Beste apotheek van Nederland

The proportion of patients with fibrosis in studies that used PGE 1 alone after at least one year
of followup ranged from 4.4 percent 365 to 23.3 percent. 372 In two of these studies no cases of
fibrosis were observed. 370,378 For example, one retrospective cohort study in Australian men 372
reported an incidence of fibrosis in 57 of the 245 patients (23.3 percent) who had been treated
with PGE 1 2–60µg (mean 13µg) for 2 years on average. The total amount of PGE 1 (p = 0.0062)
and the total number of injections (p = 0.0032) over the whole treatment period were statistically
significantly greater in the men with fibrosis. However, there were no significant differences
between the men who developed fibrosis and men who did not with regard to duration of
followup, injection frequency, or dose per injection. 372 In contrast, in another prospective trial, 365
only three (4.4 percent) of the 68 PGE1-treated patients (the mean PGE1 dose: 11.6µg)
developed fibrosis after at least one year of followup. Of these three patients, only one patient
injected PGE 1 more frequently and at a higher dose (20-60µg every 2-3 days) than it was
prescribed (one injection 10-20µg per 5-7 days).
The largest study that evaluated and compared adverse events in patients receiving ICI
injections with different medications was a retrospective U.S. study of 1089 patients who had
received either 5-10µg PGE 1 , trimix (1.47µg PGE 1 plus 4.41 mg papaverine plus 0.5 mg
phentolamine), papaverine plus phentolamine, or 10µg PGE 1 plus 30 mg papaverine for up to 80
months. This study investigated reasons for attrition in each treatment group. Of the subjects
discontinuing the treatment, penile scarring/nodules was the reason for study withdrawal in 23
percent (6/26), 11 percent (4/36), and 10 percent (8/75) of the subjects receiving triple therapy
(PGE 1 /papaverine/ phentolamine), combination papaverine and phentolamine therapy, and PGE 1
monotherapy, respectively. None of the patients receiving the combination of PGE1 with
papaverine developed penile scarring/nodules. 374 In a controlled trial conducted in Taiwan, 377 51
patients with ED (mean age: 58 years) received self-injections either with 20µg PGE 1 or 30 mg
papaverine for about 12 months (range: 1.5-30.5 months). Two patients (3.9 percent) developed
fibrosis after 60 mg papaverine injections. No cases of fibrosis were observed in patients after
PGE 1 injections. 377 Similarly, in a trial conducted in Turkey, 376 69 patients with ED (mean age:
52.6 years) were divided to receive injections either with 10µg PGE 1 (n = 13 patients) or 15-30
mg papaverine (n = 56 patients) for approximately 12 months. Two patients (3.6 percent) in the
papaverine group developed fibrosis versus none in the PGE 1 group. In a retrospective North
American cohort study, 373 108 ED patients received self-injections with either 30 mg papaverine
(n = 21 patients), the combination of 25 mg papaverine with 0.83 mg phentolamine (n = 77 ), or
PGE 1 (n = 2 patients) were followed-up for 5 years. Only one of the 108 subjects developed
fibrosis (the assigned intervention not reported). (Table 29)
104