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A summary of the side effects of the 3 mg apomorphine SL dose, as reported in several phase three trials shows the following outcome [33]: nausea 47%, headache 29%, dizziness 26%, yawning 19%, somnolence 15%, sweating 12%, vasodilation 09%, vomiting 02%, hypotension 02%, syncope 02% In apomorphine SL/alcohol interaction studies,
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7 of receptors processing the stimulatory signals, which in turn are running via oxytocinergic/ dopaminergic neurons to the spinal parasympathetic re exogenic erection center, located at the level S2 S4 Parasympathetic nerve bers, the socalled nervi erigentes, leave the re exogenic erection center and build along with the sympathetic nerve bers originating from the superior hypogastric plexus the inferior hypogastric plexus which continues in the cavernous nerves These cavernous nerves contain both sympathetic and parasympathetic bers and perforate the pelvic oor (urogenital diaphragma) to enter the cavernous bodies at the level where the cavernous crura are diverging Erection-initiating neurotransmitters are dopamine (via D2-receptors) and melanocortins, for which ve melanocortin receptors (MCR) have been identi ed, of which the MC-4-R seems of special importance for erection After entering the cavernous bodies the parasympathetic nerve bers principally divide into two different nerve terminals: cholinergic (acetylcholine, ACH) nerve terminals ending at the endothelial cells and stimulating nitric oxide (NO)-synthase, which catalyzes the production of NO from L-arginine and O2, and non-adrenergic,
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ingestion of 06 g/kg ethanol before administration of 6 mg apomorphine SL resulted in signi cant drop of blood pressure in some patients [26] Therefore patients should be counselled to reduce alcohol intake together when prescribed apomorphine SL
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As previously mentioned, due to its inferior ef cacy apomorphine SL is withdrawn from most of the markets for which it was approved in 2001/2002 In those countries where it is still available it should only, if ever, be used in those patients with proven non-organic ED
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Phosphodiesterase-5 Inhibitors: Sildena l (Viagra ), Tadala l (Cialis ) and Vardena l (Levitra )
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The physiological basis of erection (Fig 71)
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Pro-erectile impulses are generated in the parasympathetic erection centers of the limbic system and the hypothalamus, in particular in the paraventricular nucleus and the medial preoptic area, which are the key regions for the central regulation of erection [25] Perception of sexual (erotic) stimuli, such as visual, imaginary or tactile stimuli, activate a variety
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Cerebral sex centers Stimulatory neurotransmitters Dopamine, NO, Oxytocin NE (partly), Serotonin (partly) -MSH, Vasopresssin, ACTH + + ACH O2+L-Arginine eNOS G-Protein Guanylate cyclase GTP 5-GMP , 3'5 -cGMP NO+Citrulline + Parasympathetic nerves + NANC Nerve NO VIP + Adenylate cyclase ATP
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Erotic stimuli (visual, tactile, imaginary) +
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, 3'5 -cAMP
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Fig 71 Physiology of erection and the
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Phosphodiesterase V-Inhibitors; Sildenafil, Tadalafil, Vardenafil, others
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impact of PDE-5 inhibitors on erection Please see text above for an explanation of this gure
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Oral Pharmacotherapy of Erectile Dysfunction non-cholinergic (NANC-peptidergic) nerve terminals at the cavernous smooth muscle cells, from which NO and VIP (vasoactive intestinal polypeptide) are released into the smooth muscle cell There, NO activates guanylate cyclase, which catalyses the breakdown of guanosine triphosphate into 3 5 cyclic guanosine monophosphate (cGMP),the key second messenger for erection
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and therefore more effective a compound is for this enzyme
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Clinical ef cacy
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Regarding the clinical ef cacy of a PDE-5 inhibitor several tools are used in clinical trials Regarding the general assessment question (GAQ): Has the treatment you have been taking improved your erections This ef cacy tool does not really tell whether the patient is able to attain an erection suf cient for sexual intercourse or not This relatively weak ef cacy measure is widely used, especially by pharmaceutical companies, because usually it yields the highest success rates
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The Phosphodiesterase (PDE) System
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Currently the PDE system includes 11 families, with a total of more than 50 splice variants (isoforms) [34 40] The distribution and density of PDEs varies among the different tissues The PDEs catalyze the breakdown of either cGMP or cyclic adenosine monophosphate (cAMP), which are both second messengers with speci c physiologic functions By hydrolyzing the phosphodiesterase bond of cAMP or cGMP, these second messengers are converted to the biologically-inactive monophosphates, resulting in termination of their physiologic functions In addition to PDE-5, which is the most abundant one in the corpus cavernosum, to date at least 13 other PDEs have been identi ed in the cavernous bodies: PDE-1A, PDE-1B, PDE-1C, PDE-2A, PDE3A, PDE-4A, PDE-4B, PDE-4C, PDE-4D, PDE-7A, PDE-8A, PDE-9A, PDE-10A [39,40] Apart from their direct impact on cavernous function, PDE-4 and -5 inhibitors also inhibit proliferation and migration of smooth muscle cells [37] PDE-3 and PDE-4 inhibition can reduce restenosis after angioplasty procedures, individually, or by acting synergistically, and are therefore under investigation for their potential on angiogenesis [37]
International index of erectile function (IIEF) [48]
The IIEF was originally developed to evaluate the clinical ef cacy of sildena l (Viagra ) and became the most accepted and used ef cacy tool for drugs assigned to treat ED world wide It comprises 15 questions in ve domains, addressing erectile and orgasmic function, sexual desire, sexual satisfaction and overall satisfaction Each question has six response options scoring between zero (worst) and ve (best result) For evaluation of the erectile ef cacy of a drug the IIEF erectile function (EF) domain, comprising questions 1 5 and 15, represents the strongest ef cacy tool, with a score >25 indicating a normal erectile function
Sexual encounter pro le (SEP)
The sexual encounter pro le relies on the recordings of the patients in the patient diaries distributed to the patients with the study medication and collected at each study visit The SEP comprises the following ve questions: 1 Were you able to achieve at least some erection (some enlargement of the penis ) 2 Were you able to insert your penis into your partner s vagina 3 Did your erection last long enough for you to have successful intercourse 4 Were you satis ed with the hardness of your erection 5 Were you satis ed overall with this sexual experience