Beste apotheek van Nederland

Question 3a. What Are the harms of Pharmaceutical
Treatments for Male Patients with ED?
Specific Adverse Events
Oral Medications: PDE–5 inhibitors
Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
In total, 194 records were identified that discussed incidence of NAION in men treated with
sildenafil. Of these, 10 records reporting on cases of nonarteritic anterior ischemic optic
neuropathy (NAION) were included in this review. 354-363 These records were seven case
reports 354-359,363 , two case series 361,362 , and one retrospective cohort study. 360 The remaining
records not reporting NAION were excluded.
This review identified 19 cases of NAION reported between 1999 and 2007. Findings of the
retrospective cohort study, of 4,157,357 veterans 50 years of age or older indicated that men who
were prescribed PDE-5 inhibitors over the period of 2 years were not at increased risk of being
diagnosed with NAION compared with those who were not prescribed PDE-5 inhibitors (RR =
1.02, 95 percent CI: 0.92–1.12). 360 Note that for possible NAION, the corresponding relative risk
was statistically significant (RR = 1.34, 95 percent CI: 1.17–1.55). In all cases except for one, 362
the administered minimum dose of sildenafil was 50 mg. Overdose of sildenafil was reported in
two case reports. 354,363 Further details can be found in Table 28.
Injection Treatments
Penile Fibrosis (Non-randomized studies: observational studies and
clinical trials)
In total, 20 non-randomized studies (retrospective observational cohort, and clinical trials)
reporting the absence or presence of penile fibrosis in long-term followup (at least 6 months) met
the eligibility criteria for inclusion in the review (in 20 publications). 364-383 Of these, 13 were
clinical trials of prospective design 364-366,368-371,376-378,380,381,383 and seven were retrospective
cohort studies. 367,372-375,379,382
The number of subjects included in the 20 studies ranged from 10 370 to 1089. 374 The majority
of the study subjects were middle aged (mean age range: 50-62 years). Four trials included
special population subgroups such as patients diagnosed with diabetes, 366,369 multiple sclerosis, 381
and prostate cancer followed by prostatectomy. 367 One study evaluated ICI therapy in geriatric
men (age >65 years). 382
Prostaglandin (PGE 1 ) alone or in combination with other vasoactive agents (papaverine
and/or phentolamine) was evaluated in 15 studies. 364-378 Papaverine alone or in combination with
phentolamine (or verapamil) was evaluated in 13 studies. 366,367,369,371,373,374,376,377,379-383 The
duration of treatment ranged from 3 months 368 to 10 years. 366 In the majority of studies, the
approximate frequency of PGE 1 injections was up to twice per week with a mean dose of 20 μg
or lower. 365,370,372,375,378
Of the 20 studies, five explicitly reported the absence of new cases of fibrosis. 367,368,370,371,378
and six studies reported the incidence of fibrosis to be under 5 percent. 373,376,377,379-382
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