores for the 5 IIEF domains: “Erectile Function”, 122-126,128,135,137,138,142,143,147,149,155,156,160,161,164-167,169,171,173 “Intercourse Satisfaction”, 79,80,82-84,87,88,90,
91,97,104,107-109,115,122-126,137,138,142,143,147,149,155,156,160,162,164-167,171 “Overall Satisfaction”, 79,80,82-84,87,88,
90,91,97,104,107-109,115,122-126,137,138,142,143,147,149,155,156,160,164-167,171 “Orgasmic Function”, 79,80,82­
84,87,88,90,91,97, 104,107-109,115,122-126,137,138,142,143,147,149,155,156, 160,164-167,171 and “Sexual Desire”, 79,80,82­
84,87,88, 90,91,97,104,107-109,115,122-126,137,138,142,147,149,155, 156,160,164-167,171
Other commonly reported outcomes were: mean IIEF scores for responses to Q3 and Q4
(penetration and maintenance frequency), 143,147,149-151,162,165,167,173 proportion of successful intercourse attempts,
79-84,86-88,90,91,94,97-99,101,107-109,112,115,123-126,131, 133,137,138, 142,
80-84,87,94,97,98,109, 112,115,124-126,
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