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(241), the response rate to placebo was 17% in contrast to 22% with apomorphine,
a difference which is not significantly relevant, and therefore, this drug has a limited
use for these patients.
The most frequent adverse effects were nausea, dizziness, headache and
somnolence, which tend to improve with continuous use of the treatment (242;
243). A study assessed specifically its cardiovascular safety in patients treated
with antihypertensive drugs or nitrates. There were no clinically relevant changes
in blood pressure nor in cardiac frequency in those patients taking short-acting nitrates.
Men who were taking long-acting nitrates underwent changes in their blood
pressure when seated, though not when in a supine position. Apomorphine could
be safer than FDE-5 inhibitors in men treated with nitrates (242).
10.4.3. Intracavernosal alprostadil
Intracavernosal alprostadil is effective vs. placebo in that it improves erectile dysfunction.
A minor study showed no differences between intracavernosal alprostadil
and sildenafil. The most frequent adverse effect of alprostadil is penile pain,
which affects 40% of the patients (242).
RCT
1+
10.4.4. Psychosocial interventions
A recent Cochrane review has analysed the randomised or quasirandomised studies
which assess the effectiveness of psychosocial interventions in erectile dysfunction
among the general population and this included diabetic patients.
Statistical heterogeneity was found. The authors stated that psychotherapy
can be more effective, but the response to the treatment varies among the subgroups.
Group therapy proved to be more effective than the waiting list control.
The combination of sildenafil with group therapy was more effective than that
with sildenafil alone (244).
SR of
randomised
and quasirandomised
studies
1+/2+
Evidence summary
1++ There is solid evidence that phosphodiesterase inhibitors (sildenafil, tadalafil and vardenafil)
are very effective in the improvement of erectile dysfunction for men who suffer
from DM 2 (239).
1+ Sublingual apomorphine is more effective than placebo among the general population
with erectile dysfunction, though far less effective in comparison to sildenafil (240). In
the only study carried out in diabetic patients, apomorphine did not prove to be more
effective than placebo (241).
1+ Intracavernosal alprostadil is effective vs. placebo in the improvement of erectile dysfunction.
A minor study showed no differences between intracavernosal alprostadil and
sildenafil. The most frequent adverse effect was penile pain, which affects 40% of the
patients (242).
96 CLINICAL PRACTICE GUIDELINES IN THE NHS