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45 mg/05 ml 30 mg 30 mg 150 mg 300 mg 300 mg
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Montorsi et al [55]
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The Trimix stock solution of Montorsi et al [55] is in 3 ml
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8 2 mg was introduced commercially as Invicorp , available with a very user-friendly automatic injection device for single use (Senetek-CA, USA), and approved in some countries (Denmark, UK, New Zealand) Although the VIP/phentolamine combination was very promising, especially due to its self-injection device and relatively high ef cacy, it was never marketed worldwide This is presumably due to the considerable decrease of the market for injectables in ED To the knowledge of the authors, at present the VIP/phentolamine combination is not of cially available in any country
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There is no question that at present the triple drug combination represents the most effective regimen in self-injection therapy, which was also preferred over alprostadil in the cited trial [56] The major disadvantage of this powerful drug-combination is the fact that up to now, no commercially available preparation exists worldwide, ie the patients or the pharmacists have to reconstitute this combination individually, which is relatively complicated and cumbersome for many patients
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Combination of VIP and Phentolamine (Invicorp )
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The use of the combination of VIP and phentolamine in a larger series of patients with ED was published for the rst time in 1992 [57] After a couple of studies [58,59], the mixture of VIP/phentolamine in doses of 25 g/1 mg or 25 g/
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Other drug combinations for self-injection therapy
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There are a variety of other drug combinations, mostly with PGE1 (alprostadil), such as triple drug with PGE1/papaverine/chlorpromazine (05 mg/ml) instead of phentolamine, or triple drug + atropine, PGE1 + ketanserin, PGE1 + CGRP (calcitonin gene-related peptide), PGE1 + forskolin (activates the enzyme adenylate cyclase and increases intracellular cAMP), or triple drug and forskolin, but none of these combinations were able to achieve any market acceptance or of cial approval [60]
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Table 84 Equivalent ef cacy doses of alprostadil powder
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(Caverject ) and papaverine/phentolamine/PGE1 combination (triple drug solution) in 68 patients From Kulaksizoglu et al[56]
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Alprostadil powder (PGE1 (mg)) 4 8 12 16 20 Papaverine(mg)/ phentolamine (mg)/PGE1 (mg) 147/005/049 32/01/11 46/015/155 68/022/227 76/025/25
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Combination of self-injection therapy and oral drug therapy
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The successful conversion of non- responders either to high dose alprostadil mono-therapy (40 g) or to the triple drug combination (40 g PGE1/48 mg papaverine/32 mg phentolamine) by combining
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Table 85 Intra-individual comparative study of alprostadil powder (Caverject ) and papaverine/phentolamine/PGE1
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(triple drug solution) From Kulaksizoglu et al [56]
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Alprostadil powder (PGE1 Caverject) Overall assessment better Improved rigidity Erection maintenance better Reproducibility better Orgasm/ejaculation better 23% 22% 19% 15% 0 Papaverine/phentolamine/PGE1 (triple drug solution) 46% 37% 37% 35% 0 No preference (both the same) 31% 41% 44% 50% 100%
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Self-Injection, Trans-Urethral and Topical Therapy in Erectile Dysfunction
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Potential of mal-injection in self-injection technique
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Correct intrasinusoidal injection
1 Subcutaneous injection 4 Intraseptal injection
2 Intratunical injection
3 Intratrabecular injection
5 Intraurethral injection
Fig 82 Technique of self-injection therapy From Porst [60]
self-injection therapy with 100 mg sildena l, was reported in 34% [32] of 93 patients treated in this way [61] In another prospective, placebo (against sildena l) controlled study with 40 patients experiencing unsatisfactory erections at both the 50 and 100 mg dose of sildena l, the combined treatment with 20 g IC-PGE1 resulted in a statistically signi cant improvement of the erectile response as assessed by the IIEF-EF in 65% of the patients [62]
Technique and complications of self-injection therapy
In order to overcome the reservations and to increase the acceptance of patients on the one hand, but to decrease at the same time the complications of self-injection therapy on the other hand, a thorough instruction of the patients in a proper technique and use of ultra-thin needles is mandatory According to the experiences of the authors it takes, in many patients, at least two teaching sessions before the patient is sure that he has mastered this technique correctly and avoids potential mal-injection risks (see Fig 82)
The most frequent side effects encountered with self-injection therapy are: Prolonged erections/priapism: the frequency of which has been shown to be drug- and dose dependent (see Table 82) Priapisms lasting longer than six hours must be interrupted by injecting IC a sympathomimetically acting antidote (see 15 on conservative management of priapism), and/or evacuation of the entrapped blood through a butter y cannula The six hour time limit has absolutely to be considered in order to avoid irreversible ischemic damage to the cavernous tissue Fibrosis of the cavernous tissue: the occurrence of which has also shown a clear drug dependency (see Table 82) The follow up of brotic changes occurring both in the European multicenter 4-year study with alprostadil (Viridal /Edex ), or in the US 5 year trial (Caverject ), showed that between 33 47% of these nodules/plaques healed spontaneously [63,64] In a recently published study on the outcome of brotic changes due to self-injection therapy in 44 patients, 52% (n = 23) of the patients showed spontaneous improvement despite most of