Efficacy and safety of fixed-dose and dose-optimization regimens of sublingual apomorphine versus placebo in men with erectile dysfunction

Dula, Eugene; Keating, William; Siami, Paul; Edmonds, Anthony; OʼNeil, Janet; Buttler, Susan M.

doi:10.1016/s0090-4295(00)00575-6

Cited by 94 publications

(46 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Two double-blind, randomized trials have recently been reported on the safety and efficacy of apomorphine. 30,31 In the first study, patients with mixed etiologies were randomly assigned to a flexible dose of apomorphine (2 -6 mg), a fixed dose of 5 mg or 6 mg, or placebo for 8 weeks of treatment. A number of efficacy parameters were assessed including diary measures of erection and intercourse, as well as the IIEF.…”

Section: Sublingual Apomorphine (Uprima)mentioning

confidence: 99%

The International Index of Erectile Function (IIEF): a state-of-the-science review

Rosen¹,

Cappelleri

Gendrano³

2002

Int J Impot Res

896

668

View full text Add to dashboard Cite

The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity. The IIEF was developed in conjunction with the clinical trial program for sildenafil, and has since been adopted as the 'gold standard' measure for efficacy assessment in clinical trials of ED. It has been linguistically validated in 32 languages and used as a primary endpoint in more than 50 clinical trials. This review summarizes early stages in the psychometric validation of the instrument, its subsequent adoption in randomized clinical trials with sildenafil and other ED therapies, and its use in classifying ED severity and prevalence. The IIEF meets psychometric criteria for test reliability and validity, has a high degree of sensitivity and specificity, and correlates well with other measures of treatment outcome. It has demonstrated consistent and robust treatment responsiveness in studies in USA, Europe and Asia, as well as in a wide range of etiological subgroups. Although only one direct comparator trial has been performed to date, the IIEF is also sensitive to therapeutic effects with treatment agents other than sildenafil. A severity classification for ED has recently been developed, in addition to a brief screening version of the instrument. This review includes the strengths as well as limitations of the IIEF, along with some potential areas for future research.

show abstract

Section: Sublingual Apomorphine (Uprima)mentioning

confidence: 99%

The International Index of Erectile Function (IIEF): a state-of-the-science review

Rosen¹,

Cappelleri

Gendrano³

2002

Int J Impot Res

896

668

View full text Add to dashboard Cite

show abstract

“…In an 8-week, double-blind clinical trial of 569 patients in the US, apo SL 2-6 mg was investigated. 4 In this study, all the apo SL dosage groups showed a higher percentage of patients compared with patients in the placebo group achieving and maintaining an erection firm enough for intercourse (ranging from 48 to 53% in the apo SL groups versus 35% for placebo, Pr0.001) and a significantly higher percentage of attempts resulting in intercourse (45-51% in the apo SL groups versus 33% for placebo, Pr0.001). Nausea was the most common side effect, but it was dose related and decreased greatly after 4 weeks at all doses.…”

Section: Introductionmentioning

confidence: 51%

“…4 In this US study, the dose-optimisation regimen successfully decreased the occurrence of adverse events, with nausea being the most common. Among the 569 patients studied, the occurrence of nausea was reduced from 49% in the 6 mg group to 17% in the dose-optimisation group after a 2 or 4 mg dose.…”

Section: Discussionmentioning

confidence: 79%

See 1 more Smart Citation

Evaluating dose regimens of apomorphine, an open-label study

et al. 2003

View full text Add to dashboard Cite

The aim of the study was to investigate the safety and efficacy of apomorphine SL (apo SL) 2 and 3 mg, using a dose-optimisation regime in 110 Asian men with erectile dysfunction (ED) during a 10-week open-label study. Based on daily diaries kept by each patient, 63% showed an improvement in their sexual life. Patient responses to the International Index for Erection Function 15 questionnaires showed that there was an improvement in erectile function from baseline score after treatment with apo SL (from 15.9 to 20.4), and intercourse satisfaction (from 7.7 to 9.9), as well as slight improvements in orgasmic function (from 6.8 to 7.5) and total satisfaction (from 41.9 to 50.8). There was no marked improvement seen in sexual desire. In conclusion, apo SL is safe and efficacious in the treatment of ED in this patient population, irrespective of underlying diseases and concomitant medications.

show abstract

“…One of the significant adverse events occuring in the double-blind studies of sublingual apomorphine was syncope, but the patients recovered rapidly. 75 The authors found the syncopes were preceded by a prodrome including nausea, vomiting, dizziness, sweating, and pallor and suggested the mechanisms of action to be vasovagal. 75 In patients receiving nitrates the prodrome of symptoms was observed in 16% of the patients and Holter monitoring revealed sinus pauses concurrent with the prodrome of symptoms.…”

Section: Apomorphine and Drugs For Cardiovascular Diseasementioning

confidence: 99%

Interactions between drugs for erectile dysfunction and drugs for cardiovascular disease

Simonsen

2002

Int J Impot Res

View full text Add to dashboard Cite

The association of erectile dysfunction (ED) and cardiovascular disease is well-documented in the literature and both conditions share risk factors. Therefore, it is difficult to distinguish the effect of underlying disease and adverse effects of the drugs and=or interactions between ED drugs and drugs implemented for cardiovascular disease. The known interactions of systemic administered drugs for ED with drugs for cardiovascular disease are mainly pharmacodynamic. Thus, nitrates enhance the production of cyclic GMP and combined with phosphodiesterase type-5 inhibitors this can lead to severe hypotension. The same is the case for the treatment with phentolamine in patients treated with b-adrenoceptor antagonists. Due to increased partial thromboplastin time, the risk of bleeding is enhanced for intracavernous alprostadil injection in heparin-treated patients. Pharmacokinetic interactions of clinical importance have been described for ED drugs with other therapeutic groups such as sildenafil with the antifungal drug, ketoconazole, and apomorphine with the antiparkinson drug, entacapon. Although sildenafil and antihypertensive dihydropyridines like amlodipine are metabolized by the same cytochrome P450 enzyme, CYP3A4 in the liver, the combination of these drugs does not exhibit a synergistic blood pressure lowering action. Unfortunately documentation concerning drug interactions is often poor and occasional.

show abstract

Efficacy and safety of fixed-dose and dose-optimization regimens of sublingual apomorphine versus placebo in men with erectile dysfunction

Cited by 94 publications

References 17 publications

The International Index of Erectile Function (IIEF): a state-of-the-science review

The International Index of Erectile Function (IIEF): a state-of-the-science review

Evaluating dose regimens of apomorphine, an open-label study

Interactions between drugs for erectile dysfunction and drugs for cardiovascular disease

Contact Info

Product

Resources

About