Oral treatment of erectile dysfunction with apomorphine SL.

Apomorphine SL (Ixense, Uprima) is a new oral medication shown to be effective in the treatment of erectile dysfunction. This compound is a dopaminergic agonist with affinity for dopamine receptor sites - mostly D(2) - within the brain known to be involved in sexual function. Apomorphine induces selective activation in the nucleus paraventricularis leading to erectogenic signals. More than 5,000 men with erectile dysfunction participated in phase II/III clinical trials assessing the safety and efficacy of doses ranging from 2 to 6 mg. The most favorable risk/benefit ratio is seen with a dose-optimization regimen of 2-3 mg: the 3-mg dose provides efficacy comparable to that of 4 mg but with fewer side effects. Consequently, review of clinical studies focuses on data with the 2- to 3-mg dose, the registered dose for use in clinical practice. The primary efficacy endpoint in most clinical trials with apomorphine SL was the percentage of attempts resulting in erections firm enough for intercourse - one of the most rigorous endpoints used in ED trials to date. These data were collected from both patients and their partners by reviewing entries in patient diaries and partner BSFI questionnaires. Secondary endpoints included percentage of attempts resulting in intercourse and improvement in ED severity based on the International Index of Erectile Function (IIEF). The proportion of attempts resulting in erections firm enough for intercourse was 49.4% with 3 mg compared with the baseline value of 24.3%. Partner evaluations corresponded with those of the patients. Erections occurred between 18 and 19 min after taking apomorphine SL 2 or 3 mg. The most common side effect was nausea which declined with continued use. Vasovagal syncope was reported in <0.2% of men, and was preceded by clear prodromal symptoms. Thus, apomorphine SL is an effective, well-tolerated drug for erectile dysfunction.     

Adverse Events and Patient Tolerability of Apomorphine SL 2 and 3 mg: A Cross-Study Analysis of Phase II and III Studies

Background: In 1999, the World Health Organization (WHO) Consensus Panel recommended orally administered drugs as first-line treatment of erectile dysfunction. Apomorphine SL, a sublingually administered erectogenic agent with a favorable therapeutic index, has been studied extensively in clinical trials.Methods: The safety and tolerability of apomorphine SL 2 and 3 mg was assessed in 14 phase II and III clinical studies, in which 2908 patients received the 2 mg dose and 1331 patients received the 3 mg dose of apomorphine SL. Of the 3183 patients who received at least one dose of the 2 or 3 mg dose of apomorphine SL, 1040 received the 3 mg dose after first having been exposed to the 2 mg dose in a dose-optimizing treatment regimen. Adverse event outcomes from fixed-dose and dose-optimization studies were analyzed.Results: Across all apomorphine SL studies, the adverse events most commonly seen were nausea, headache and dizziness. The incidence of adverse events was lower with the 3 mg dose in those patients who received an initial 2 mg dose in a dose-optimizing regimen, and no individual adverse event was reported by >5% of patients in the dose-optimization cohort. Nausea, headache and dizziness occurred in 4.2%, 3.0% and 1.8% of patients, respectively, in the 3 mg dose-optimization group, and the overall incidence of any adverse event was 12.5% in these patients. Hypotension and vasovagal syncope occurred rarely at the 2 and 3 mg doses, particularly when a dose-optimization regimen was used, where 0.1% of patients reported syncope. No death, stroke, myocardial infarction, priapism, or inappropriate erection has been associated with apomorphine SL at any dose level.Conclusion: The favorable tolerability and safety profile of apomorphine SL 2 and 3 mg suggests that this drug be considered a first choice treatment for the majority of patients with erectile dysfunction.     

Clinical efficacy of Apomorphine SL in erectile dysfunction of diabetic men

Although subgroup analyses from large randomised premarketing studies have shown that Apomorphine SL enhances the percentage of erections firm enough for sexual intercourse in diabetic men, the clinical role of the drug in this patient population remains to be elucidated. The aim of the present study was to assess the efficacy of Apomorphine SL in diabetic males with erectile dysfunction (ED) and to identify factors predicting those who may benefit from the treatment. A total of 130 diabetic patients were randomised to receive either four tablets of 3 mg Apomorphine or a matching placebo. Assessments of efficacy comprised the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and the one-item global efficacy question (GEQ). Patients with both a positive response to the GEQ and an improvement of at least 5 points in the EF domain of the IIEF were considered responders and subanalysed by several parameters indicative of the severity of both ED and diabetes. Response rate was 17% after placebo and 22% after Apomorphine SL. The EF domain of the IIEF and both questions 3 and 4 scores did not significantly improve in either of the two arms over the baseline. A younger age and a lower Hb1Ac were significantly linked to the status of responder in the Apomorphine arm. Apomorphine SL failed to show a statistically significant benefit over a placebo, but 22% of patients had a clinically significant erectile response. These figures seem to suggest that the drug has a limited use for ED diabetic patients.     

Apomorphine: an update of clinical trial results

Apomorphine SL (TAP Holdings, Deerfield, IL) is a centrally acting treatment for erectile dysfunction (ED) that has been undergoing phase III trials. Over 3000 men have received apomorphine SL and over 75,000 doses have been taken. In the first three phase III parallel arm cross-over double-blind studies 854 patients were given a total of 8263 tablets of apomorphine SL in 2 and 4 mg doses. The patients were between 18 and 70 y old and outcome measures included per attempt rates of intercourse and erections firm enough for intercourse as well as psychometric instruments and partner responses. The majority (74.1%) had moderate and severe grades of ED on admission to the studies, 31% had hypertension, 16% had documented coronary artery disease, 16% had dyslipidemia and 16% had diabetes. Erections occurred rapidly (10-25 min) and in 54.4% of attempts at 4 mg (vs 33.8% placebo). A majority of the attempts at intercourse (50.6%) were successful at 4 mg in patients when recorded on a per-attempt basis. The most common but infrequent and mild side effect of nausea decreases with use. The phase III trials of apomorphine SL show that there is a clinically important restoration of erectile function from this new formulation of apomorphine. It has a rapid and safe effect through action in the central nervous system. Apomorphine SL brings a new choice to the management of ED that will further benefit the millions of couples affected. International Journal of Impotence Research (2000) 12, Suppl 4, S67-S73.     

The Role of Apomorphine SL in the Treatment of Erectile Dysfunction

Epidemiological data indicate that erectile dysfunction (ED) affects over 140 million men worldwide, with the highest prevalence in men over 60 years. While the condition is often associated with coronary artery disease, hyperlipidemia, hypertension and diabetes, and may be a marker for these conditions, most men who present with ED for treatment have mild to moderate dysfunction. Treatment guidelines developed by an international, multidisciplinary panel of experts as a “process of care model for erectile dysfunction” recommend the implementation of oral agents as first-line therapy. Sublingual apomorphine SL is the first medication for the treatment of erectile dysfunction with a central mechanism of action. In clinical studies, apomorphine SL provides clinical erectogenic benefits at 2 and 3 mg doses particularly in those patients with mild to moderate ED. Apomorphine SL has the added advantages of a rapid onset of action, resulting in erection in less than half the time required by sildenafil, and a highly favorable tolerability and safety profile, especially in patients with coronary artery disease receiving nitrates. Apomorphine SL is an important addition to the armamentarium of primary care clinicians and urologists treating male erectile dysfunction, due to enhanced erectile function, speed of onset, convenience of dosing, and favorable side effect profile. Apomorphine SL 2 and 3 mg is an effective first-line treatment option for men presenting with mild to moderate ED, who have a degree of residual erectile function that is inadequate for satisfactory sexual performance.     

Double-blind, crossover comparison of 3 mg apomorphine SL with placebo and with 4 mg apomorphine SL in male erectile dysfunction.

OBJECTIVE: To establish the efficacy and safety of a fixed, 3-mg dose of apomorphine SL compared with placebo, and to compare 3 mg with 4 mg apomorphine SL in patients with erectile dysfunction. METHODS: This randomized, double-blind, crossover study included 296 heterosexual men with ED of various etiologies and severities. Two crossover groups were evaluated separately: 3 mg apomorphine SL vs. placebo (n = 194), and 3 vs. 4 mg apomorphine SL (n = 102). The primary efficacy variable was the percentage of attempts resulting in erections firm enough for intercourse; additional variables included the percentage of attempts resulting in intercourse and time to erection. Partner assessments were also analyzed. RESULTS: 3 mg apomorphine SL was significantly more effective than placebo (p<0.001) for the percentage of attempts resulting in erections firm enough for intercourse and resulting in intercourse, as assessed by both patients and partners. Median time to erection was 18.8 min. The 3-mg dose was not significantly different from 4 mg in the evaluation of efficacy variables, but the incidence of adverse events was higher with 4 mg. Nausea was the most common event, reported by 3.3% of patients on 3 mg vs. 14.1% on 4 mg; in the placebo comparison, nausea was reported by 7.0% of patients taking 3 mg apomorphine SL vs. 1.1% of those taking placebo. CONCLUSIONS: 3 mg apomorphine SL was significantly more effective than placebo and comparable to 4 mg, while offering an improved risk-benefit ratio.     

Key issues from the clinical trials of apomorphine SL

The central nervous system has the capacity to enhance the activity of dysfunctional penile tissue in men with erectile dysfunction (ED). Phase III clinical trials have been conducted using Apomorphine SL (TAP Pharmaceuticals, Deerfield, IL) as a centrally acting treatment for ED. Apomorphine SL has been administered to over 3000 men in over 75,000 doses. In three phase III crossover double blind studies 854 patients were given a total of 8263 tablets of apomorphine SL in 2 and 4 mg doses. The patients were between 18 and 70 years old and had multiple co-morbid conditions. Outcome measures included intercourse rates and erection rates on a per attempt basis as well as psychometric instruments and partner response evaluations. The results show that 74.1% of patients had moderate or severe grades of ED on inclusion into the studies, 31% had hypertension, 16% had documented coronary artery disease, 16% had dyslipidemia, and 16% had diabetes. Erections occurred rapidly (10–25 min). In 54.4% of attempts at 4 mg (vs 33.8% placebo, P < 0.001) erections suitable for intercourse were documented. A majority of the attempts at intercourse (50.6%, P < 0.001) were successful at 4 mg – a doubling of baseline rates. Mild nausea was the most common but infrequent side effect and the rare occurrence of syncope was the most significant. No cardiac deaths were attributed. It is concluded that the clinical trials of apomorphine SL demonstrate a safe and significant rate of restoration of erectile function by means of a central mode of action. Efficacy has been shown in men with cardiovascular disease and severe grades of ED.     

Tadalafil Phase 3 Experience

Objectives: To evaluate the efficacy and safety of tadalafil, a potent, oral phosphodiesterase type 5 inhibitor for erectile dysfunction.Methods: Integrated analyses of five 12-week, randomized, double-blind, placebo-controlled phase 3 clinical trials involving 1112 men with mild-to-severe erectile dysfunction of various etiologies taking as-needed tadalafil 2.5, 5, 10 or 20 mg (n=804) or placebo (n=308) were conducted.Results: Tadalafil therapy significantly enhanced erectile function (versus placebo), eliciting robust changes that were consistent across a number of efficacy outcome measures. Ratings of erectile function, the likelihood of successfully completing intercourse, and proportions of men reporting enhanced erectile function were significantly higher in tadalafil patients compared with placebo controls. Eighty-one percent of all men who were treated with tadalafil 20 mg reported improved erections at study endpoint compared with 35% of placebo controls. Tadalafil was well tolerated, with headache and dyspepsia being the most frequent treatment-emergent adverse events. These events tended to be mild or moderate and to abate with continued dosing.Conclusions: Tadalafil therapy significantly ameliorated erectile function and was well tolerated by a broad spectrum of men with erectile insufficiency.     

Analyzing the efficacy of a new natural compound made of the alga Ecklonia bicyclis,Tribulus terrestris and BIOVIS® in order to improve male sexual function

BackgroundWe investigated the therapeutic efficacy of a new composite natural drug based on Tribulus terrestris, BIOVIS^® and the alga Ecklonia bicyclis in order to improve male sexual function, selecting patients using the International Index of Erectile Function (IIEF), Nocturnal Penile Tumescence and Rigidity Testing (NPTR) using the RigiScan^® device and hormonal levels.Materials and methodsA total of 164 patients with erectile dysfunction (ED) were enrolled between September 2009 and January 2010. Patients were classified as having mild (n = 64), moderate (n = 62) or severe (I = 38) ED. Mean age was 53.1 years. A new compound (150 mg of the alga Ecklonia bicyclis, 396 mg of Tribulus terrestris and 144 mg of BIOVIS^®) was administered to all patients twice a day for 60 days. The IIEF questionnaire was administered and NPTR testing was carried out using the Rigiscan^® device both pre and post-treatment with all patients.Results150 patients were evaluable, and their IIEF scores were all significantly improved, with an increase of 78% in the mild ED group, an 80% improvement in the moderate ED group, and an improvement of 108% in the severe ED group compared with the baseline. The mean IIEF scores for all the patients showed significant improvement after 8 weeks of treatment with this new composite drug (baseline 14.3 ± 1.5 to 26.2 ± 3.2; P = 0.01). Among other parameters penile rigidity and tumescence, as tested using the RigiScan^® showed significant improvement for treated patients. Furthermore, no significant side effects were claimed.ConclusionThe active components of these three natural compounds (namely protodioscin, a steroidal saponin, contained in Tribulus terrestris; the polyphenols, dieckol, florofucofuroeckol and bieckol, contained in the alga Ecklonia bicyclis; and the polymers of d-glucosamine and n-acetyl-d-glucosamine contained in BIOVIS^®) when combined, seem to work in synergy not only improving erectile function but also stimulating testosterone-dependent sexual desire. Protodioscin is able to stimulate testosterone production and it also has an androgen-mimetic action, binding and activating the testosterone receptors. Polyphenols play an anti-nflammatory role, modulating the cytokines (lipopolisaccarids, TNF-alpha, IFN-gamma) with a potent antioxidant and antifibrotic effect. BIOVIS^® acts on both the non-adrenergic and non-cholinergic system (NANC) and on the endothelial cell system as a strong nitric oxide synthetase (NOS) stimulator. Our study demonstrated that this new composite drug was effective in the oral treatment of ED.     

A European multicentre study to evaluate the tolerability of apomorphine sublingual administered in a forced dose-escalation regimen in patients with erectile dysfunction

OBJECTIVE: To determine the risk-benefit ratio of a forced dose-escalation regimen (2 to 3 to 4 mg) in a European clinical study evaluating apomorphine sublingual (SL) in treating erectile dysfunction (ED), by evaluating the overall tolerability and efficacy of the regimen compared with placebo in patients with ED, and evaluating efficacy by assessing the proportion of successful attempts resulting in sexual intercourse. PATIENTS AND METHODS: This randomized, double-blind, two-arm, parallel-group study was conducted in 507 patients enrolled at 34 European sites. After a 1-2 week screening period, patients were treated for 8 weeks with either placebo or apomorphine SL administered as a forced dose-escalation regimen. Heterosexual men (aged 18-70 years) were eligible for participation in the study if they were in stable health, a stable relationship of > or = 6 months duration, had a history of erectile inability, and were diagnosed with ED (successful in fewer than half of attempts to attain and maintain an erection firm enough for intercourse during the 30 days before screening). Patients provided information (recorded on diary cards and reviewed at each study visit) about the frequency and success in achieving erections and of sexual intercourse attempts during both the screening and treatment periods. The dosing regimen required patients to take one tablet of apomorphine SL (2 mg for 2 weeks, then 3 mg for 2 weeks and finally 4 mg for the remaining 4 weeks) or placebo 15-25 min before intercourse, and intercourse was to be attempted at least twice a week. Safety data were collected throughout the 8-week study period, and included recording adverse events, vital signs and changes in laboratory test values for standard haematology and biochemistry variables. The primary efficacy variable was the proportion of successful attempts, defined as an erection rigid enough for sexual intercourse, occurring after dosing (successful intercourse rate). The proportion of erections achieved was a secondary efficacy variable. RESULTS: Of the 507 patients, 254 received apomorphine SL and 253 received placebo; 87% of patients in both groups completed the 8-week treatment period. Of the patients receiving apomorphine SL, 24% had hypertension, 11% had coronary artery disease, 10% had diabetes, and 5.5% had benign prostatic hypertrophy; 62.6% of treated patients received concomitant medications for these maladies. The treatment groups were balanced for demographic and baseline variables, including comorbidity factors. Treatment-emergent adverse events, reported by > 5% of patients in the treated group, were nausea (9.8%), dizziness (7.1%) and headache (6.7%), compared with 0.4%, 2.4% and 4.0%, respectively, in the placebo group. Sixty-six patients withdrew from the study, 16 because of study drug-related adverse events (12 from the apomorphine and four from the placebo group). Six patients (three in each group) reported a total of nine serious treatment-emergent adverse events, all of which resolved by the end of the study. In the intention-to-treat population, the proportion of successful attempts at sexual intercourse and of erections were statistically greater in the apomorphine than in the placebo group (P = 0.001 and 0.021, respectively); analysis of the per-protocol population results confirmed this significant difference. CONCLUSION: This European study supports the safety and tolerability of apomorphine SL despite the forced escalation to a 4-mg dose (exceeding the approved 2-3 mg dose). Adverse effects were not treatment-limiting. These results further support the clinically significant efficacy of apomorphine SL for treating ED at all doses used. The risk/benefit ratio supports apomorphine SL as a safe and effective alternative in managing ED.     

Efficacy and safety of fixed-dose and dose-optimization regimens of sublingual apomorphine versus placebo in men with erectile dysfunction. The Apomorphine Study Group

OBJECTIVES: A sublingual (SL) formulation of apomorphine has been developed and found effective in penile erectile dysfunction (ED). This study assessed the efficacy and safety of several doses of apomorphine SL in a dose-optimization schedule compared with placebo. METHODS: In this 8-week, multicenter, double-blind clinical trial, 569 patients were randomized to four groups: 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; two fixed-dose groups of either 5 or 6 mg; and a placebo group. Efficacy was assessed by patient and partner responses to home-use questionnaires about sexual function and activity and by responses to the International Index of Erectile Function and the Brief Sexual Function Inventory. RESULTS: In all apomorphine SL groups, a significantly higher percentage of patients compared with the placebo group achieved and maintained an erection firm enough for intercourse (48% to 53% versus 35% for placebo, P < or =0.001) and a significantly higher percentage of attempts resulted in intercourse (45% to 51% versus 33%, P < or =0.001). The responses to the questionnaires completed by the patients and partners were similar. Apomorphine SL was well tolerated; nausea, the most common side effect, was dose related and diminished substantially during the second 4-week period at all doses. The dose-optimization schedule resulted in fewer adverse events without impacting efficacy. CONCLUSIONS: Apomorphine SL is an effective and safe treatment for ED, with 2 and 4 mg providing the most acceptable therapeutic index.     

Tribulus terrestris versus placebo en el tratamiento de la disfunción eréctil: un estudio aleatorizado,prospectivo y doble ciego

ObjectivesTo evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels.Design and methodsProspective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way.ResultsThe groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914).ConclusionsAt the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone.     

Safety and Tolerability of Apomorphine SL in Men with Cardiovascular Disorders

Objective: Since many men with erectile dysfunction (ED) also have cardiovascular (CV) disease and are likely to be taking antihypertensive medications, nitrates, or other medications, the risk of side effects of oral drug therapy for ED in the presence of these conditions was evaluated.Methods: Clinical trials involving apomorphine SL for ED were evaluated to determine the safety and tolerability profile in men with coronary artery disease, hypertension, hyperlipidemia, and diabetes mellitus in comparison to other oral agents.Results: None of the subpopulations of men, whether analyzed by specific CV disease, presence of diabetes, or any concomitant medication were at increased risk for side effects and adverse events associated with apomorphine SL treatment. In particular, there were no substantive changes in the adverse event rates in those patients concurrently receiving antihypertensive medications nor in those men treated with short- or long-acting nitrates.Conclusions: Apomorphine SL is well tolerated and safe in men with ED associated with concomitant CV disorders or risk factors. Furthermore, apomorphine SL is not contraindicated in men with stable coronary artery disease who take nitrate medication and is well tolerated and safe in men concurrently receiving CV medications including nitrates and various classes of antihypertensives.     

Psicoterapia: una pieza que falta en el puzle de la rehabilitación de la disfunción eréctil tras prostatectomía radical

ObjectivesTo measure the impact of psychotherapy associated to the use of Tadalafil in the improvement of erectile function after radical prostatectomy.MethodsFrom 132 patients surgically treated for prostate cancer, thirty sequential patients with bilateral nerve sparing, low risk controlled disease and post-surgery erectile dysfunction (ED) took Tadalafil 20 mg and underwent psychotherapy sessions, both weekly for three months. Patients were interviewed to establish the quality of erection using the instrument IIEF-5 and to measure psychological features impacting erectile function, aspects related to function, dysfunction, physical and emotional discomfort were evaluated with the help of an intensity scale.ResultsThe average age was 62.5 (46 to 77 years), 96.7% had a stable relationship, 56.6% of the patients accepted the diagnosis and 43.2% exhibited defense mechanisms (3.3% negation, 6.6% revulsion, 33.3% concern). A positive correlation was observed between erectile function and time exposed to treatment (IIEF-5 - 9.7 to 13.3, p = 0.0006), with increased satisfaction with life in general (2.1 to 2.7, P = .028) and sexual life (3.1 to 3.7, P = .028), added to facilitation of expressing feelings/emotions (1.8 to 3.0, P = .0008). Satisfaction with relationship and intimacy with partner did not present significant improve (P = .12 and P = .61, respectively).ConclusionsA holistic patient care with more complete ED rehabilitation includes psychotherapy with a positive correlation between erectile function and treatment exposition. Psychotherapy allowed the identification of important spouse related factors in this scenario.     

Clinical,cultural and psychosocial impediments to self reporting of erectile dysfunction by men in Edo state,Nigeria

IntroductionOrganic ED is presently considered as vasculogenic in the majority of affected middle age and elderly men and a sentinel event for cardiovascular disease. When men present with ED, it is advised that the opportunity should be used to assess their cardiovascular health.ObjectiveTo determine the impediments to self reporting of ED and to assess the help seeking habits of men in Edo state with regards to ED. The secondary objective is to evaluate how acceptable sexual assessment is to these men when they present.Subjects and methodsThis is a cross sectional study using a multi-facet, questionnaire with a section consisting of the international index of erectile function (IIEF). All men above 30 years who consented were included.ResultsThe response rate was 71.1%. The mean IIEF score was 20.33 with standard deviation of 4.656. The overall prevalence of ED was 51.2. Three hundred and eight of the respondents (33.3%) did not know where ED is treated, 273 (29.5%) thought that it is treated by complementary and alternative medicine practitioners while 237 (25.6) opted for the hospital as a point of care. This had a statistically significant correlation with location of the respondent (P = 0.000), level of education (P = 0.000) and senatorial zone (P = 0.000). Sexual evaluation was acceptable to 384 (41.5%) respondents when men present without ED and 757 (81.8%) when ED has occurred. This had a statistically significant correlation with level of education (P = 0.000), alcohol consumption (P = 0.000) and senatorial zone (P = 0.000).ConclusionsED is highly prevalent in this community. Alcohol consumption, low educational level, ignorance of who and where ED is treated, location of respondent (rural) indifference, presence of co-morbidities and tribal beliefs appear to be associated with low self reporting. Affected men are more likely to patronize complementary and alternative medicine (CAM) practitioners than medical practitioners or may be out rightly indifferent. Acceptability of sexual evaluation of men is low when ED is absent and high when it has occurred.     

Apomorphine sublingual as primary or secondary treatment for erectile dysfunction in patients with spinal cord injury

OBJECTIVES: To evaluate the effectiveness of apomorphine sublingual (SL) 3 mg, as a primary or secondary treatment for erectile dysfunction (ED) in patients with spinal cord injury (SCI), and to determine possible differences in efficacy considering clinical, urodynamic and neurophysiological findings. PATIENTS AND METHODS: The study included 22 patients with chronic SCI and neurogenic ED who were examined physically and by a video-urodynamic evaluation. A neurophysiological evaluation included somatosensory evoked potentials of the pudendal nerve, palmar and plantar sympathetic skin responses and bulbocavernous reflex recordings. Thereafter the patients received 8 tablets of apomorphine SL 3 mg and were asked to complete the International Index of Erectile Function questionnaire before and after treatment. Side-effects, subjective efficacy compared with other treatments and satisfaction with the SL administration were recorded. RESULTS: Of the 22 men, 11 had upper motor neurone lesions (six complete, five incomplete), eight lower motor neurone lesions (seven complete, one incomplete) and three had mixed lesions. In all, 12 patients took sildenafil citrate and five alprostadil intracavernosally beforehand, and five had used nothing to treat their ED. Seven patients had some response and reported that the drug helped them to obtain an erection, but only two reported erections sufficient for intercourse and would agree to continue apomorphine SL as their standard treatment; all the others reported being disappointed. Nine patients reported side-effects. There were no significant correlations for electrophysiological or urodynamic findings and treatment success. Of the 22 patients 20 preferred SL rather than the normal administration. CONCLUSIONS: Apomorphine SL, a D1/D2 dopamine agonist, facilitates erectile function in a heterogeneous group of patients with no significant relationship with any of the assessed urodynamic or electrophysiological variables. The overall low rates of response either for primary or secondary treatment suggests that apomorphine will have limited applicability in patients with SCI.     

Efficacy of apomorphine and sildenafil in men with nonarteriogenic erectile dysfunction. A comparative crossover study

To compare the efficacy of apomorphine and sildenafil in men with nonarteriogenic erectile dysfunction (ED), 40 men were studied. Post-injection penile peak systolic velocity was greater than 25 cm s(-1). Twenty men started on apomorphine 2 mg and 20 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg, respectively, if necessary. After a 1-week washout period each group switched to the other treatment mode. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on an event log data. The majority (85%) of the men had concomitant diseases, risk factors for ED and 95% were heavy smokers. The overall success rate of apomorphine was 62.7%, compared with 73.1% of sildenafil (Yates-corrected chi-square, P < 0.0004). The response to apomorphine 2 mg and sildenafil 50 mg was age related. Sildenafil was statistically more effective than apomorphine in impotent men with normal penile Doppler. Given the contraindication of sildenafil in men taking nitrates and the quick time of action of apomorphine, the two drugs are satisfactory first line therapeutic tools in such individuals and the choice should be based on patient's needs and preferences.     

Comparison of the effect of sildenafil and apomorphine SL on nocturnal erections in healthy volunteers: a placebo-controlled study

OBJECTIVE: To compare the effects of sildenafil and sublingual (sl) apomorphine on nocturnal erections. METHODS: In a prospective, single-blinded, placebo-controlled at-home study we compared the effect of apomorphine sl and sildenafil on sleep-related erectile activity in 30 healthy potent volunteers (mean age, 26.4 years; range, 23-35 years; Erectile Function domain of the International Index of Erectile Function > or =26), not reporting any subjective sleep abnormality during 4 consecutive nights with rigidity monitoring (NPTR) with the RigiScantrade mark device. After the first night of adaptation, they were randomized to receive placebo or apomorphine sl 2mg or sildenafil 50mg taken at bedtime during the following 3 consecutive nights. RESULTS: Sildenafil increased the mean+/-SE number of erections, overall length of erectile events, and the time of erections with rigidity >60% at both tip and base, as compared to placebo. The same parameters were reduced after administration of apomorphine sl. Similar findings were observed with regards to Rigidity Activity Units and Tumescence Activity Units. CONCLUSIONS: Our results confirm that sildenafil taken at bedtime might increase nocturnal erectile activity also in young potent men as compared to placebo. Apomorphine sl taken at bedtime seems to have the opposite effect.