Double&amp;ndash;Blind, Crossover Comparison of 3 mg Apomorphine SL with Placebo and with 4 mg Apomorphine SL in Male Erectile Dysfunction

Dula, Eugene; Bukofzer, Stan; Perdok, Renee; George, Michael

doi:10.1159/000052503

Cited by 130 publications

(95 citation statements)

References 12 publications

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“…The number of attempts resulting in an erection firm enough for intercourse was 47% on 3 mg apomorphine and 32% on placebo. 6 In all cases, successful attempts were significantly greater upon apomorphine SL (Uprima 1 ) than placebo. It is noteworthy that these studies are consistent in their methodology and primary end points, and distinct from other series of studies on PDEV inhibitors.…”

Section: Central Target Of Apomorphine In Ratsmentioning

confidence: 86%

“…3,4 Recent double-blind placebo controlled studies demonstrated that higher doses of apomorphine (2 -4 mg) delivered sublingually could increase the likelihood of penile erections in men with erectile dysfunction, leading to registration of apomorphine SL 2 and 3 mg in Europe in May 2001. 5,6 A shift of predominantly antierectile sympathetic tone in favor of proerectile parasympathetic tone is likely at the origin of penile erection. 7 The sympathetic nuclei are located in the intermediolateral cell column and the dorsal grey commissure at the thoracolumbar level of the spinal cord, and the parasympathetic nuclei at the sacral level in the intermediolateral cell column.…”

Section: Introductionmentioning

confidence: 99%

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Apomorphine SL (Uprima®): preclinical and clinical experiences learned from the first central nervous system-acting ED drug

Giuliano

Allard²

2002

Int J Impot Res

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An exclusive central site of action for the proerectile effect of apomorphine, including not only the brain but also the spinal cord, is supported by extensive experimental data. Assuming that the mechanisms of action of apomorphine are similar in humans and animal models, its use for the treatment of erectile dysfunction (ED) validates the emerging idea that erectile response could be enhanced by acting directly within the central nervous system (CNS). It also emphasized the key role of the dopaminergic system in the control of erection. As exemplified with the clinical development of apomorphine, targeting the CNS does not rule out the occurrence of undesirable side effects. Because the rare event of syncope induced by apomorphine is not well understood, further research should be conducted to explore its possible mechanisms. In clinical practice, however, approved doses of apomorphine SL are well tolerated. It is noteworthy that no modification of sexual desire was observed with apomorphine. Indeed, drugs acting within the CNS may more likely interact with sexual desire than peripherally acting drugs, and care should be taken to assess this point in the future. Although our knowledge of the control of penile erection by the CNS is restricted, there are many potential sites for CNS-acting ED drugs. New centrally acting therapy for ED should concentrate on receptor targets more specific to erectile command. Clinical efficacy of new centrally-acting compounds will assess the well-founded purpose of this rationalization.

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Section: Central Target Of Apomorphine In Ratsmentioning

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Apomorphine SL (Uprima®): preclinical and clinical experiences learned from the first central nervous system-acting ED drug

Giuliano

Allard²

2002

Int J Impot Res

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“…[20][21][22][23] It is degraded by the first-pass metabolism, so must be taken via injection, sublingually, or via a nasal spray formulation. The drug is not approved in the United States for an ED indication, but is available in the European Union.…”

Section: Dopaminergic Agentsmentioning

confidence: 99%

“…24 One of the largest clinical trials of apomorphine was a double-blind, dose-escalation study. 23 A total of 569 patients were randomized to four groups: (1) a dose-optimization group in which patients began with 2 mg, increased or decreased the dosage as needed for 4 weeks, and thereafter maintained an optimal dose for 4 weeks; (2) a fixed-dose group of 5 mg; (3) a fixed-dose group of 6 mg; and (4) a placebo group. A statistically significantly higher percentage of patients receiving apomorphine reported achieving and maintaining erections firm enough for intercourse versus the placebo group (48-53% vs 35% for placebo, Pp0.001).…”

Section: Dopaminergic Agentsmentioning

confidence: 99%

Clinical applications of centrally acting agents in male sexual dysfunction

Hellstrom

2008

Int J Impot Res

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Currently available agents for erectile dysfunction (ED) share the same mechanism of action and pharmacologic properties. Therefore, they share the same limitations, including a principal focus on erection as an end-organ process. One of the relatively unexplored areas of research has been the potential for centrally acting agents to improve male sexual response. A variety of neurohormones and neurotransmitter systems are involved in the male sexual response, including testosterone, dopamine, serotonin and the melanocortin systems. Investigations to determine the utility of centrally acting agents as monotherapy or adjunctive therapy in men with ED or other forms of sexual dysfunction are underway. Bremelanotide, a melanocortin agonist, has been tested in men with ED and may prove to be one of the first centrally acting agents to have clinical utility in male sexual dysfunction.

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“…One study analyzed the results for a subset of patients with other concomitant diseases and found that 50% of patients with ED and BPH who took 3 mg of apomorphine achieved an erection with sufficient firmness to engage in sexual intercourse vs 33% of those who took placebo. 34 Vacuum devices and constriction rings. The application of a vacuum to the penis causes venous blood to be aspirated into and fill the corpora cavernosa.…”

Section: S22mentioning

confidence: 99%

Specific aspects of erectile function in urology/andrology

et al. 2004

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The urologist/andrologist is the specialist responsible for diagnosis and treatment of health problems related to the genitourinary tract, and his or her participation in comprehensive care for a patient with erectile dysfunction (ED) is fundamental and often indispensable. The urologists/ andrologists should characterize the origin of ED because of their knowledge and familiarity of all diagnostic tests and second-and third-line therapy. The origin of ED is important to determine for various reasons, such as young people suitable for etiologic treatment, medicolegal reasons, or patients' wishes for a better understanding of their condition. A review of the diagnostic tests available as well as indications for second-and third-line therapy is presented. The close relationship between ED and urological disorders, such as benign prostatic hyperplasia, prostate cancer and their treatments, and renal failure, in association with penile conditions like Peyronie's disease, priapism, and possible androgen deficiency in men older than 50 years, places the urologist at the center of integrated treatment of male ED.

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Double–Blind, Crossover Comparison of 3 mg Apomorphine SL with Placebo and with 4 mg Apomorphine SL in Male Erectile Dysfunction

Cited by 130 publications

References 12 publications

Apomorphine SL (Uprima®): preclinical and clinical experiences learned from the first central nervous system-acting ED drug

Apomorphine SL (Uprima®): preclinical and clinical experiences learned from the first central nervous system-acting ED drug

Clinical applications of centrally acting agents in male sexual dysfunction

Specific aspects of erectile function in urology/andrology

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