Drug combinations for self-injection therapy General considerations in .NET framework

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Drug combinations for self-injection therapy General considerations
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PGE1 is still the rst line option for patients who either do not respond or show contraindications for oral phosphodiesterase-5 inhibitors Besides PGE1 mono therapy, several potentially useful combinations have been used for self-injection therapy as second line options The vasoactive agents most commonly used in combination therapy, were phentolamine, papaverine, PGE1, and VIP Potential advantages of the use of combination therapies over mono therapy may depend on the number of drugs/strength of the mixtures used, an increase of ef cacy by targeting different sites of action in the erection process, reduction of side effects such as priapism or brosis, and reduction of costs per application For instance, in vitro studies on human and rabbit cavernosal strips demonstrated that phentolamine signi cantly potentiated relaxation induced by sildena l, VIP and PGE1 These vasodilators also signi cantly enhanced relaxation induced by phentolamine in the cavernosal tissue strips The enhancement of VIP and PGE1-induced relaxation (cAMP-mediated) by phentolamine suggests a synergistic interaction, while the interaction between phentolamine and sildena l (cGMP-mediated) appears to be additive [47] The same investigators were also able to show that sildena l and PGE1 has additive and synergistic effects, respectively, with phentolamine-induced relaxation Therefore, in combination therapy using phentolamine as an adjunct, the ef cacy of vasodilators that initiate erection via independent relaxant pathways is increased due to a reduction in adrenergic tone, through the adrenoceptor blockade
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Combination of papaverine and phentolamine (Androskat )
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The combination of papaverine/phentolamine has become popular since the publication of Adrian
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Self-Injection, Trans-Urethral and Topical Therapy in Erectile Dysfunction Zorgniotti 1985, and has competed with alprostadil mono therapy for a long time [34] The mixture of papaverine/phentolamine is commercially available and approved as Androskat in several countries worldwide, especially in Europe Androskat is marketed in 2 ml ampoules containing 15 mg papaverine and 05 mg phentolamine per 1 ml, ie a total content of 30 mg papaverine +1 mg phentolamine per ampoule As a rule of thumb, the ef cacy of one ampoule Androskat is comparable to 10 g alprostadil, and two ampoules Androskat to 20 g alprostadil [15] (Table 81) The major disadvantages of papaverine/phentolamine is its relatively high risk of priapism >6 hours ranging between 2 and >10% (mean 78%) depending on the concentration of the rst dose used [15], (Table 82) The main indication for using the mixture of papaverine/phentolamine are patients with ED in whom PGE1-induced erections were felt intolerably painful, which is relatively often the case
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after major pelvic surgery (RRP, cystectomy, rectum amputation), or this minority of patients in whom PGE1 mono therapy turned out to be inferior to papaverine/phentolamine Long-term use of the mixture of papaverine/phentolamine was marked with a considerably higher risk of cavernous brosis compared to alprostadil monotherapy [15]
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Combination of papaverine/phentolamine/PGE1 (Triple drug, syn Trimix)
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The use of the triple drug combination of papaverine/phentolamine/PGE1 was reported for the rst time in 1990 by Goldstein [48] Since this publication a variety of reports on the usefulness of this drug combination was published in the literature, with wide range of dose recommendations (see Table 83) A direct comparative study investigated the equivalent doses of alprostadil monotherapy to the tripledrug combination in terms of ef cacy [56] (Tables 84 and 85)
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Table 83 Triple drug compositions: intracavernous injection of Trimix, a mixture of papaverine, phentolamine and PGE1,
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is indicated for patients unsuitable for PGE1 injection due to poor response, pain or cost Various dose combinations have been reported with the range of ratio (based on mass) for papaverine [12 30]: PGE1 (0006 002): phentolamine (taken as 1)
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Injection volume (ml)
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Reference Papaverine Bennett et al [49] Govier et al [50] Israilov et al [51] Marshall et al [52] Shen eld et al [53] Mulhall et al [54] 176 mg/ml 225 mg/ml 194 mg 12 mg
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Trimix Stock Solution PGE1 59 g/ml 83 g/ml 164 9 g 5 g/05 ml 10 g 25 g 30 g 100 g 200 g Phentolamine 059 mg/ml 083 mg/ml 16 1 mg 025 mg/05 ml 1 mg 2 mg 5 mg 10 mg 20 mg Papaverine 30 27 121 12 18 30 15 30 30 15
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Ratio (equimass basis) PGE1 001 001 001 0009 002 001 00125 0006 001 001 Phentolamine 1 1 1 1 1 1 1 1 1 1
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