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PubMed2006

Vardenafil 20-mg demonstrated superior efficacy to 10-mg in Japanese men with diabetes mellitus suffering from erectile dysfunction.

AIM: Vardenafil is a highly selective and potent phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). The efficacy of vardenafil has been demonstrated in a broad range of ED populations, but has not yet been assessed in Japanese patients with diabetes mellitus (DM), although DM is frequently associated with difficult-to-treat ED. This is the first study to investigate whether high-dose vardenafil (20 mg) can demonstrate superior efficacy to the usual dose (10 mg) in this subpopulation in Japan. METHODS: The study was a randomized, placebo-controlled, double-blind, multi-centre, parallel group comparison 12-week study. Following 4 weeks observation period, 778 patients aged 26-64 years old with ED and DM (HbA1c >12% at screening was excluded) both of more than 3 years duration were randomly allocated to one of the three groups, vardenafil 10 mg, 20 mg, or placebo (randomization ratio 3:3:1). Erectile function (EF) domain score of the International Index of Erectile Function was estimated as the primary efficacy parameter. RESULTS: Vardenafil 10 and 20 mg both significantly improved the EF domain score from 13.6 and 13.9 at baseline to 21.8 and 22.9 at last observation carried forward (LOCF), respectively, compared to placebo (13.7 at baseline to 16.3 at LOCF; p<0.0001). In addition, vardenafil 20 mg demonstrated superior efficacy to 10 mg (p<0.05), and the difference was more evident in severe ED patients (baseline EF domain score <11). The safety profile was comparable between these two doses (drug-related adverse events: 6.6, 22.0 and 24.2% in placebo, vardenafil 10 mg, and 20 mg arms, respectively). The most common adverse events were hot flush, headache and nasal congestion, which were mild in intensity and transient, and are known to be common to PDE5 inhibitors. CONCLUSION: In Japanese men with DM and ED, vardenafil 10 mg and 20 mg were effective in improving erectile function with comparable safety profiles. Vardenafil 20 mg demonstrated superior efficacy compared with 10 mg, suggesting incremental clinical benefit in using the higher dose in this difficult-to-treat population.

Adult↗

PubMed2006

Udenafil, a long-acting PDE5 inhibitor for erectile dysfunction.

Udenafil is an oral PDE5 inhibitor that is currently available in South Korea for the treatment of erectile dysfunction (ED). Phase II clinical data presented at the 11th World Congress of the International Society for the Sexual and Impotence Research showed that in men with mild-to-severe ED, the drug produced a significant improvement in erectile function after 12 weeks of treatment. Udenafil has been reported as being well tolerated, although in August 2005, the Korean Food & Drug Administration had demanded further details regarding the presence of carcinogenic substances in the drug. A phase IIa clinical trial for ED is currently underway in the US, and phase III trials are planned for 2006.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMed1996

Multifactorial evaluation of diabetic erectile dysfunction.

We determined arterial venous and sinusoidal factors in 20 patients with insulin dependent diabetes mellitus and erectile dysfunction by performing dynamic infusion cavernosometry (DIC), colour flow Doppler ultrasonography, penile biothesiometry and corpus cavernosum electromyography (CCE). DIC, colour flow Doppler ultrasonography and penile biothesiometry were done in standard fashion except for CCE. Paradoxical increase in the electrical activity of corpus cavernosum after intracavernous (IC) papaverine was called a discoordination that was due to cavernous smooth muscle contraction instead of relaxation. Arterial and accompanying pathologies were found in 10 (50%) patients. In 3 (15%) of them pure arterial pathology, in 6 (30%) patients arterial and veno-occlusive dysfunction (VOD) and in one patient arterial pathology with abnormal biothesiometry were found. VOD and accompanying pathologies were found in 12 (60%) patients. In 6 (30%) of them VOD and arterial, in 4 (20%) patients VOD and discoordination and in 2 (10%) patients VOD and abnormal biothesiometric values were present. A higher frequency and coexistence of VOD and discoordination pattern were observed. In conclusion, patients with diabetic impotence show a wide range pathophysiology of erection and the evaluation of these patients must include multistep techniques.

Adult↗

PubMed2004

[Investigation of diabetic men with erectile dysfunction to determine coronary flow reserve (CFR) and cardiac risk under medication with sildenafil (Viagra)].

PURPOSE: Since Sildenafil (Viagra) has become available, there have been reports of death and cardiac risks associated with its use. As large doses of Sildenafil medication is often prescribed particularly in diabetic patients with erectile dysfunction (ED), our study was designed to evaluate the coronary flow reserve (CFR) and possible resulting cardiac risk specifically in diabetic men. MATERIALS AND METHODS: Because these men often suffer from clinically significant ischaemic heart problems without their knowledge and without symptoms, all of our patients were examined by treadmill ECG and CFR. RESULTS: In 44 men (35 - 74 years) with type I and II diabetes also suffering from ED objectified by FCDS measurement of the penile vessels, a surprisingly high rate of objective cardiac problems were found, which were then verified by coronary angiography. These patients are at risk for ischaemic problems during Sildenafil-assisted intercourse and were excluded from further study. Interestingly, only 3 of theses 11 men would have been detected by conventional examinations. Patients free of coronary stenosis who received 50 mg Sildenafil (20 patients) showed no cardiac problems during treadmill exercise and CFR measurement. CONCLUSIONS: Coronary flow reserve in diabetic men lies at the lower end of the normal range, but is not further decreased by Sildenafil. However, diabetics with ED frequently showed coronary artery stenosis that was not clinically symptomatic. Furthermore, conventional cardiological examinations often fail to detect these patients, although they are at ischaemic risk during medically assisted intercourse. Furthermore, although 5 of 20 men who received Sildenafil had an increase in penile blood flow without sexual stimulation, only 7 of 20 were responders to Sildenafil after take home medication. Thus, Sildenafil medication is not a suitable test medication for organic erectile dysfunction.

Adult↗

PubMed2006

Significance of hypogonadism in erectile dysfunction.

To review the role and significance of hypogonadism, defined as a low testosterone (T) level, in erectile dysfunction (ED). Review of literature. Serum T is below 3 ng/ml in 12% of ED patients, including 4% before and 15% after the age of 50. Replacement studies in men with severe hypogonadism demonstrate that sexual desire and arousal, as well as the frequency of sexual activity and spontaneous erections are clearly T-dependant. Psychic erections are partly T-dependant. The effects of T upon sexual function are dose-dependant up to a threshold level that is consistent within an individual, but markedly variable between individuals, ranging from 2 to 4.5 ng/ml. More evidence is required to confirm a significant impact of T on the intrapenile vascular mechanisms of erections in men as it is the case in animals. No convincing association of T with ED has been found in epidemiological studies. As concerns clinical experience, although a meta-analysis of the randomized controlled trials established that T therapy consistently restores erectile function in young hypogonadal patients with T below 3.46 ng/ml, the effects of this treatment have been mostly disappointing when used alone in older patients consulting for ED who are subsequently diagnosed to have hypogonadism following routine T measurement. These poor results may probably be explained by the high prevalence of co-morbidities, and by the fact that ED itself may induce hypogonadism. Combination therapy with T and PDE5 inhibitor (PDE5I) may be effective in the hypogonadal ED patients when T therapy alone fails. However, more evidence is required to confirm the hypothesis that a minimum level of T is required for a complete effect of PDE5I in certain men, since a PDE5I was able to restore complete erections in severely hypogonadal men. Though a low T level is not always the only cause of ED in hypogonadal ED patients, there are important benefits in screening for hypogonadism in ED. A low T level justifies a 3 month trial of T therapy, before combining a PDE5I if T therapy alone fails.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMed2005

Sildenafil: efficacy, safety, tolerability and mechanism of action in treating erectile dysfunction.

Sildenafil citrate is marketed under the trademark name Viagra and is widely used to treat male erectile dysfunction; therapeutic uses of this medication for other diseases related to vascular dysfunction are emerging. When used as recommended, the drug has a strong clinical efficacy and safety profile in a broad spectrum of the male population. Its widespread use and effects of long-term exposure to the drug due to particular treatment regimens or inappropriate use mandate an ongoing update of its molecular mechanism, pharmacological profile and associated safety issues. This review focuses on biochemical and pharmacological features of sildenafil, the active component in Viagra, interaction of sildenafil with phosphodiesterase 5, pharmacokinetic parameters, action in smooth muscle, side effects, safety profile and prospects for other uses.

Area Under Curve↗

PubMed1995

Penile sympathic skin response in erectile dysfunction.

Penile sympathic skin response (PSSR) was measured in 20 normal patients and in 46 patients with erectile dysfunction (ED). PSSR could be registered in 80% of normal patients. The latencies were 1,100-1,600 ms. In patients with ED, latencies were 1,240-3,640 ms. A reproducible normal latency of PSSR (< 1,600 ms) indicates a normal sympathic innervation of the penis. Long latencies (> 1,800 ms) indicate neuropathy of unmyelinated nerval fibers. The loss of a reproducible answer however allows no exact diagnostic information. PSSR is a useful diagnostic test for detecting neuropathy of unmyelinated nerval fibers as a possible cause of ED.

Adult↗

PubMed2004

Uropharmacology: current and future strategies in the treatment of erectile dysfunction and benign prostate hyperplasia.

Because of the increasing percentage of the world male population suffering from erectile dysfunction (ED) and benign prostate syndrome (BPS), there is a need for new and innovative therapeutic approaches. Pharmacotherapy is an avenue presently being followed in the treatment of both these syndromes. A profound change in the therapy of ED has been obtained through use of the selective phosphodiesterase inhibitor sildenafil. The incidence of surgical intervention in BPS has been reduced by the introduction of uroselective alpha1-receptor antagonists and the new 5alpha-reductase inhibitors (such as finasteride, dutasteride). The investigation of mechanisms in CXC chemokine expression also offers new therapeutic possibilities in these diseases.

Adrenergic alpha-Antagonists↗

PubMed1983

Noninvasive penile arterial evaluation in 120 males with erectile dysfunction.

One hundred twenty males referred to a hospital-based Medical Sexology Program for evaluation of erectile dysfunction had, as part of that workup, a noninvasive penile arterial assessment which included determination of (1) blood pressure in each of the six penile arteries, (2) patency of each cavernosal artery, and (3) brachial blood pressure. The systolic pressures in each of the six penile arteries were averaged and divided by the brachial systolic pressure to determine the penile brachial index (PBI). When a PBI of 0.75 or less was correlated with a history of myocardial infarction, coronary artery bypass, or cerebral vascular accident, a P value of 0.069 resulted, certainly suggesting that each is a manifestation of arterial disease.

Adult↗

PubMedDate not supplied

[Prediction of clinical efficacy of levitra (vardenafil) in patients with arteriogenic erectile dysfunction].

Oral inhibitors of phosphodiesterase of type 5 (PDE-5) are drugs of choice in therapy of erectile dysfunction (ED). However, 20-30% patients do not respond to them. We studied potentialities of ultrasonic investigation (UI) of postcompression increase in cavernous arteries diameter (PICAD) after intake of vardenafil (levitra, Bayer&GlaxoSmithKline) which is a PDE-5 inhibitor in prediction of clinical efficacy of this medicine. A total of 75 males with ED participated in the study. Significant correlations were found between PICAD after vardenafil administration and clinical efficacy of the drug in patients with arteriogenic ED. The highest response to the drug was observed at PICAD value > or = 50%. High sensitivity and specificity of the PICAD threshold value obtained indicate high potentialities of the method in decision making on treatment policy in patients with organic ED.

Adult↗

PubMed1981

Dating skills training in the group treatment of erectile dysfunction for men without partners.

This study was a controlled evaluation of men's group treatment of erectile dysfunction that emphasized communication and dating skills training for men without partners. Following a 6-week pretreatment waiting period, 11 men were seen for 10 sessions in two men's groups led by different cotherapy teams. Several female guest therapists attended three sessions to help the men role-play a sequence of difficult social interactions. A series of communication/dating homework assignments was added to the weekly sensual/sexual assignments. The results indicated no improvement during the waiting control period, but significant improvement on measures of sexual attitudes and behaviors following treatment. There was a significant reduction in the frequency of erection difficulties before intercourse and a trend toward reduction of erection difficulties during intercourse. These improvements were maintained over a 6-month follow-up.

Adult↗

PubMed2005

Hypogonadism in the man with erectile dysfunction: what to look for and when to treat.

Hypogonadism (low serum testosterone) is commonly associated with erectile dysfunction (ED). However, many urologists may lack appreciation of the relative merits of treating hypogonadism compared with oral phosphodiesterase inhibitors for sexual dysfunction. Testosterone-replacement therapy (TRT) may be the best treatment for men with ED when the presentation includes diminished libido or other sexual symptoms or when non-sexual symptoms such as depressed mood, decreased sense of vitality, and increased fatigue also exist. The health benefits of TRT also include improvements in body composition, bone density, cognition, and sense of well-being. Thus, there may be good reasons to use TRT as first-line therapy for the man with ED. Concerns regarding prostatic and cardiovascular risks of TRT have not been supported by the literature. Nevertheless, men receiving TRT must be monitored at regular intervals with digital rectal examination and blood testing for prostate-specific antigen. Hematocrit or hemoglobin also should be obtained regularly due to the risk of erythrocytosis. Awareness of the benefits of TRT in the man with ED may improve clinical outcomes.

Androgens↗

PubMed2003

The interlinked depression, erectile dysfunction, and coronary heart disease syndrome in older men: a triad often underdiagnosed.

The prevalence of depression, erectile dysfunction (ED), and coronary heart disease (CHD) increases with age, and the symptoms related to these three illnesses are closely interlinked. The term "DEC syndrome" is introduced to refer to this triad of comorbid conditions. When a patient presents with one component of the DEC syndrome, physicians should also screen for the other two components. Studies have shown that depression may predispose an individual to an increased risk of developing CHD, and older men with CHD are more likely to be depressed. Likewise, patients with ED are more likely to be clinically depressed, and patients with clinical depression often have ED. Furthermore, patients presenting with ED are often hypertensive, and thus have a significantly higher prevalence of cardiovascular complications. Multifactorial problems require multifactorial approaches, and the care of older men can improve if physicians are aware of this interlinked syndrome.

Activities of Daily Living↗

PubMed1994

Can the vacuum test be used as a diagnostic method for determining the degree of severity of erectile dysfunction?

We performed the vacuum test (VT) using the Osbon Erec Aid System on 224 patients with erectile dysfunction (ED). The age range was 26-78 years. The vacuum procedure was performed three times at intervals of 2-8 days, using the negative pressure device (NPD). Negative pressure was created for 3-5 minutes, followed by the removal of the cylinder; the tension ring was left in place for an additional 1-2 minutes. During each procedure, we observed color and temperature changes in the glans penis and changes in the tumescence and maximal rigidity of the penis (MRP); dynamic changes in MRP were noted again 1-2 minutes after the procedure. For comparison and verification, we carried out parallel tests: nocturnal penile tumescence (NPT), penile brachial index (PBI), and Doppler penile ultrasound (DPU). On completion of the investigation, we found that 10.3% had mild ED, 38.5% moderate ED, and 41.5% severe ED. The parallel tests confirmed the diagnosis reached by VT. Thus, changes after vacuum procedures together with local symptoms can serve as criteria for determining the degree of severity of ED.

Adolescent↗

PubMed2005

Lifestyle management of erectile dysfunction: the role of cardiovascular and concomitant risk factors.

The influence and significance of lifestyle factors in erectile dysfunction (ED) have been demonstrated in cross-sectional and prospective, randomized, controlled trials. Recent epidemiologic studies in several countries have shown that modifiable lifestyle or risk factors, including physical activity in particular, are directly related to the occurrence of ED. In this article, we review several recent observational studies, 2 of which include a longitudinal follow-up component in the study design. The levels of physical activity in both of these studies predicted ED prevalence and incidence. Furthermore, the role of lifestyle changes (weight loss, physical activity) were recently demonstrated to be effective in modifying ED in a prospective, randomized Italian trial in moderately obese, sedentary men. Men without overt diabetes mellitus or cardiovascular disease participated in this landmark study. Other studies have shown that aggressive management of cardiovascular risk factors can increase the effectiveness or outcomes associated with pharmacologic management of ED. Taken together, these studies support the value of risk factor modification and lifestyle change in the clinical management in men with ED and concomitant cardiovascular illness.

Cardiovascular Diseases↗

PubMed2003

Severe Raynaud's phenomenon with yohimbine therapy for erectile dysfunction.

Yohimbine is a selective alpha-2 adrenergic antagonist that has been used in the pharmacologic management of erectile dysfunction (ED). We describe a patient with CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasia) who paradoxically experienced worsening of Raynaud's phenomenon when using yohimbine for ED.

Adrenergic alpha-Antagonists↗

PubMed1997

Double-blind, placebo-controlled safety and efficacy trial with yohimbine hydrochloride in the treatment of nonorganic erectile dysfunction.

This double-blind, placebo-controlled clinical trial of yohimbine hydrochloride included 86 patients with erectile dysfunction and without clearly detectable organic or psychologic causes. The patient group fulfilled all entry criteria; 85 of these could be considered for the Safety-respectively 83 for the Intention-to-treat (ITT)-analysis. Yohimbine was administered orally in a dosage of 30 mg a day (two 5 mg tablets three times daily) for eight weeks. Patients were seen for follow-up after four weeks' treatment, and for a final visit after eight weeks. Efficacy evaluation was based on both subjective and objective criteria. Subjective criteria included improvement in sexual desire, sexual satisfaction, frequency of sexual contacts, and quality of erection (penile rigidity) during sexual contact/intercourse. Objective criteria of outcome were based on improvement in penile rigidity determined by use of polysomnography in the sleep laboratory. Overall Yohimbine was found significantly more effective than placebo in terms of response rate: 71 vs 45%. Yohimbine was well-tolerated: Only 7% of patients rated tolerability fair or poor, and most adverse experiences were mild. There was no serious adverse event.

Adrenergic alpha-Antagonists↗

PubMed2005

Erectile dysfunction and its influence on quality of life in patients with essential hypertension.

Epidemiological studies indicated that erectile dysfunction (ED) is more frequent and their quality of life (QOL) is deteriorated in patients with essential hypertension as compared with normotensive subjects. Since both ED and hypertension influence QOL, it is not clear which malady has a more serious influence on QOL. We conducted a case control study to investigate incidence and impact of ED on QOL. In 102 patients aged 40 to 59 under treatment for hypertension (Hypertensive group) and in 245 age-matched normal subjects (Control group), QOL and ED were assessed by SF-36 and IIEF5. Criteria for presence of ED is IIEF5 score less than 12. Age adjusted incidence of ED in Hypertension group was higher than that in Control Group (odds ratio 1.7, P < .05). Multivariate logistic regression analysis showed hypertension was related only to a low score in general health, ED was related to low scores in physical, mental health, emotional, vitality, and general health. These data suggest that the influence of ED on QOL is more serious than hypertension in middle age men.

Adult↗