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apomorphine (5 and 6 mg: 38 and 49 percent of patients, respectively). Statistical test results for
significance were not reported.
Efficacy. Neither of the two trials 252,253 identified a dose-response effect on the percentages of
successful intercourse attempts and attempts resulting in erections firm enough for intercourse.
For example, in one trial 252 the percentage of successful intercourse attempts was similar in
patients who received 3 and 4 mg doses of apomorphine (48.4 versus 49.6 percent, respectively;
p >0.4). In the other trial, 253 the percentage of successful intercourse attempts was numerically
similar for patients in two dose-escalation (2–4 mg and 2–4 mg to 5–6 mg) and two fixed-dose (5
mg and 6 mg) apomorphine groups, ranging from 45.1 percent (2–4 mg) to 50.9 percent (5 mg).
Apomorphine mono versus sildenafil mono. Five trials compared the efficacy/safety of
apomorphine monotherapy to that of sildenafil monotherapy 114,117,120,148,159
Harms. In two trials, 117,159 the number of patients who experienced any adverse event(s) was
numerically greater in the sildenafil groups (94.0 and 35.7 percent, respectively) in comparison
with the apomorphine groups (64.0 versus 21.8 percent, respectively). In another trial, 120 the
proportions of patients with any adverse events in sildenafil and apomorphine groups were 7
percent (3/43) and 14 percent (6/43), respectively. One trial 117 explicitly stated that none of the
patients had died during the trial and reported that five patients had had at least one serious
adverse event; of these patients, three were receiving sildenafil (deterioration of arthritic
shoulder in one patient and myocardial infarction/atrial fibrillation in two patients) and two were
receiving apomorphine (myocardial infarction and deterioration in Dupuytren’s contracture). In
another trial, 159 serious adverse events occurred in two patients from the sildenafil group
(exacerbation of chronic bursitis and stroke) and in two patients from the apomorphine group
(stricture of the urethra and sudden cardiac death). The number of patients with vasodilation was
numerically higher in the 50 mg sildenafil than in the 3 mg apomorphine group (6 versus 0) 148
In three trials, 117,120,159 the number of patients who withdrew due to adverse events ranged
from one 159 to three 117 for the apomorphine arms and from zero 120,159 to two 117 for the sildenafil
arms.
Some specific adverse events that occurred in one trial in sildenafil versus apomorphine
groups were headache (16 versus 5 percent) and nausea (3.2 versus 5.6 percent). 117 In another
trial, 159 the proportions of patients with headache in the sildenafil versus apomorphine groups
were 10.3 versus 3.2 percent, respectively.
Efficacy. All five trials 114,117,120,148,159 measuring the number of successful intercourse
attempts showed that the mean percentage of successful intercourse attempts was higher in
patients who had received sildenafil (range 62.7–81.0 percent ) compared with those receiving
apomorphine (range 28.3–62.7 percent). The observed differences were statistically significant.
In fact, in three trials, 117,120,159 the percentage of successful intercourse attempts in the sildenafil
groups was about twice as that in the apomorphine groups. For example, in one trial, 117 the
percentages of successful intercourse attempts in sildenafil and apomorphine groups were 75.1
percent (95 percent CI: 69.2–81.0) and 35.3 percent (95 percent CI: 29.4–41.3) respectively, with
a mean difference of 39.7 percent (95 percent CI: 33.0–46.5) between the two groups. In the
other trial, 120 the corresponding values of the mean percentage of successful intercourse attempts
in the sildenafil (50–100 mg) and apomorphine (2–3 mg) groups, regardless the dose, were 63.7
and 32.1 percent, respectively (p < 0.01). Similarly, in another trial, 114 overall, patients receiving
sildenafil (50–100 mg) had a statistically significantly greater mean percent of successful
intercourse attempts than those receiving apomorphine (2–3 mg) (73.1 versus 62.7 percent, p =
0.0004).
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