Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.     

Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects

OBJECTIVES: To evaluate the efficacy, safety, and tolerability of sildenafil in men with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy control subjects. METHODS: One hundred eleven patients were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments included the International Index of Erectile Function (IIEF), a global assessment question, and patient event log data. In a separate, nontreatment study, 109 control subjects also completed the IIEF. RESULTS: Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED. After treatment, mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo (P<0.01). Responses to the global assessment question and patient log data corroborated the IIEF results. Sildenafil was well tolerated, with no discontinuations because of adverse events. CONCLUSIONS: The results indicate that sildenafil, an effective oral therapy for the treatment of broad-spectrum ED, is associated with a near normalization of patient erectile function.     

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.     

Clinical efficacy and safety of sildenafil in elderly patients with erectile dysfunction

Erectile dysfunction (ED) is a common medical disorder affecting elderly men. Sildenafil citrate has been shown to be an effective and well-tolerated oral agent for treating ED in the general population of adult men with ED of broad-spectrum etiology. Elderly men are more likely to have concomitant medical problems than the general population of men with ED. In this study, we examined the efficacy and safety of sildenafil administration in elderly patients with ED. Forty-four elderly men with ED (> or = 60 years old) of broad-spectrum etiology were treated with 25 mg or 50 mg doses of sildenafil citrate. Age ranged from 60 to 78 years (65 +/- 4.5; means +/- S.D.). Mean follow-up period was 12.3 +/- 6.5 months, with a range of 1 to 25 months. Primary efficacy assessments were performed using the International Index of Erectile Function 5 (IIEF5) before their first dose of sildenafil and after at least 4 weeks of therapy. Serum testosterone was measured before treatment. The mean IIEF5 among all patients increased from 8.5 +/- 3.9 to 20 +/- 4.2 after sildenafil use (P < 0.0001). In patients younger than 70 years, the IIEF5 score increased from 9.5 +/- 5.0 to 17 +/- 4.3 while in patients 70 years and older, the score increased from 8.2 +/- 3.6 to 21 +/- 3.9, a near normalization. The rate of improvement in younger men was higher than in older men. Serum testosterone before treatment was similar in the two groups. The most commonly experienced adverse events were flushing and dyspepsia, which occurred in 6.8% and 2.3%, respectively. No patients discontinued sildenafil treatment due to adverse events. In conclusion, oral sildenafil is efficacious and well tolerated by elderly men with ED, even among those older than 70 years.     

Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.     

Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia,Ecuador, and Venezuela: a double-blind,multicenter, placebo-controlled study

The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve/maintain erections (P<0.01). Seventy-seven per cent of sildenafil- vs 46% of placebo-treated patients reported improved erections (P<0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P<0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P<0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.     

Sildenafil combined with continuous positive airway pressure for treatment of erectile dysfunction in men with obstructive sleep apnea

Objectives To assess efficacy and safety of the combination of sildenafil and continuous positive airway pressure (CPAP), and satisfaction with treatment for erectile dysfunction (ED) in men with obstructive sleep apnea (OSA). Patients and methods Forty men suffering from OSA and concurrent ED were treated with CPAP after a thorough investigation. After a 4-week run-in period, the patients were randomly allocated to treatment for 6 weeks; 20 men to the combination group, receiving additionally 100 mg sildenafil on demand for intercourse, and 20 men to CPAP alone. After a 1-week washout phase, the two groups switched to the other treatment arm for an additional 6 weeks period. End points for efficacy evaluation were the percentage of successful attempts for intercourse based on an event log and the overall satisfaction with sildenafil in the treatment of ED. Results The patients recorded a total of 149 attempts for intercourse during the run-in phase with a success rate of 19.5%. During the 12 weeks of treatment, the success rate of intercourse attempts was 24.8% when only on CPAP and 61.1% when in combination with sildenafil (P < 0.001). Of the studied men, 70% were satisfied with the use of sildenafil while 30% remained unhappy with this additional treatment. Conclusions Sildenafil in combination with CPAP appears clearly superior to CPAP alone. The efficacy of this combination is superior to that of sildenafil alone, as reported in previous studies. Both treatment modalities are safe and well tolerated. However, approximately one-third of the patients remain unsatisfied even from the␣combination treatment. Further treatment options are needed.     

Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial

OBJECTIVE: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile. CONCLUSION: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).     

Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal

The long-term efficacy and safety of oral Viagra (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10-100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil. Sildenafil was taken as needed (not more than once daily) approximately 1 h prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording. In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%). Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. In men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.     

Tolerability and safety profile of sildenafil citrate (Viagra) in Latin American patient populations

Safety data from 546 men with erectile dysfunction (ED) enrolled in three double-blind, placebo-controlled studies conducted in distinct regions of Latin America were pooled and analyzed. The most commonly reported adverse events of all causalities associated with sildenafil treatment were headache (19%), flushing (14%), dyspepsia (6%), and nasal congestion (4%), reflecting the inhibitory effects of sildenafil on cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) in the peripheral vasculature, gastroesophageal sphincter, and nasal mucosa. Visual symptoms were reported in 5.5%, reflecting sildenafil's minor inhibitory effects on cGMP-specific PDE6 in the retina. These adverse events were generally transient and mild, and rarely resulted in discontinuation of sildenafil therapy. Thus, in this representative sample of Latin American men with ED, including those with concomitant stable cardiovascular disease, sildenafil treatment was well tolerated with an incident rate of adverse events similar to reports from other patient populations.     

Self-esteem, confidence and relationship satisfaction in men with erectile dysfunction: a randomized, parallel-group, double-blind, placebo-controlled study of sildenafil in Mexico

Erectile dysfunction (ED) negatively impacts self-esteem and relationship satisfaction. The Self-Esteem and Relationship (SEAR) questionnaire is a validated, ED-specific, patient-reported instrument that specifically addresses self-esteem and relationship issues within the context of ED. Effective ED treatment with sildenafil in a double-blind, placebo-controlled clinical trial conducted in Brazil, Mexico, Australia and Japan showed pooled cross-cultural improvements in self-esteem, confidence and relationship satisfaction. This report focuses on the results from the subgroup of men from nine Mexican centers who participated in the multinational study. A total of 95 men aged >or=18 years with clinically diagnosed ED and currently in a stable relationship were randomized to placebo (n=47) or sildenafil (n=48). The SEAR results for Mexican men showed that sildenafil treatment led to significant improvements in self-esteem, confidence and relationship satisfaction. These data support an earlier study showing that Latin American men taking sildenafil have similar safety and efficacy profiles compared to non-Latin counterparts.     

ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.     

Erectile dysfunction in men with obstructive sleep apnea syndrome: a randomized study of the efficacy of sildenafil and continuous positive airway pressure

The aim of this study was to compare the efficacy of sildenafil and continuous positive airway pressure (CPAP) in men with erectile dysfunction (ED) and obstructive sleep apnea syndrome (OSAS). In all, 30 men were randomly treated for 12 weeks either with sildenafil 100 mg before intercourse (15 men) or CPAP during night time sleep (15 men). Under sildenafil, 97/180 (53.9%) of attempted intercourses were successful compared to 33/138 (23.9%) under CPAP. The mean IIEF (erectile function domain score) was 12.9 and 9.3 after sildenafil and CPAP treatment, respectively (P=0.007), compared to 7.9 and 7 at baseline. In all, 53.3% of patients were satisfied with sildenafil and 20% with CPAP for ED treatment (P=0.058). Although sildenafil was superior to CPAP, comorbidities and OSAS per se possibly resulted in a lower effectiveness of sildenafil compared to that in the general population of ED men. While about half of the patients were not satisfied even with the more effective treatment, we conclude that a combination of the two therapeutic tools or a different therapeutic mode should be studied further.     

Sildenafil versus continuous positive airway pressure for erectile dysfunction in men with obstructive sleep apnea： a comparat-ive study of their efficacy and safety and the patient＇s satisfaction with treatment

Aim： To assess the efficacy of sildenafil and continuous positive airway pressure （CPAP） in the treatment of concurrent erectile dysfunction （ED） with obstructive sleep apnea （OSA）, and to gauge the level of treatment satisfaction in patients and their partners. Methods： Forty men were treated for 12 weeks with sildenafil 100 mg （20 men） or CPAP during nighttime sleep （20 men）. Treatment efficacy was assessed by the rate of successful intercourse attempts, and satisfaction with treatment was assessed by patients＇ and partners＇ answers to question 1 of the Erectile Dysfunction Inventory of Treatment Satisfaction. Results： Under sildenafil, 128 of 249 （51.4%） intercourse attempts were successful; under CPAP, 51 of 193 （26.9%） attempts were successful （^cp 〈 0.001）. Erectile function was improved in both groups. After sildenafil and CPAP treatment, the mean International Index for Erectile Function domain scores were 14.3 and 10.8, respectively （^bp = 0.025）, compared to 7.8 and 7 at baseline, respectively. CPAP and sildenafil were well tolerated. Sporadic episodes of nasal dryness under CPAP and transient headache and flushing under sildenafil were not significant. Fifty percent of patients treated with sildenafil and 25% with CPAP were satisfied with the treatment, and their partners were equally satisfied. The satisfaction scores for both patients and partners under sildenafil were superior to those under CPAP （^cP 〈 0.002）. Conclusion： Both sildenafil 100 mg and CPAP, used separately, had positive therapeutic impact but sildenafil was superior. Patients and their partners were more satisfied with sildenafil for the treatment of ED. However, because of the high proportion of dissatisfied men and partners, new therapeutic agents or a combination of the two methods must be studied further.     

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.     

Prognostic factors predicting successful response to sildenafil after radical cystoprostatectomy

OBJECTIVES: To assess the efficacy and safety of sildenafil citrate in the management of erectile dysfunction (ED) following radical cystectomy (RC) and to define the different prognostic factors predicting the response to sildenafil in such a challenging group of patients. MATERIAL AND METHODS: One hundred patients with ED following RC participated in an open-label, non-randomized, prospective, dose-escalation study. The median age of the patients was 53 years and the mean period after RC was 80.7 +/- 54.8 months. The study duration was 12 weeks, comprising a 4-week run-in period followed by two active treatment periods of 4 weeks each with 50 and 100 mg of sildenafil. Patients were assessed by means of the International Index of Erectile Function (IIEF) questionnaire at baseline and after each treatment period. At the end of the study, the Global Efficacy Assessment Question was used to evaluate treatment satisfaction. Factors affecting the patient's response to sildenafil were assessed by means of uni- and multivariate analysis. RESULTS: The entire study group was suffering from severe ED at baseline, with a mean erectile function (EF) domain score of 6.5 +/- 0.93. EF scores improved to 12.2 +/- 7.76 and 18 +/- 10.3 with 50 and 100 mg of sildenafil, respectively. Sildenafil therapy significantly improved the ability of many patients to achieve and maintain an erection. The mean scores for question 3 of the IIEF were 1 +/- 0.14, 2.1 +/- 1.4 and 3 +/- 1.8 at baseline and with 50 and 100 mg of sildenafil, respectively, while the corresponding scores for question 4 were 1 +/- 0.10, 1.9 +/- 1.35 and 3 +/- 1.85. The satisfaction rate was 54%. The response was dose-dependent but the incidence of adverse effects increased from 6% with 50 mg of sildenafil to 34% with 100 mg. In univariate analysis, tumor histology and grade and postoperative partial tumescence were found to significantly impact the patient's response to sildenafil. In multivariate analysis, postoperative partial tumescence was the only independent predictive variable. CONCLUSIONS. Sildenafil was found to be a safe and satisfactory treatment for post-RC ED. The effect was dose-related. Patients with postoperative partial tumescence were the best responders.     

Efficacy of sildenafil for Japanese patients with audio-visual sexual stimulation (AVSS) test by the RigiScan Plus

Sildenafil is most effective in men with mild-to-moderate ED, but not severe ED in Japan. In order to evaluate the efficacy of sildenafil, we conducted the present study using the AVSS test by the RigiScan Plus. The subjects were 56 patients (age: 34-82 years, mean: 60.5 years) with ED. The IIEF5 questionnaire and the AVSS test were conducted before and after administration of sildenafil. The penile rigidity could not be measured in 19 patients. Of these 19, sildenafil was effective in 7 and not effective in 12. The 7 cases in whom sildenafil was effective were all false-negatives. The sensitivity of sildenafil was 84%, and its specificity was 100%. This study suggests that the AVSS test by RigiScan Plus can objectively evaluate the efficacy of sildenafil, and shows potential for predicting that efficacy.     

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.     

西地那非和育亨宾治疗勃起功能障碍疗效比较

为了对照性研究应用西地那非（Ｓｉｌｄｅｎａｆｉｌ,Ｖｉａｇｒａ＾ＴＭ）和育亨宾治疗男子阴茎勃起功能障碍（ＥＤ）的疗效。把２３４例ＥＤ（器质性４１％,心理性４６％,混合性１３％）随机双盲分为两组,西地那非组１３４例,用西地那非５０～１００ｍｇ,性交前６０分钟口服,每天一次,连服２天后,改为２～３天服一次,连用４～１２周。育亨宾组１００例,用育亨宾（Ｙｏｈｉｍｂｉｎｅ）５．４～１０．８ｍｇ,每天服３次     

Salvage of sildenafil failures with cabergoline: a randomized, double-blind, placebo-controlled study

To evaluate the safety and efficacy of cabergoline in men with erectile dysfunction (ED) who did not respond to sildenafil. Four hundred two sildenafil nonresponders aged from 21 to 59 years were included in the study. Patients were randomly divided into group 1, those who received 0.5-1 mg cabergoline weekly for 6 months and group 2, who received placebo for the same period. They underwent preliminary assessment, including medical and sexual history, self-administered International Index of Erectile Function (IIEF) and intravaginal ejaculatory latency time (IVELT) evaluation. Standard biochemistry and hematological laboratory tests, and measurement of serum testosterone and prolactin levels were also carried out. When indicated, other tests were used to establish the diagnosis of vasculogenic and neurogenic ED, including penile color duplex Doppler ultrasonography, pudendal nerve conduction test and impaired sensory-evoked potentials studies. The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of the study, using responses to IIEF, IVELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. The trial was completed by 370 (92%) men. Positive clinical results were seen in 31.2% of patients in the cabergoline group compared with 7.1% of patients in the placebo group (P=0.04). The mean weekly intercourse episodes increased from pretreatment values of 1.4 and 1.2 to 2.2 and 1.4, for cabergoline and placebo, respectively (P=0.04). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 15 and 10 at 6-month treatment in groups 1 and 2, respectively (P=0.04). The IVELT after cabergoline and placebo gradually increased from 98 and 101 s to approximately 242 and 116 s, respectively (P=0.001). More drug-related adverse effects occurred in cabergoline group and 12 (5.9%) had to discontinue treatment (P=0.001). Cabergoline is moderately effective salvage therapy for sildenafil nonresponse. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in ED.