Beste apotheek van Nederland

Sublingual Treatments - Apomorphine
Literature Search
In total, 12 unique randomized controlled trials (RCTs) (11 publications) met the eligibility
criteria and were included in the review. 114,117,120,148,159,248-253 One report 252 described two distinct
trials (a and b).
Overview of Trials
The trials were published between 2000 253 and 2007 159 inclusively, and were conducted in
the US, 251-253 Europe, 114,120,148,159,248-250 the United Kingdom, 117 and Mexico. 251 The trials were
supported by funds from Abbot Laboratories, 248,250,252 Takeda, 248,252 Pfizer UK, 117,159 and
Zonagen Inc. 251 Funding sources were not reported for four trials. 114,120,148,249 The duration of
followup of eight trials 114,117,120,248,249,252,253 ranged from 4 weeks 249,252 to 8 weeks. 117,148,159,248,253
The duration of followup for two trials could not be ascertained. 250,251 Of the 12 trials, four were
parallel-group 248-250,253 and eight were crossover studies. 114,117,120,148,159,251,252 Of the four parallelgroup
RCTs, three were two-armed 248-250 and one was a four-armed trial. 253 Further information
on trial characteristics is provided in (Table F-4, Appendix F).
Populations
The included trials involved men diagnosed with erectile dysfunction (ED). The total and
mean (range) numbers of patients randomly assigned to trial arms were 1975 and 179 (12–569),
respectively. The inclusion criteria across the trials were adult men (age ≥ 18 years) diagnosed
with ED in a stable heterosexual relationship of at least 6 months of duration. The inclusion
criteria in two studies 114,120 were restricted either to patients with arteriogenic 120 or
nonarteriogenic ED. 114 In one trial, 249 the inclusion criteria were restricted to patients with ED
and a history of diabetes (type I or II) who had been naïve to any ED-related treatment. The
enrolled patients in one trial 159 had to be naïve to ED drug therapy and had to have an IIEF–5
score ≤ 21.
The exclusion criteria in the majority of the included trials were spinal cord injury 114,120,248,253
and penile/testicular deformity. 114,120,148,159,248,249,251-254 Other frequently reported exclusion
criteria were uncontrolled hypertension, 114,148,251-253 diabetes, 148,248,252,253 endocrine disease, 114,248,
251-253 any major hepatic/renal disease, 117,148,251 prostatectomy, 148,248,251,253 peptic ulcers, 159 HIVpositivity/AIDS,
248,252,253 the use of nitrates, 114,117,120,148,159,251 a history of cancer, 248,252,253 and
serious cardiovascular diseases (e.g. angina pectoris). 148,159 Only one trial failed to report
exclusion criteria. 250
The mean age of the study participants across the included trials ranged from 35 250 to 59
years. 120 The race of the study participants was reported in six trials. 117,159,248,252,253 The
proportion of Caucasians across these trials ranged from 85 percent 252 to 99 percent. 248 The
duration of ED was at least 3 months at study entry in all trials. The longest mean duration of ED
(3.5–4.2 years) was reported in the trial by Porst et al 2007. 159 Most commonly reported
comorbidities among the study participants were diabetes, 114,120,148,159,248,252,253 hypertension, 114,
120,148,159,248,249,252,253 ischemic heart disease, 114,249 and coronary artery disease. 120,159,248,252,253 The
presence or absence of comorbidities could not be ascertained from three trials. 117,250,251 The
underlying cause of ED (i.e., etiology) in the patients was specified in three trials to be
nonarteriogenic (all patients), 114 arteriogenic (all patients), 120 and various causes (patients with
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