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Vardenafil improved erectile function in a "real-life" broad population study of men with moderate to severe erectile dysfunction in Australia and New Zealand.

INTRODUCTION: Phosphodiesterase type 5 inhibitor drugs produce vasodilatation by inhibiting the breakdown of cyclic guanosine monophosphate and have proven efficacy in treating erectile dysfunction (ED). AIM: To evaluate the efficacy, safety, and tolerability of vardenafil in men with moderate to severe ED of broad etiology. MAIN OUTCOME MEASURES: The erectile function (EF) domain score, the response to Questions 13 and 14 of the International Index of Erectile Function (IIEF) questionnaire, and the proportion of "yes" responses to questions 2 and 3 of the Sexual Encounter Profile (SEP), a Global Assessment (GAQ), and Global Satisfaction Questions (GSQ) were compared at baseline and at 12 weeks of treatment with as-needed vardenafil. METHODS: A total of 326 subjects with a mean age of 57.6 years and moderate to severe erectile dysfunction of various etiologies received vardenafil (5-20 mg) for 12 weeks in a prospective multicenter, open-label flexible-dose study. RESULTS: Compared with baseline, vardenafil was superior in all efficacy outcomes. A significant mean improvement of 13.4 (P < 0.001) in the EF domain from baseline was obtained at week 12. Subjects who received 5, 10, and 20 mg vardenafil at week 12 experienced improvements of 11.9, 15.1, and 12.9 respectively in the EF domain score. Sexual intercourse was successfully completed (SEP3) in 76.3%, 80.1%, and 74.3% of subjects receiving 5, 10, and 20 mg vardenafil compared with 25.9%, 17.9%, and 19.2% at baseline, respectively. For all doses combined at week 12, the change in SEP3 from baseline was 56.7% (P < 0.001). Treatment with vardenafil was well tolerated, and headaches, flushing, nasal congestion, and dyspepsia were the most frequently observed adverse events. CONCLUSIONS: Vardenafil was effective and well tolerated in men with moderate to severe erectile dysfunction. Treatment with vardenafil was associated with a significantly higher IIEF erectile function domain score and completion of successful intercourse rate compared with baseline.

Adult↗

[Association between lower urinary tract symptoms and erectile dysfunction].

Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are highly prevalent in aging men and both of the conditions have a significant impact on the quality of life. In the past few years, various epidemiological trials were conducted to assess the association between LUTS and ED. These studies showed that LUTS, particularly the voiding symptoms, nocturia and the others caused by LUTS, independently increased the incidence of ED. There are some factors involved in the link between LUTS and ED: (1) rho-kinase expression/activity increased; (2) nitric oxide release decreased and corpus cavernosum smooth muscle contraction strengthened due to endothelin-1; (3) the composition of myosin isoform altered; (4) sympathetic hyperactivity and innervation of the corpus cavernosum smooth muscles decreased. These findings concerning the relationship between LUTS and ED have offered some new insights into the evaluation and treatment of patients with these conditions. The present paper briefly reviews the recent studies of the association between LUTS and ED.

Adult↗

Treatment of male erectile dysfunction using the active vacuum assist device.

Erectile dysfunction is a common feature in men with diabetes. The efficacy and acceptability of a new battery-powered vacuum assist device, the 'Active' was assessed over 6 months in 19 diabetic men, median age 59 (38-66) years, of whom 9 had ECG evidence of autonomic neuropathy. Their pre-treatment duration of impotence was 24 (12-168) months and their expectation of restored sexual activity was 8 (1-28) times per month. The effect of the device was assessed using visual analogue scales (range 1-10) at 3 and 6 months. Eleven patients continued to use their device over 6 months. Self-assessment values for sexual satisfaction, partners's sexual satisfaction, and self-esteem significantly increased over 6 months. In those continuing to use the device, it was considered highly effective, painless in use and not embarrassing. Despite wearing a constriction ring to maintain their erection, ejaculation was satisfactory. The device was used four times per month on average.

Adult↗

[Test with intracavernous injection of PGE1 in erectile dysfunction: our experience].

OBJECTIVES: To evaluate the answer and side-effects after the test of intracavernous injection of prostaglandin E1 in patients with erectile dysfunction. MATERIAL AND METHOD: In the last three years we have carried on 500 tests of intracavernous injection of prostaglandin E1 with the support of infirmary. The purpose was to train the patient and his partner on this technique. RESULTS: The more frequent cause of erectile dysfunction turned to have a vascular origin. In most of the cases, once that the technique has been learnt, the intracavernous injection has been carried on by the patient. The level of acceptance has reached a 85%, with a very low rate of complications. According with our protocol, the learning process has required of a media of 2 or 3 visits where the couple has been trained on this technique and the optim individual dose has been set. CONCLUSION: The intracavernous injection test carried on by an erectile dysfunction unit with the support of an infirmary team reach a high level of acceptance and efficiency. Although new medicine has appeared, we considered the objectification test of the erection with PGE1 very useful, easy-to-use and with low complication rate. It can also be used as a therapeutical option.

Alprostadil↗

Smoking and other lifestyle factors in relation to erectile dysfunction.

OBJECTIVE: To assess the association between erectile dysfunction (ED) and various lifestyle and medical factors, including smoking and cardiovascular disease (CVD) medications, among men attending urology clinics in Kingston, Canada. SUBJECTS AND METHODS: We conducted a case-control study of men aged 50-80 years in Kingston, Ontario who agreed to participate at visits to urology clinics during 1997-99. We compared 101 men with clinically diagnosed ED and 234 controls with various benign urological conditions. All men completed a questionnaire on lifestyle and medical factors. RESULTS: Men with ED were twice as likely to be former smokers (odds ratio 2.2, 95% confidence interval, 1.2-3.9), and cumulative smoking in pack-years suggests a dose-response pattern with the risk of ED. Having diabetes was associated with double the risk of ED, and increased alcohol intake appeared to increase the risk. CONCLUSION: There was a greater risk of ED among former smokers, and the suggestion of a dose-response relationship with cumulative smoking.

Age Distribution↗

New oral agents for erectile dysfunction: what is changing in our practice?

Erectile dysfunction (ED) is a highly prevalent disorder affecting an estimated 152 million men worldwide and is associated with a variety of behavioral risk factors, such as cigarette smoking and excessive alcohol consumption, as well as numerous age-related medical conditions, notably type-2 diabetes mellitus and cardiovascular disease. A rational step-wise approach which includes comprehensive medical and sexual history, a focused physical examination and essential laboratory tests such as fasting glucose, lipid profile and testosterone assay is to be preferred. Current diagnostic work-up does not recommend any of the specialized tests which were previously considered mandatory-i. e. penile pharmacotesting, Duplex ultrasound and nocturnal penile tumescence. Hormonal replacement therapy is appropriate only in the hypogonadal male with ED. Prior to direct intervention, the physician should consider altering modifiable risk factors or causes, although frequently insufficient to reverse ED completely. When indicated, oral therapy with new molecules (phosphodiesterase inhibitors or apomorphine) is the first-line treatment for the majority of patients because of potential benefits and lack of invasiveness.

Administration, Oral↗

[A new approach to raising the efficiency of drug therapy for erectile dysfunction].

AIM: To try combined treatment of erectile dysfunction with viagra and alprostadil in case of failure of their monotherapy; to compare effectiveness of viagra in dynamics of treatment, in various doses and dose adjustment. MATERIAL AND METHODS: 82 patients with ED of different genesis received a course of intracavernous injections of alprostadil followed by a course of viagra; 25 patients received combined treatment with alprostadil and viagra. Each course lasted for 3 months. Viagra efficiency was also assessed in long-term use (12 months) and different initial doses (50 or 100 mg). RESULTS: Monotherapy with alprostadil or viagra was effective in 73.2 and 75.6% patients, respectively. Their combination was more beneficial--88.0%. When used for a long time, viagra lost efficiency in psychogenic ED by 17.7%, in organic ED--by 16.9%. In an initial viagra dose 50 mg efficiency reached 70.3%, 100 mg--80.0%. CONCLUSION: Combined treatment of ED is a method of choice in monotherapy failure and in severe ED. Lowering of viagra efficiency in long-term administration may be explained by disappearance of placebo effect.

Adult↗

Dietary factors in erectile dysfunction.

The role of dietary factors in erectile dysfunction (ED) has never been addressed. In the present case-control study, we investigated the relation of the Mediterranean diet with ED. A total of 100 men with ED were compared with 100 age-matched men without ED. A scale indicating the degree of adherence to the Mediterranean diet was constructed: the total Mediterranean diet score ranged from 0 (minimal adherence to the Mediterranean diet) to 9 (maximal adherence). The percentage of physical inactivity was greater in the ED group (35 vs 19%, P=0.04), whereas the diet score was lower (4.7+/-0.5 vs 5.4+/-0.5, P<0.01), indicating a reduced adherence to the Mediterranean diet. In analyses adjusted for the prevalence of associated risk factors (hypertension, hypercholesterolemia), body mass index, waist, physical inactivity and total energy intake, the intake of fruits and nuts, and the ratio of monounsaturated lipids to saturated lipids remained the only individual measures associated with ED. In conclusion, the results of the present study show that dietary factors may be important in the development of ED: adoption of healthy diets would hopefully help preventing ED.

Body Weight↗

Intracavernous self-injection therapy for the treatment of erectile dysfunction.

Fifty-one patients with chronic erectile dysfunction were selected for this study involving intracavernous self-injection therapy with papaverine or prostaglandin E1 (PGE1). Patients were screened and grouped as follows: pronounced vasculogenic, mild vasculogenic, venous leakage, neurogenic and psychogenic impotence. The duration of follow-up in these 51 patients was from 1.5-30.5 months (average, 11.8 months). The average effective dosage of papaverine and PGE1 was variable among the different groups. This kind of therapy proved to be effective in our preliminary results, which showed that 35 patients (68.6%) were found to be good responders and eight patients (15.7%) were temporary responders. In our detailed questionnaire, answered by all 51 patients, we found 29 patients (56.9%) had increased their frequency of sexual activity, 38 patients (74.5%) had sustained their erection more than they ever had before, and 43 patients (84.3%) had enjoyed sexual orgasm following this pharmacologically assisted erection. Compared with papaverine, PGE1 was found to have fewer complications. None of the patients complained of any discomfort after long-term, self-injection with PGE1. However, two patients (3.9%) had sustained erections and two patients (3.9%) developed palpable fibrotic plaque after papaverine injection in our study.

Adult↗

[Pharmacocavernosometry and pharmacocavernosography in erectile dysfunction].

In about 30% of patients with erectile dysfunction (ED), insufficiency of the corpus cavernosum, or a so-called venous outflow disturbance, pharmacocavernosometry (PCM) and pharmacocavernosography (PCG) are at present the most physiological modes of investigation for the use of vasoactive substances. The investigation technique is described and the results of 364 studies are reported. Using PCM, it is possible to quantify venous outflow disturbances and PCG permits them to be localized. In 111 patients, both PCM and PCG were performed, using a new cavernosography pump (AP300, Fresenius). Much lower flow values were found for maintenance flow than had previously been assumed (normal value: less than 15 ml; suspect: 15-30 ml; pathological: greater than 30 ml/min). Pressure drop time was the new measurement used, i.e., the time required for an intracorporal pressure drop from 150 to 50 mmHg. A value of greater than 1 min was established to be the normal value. In cases of pronounced insufficiency of the corpus cavernosum, the pressure drop time amounts to only a few seconds. Evaluation of 200 PCGs showed that an isolated pathological outflow via the deep dorsal vein of the penis could be demonstrated in only 10%, whereas in 72% the deep veins of the penis were involved. These results show that the operative indications for so-called venous outflow disturbances are considerably restricted.

Alprostadil↗

Combining testosterone and PDE5 inhibitors in erectile dysfunction: basic rationale and clinical evidences.

INTRODUCTION: Erectile dysfunction (ED) and decline of testosterone levels are frequently observed with age and also in illnesses with a common basis of endothelial damage. OBJECTIVES: To review molecular mechanisms underlying androgen action upon its receptor and phosphodiesterase type 5 (PDE5) expression and regulation by testosterone in cavernous tissue and their clinical implication in the treatment of ED refractory to PDE5 inhibitors (PDE5-Is). METHODS: From January 2003 to May 2006 [corrected] we performed an extensive, unsystematic MEDLINE literature search reviewing relevant data on basic and clinical studies regarding the efficacy of combination therapies. RESULTS: Most trials using testosterone alone for treatment of ED in hypogonadal men suffer from methodologic problems and report inconsistent results, but overall the trials suggest that testosterone is superior to placebo. Orally effective PDE5-Is, such as sildenafil, tadalafil, or vardenafil, may be ineffective depending on the demonstration of testosterone regulation of PDE5 expression in human corpus cavernous, and their efficacy may be enhanced by testosterone adjunction whenever necessary. CONCLUSIONS: Screening for hypogonadism in all men with ED is necessary to identify men with severe hypogonadism and some cases of mild to moderate hypogonadism, who may benefit from testosterone treatment. Identification of threshold values for testosterone supplementation to appropriately benefit from PDE5-Is failure may improve clinical management of unresponsive patients with minimization of unwanted effects.

3',5'-Cyclic-GMP Phosphodiesterases↗

Aging and pathogenesis of erectile dysfunction.

The prevalence and the severity of erectile dysfunction (ED) increase with advancing age; different pathogenetic factors could contribute to age-related ED. We studied organic, relational and intrapsychic components of ED as a function of patients' age in a consecutive series of 977 patients with ED, using the specifically designed structured interview SIEDY. A complete physical examination and a series of biochemical, hormonal, psychometric and penile vascular tests were also performed. Relational factors seems to be more relevant in patients aged over 60 y, while intrapsychic disturbances play a major role in younger subjects. Organic factors are the most important determinant of ED in all age groups, but their contribution is more important in older patients. In fact, basal and dynamic peak cavernosal velocity at Doppler ultrasound penile examination was reduced in older patients. Among hormonal factors, the body mass index-dependent reduction of testosterone in older patients does not seem to play a crucial role in the pathogenesis of ED. No significant correlation was observed between testosterone level and the severity of ED, although patients reporting hypoactive sexual desire showed significantly lower testosterone levels when compared with the rest of the sample. A better understanding of the relative contribution of age-related pathogenetic factors of ED could be of help in the design of appropriate therapeutic approaches.

Adult↗

How much of a priority is treating erectile dysfunction? A study of patients' perceptions.

BACKGROUND: Erectile dysfunction (ED) is one complication of diabetes for which the treatment is rationed. Despite considerable public debate there has been no formal assessment of the views of patients and sufferers of the priority of treating ED. AIMS: To determine the perceptions of diabetic patients of the relative priority of treating ED in comparison with treatments for other diabetic complications and common medical conditions. METHODS: Psychological measures were used to assess subjects' perceptions of the relative importance of ED in comparison with eight other common problems (blindness, foot ulcers, high blood pressure, impotence, kidney disease, high cholesterol, migraine, mild indigestion and sleeping difficulties). The concept of willingness to pay was used to assess the amount per month participants would be prepared to pay for treatment for ED and other conditions. Four groups (controls, healthy diabetic men, impotent diabetic men and impotent diabetic men not in a sexual relationship) were studied. RESULTS: Significant differences were found between the four groups with regard to the ranking of the importance of ED compared with other health problems. Impotent diabetic male patients were prepared to pay more for treatment for their condition than all other conditions except blindness and renal failure. CONCLUSIONS: Men with diabetes, in particular ED sufferers, believe ED has a major impact on quality of life and is as important to treat as many other conditions associated with diabetes.

Adaptation, Psychological↗

Future options for combination therapy in the management of erectile dysfunction in older men.

The prevalence of erectile dysfunction (ED) has dramatically increased in parallel with the aging of the Western industrialised population. The estimated prevalence of ED worldwide in 1995 was 152 million men. As the population in industrial nations ages, an estimated 322 million men will be affected by ED by the year 2025. Oral drug therapy with the phosphodiesterase (PDE) type 5 inhibitor sildenafil fails in some patients with ED; however, several different classes of drugs demonstrate efficacy in treating ED, creating the potential for pharmacological combination therapy. Pharmaceutical products that lead to the activation of or an increase in cyclic nucleotides (cyclic adenosine monophosphate and cyclic guanosine monophosphate), with or without nitric oxide donors or nitrates, as well as alpha-adrenoceptor antagonists, have been used to treat ED. Sildenafil has been used in combination with alprostadil (prostaglandin E1) and administered via intraurethral or intracavernous route. Successful intercourse using this combination of agents varies from 47% to 100% following failed monotherapy. Various combination therapies for ED are being studied using PDE5 inhibitors, together with other agents, alpha-adrenoceptor antagonists, and testosterone replacement therapy for men with hypogonadism. The combination of centrally acting agents with PDE5 inhibitors, e.g. a regimen of apomorphine plus PDE5 inhibitor, is an attractive approach because the two therapies target different mechanisms. New PDE5 inhibitors such as vardenafil should be tried first as therapy for sildenafil nonresponders before exploring any combination therapy options. Preliminary observations of combination therapy have been encouraging and provide a scientific rationale for prospective, randomised clinical trials with adequate numbers of patients.

3',5'-Cyclic-GMP Phosphodiesterases↗

Attitudes of men with erectile dysfunction: a cross-national survey.

INTRODUCTION: Erectile dysfunction (ED), the inability to achieve or maintain an erection sufficient for sexual performance, is a complex disorder involving multiple biopsychosocial factors. AIM: To better understand the psychological and behavioral aspects of ED and compare the attitudes of ED patients in different countries. METHODS: The Cross-National Survey on Male Health Issues surveyed men aged 20-75 years in six countries. Participants completed questionnaires on attitudes, behavior, doctor-related issues, and comorbidities. MAIN OUTCOME MEASURES: Men rated their attitudes using a scale of 1 (strongly disagree) to 5 (strongly agree). Responses of "somewhat agree" and "strongly agree" were combined and the percentage calculated for each country and overall. A mean score for all responses (1-5) was calculated for each country. RESULTS: Attitudes held by men with ED overlap significantly when compared between countries. Men in all countries agreed that ED was a source of great sadness for themselves and their partners, and nearly all disagreed with the idea that they were too old for sex. Men in all countries agreed that it was important to know they had the capacity to perform sexually, and half of all men reported they would do "nearly anything" to cure their ED. Men in all countries also agreed that their doctor was the best source of information on sexual issues. Men in the United States and the United Kingdom were less willing to accept ED, more motivated to find a cure, and less likely to consider ED a result of psychological problems. CONCLUSIONS: Attitudes of men with ED overlap significantly when compared between countries, but interesting differences were seen. Additional research is needed to understand how attitudes and behaviors reported reflect actual experiences. This study highlights some of the barriers that exist between physician-patient communication surrounding identification and treatment of ED.

Adult↗

Effect of chronic diseases on incidence of erectile dysfunction.

OBJECTIVES: To estimate the incidence of erectile dysfunction (ED) in a population-based sample during 5 years' follow-up and determine how the rate was affected by age and medical conditions. METHODS: The target population comprised all men aged 50, 60, or 70 years residing in the study area at the time the study began. Questionnaires were mailed to 3143 men in 1994 and to 2864 men in 1999. The follow-up sample consisted of the 1442 men who responded to both the baseline and the follow-up questionnaires. ED was assessed by two questions concerning the subject's ability to achieve and maintain an erection sufficient for intercourse. We estimated the incidence of minimal ED among the 391 men free of ED, of moderate ED in the 1130 with no or minimal ED, and of complete ED among the 1323 men free of complete ED at baseline. RESULTS: The incidence of minimal ED was 127 cases per 1000 person-years (95% confidence interval 110 to 148). For moderate ED, it was 41 (95% confidence interval 36 to 47) and for complete ED, it was 18 (95% confidence interval 15 to 22). The incidence of minimal ED increased 40% and moderate ED 80% with each decade increment in age; the incidence of complete ED increased 190%. The incidence of ED was increased in men with diabetes (rate ratio 2.4 for minimal, 2.6 for moderate, and 3.4 for complete ED). Hypertension, heart disease, arthritis, pulmonary disease, and cerebrovascular disease had little or no effect on the incidence of ED. CONCLUSIONS: ED is a commonly occurring disorder that increases in incidence strongly between 50 and 75 years of age. Diabetes is a major determinant of ED, but hypertension, heart disease, arthritis, and cerebrovascular disease increase the incidence of ED only marginally.

Age Distribution↗

A comparative review of apomorphine formulations for erectile dysfunction : recommendations for use in the elderly.

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. First-line oral therapy for ED includes the use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil and vardenafil) and sublingual apomorphine. Apomorphine is a dopamine D(1) and D(2) receptor agonist that has been approved for marketing in Europe. Different apomorphine formulations have been tested, such as sublingual, subcutaneous and intranasal. However, the sublingual formulation has shown the best results in terms of efficacy, safety and tolerability, especially the 2mg and 3mg doses. Although clinical studies of the efficacy and tolerability of apomorphine sublingual (SL) have included older patients, who are more likely to have ED, no study has specifically assessed the efficacy and tolerability of different doses of apomorphine SL in aging men. Therefore, a MEDLINE search was conducted from January 1987 to November 2005 to identify studies of the efficacy, safety (in particular cardiovascular safety) and tolerability of different apomorphine formulations and doses as treatments for ED in the subcohort of aging men. On the basis of the most recent peer-reviewed publications, the first part of this article critically evaluates data regarding the epidemiology of ED in the aging population. The second part of the article focuses on the mechanism of action and pharmacokinetics of apomorphine both in the general and the elderly population. Finally, a critical analysis of the efficacy and safety of different apomorphine formulations and doses for the treatment of ED is reported. Apomorphine represents a first-line oral treatment for ED. Available formulations include only sublingual administration. Few studies have assessed the efficacy and safety of apomorphine in the elderly population. However, in clinical practice, older patients with multiple vascular risk factors and systematic vascular damage show poor overall response to apomorphine SL for the treatment of ED.

Aged↗

Understanding the needs and objectives of erectile dysfunction patients.

Consideration of the needs and objectives of individual patients significantly influences the behavior of erectile dysfunction (ED) patients and their partners. Evaluation of an erectile dysfunction (ED) patient requires individualized consideration of the expectations, needs, and objectives of the affected couple. These factors can influence attitudes toward diagnosis, treatment seeking, and ultimately treatment compliance and dropout. Relevant ED market research studies were presented at the 2006 annual meeting of the American Urological Association. The studies explored the prevalence of ED, access to treatment, and ED patient attitudes and preferences. Several barriers continue to influence treatment-seeking behavior in men with ED. These barriers have had a negative impact on the ED patient and marketplace resulting in low rates of utilization and high rates of dropout from therapies for ED.

Clinical Trials as Topic↗