西地那非治疗勃起功能障碍无效的原因分析及治疗对策

目的 分析按需口服西地那非治疗勃起功能障碍(ED)无效原因并制定治疗策略.方法 2009年1-12月因ED就诊、正确服用西地那非100 mg、至少4次无效的患者126例.采用国际勃起功能指数调查表5个简化问题(IIEF-5)评分、实时勃起功能检测、血清睾酮检测、阴茎多普勒超声检查评估ED治疗无效的原因,患者进行充分的性教育,接受每晚西地那非50 mg治疗.采用IIEF-5评分和性生活日记问题2和3评价再次治疗后的效果.结果 126例ED患者中心理性ED41例,合并睾酮水平低下39例,糖尿病性ED 28例,血管性ED 18例.经过每日小剂量西地那非治疗4周,治疗前后IIEF-5评分分别为(12.3±2.9)分和(18.8±4.4)分,差异有统计学意义(P＜0.05).成功完成性生活者78例,有效率61.9%.结论按需口服西地那非治疗无效的患者经过充分的性教育、长期小剂量治疗后,大部分患者对西地那非治疗仍然有效.

Abstract：

Objective To assess the causes of sildenafil failure and the feasibility of successfully rechallenging non-responding patients. Methods A total of 126 consecutive erectile dysfunction (ED) patients from Jan 2009 to Dec 2009 who claimed poor response to sildenafil (sildenafil 100 mg on demand, at lease 4 epiodes) were enrolled into the study. All patients received sexual reeducation and were treated with sildenafil, taken on a daily dose of 50 mg for 4 weeks. The International Index of Erectile Function-5 (IIEF-5), Rigiscan, serum testosterone or penile Doppler were used to evaluate ED and the cause of on-demand sildenafil failure. End point efficacy of rechallenging was evaluated using the IIEF-5 and the sexual encounter profile (SEP) 'Were you able to insert your penis into your partner's vagina?' and 'Did your erection last long enough to achieve successful intercourse?'. Results The recruited patients comprised of 41 cases with psychological ED, 39 cases with hypogonadism ED, 28 cases with diabetes mellitus ED and 18 cases with vascular ED. Compared with pretreatment and on-demand sildenafil baseline, daily administration of sildenafil significantly enhanced all efficacy outcome variables. The IIEF-5 was significantly improved after daily sildenafil (12.3 ± 2.9 vs18. 8±4.4, P＜0.01), 78 patients responded to daily sildenafil. The overall salvage rate was 61.9%(78/126). Conclusions Sexual reeducation and daily administration of sildenafil may be able to salvage many patients with ED who were sildenafil non-responders.     

Sildenafil test: Changes in the diagnostic and therapeutic management of erectile dysfunction

Objective: To assess the efficacy of sildenafil as a first-step diagnostic and therapeutic tool for erectile dysfunction (ED) and to evaluate the consequent changes in the management of male sexual insufficiency.Materials and methods: Sildenafil in titrating doses up to 100 mg was prescribed to 50 men presenting to a sexual dysfunction clinic with medically documented ED. They had not undergone any specific diagnostic test before starting sildenafil.Results: Of the 50 men, 24 (48%) responded to sildenafil. Of these, 8 (33.3%) responded to 50 mg and 16 (66.7%) to 100 mg of sildenafil. Of the responders, 9 representing 18% of all studied men were discharged achieving spontaneous erections in a mean follow-up of 5.3 months. Men with no medical history, men with hypertension and men with mild coronary artery disease responded better.Conclusions: The sildenafil test revealed that 48% of men responded to this therapy with no requirement for more invasive tests and that 18% of men required no further treatment at all. In addition this test reduced the overall cost of the diagnostic investigation. It is proposed that the sildenafil test should be used in cases with no significant medical history or in men with hypertension or mild coronary artery disease although almost all men with ED could be categorized as sildenafil-responders or sildenafil-resistant. It is also suggested that the sildenafil test would result in the ability for more men with ED to be managed exclusively in the primary care sector.     

Rechallenge prior sildenafil nonresponders

To assess inappropriate use as a cause of sildenafil (Viagra ) failure and the feasibility of successfully rechallenging nonresponding patients, a total of 60 consecutive erectile dysfunction (ED) patients who first presented to our hospital and claimed poor response to sildenafil were enrolled into the study. The International Index of Erectile Function-5 (IIEF-5) was used to evaluate their baseline ED status and a self-administered sildenafil-use questionnaire composed of nine questions (SUQ-9) to assess how they had used sildenafil. A total of 44 subjects consent to rechallenge with sildenafil and were given thorough instruction based on individual answers to SUQ-9 and four doses of sildenafil 100 mg. After a 4-week follow-up, end point efficacy of rechallenge was evaluated using the IIEF-5 and the global assessment question (GAQ), 'After the treatment, did you have successful sexual intercourse?' Of the 60 subjects, 44 (77.3%) had one or more areas of major suboptimal use of sildenafil: 18 (30.0%) did not know that sexual stimulation was necessary for sildenafil to work, 36 (60.0%) attempted to use sildenafil less than four times, and 27 (45.0%) took a maximal dose less than 100 mg. Of the 44 patients undergoing sildenafil rechallenge, 34 (77.3%) completed the follow-up, while seven (15.9%) received only GAQ assessment by telephone interview and three (6.8%) were lost to follow-up. The total follow-up rate was 93.2% (41/44). Based on answers to the GAQ, the response rate to rechallenge was 58.5% (24/41). The mean improvement in the IIEF-5 score was 8.4+/-5.5 in responders (P <0.05). With individualized thorough instruction based on answers to SUQ-9 and scheduled follow-up, a high success rate was achieved by rechallenge with sildenafil in prior failures. The efficacy of sildenafil could be improved to a great extent by adequate education of patients and continuing medical education given to primary-care physicians.     

Treatment of erectile dysfunction following therapy for clinically localized prostate cancer: patient reported use and outcomes from the Surveillance, Epidemiology, and End Results Prostate Cancer Outcomes Study

PURPOSE: Erectile dysfunction (ED) persists for years following curative therapies for clinically localized prostate cancer. We report use and treatment outcomes in a 5-year interval in a population based cohort from the Surveillance, Epidemiology, and End Results Prostate Cancer Outcomes Study. MATERIALS AND METHODS: A sample of 1,977 men with localized prostate cancer who received external beam radiation therapy or radical prostatectomy in 1994 to 1995 were surveyed for 5 outcome measures of ED treatment, namely treatment, perceived helpfulness, erectile sufficiency, sexual activity frequency and erection maintenance. Subjects were surveyed 6, 12, 24 and 60 months after prostate cancer diagnosis. RESULTS: Overall 50.5% of men ever used ED treatment. The use of ED treatments increased during the study course. Subject age, regular sexual partner and baseline sexual activity were factors positively associated with ED treatments. While it was used uncommonly (1.9%), a penile prosthesis was perceived as the most helpful ED treatment (helped a lot in 52% of respondents). Sildenafil helped a lot in 12% of respondents. Erectile fullness, erection maintenance and sexual activity frequency were modestly improved in men using ED treatment compared with those in men not using ED treatment. CONCLUSIONS: Approximately half of the patients in this population based cohort of men used ED treatment during the 5 years following prostate cancer diagnosis. Men using ED treatments had modest improvement in sexual function compared with men that in who did not receive ED treatment at 60 months. More effective treatments for ED following local therapy for prostate cancer are needed.     

DOES SILDENAFIL COMBINED WITH TESTOSTERONE GEL IMPROVE ERECTILE DYSFUNCTION IN HYPOGONADAL MEN IN WHOM TESTOSTERONE SUPPLEMENT THERAPY ALONE FAILED?

PURPOSE: We evaluated the efficacy of testosterone gel (T-gel) alone and in combination with sildenafil in hypogonadal patients with erectile dysfunction (ED). MATERIALS AND METHODS: A total of 49 hypogonadal men (mean age 60.7 years) with ED participated for a mean of 20.2 months. Blood was tested for total and bioavailable testosterone, and prostate specific antigen. Sexual function was assessed using the International Index of Erectile Function questionnaire and a global assessment question (GAQ). Men received 1% 5 gm T-gel for 6 months, and 100 mg sildenafil was added to those with a "no" response to the GAQ after 3 months on testosterone supplement. RESULTS: A total of 31 patients reported significant improvement in the sexual desire domain (from a mean +/- SD of 4.2 +/- 0.8 to 8.6 +/- 0.4) and erectile function (EF) domain (from 13.6 +/- 1.9 to 27 +/- 0.8) following treatment with testosterone supplement alone. One patient was excluded from study after urinary retention developed and 9 reported irritation at the gel application site. In spite of normalization of total and bioavailable testosterone values, and significant improvement of sexual desire domain scores, the EF of 17 men remained less than 26 or they responded "no" to the GAQ. These men received combined T-gel and sildenafil, after which all graded EF greater than 26 and responded positively to the GAQ. CONCLUSIONS: Combined treatment with sildenafil and T-gel has a beneficial effect on ED in hypogonadal patients in whom treatment with testosterone supplement alone failed.     

Treatment of erectile dysfunction reduces psychological distress

Mental stress is a risk factor for cardiovascular events in men with vascular risk factors (VRFs) and is also associated with erectile dysfunction (ED), a frequent complaint of men with VRFs. The aim of this study was to investigate the effect of inhibition of phosphodiesterase-5 or of placebo in men with ED and VRFs on self-evaluated psychological distress, erectile function and quality of sexual life. Thirty-six men with ED and VRFs were randomized to 4 weeks of tadalafil (20 mg/every other day) or placebo treatment. Sexual Health Inventory for Men (SHIM), questions 1–3 of Life Satisfaction (LiSat) questionnaire, Symptom Check-List-90R, a multidimensional inventory exploring psychological dimensions were applied before and after treatment. The SHIM score improved after treatment with tadalafil compared with baseline and with placebo ( F  = 10.38; p  =   0.0030). Sexual life satisfaction (LiSat-2) was significantly improved after tadalafil and after placebo, but a strong positive correlation was observed between LiSat-2 and SHIM score after tadalafil treatment ( r  = 0.59, p  = 0.0003) and not after placebo ( r  = 0.22, p  = 0.189). Psychological features were significantly changed after treatment, although a specific effect of tadalafil vs. placebo was observed only for interpersonal sensitivity ( F  = 4.48; p  =   0.042). Obsessive–compulsive dimension, depression, anxiety, psychoticism were significantly improved in the tadalafil group and in the placebo group, although the improvement was always more relevant after treatment with tadalafil. These preliminary data suggest that a short treatment of ED reduced psychological distress and improved quality of sexual life in men with VRFs.     

Sildenafil improves quality of life in men with heart failure and erectile dysfunction

Patients with congestive heart failure (CHF) have specific factors that enhance the risk for erectile dysfunction (ED), such as low cardiac output and the use of drugs with vasodilator effect. ED can negatively affect interpersonal relationships and self-esteem, with significant impact on the quality of life. We hypothesized that the improvement of the sexual dysfunction would enhance the quality of life of individuals with systolic heart failure. This is a prospective study of 12 male CHF patients using a fixed dose of sildenafil during 1 month. Patients were included if they had left ventricular ejection fraction lower than 40% documented by echocardiography and International Index of Erectile Function (IIEF) score lower than 21. The effect of sildenafil in quality of life was evaluated by the Minnesota questionnaire. Improvement in ED was assessed using the IIEF. The mean IIEF5 score was 9.6 (+/-3.8) before the use of sildenafil and 19.3 (+/-4.3) after sildenafil (P = 0.0001). The mean Minnesota score was 28.75 (+/-21) before treatment and 12.75 (+/-10.1) after the intervention (P = 0.012). In conclusion, the sexual function improvement provided by sildenafil enhances quality of life in individuals with systolic heart failure.     

Diagnosis and treatment of erectile dysfunction in retrospect

Background We sought to establish relationships between current sexual functioning, the findings of initial psychophysiological screening (PPS) and the treatment undergone in patients with erectile dysfunction (ED).
Methods A follow-up study (1–4 years later; mean time period 1.9) was carried out among 406 patients with ED, of which a representative sample of 237 responded. An extensive questionnaire was used including items dealing with the original medical examination, including PPS, treatment, subjective experience of the treatment and psychosexual functioning over the 3 months prior to the questionnaire study. Questionnaire data were linked with originally collected PPS data, including the sexual-history data.
Results Present sexual satisfaction was positively correlated with original numbers of spontaneous daytime and morning/night erections, but was not correlated with the degree of genital and sexual arousal elicited by visual sexual stimulation (VSS). Treatment results were not satisfactory in 55% of patients. Autoinjection therapy (AIT) and psychotherapy yielded higher satisfaction scores than other treatments. In general men < 40 years appeared to be more sexually active and satisfied, and to experience fewer sexual problems than the older patients.
Conclusions The occurrence of spontaneous daytime erections and morning/night erections, obtained by history taking, indicates a psychogenic cause of the ED, and has clear predictive significance for later sexual functioning. While a positive outcome of PPS suffices to make the diagnosis of non-organic ED, it does not, contrary to what we had expected, predict later sexual functioning.     

Comparative cross-over study of sildenafil and apomorphine for treating erectile dysfunction

OBJECTIVE

To compare the effectiveness, safety and tolerability of sildenafil and apomorphine in Brazilian patients with erectile dysfunction (ED) of various causes.

PATIENTS AND METHODS

In all, 108 patients (mean age 55 years, sd 11) and documented ED for ≥6 months were included in 12 centres in Brazil. The patients were initially followed for 2 weeks and then randomized to initial treatment with apomorphine or sildenafil, taken before sexual intercourse, no more than once a day. The initial dose (2 mg apomorphine and 50 mg sildenafil) could be adjusted (to 3 mg apomorphine, or to 25 or 100 mg for sildenafil) depending on the effectiveness and tolerability during the first 4 weeks of treatment. The patients were re‐evaluated after 8 weeks on treatment and, after a wash‐out period of 2 weeks (no treatment), received the other study drug (other than that received in the first phase), and then had the same procedures as in the first phase.

RESULTS

In all, 97 patients were evaluated for therapeutic effectiveness, the overall effectiveness being assessed using two questions; sildenafil had a significantly higher proportion of affirmative answers for both (P < 0.001). Likewise, the estimates for the mean (sd ) proportion of successful sexual intercourse, of 83.3 (4.7)% vs 40.3 (4.7)% and the total ED Inventory of Treatment Satisfaction score, of 86.7 (2.9) vs 56.9 (2.9) (P < 0.001) were higher for sildenafil. At the end of the study, 93.8% of the patients randomized to initial therapy with apomorphine declared a preference for sildenafil, and 81.3% of those initially treated with sildenafil declared a preference for that drug. The two drugs were well tolerated, and the main adverse events for apomorphine were nausea, vomiting, headache, taste perversion and dizziness; for sildenafil they were headache, flushing or vasodilatation, abdominal pain or dyspepsia and nasal congestion.

CONCLUSIONS

Sildenafil is more effective than apomorphine for treating ED, in the domains of erectile function, satisfaction with sexual intercourse and overall satisfaction, and was the drug preferred by most of the patients.     

The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile dysfunction

PURPOSE: We evaluate the efficacy and safety of tadalafil, taken as needed, in men with mild to severe erectile dysfunction (ED) and assess sexual intercourse attempt patterns. MATERIALS AND METHODS: In this multicenter, double-blind, placebo controlled, parallel study conducted in the United States and Puerto Rico 207 men with ED were randomized to placebo or 20 mg tadalafil for 12 weeks. The primary efficacy variables were changes from baseline in the mean International Index of Erectile Function erectile function domain score and mean per patient percentage of "yes" responses to Sexual Encounter Profile (SEP) diary questions 2 (successful penetration) and 3 (successful intercourse). The Global Assessment Question was a secondary end point and post hoc analyses on sexual intercourse attempt patterns were conducted. RESULTS: Men treated with tadalafil compared with placebo reported greater mean changes from baseline on the erectile function domain score (9.3 vs 0.3 with placebo, p <0.001) and on the mean per patient percentage of successful penetration (SEP question 2, 31.6% vs 2.3% with placebo, p <0.001) and successful intercourse attempts (SEP question 3, 43.6% vs 3.5% with placebo, p <0.001). The per treatment group percentage of successful intercourse attempts during treatment was higher for tadalafil than placebo (67.6% vs 24.1%, respectively, p <0.001) and most successful intercourse attempts occurred between 4 and 36 hours after taking tadalafil. Of the men treated with tadalafil 82.8% reported improved erections versus 19.6% taking placebo (Global Assessment Question, p <0.001). The most common treatment emergent adverse events were headache (15.7% vs 6.3% with placebo), back pain (8.8% vs 0%), and dyspepsia (7.5% vs 0%). CONCLUSIONS: Tadalafil (20 mg) significantly improved erectile function and patients did not closely temporally link sexual intercourse attempts with taking tadalafil. Tadalafil was also well tolerated in both groups of men with mild to severe ED.     

The utility of sildenafil citrate for infertile men with sexual dysfunction: a pilot study

OBJECTIVE: To investigate the use the sildenafil citrate, recognized as a first-line therapy for men with erectile dysfunction (ED), and which is safe and effective in men with various causes and severity of ED, including psychogenic ED, in a population of infertile men with sexual dysfunction. PATIENTS AND METHODS: Infertility is a major source of life stress and might be associated with sexual dysfunction through the erosion of self-esteem and self-confidence, and in stimulating discord in a relationship. Men presenting for evaluation of fertility who on questioning by the physician reported the recent onset of sexual dysfunction, had a history taken, a physical examination, hormonal profile, and completed the International Index of Erectile Function (IIEF), a validated inventory for assessing sexual dysfunction. Thirty men with a score of <26 on the erectile function domain of the IIEF, or who complained of new onset rapid or delayed ejaculation, were treated with sildenafil with no randomization or placebo control. The evaluation was repeated and the IIEF completed again > or =3 months after starting treatment. RESULTS: For men complaining of ED, subjective erectile rigidity, duration of erection, and the percentage of successful penetration attempts significantly improved with sildenafil. The mean (sd) IIEF domain scores for erection and satisfaction, at 18 (4) vs 27 (3), and 12 (2) vs 16 (3) (both P = 0.01), and orgasm, at 4 (1) vs 6 (3) (P = 0.001), respectively, significantly improved after treatment. In patients with ejaculatory dysfunction, the function improved in 64% after sildenafil therapy. CONCLUSIONS: We identified the nature of sexual dysfunction associated with male-factor infertility, and showed the efficacy of sildenafil therapy in men with this condition.     

Improvement in emotional well-being and relationships of users of sildenafil

PURPOSE: We estimated the association of sildenafil use with erectile function, relationship with sexual partner, functional status and emotional well-being in men with erectile dysfunction. MATERIALS AND METHODS: Letters were mailed to eligible patients at a university hospital urology and internal medicine clinic, and university affiliated community primary care clinics by the primary care provider or urologist inviting them to participate in the study. Of the eligible sample 124 men (53%) completed and returned a survey, including 85 who reported current sildenafil use. Change scores in these patients were calculated using the International Index of Erectile Function, marital interaction scale from the Cancer Rehabilitation Evaluation System Short Form, 5-item emotional well-being scale of the RAND 36-Item Health Survey and 12-Item Short Form Health Survey. RESULTS: Sildenafil users reported an 88% increase in erectile function scores, 60% increase in overall sexual satisfaction and 36% increase in intercourse satisfaction related to the use of sildenafil (p <0.001). Of the respondents 38% indicated that using sildenafil had definitely improved quality of life. Likewise 29% of respondents indicated that using sildenafil had definitely improved the relationship with their partner. With sildenafil there was a statistically significant improvement in the scores of erectile and sexual function (p <0.001), sexual partner relationship (p = 0.007) and emotional well-being (p <0.001). In a multivariate model improved erectile function and sexual partner relationship were each significantly associated with improved emotional well-being (R2 = 0.20, p <0.001). CONCLUSIONS: Sildenafil users reported significant improvements in erectile and sexual function that were associated with positive changes in emotional well-being and the sexual partner relationships with their sexual partner.     

Antioxidant treatment associated with sildenafil reduces monocyte activation and markers of endothelial damage in patients with diabetic erectile dysfunction: a double-blind, placebo-controlled study

OBJECTIVE: To investigate the synergic effect of propionyl L-carnitine (PLC) plus sildenafil in reducing monocyte oxidative activity and endothelial dysfunction markers in diabetic patients with erectile dysfunction (ED). METHODS: Thirty-two type 2 diabetic patients with ED (according to the International Index of Erectile Function-5 [IIEF-5]) were randomized to receive PLC (2 g/d) alone (n=8) or combined with sildenafil (50 mg/d twice weekly) (n=8), sildenafil alone (50 mg/d twice weekly) (n=8), or placebo (n=8) in a double-blind, fixed-dose study. Monocyte oxidative activity (stimulation index [SI]), intercellular adhesion molecule-1 [ICAM-1], P-selectin, advanced glycation end product (AGE) levels, Doppler sonography (recording peak systolic velocity [PSV]; end diastolic velocity [EDV]; systolic wave time [SWT]; resistive index [RI]), and IIEF score were evaluated before and after 12 wk of treatment; IIEF-5 was evaluated again 4 wk posttreatment. RESULTS: SI was reduced by treatment with PLC alone or combined with sildenafil (p<0.05). In patients treated with PLC plus sildenafil, a decrease in ICAM-1, P-selectin, and EDV values was observed compared with patients treated with sildenafil alone (p<0.05, p<0.01, p<0.001, respectively). IIEF-5 improved in all patients treated with PLC plus sildenafil or sildenafil alone (p<0.03, p<0.05, respectively). Four weeks posttreatment, patients treated with PLC plus sildenafil maintained the improvement of the IIEF-5 compared with patients on sildenafil alone (p=0.05). In patients on PLC treatment (with or without sildenafil), SI was correlated with IIEF-5 (p<0.001), glycemia with STW (p<0.03), and AGEs with IIEF-5 (p<0.01). CONCLUSION: PLC plus sildenafil was more effective in reducing SI and endothelial dysfunction markers in patients with type 2 diabetes and ED.     

Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies

OBJECTIVES: To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies. METHODS: In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire. RESULTS: Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.     

High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction

The objectives of this study were to evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Fifty four fully evaluated patients with chronic erectile failure (ED) who had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for sexual intercourse were studied. Each man was treated at home with sildenafil at escalating doses of up to 200 mg until either maximal response or intolerable adverse effects occurred. Erectile function was quantified using the erectile function domain of the International Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and with maximal dose of sildenafil and a global efficacy question after 4 weeks of treatment.The mean age of the study group was 59.6+/-11.2 y. 13/54 (24%) had arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg. 41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5 with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively. After 4 weeks, treatment was regarded as having improved their erections by 37%, 46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg, respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to continue treatment due to adverse effects.In conclusion, sildenafil at doses of up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil non-responders but is limited by a significantly higher incidence of adverse effects and a 31% treatment discontinuation rate.     

Time from dosing to sexual intercourse attempts in men taking tadalafil in clinical trials

OBJECTIVE: To determine whether patients with erectile dysfunction (ED) and treated with tadalafil use the 36-h duration of effect of the drug, and to discern if the timing of intercourse attempts is influenced by patient age, baseline severity of ED, or previous experience with sildenafil citrate. PATIENTS AND METHODS: In 11 multicentre, double-blind, placebo-controlled studies, 2102 patients with ED were randomized to a maximum of one dose per day of tadalafil 10 or 20 mg (1464 men), or placebo (638 men) with no time restrictions before attempting sexual activity after the dose. A post hoc analysis was used to determine the proportion of men with ED who attempted sexual intercourse during various intervals (>0 to < or = 1, >1 to < or = 4, and >4 to < or = 36, including >12 to < or = 36 h) after dosing with tadalafil or placebo over a 12-week period. Patients were stratified by age, baseline severity of ED, and previous history of sildenafil use. RESULTS: Of patients in different age groups and various ED severity, > or = 79% and > or = 53% chose to attempt sexual intercourse at least once during the 12-week treatment period at 4-36 and 12-36 h, respectively, after taking tadalafil. Regardless of previous experience with sildenafil, about a third of patients using tadalafil attempted intercourse a mean of at least once per week at 4-36 h after the dose over 12 weeks. Furthermore, 58% of patients attempted intercourse at least once during two intervals (>1 to < or = 4 h and >12 to < or = 36 h) after separate doses of tadalafil. CONCLUSION: Regardless of age, ED severity, or previous experience with sildenafil, most patients attempted sexual intercourse at least once at 12-36 h after one dose of tadalafil over a 12-week treatment period. Furthermore, by engaging in sexual intercourse at both earlier and later intervals after separate doses, most patients on treatment did not adhere to a fixed schedule of intimacy and thus took advantage of the 36-h duration.     

Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction

The aim of this study was to evaluate the efficacy and safety of oral sildenafil to treat erectile dysfunction (ED) in chronic renal failure in patients on hemodialysis (HD). A double-blind, randomized, placebo-controlled study of oral sildenafil (50 mg) administered as required in HD patients with ED was designed. Patients on HD for at least 6 mo and who had a stable relationship with a female sexual partner were included. Patients older than 70 yr with penile anatomic abnormalities, cirrhosis, diabetes, angina, severe anemia, and those who were on nitrate treatment or with a recent history of stroke or myocardial infarction were not included. The International Index of Erectile Dysfunction (IIEF) was employed to evaluate ED and treatment response. Forty-one patients were evaluated (21 received placebo, and 20 sildenafil). Baseline clinical and demographic parameters were similar in both groups. Sildenafil was associated with improvement in the score of all questions and domains of the IIEF, except those related to sexual desire. Using the erectile function domain to evaluate primary efficacy, improvement was observed in 85% of the sildenafil patients compared with 9.5% of placebo patients. Sildenafil use resulted in normal EF scores in 35% of sildenafil patients. Sildenafil was well tolerated. Headaches and flushing occurred in both groups. Dyspepsia was reported by two patients in the sildenafil group. In conclusion, oral sildenafil seems to be an effective and safe treatment for ED in selected patients with chronic renal failure on hemodialysis.     

Sildenafil influences lower urinary tract symptoms

OBJECTIVE: To assess the possible relationship between erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) in men, and whether treatment of their ED with sildenafil influences their LUTS. PATIENTS AND METHODS: In all, 112 men with ED attending the andrology outpatient clinic were offered oral sildenafil and reviewed 1 and 3 months after treatment. They completed the International Index of Erectile Function and the International Prostate Symptom Score (IPSS) questionnaires at baseline and each review. Scores were designated to indicate the visit number and differences between the visits calculated. RESULTS: A third of the men had an initial IPSS of > 7; there was no relationship between baseline urinary and sexual function scores. After treatment with sildenafil, the urinary scores at 3 months correlated strongly with the sexual function scores. There was a significant inverse relationship between the baseline IPSS and sexual function scores after treatment. The overall trend in the IPSS was towards improvement after treatment with sildenafil. CONCLUSIONS: In men with ED there is no relationship between sexual function scores and urinary symptom scores before treating ED. Treatment with sildenafil appears to improve urinary symptom scores. A lower IPSS at baseline appears to predict a better response to ED therapy with sildenafil.