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Serotonin receptor agonists
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Placebo 5mg PT-141 10mg PT-141 15mg PT-141 20mg PT-141
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Fig 91 At home ef cacy of PT-141, an intranasal MCR-
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agonist, in 271 sildena l-responsive patients [5]
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min (6 mg dose) and 54 min (20 mg dose), respectively, compared to 185 min in patients receiving placebo [3] Co-administration of low doses of intranasal PT-141 (75 mg) and sildena l (25 mg) in men suffering from ED resulted in an enhanced erectile response [6] A major problem with this new MCR agonist may be its side effect pro le, with nausea rates up to 36% after 6 mg sc and 17% after intranasal application [3,4] Further drug related side effects >5% were headache (up to 27%), ushing (up to 17%) vomiting (up to 9%), back-pain (up to 9%), muscle cramps (up tp 9%), and fatigue (up to 8%) There is no doubt that this completely new approach with MCR agonists seems to be promising in terms of ef cacy, but at present there are some uncertainties regarding their side effect pro le
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Generally speaking, serotonin (5-hydroxytryptamine, 5-HT) receptors are attributed inhibitory effects in the erectile mechanism, but the serotonin receptor subtypes 5-HT1C/2A and C are suggested to facilitate both erection in male and female sexual proprioceptive behaviour [12 14] There were two 5-HT2C agonists in preclinical or clinical phase I/IIA investigations named RSD 992 and YM 348, with no results being reported so far The pro-erectile effects of RSD 992 were blocked by the 5-HT2A/C antagonist ritanserin but not by the 5-HT2A antagonist ketanserin, indicating that the 5-HT2C receptor is the more important one in facilitating an erectile response [14]
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Glutamate
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In the rat model it was shown that hippocampal glutamate receptors are involved in the erectile response [15] The injection of glutamate subtype receptor agonists such as NMDA, ACPD and AMPA, resulted in multiple episodes of erectile responses [15]
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Hexarelin analogues
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Hexarelin, a growth hormone (GH)-releasing hexapeptide, induced erections upon intraparaventricular injection [16] In the rat model several hexarelin analogues were able to induce erections after injection into the paraventricular nucleus, which resembled the erections caused by apomorphine [16,17]
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Centrally Acting Compounds with the Potential for Pharmacotherapy in ED
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Positive effects on the erectile mechanism were reported from the following centrally-acting compounds
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Oxytocin
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In the rat model oxytocin micro-injections into the nucleus paraventricularis and the medial septum of the hippocampus induced erections [7], which is not the case if these regions were injured through trauma [8] In small clinical trials, conducted about 30 years and 10 years ago, oxytocin was able to im-
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Peripherally-Acting Drugs Under Clinical Investigation
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New PDE-5 inhibitors
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DA 8159 is a new PDE-5 inhibitor from a South Korean pharmaceutical company with a selectivity that is similar to sildena l with a Tmax of 10 15 h and a T1/2 of 11 13 h This new PDE-5 inhibitor was recently investigated in a large multicenter, double-
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Future Aspects of Pharmacotherapy in Erectile Dysfunction blind placebo-controlled home trial for 12 weeks, in doses of 100 and 200 mg, in 319 men with ED [18] As shown in Fig 92, the SEP 3 rates reached nearly 70%, against only 17% at baseline Side effects >5% were ushing and headache TA-1790 (avana l) is also a new PDE-5 inhibitor developed for the treatment of ED Its pharmacokinetic pro le shows a Tmax < 1 h and a T1/2 of about 1 hour In a phase II A Rigiscan study, doses of 50/100/200 mg TA 1790 were compared to sildena l 50 mg and placebo Whereas the ef cacy (rigidity >60% at penile base) of TA 1790 was superior to sildena l in a time frame of 20 40 min after application, it was inferior to sildena l after a time frame of 100 120 min [19] The most commonly observed adverse event was ushing in between four and 11% of patients The future will show whether these two PDE-5 inhibitors will be developed up to market approval, and whether these two PDE-5 will have the potential to compete with the three marketed PDE-5 inhibitors
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adrenoceptor blocking properties but enhances their erectile-inducing ef cacy by the additional NOdonor activities Although this concept was introduced nearly 10 years ago, no results of clinical studies are reported to date
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