Beste apotheek van Nederland

organic, psychogenic or mixed origin ED). 159 In four trials, 114,120,249,250 the proportion of smokers
ranged from 35 percent 249 to 95 percent. 114,120 In the remaining trials this proportion could not be
ascertained. 117,148,159,248,251-253
In seven trials 117,159,248,249,252,253 the authors provided baseline arm-specific distributions of the
patients’ sociodemographic and clinical characteristics (e.g. age, race, duration/severity of ED,
comorbidities) and explicitly stated that the distribution of these characteristics between the
randomized arms was generally similar. The authors of the remaining five trials 114,120,148,250,251
did not report this information.
Interventions
Patients in all reviewed 12 trials 114,117,120,148,159,248-253 received apomorphine sublingually with
a dose ranging from 2 mg 159,248 to 6 mg. 251,253 In all trials except one, 251 patients received
apomorphine monotherapy. In this one trial, 251 two groups of patients received the combination
of apomorphine either with phentolamine (40 mg) or with phentolamine (40 mg) plus papaverine
(150 mg). One trial did not report the dose of apomorphine. 117
In six trials 148,249-252 apomorphine was given only at a fixed dose. A flexible-dose-only
regimen was used in other five trials. 114,117,120,158,248 In one trial, 253 patients were randomly
assigned to receive either a fixed (5 mg or 6 mg) or flexible dose (2 mg–6 mg) of apomorphine.
The duration of apomorphine treatment across the trials ranged from 4 weeks 249,252 to 8
weeks. 117,148,159,248,253 Patients in the control arms received placebo in five trials, 248-250,252,253
sildenafil (50-100 mg/d) in six trials, 114,117,120,148,159,251 and apomorphine (control dose) in two
trials. 252 b 253 . An additional comparison group of patients in one trial 251 received a combination of
phentolamine (40 mg) and papaverine (150 mg).
Outcomes
Harms. All trials but one 114 reported some information on the absence and/or occurrence of
adverse events: any adverse events, 117,159,248,250,251 serious adverse events (including death), 117,159,
248,250,251 withdrawals due to adverse events, 117,120,159,248,249,253 and frequently reported (≥5
percent) specific adverse events. 120,148,159,248-253
Efficacy. The efficacy outcomes measured in the 11 trials varied to some degree. The most
commonly measured and reported outcome across the trials was the percentage of successful
intercourse attempts. 114,117,120,148,159,248,252,253 In four trials, the percentage of attempts resulting in
erections firm enough for intercourse was also measured 148,252,253 . Similarly, in one trial, 251 the
proportions of successful vaginal penetration and vaginal intercourse leading to orgasm were
estimated. The above-mentioned outcomes were calculated based on the patients’ and/or their
partners’ responses to pre-specified questions provided in home-use diaries.
In five trials, the mean IIEF score (domains of “erectile function,” “orgasmic function,”
“sexual desire,” “intercourse satisfaction,” “overall satisfaction”) was used to assess the relative
efficacy of apomorphine. 117,148,159,249,253 For example, in one trial 117 the primary endpoint was the
mean difference in IIEF score for the “erectile function” domain, whereas secondary endpoints
were mean difference IIEF scores for other domains (e.g. “orgasmic function,” “sexual desire,”
“intercourse satisfaction,” and “overall satisfaction”). In another trial, 253 the authors provided
differences between treatment-arm specific mean IIEF scores for the “erectile function,”
“intercourse satisfaction,” and “overall satisfaction” domains as secondary efficacy endpoints. In
this trial, 249 primary efficacy endpoint was a response rate defined as the proportion of patients
who answered “yes” to a Global Efficacy Question (GEQ) (i.e., “Has the treatment you have
67