Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care

To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.     

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.     

A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction

OBJECTIVE: To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. PATIENTS AND METHODS: In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data. RESULTS: After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. CONCLUSION: Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.     

Efficacy and safety of sildenafil for treating erectile dysfunction in patients on dialysis

OBJECTIVE: To assess the efficacy of sildenafil for erectile dysfunction (ED) in patients on haemodialysis (HD) or peritoneal dialysis (PD), as men with end-stage renal disease (ESRD) often have sexual dysfunction (up to 82% among those on chronic dialysis). PATIENTS AND METHODS: Forty-one patients with ED and in ESRD participated in an open-label prospective study. Thirty patients on HD and 11 on PD were asked to complete the International Index of Erectile Function (IIEF) and Fugl-Meyer life-satisfaction scale before and after sildenafil treatment. A total score in the erectile function domain of < or = 25 was accepted as indicating ED. All patients were started on a 25-mg dose, which was increased to 50 mg if there was no response after two trials. In addition, the overall efficacy question was used to evaluate satisfaction, and patients reported any side-effects during treatment. RESULTS: The erectile function and intercourse satisfaction domains improved significantly in both groups (P < 0.01). After sildenafil treatment, two-thirds of those on HD (20/30) and nine of the 11 on PD recovered their erectile function. The pretreatment scores on the IIEF and four domains (except sexual desire) of those responding were significantly higher than in those not responding (P < 0.05). The satisfaction rate on the overall efficacy question was 80% and 82% for the HD and PD groups, respectively. At least one side-effect was seen in 17 patients (43%); one had severe hypotension in the PD group. Overall, mild headache (seven patients, 18%) and flushing (12, 30%) were reported most often. CONCLUSIONS: Sildenafil is a safe and satisfactory drug for improving erectile function in patients with ESRD. Patients were satisfied whether treated by HD or PD. Pretreatment scores on the IIEF may be useful for predicting the success of treatment.     

A baseline-controlled,open-label,flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction

Although sildenafil citrate (Viagra) has demonstrated effectiveness in the treatment of erectile dysfunction (ED), the dosing regimens often used in clinical trials may not always match those employed in clinical practice. This study was undertaken to further assess the efficacy and safety of sildenafil taken as required in male outpatients 18 years of age and older with ED (n=71). It was conducted as a placebo-baseline-controlled, open-label, flexible dose-escalation study, with sildenafil (25,50, or 100 mg) administered for 8 weeks following a 4-week placebo run-in. Efficacy variables included questions 3 and 4 of the International Index of Erectile Function (IIEF), other IIEF domains, patient event logs, and quality-of-life (QOL) assessments. Treatment with sildenafil resulted in improvements from baseline in all IIEF domains analyzed (all P<0.0001), as well as overall QOL and amelioration of specific sexual and social relationships (all P&<0.0001). Sildenafil was well tolerated. One participant discontinued treatment because of adverse events. Results suggest that flexible dosing with oral sildenafil is safe and has beneficial effects on all indices of erectile function and QOL.     

The efficacy of sildenafil in different etiologies of erectile dysfunction

PURPOSE: The aim of this study was to evaluate the efficacy of sildenafil and success of treatment in particular etiological causes in erectile dysfunction lasting more than 3 months. MATERIAL AND METHODS: A total of 141 patients between 27 and 78 years old without any cardiac compromise, despite controversial, which precludes sildenafil (Viagra) treatment, were included in this study. All patients had only International Index of Erectile Capacity Form (IIEF) for pre-treatment evaluation and 50 mg sildenafil was started. Patients were assessed monthly for 6 months thereafter. Erectile capacity changes were questioned by IIEF on each follow-up and 100 mg sildenafil was given in patients without a response and monthly follow-up was scheduled. All patients had SMA-12, hormonal analyses and penile colour Doppler ultrasonography during the treatment course. The difference between IIEF score of each patient was displayed by Paired-t test and p-values less than 0.05 was applied as significant. RESULTS: The average beginning IIEF score of 141 patients was 11.80 +/- 0.47 [6-22], and increased to 20.70 +/- 0.62 [6-30] after a month of 50 mg sildenafil treatment. The mean increase was 75.4% and found to be significant (p = 0.000, p < 0.05). The average IIEF scores were recorded as 22.57 +/- 0.69 after 3, and 22.12 +/- 0.24 after 6 months. There was no difference between these values and 2nd month controls (P3 month = 0.5675, P6 month = 0.6138, p > 0.05). A positive response was recorded in 102 patients (72.3%) and 39 (27.7%) patients were unresponsive. Doubled doses of sildenafil (100 mg) was effective in additional 17 patients. After overall treatment, 119 (84.4%) patients had benefit from sildenafil. Penile Doppler ultrasonography displayed arterial insufficiency in 79 (56.03%), veno-occlusive dysfunction in 14 (9.93%), mixt vascular pathology in 14 (9.93%) patients. Normal ultrasonographic findings in 32 patients (22.7%) were classified as psychogenic dysfunction. Among the organic causes, sildenafil was found to be most effective in arterial insufficiency group. CONCLUSION: Sildenafil is a successful management modality in erectile dysfunction with minimal pre-treatment evaluation. As far as etiological causes concerned, sildenafil was found to be most effective in arterial insufficiency group and psychogenic group. The efficacy of sildenafil treatment has not been changed with the treatment time, since IIEF scores were stable during follow-up controls.     

国产枸橼酸西地那非治疗男性勃起功能障碍的安全性和有效性研究

目的:评价国产枸橼酸西地那非(金戈)治疗男性勃起功能障碍(ED)的安全性、有效性和耐受性。方法:采用多中心、随机、双盲、安慰剂对照研究方法,在国内5家医院泌尿外科或男科门诊纳入222例ED患者,随机分为西地那非组(111例)和安慰剂组(111例),进行为期8周的临床治疗观察。以国际勃起功能问卷(IIEF)评分、性交成功率作为有效性评价指标,以不良事件发生率作为安全性评价指标。结果:西地那非组和安慰剂组患者年龄分别为(47.20±11.32)岁和(46.67±13.08)岁(P0.05),ED病因分别为心理性(27.93% vs 23.42%)、器质性(21.62% vs 29.73%)和混合性ED(50.45% vs 46.85%)(P均0.05),其他流行病学数据如身高、体重、民族、吸烟、饮酒、药物过敏史等一般情况也均无统计学差异。对主要疗效指标的分析结果显示,西地那非组与安慰剂组对勃起功能显著有效率分别为78.90%和29.91%(P0.01);西地那非组性交成功率和总体疗效分别为63.87%和77.98%,均明显高于安慰剂组的29.16%和34.58%(P均0.01)。在对于不同种类ED的治疗上,西地那非对心理性、器质性和混合性ED的有效率分别为64.52%、83.33%和82.14%,明显高于安慰剂组的46.15%、21.21%和25.00%(P均0.01)。安全性评价结果显示,共有45例(20.27%)受试者出现了各种不良事件(西地那非组有32例,安慰剂组有13例),所出现的不良事件大多数为轻度、一过性的。结论:国产枸橼酸西地那非是一种可治疗各种病因导致ED的安全有效的药物,且患者耐受性较好。     

A comparative, crossover study of the efficacy and safety of sildenafil and apomorphine in men with evidence of arteriogenic erectile dysfunction

The aim of the study was to establish and compare the efficacy and safety of sildenafil and apomorphine in men with arteriogenic erectile dysfunction (ED). In all, 43 men with ED and postinjection max penile systolic velocity <25 cm/s in repeated Doppler ultrasonography were included. Of these, 24 men started on apomorphine 2 mg and 19 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg according to effectiveness and tolerability. Safety was evaluated according to adverse events (AEs) and patient withdrawal. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on event log data. The incidence of AEs with apomorphine 3 mg was higher than with sildenafil 100 mg. Two men on apomorphine 3 mg discontinued treatment due to AEs. The overall success rate of sildenafil was 63.7% compared to 32.1% of apomorphine (Pearson chi(2), P<0.01). Of all men, 25 (58.1%) responded to sildenafil 50 mg without the need for dose increase, while only one responded to apomorphine 2 mg. The response to sildenafil 50 mg was age related (analysis of variance, p=0.04). Satisfaction was reported by 76.75 and 13.95% of patients for sildenafil and apomorphine, respectively, but 20.9% were not satisfied with any of the two drugs. In conclusion, this study provides clear evidence that sildenafil, even at 50 mg dose, is more effective than apomorphine 3 mg in men with arteriogenic ED. The fact that one out of five patients is not satisfied with the above-studied drugs shows that new oral agents need to be evaluated for the treatment of this disorder.     

Comparison of the efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand sildenafil for erectile dysfunction

BackgroundLow-intensity extracorporeal shock wave therapy (Li-ESWT) is an effective therapy for erectile dysfunction (ED) but is not widely recognized and applied. This prospective nonrandomized study aimed to investigate the efficacy and safety of Li-ESWT.MethodsAfter a 4-week washout period of past ED treatment, patients entered one of 2 active treatment groups, either 9-week Li-ESWT or 100 mg on-demand sildenafil. Patients were evaluated in the first- and third-month following initiation of treatment. The Li-ESWT protocol comprised 2 sessions per week for 3 weeks, which were repeated after a 3-week interval. Patients in the drug group took self-administered sildenafil at a dose of 100 mg before intercourse. The primary outcome was the effectiveness of Li-ESWT measured by the International Index of Erectile Function-5 (IIEF-5) scores. Other measurements included erection hardness score (EHS) and Self-Esteem And Relationship (SEAR).ResultsA total of 78 participants completed the study (46 in the Li-ESWT group and 32 in the sildenafil group). Overall, 26.9% of the participants (21/78) included were psychogenic. In the third month, the outcome measured by IIEF-5 was 21.52 in the Li-ESWT group and 21.26 in the sildenafil group (P>0.05). Proportion of improvement defined by minimal clinically important difference (MCID) criteria was 52.2% in the Li-ESWT group and 59.4% in the sildenafil group (P>0.05). The EHS and SEAR improvement was similar in the 2 groups (P>0.05 at baseline and third month). Transient and mild adverse events were observed in both groups.ConclusionsIn our study, a similar treatment efficacy and safety was shown by the application of Li-ESWT as on demand sildenafil.     

西地那非治疗老年男性勃起功能障碍的疗效观察

目的分析口服西地那非治疗老年男性勃起功能障碍（ED）的有效性及安全性。方法 对86例因ED口服西地那非治疗的老年患者进行回顾性分析，总结其临床资料。结果86例4周服药4次52例，5次26例，6次5例，8次3例。第1次建议服药剂量25mg，4周结束时39例（45.3%）维持25mg，32例（37.2%）服用50mg，仅5例（17.4%）服用10mg。未发现严重的不良反应。西地那非治疗ED的总有效率为86.0%。结论西地那非对老年男性因各种原因引起的ED有明显疗效，副作用少，是老年男性勃起功能障碍的首选疗法。     

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.     

Assessment of the efficacy and safety of Viagra (sildenafil citrate) in men with erectile dysfunction during long-term treatment

Long-term efficacy and safety of sildenafil was assessed in 1008 patients with erectile dysfunction (ED) enrolled in four flexible-dose (25 - 100 mg), open-label, 36- or 52-week extension studies. After 36 and 52 weeks, 92% and 89% of patients felt that treatment with sildenafil had improved their erections. Responses to a Sexual Function Questionnaire indicated that 52 weeks of sildenafil treatment resulted in clinically significant improvements in the duration and firmness of erections, overall satisfaction with sex life, and the frequency of stimulated erections. Commonly reported adverse events (AEs) were headache, flushing, dyspepsia, and rhinitis, which were generally mild to moderate. Reports of abnormal vision were consistent with previous clinical trials. The occurrence of treatment-related cardiovascular AEs, such as hypertension, tachycardia, and palpitation, was <1%. Discontinuations due to treatment-related AEs were low (2%). Long-term therapy does not diminish the efficacy of sildenafil in patients with ED and remains well tolerated.     

Prognostic factors for response to sildenafil in patients with erectile dysfunction.

OBJECTIVE: To assess the clinical efficacy of sildenafil as treatment for erectile dysfunction (ED) the factors associated with treatment failure were investigated. METHODS: Open, prospective study including 244 patients suffering from ED who were evaluated by anamnesis, physical exploration, blood test, dynamic penile color duplex ultrasonography and Sexual Health Inventory for Male (SHIM). The efficacy of sildenafil was assessed by repeating the SHIM 2 months after therapy, independent of the final dose used. Side effects were also recorded. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis. RESULTS: Overall, sildenafil was effective in 56.8% of 213 eligible patients. When the etiologic diagnosis was not included in the multivariate analysis, antecedents of diabetes mellitus, non-nerve-sparing radical prostatectomy and SHIM basal score were selected as predictors of a poor response. In a second analysis including etiologic diagnosis, only SHIM basal score and etiological diagnosis proved to be of prognostic value. Side effects were noticed by 24.4% of patients, none of them being severe. CONCLUSIONS: Sildenafil is a rather effective and well-tolerated treatment for ED. The basal severity of ED and etiological diagnosis are the prognostic factors most significantly associated with treatment outcome.     

后尿道创伤及修复手术致男性性功能障碍和疗效观察

目的 探讨骨盆骨折合并后尿道损伤及其修复手术对性功能的影响和枸橼酸西地那非治疗的效果.方法 41例骨盆骨折合并后尿道损伤导致尿道狭窄的患者,采用IIEF-5评分表对其勃起功能状况进行自我评分,测定时间分别为回顾创伤前,创伤后(入院时),尿道修复手术后拔管后2周以及口服枸橼酸西地那非治疗3个月后4个时间点;血管活性药物注射下阴茎Doppler超声(PPUD)检测阴茎海绵体血流动力学,区分动脉性、静脉性和非血管性ED.尿道修复手术后给予西地那非口服治疗,每次100mg,每周3次,连续3个月.结果 所有患者创伤后均存在不同程度的勃起功能障碍,其发生率为95.1%,所有患者在受伤前后的IIEF-5评分比较,差异有统计学意义;尿道修复手术后IIEF-5评分有轻度下降,但术前和术后比较差异无统计学意义;西地那非治疗后IIEF-5评分明显提高,差异有统计学意义:手术后患者ED的程度与狭窄部位无明显关系.ED患者手术后IIEF-5评分与狭窄长度有一定的关系,长度越长,评分越低,但差异并没有统计学意义.采用西地那非治疗有效率为81.0%:疗效与年龄无关;但与ED程度有关,即ED程度越轻,疗效越好.治疗后IIEF-5评分呈非血管性＞动脉性＞静脉性,但差异无统计学意义.总副反应发生率19.5%,所有患者均能耐受,完成服药治疗过程.结论 尿道损伤往往伴有性功能的创伤,而尿道修复手术对性功能也可能有一定的影响,其中包括诸多因素,如:患者年龄和狭窄长度等.西地那非对不同程度和不同类型的性功能障碍均有治疗作用,且方便和安全.     

西地那非规律服用治疗勃起功能障碍疗效及安全性评估

目的:探讨西地那非规律服用治疗阴茎勃起功能障碍(ED)的疗效及安全性。方法:334例ED患者随机分为3组,分别给予西地那非50 mg每日1次口服(西地那非规律治疗组,n=111)、西地那非100 mg性生活前30 min口服(西地那非按需治疗组,n=102)、他达拉非10 mg每日1次口服(他达拉非规律治疗组,n=121)。3个月后评估国际勃起功能指数(IIEF-5)评分、阴茎勃起硬度评分(EHS)以及不良反应等。结果:334例ED患者中316例获得随访,3组患者年龄、BMI、受教育情况、病程、失访率、基线IIEF-5评分及EHS评分无统计学差异(P0.05)。3组患者治疗后IIEF-5评分及EHS评分均较治疗前明显改善,差异有统计学意义(P0.05)。治疗后西地那非规律治疗组、西地那非按需治疗组及他达拉非规律治疗组IIEF-5评分[(15.15±2.05)分vs(15.55±2.36)分vs(15.54±2.27)分]无统计学差异(P0.05),但西地那非规律治疗组EHS评分[(3.12±1.52)分]低于西地那非按需治疗组[(3.48±1.80)分](P0.05)。西地那非规律治疗组、西地那非按需治疗组及他达拉非规律治疗组治疗有效率分别为76.2%、62.4%和80.8%,西地那非按需治疗组明显低于其他两组(P0.05)。3组不良反应均较轻微,且3组之间不良反应发生率无明显统计学差异(P0.05)。结论:西地那非规律治疗与他达拉非规律治疗疗效相当,优于西地那非按需治疗,且不良反应无明显增加,是一种值得推荐的ED治疗方法。     

Comparison of the efficacy and safety of sildenafil citrate (Viagra) and oral phentolamine for the treatment of erectile dysfunction

This open-label, multi-center study from Mexico compared the efficacy and safety of oral sildenafil and phentolamine in men with erectile dysfunction. Patients received sildenafil (25-100 mg; n=123) or phentolamine (40 mg; n=119) for 8 weeks, and efficacy was assessed using the International Index of Erectile Function (IIEF) as well as two global efficacy questions. Mean scores for the erectile function domain of the IIEF were significantly higher for sildenafil (27.23 +/- 0.62; P=0.0001) than for phentolamine (19.35 +/- 0.66). Approximately twice as many men receiving sildenafil had successful attempts at sexual intercourse (88% vs 42%), improved erections (95% vs 51.1%), and improved ability to have sexual intercourse (94.4% vs 46.4%) compared with phentolamine. The most common adverse events included rhinitis, headache, tachycardia, and nausea, with a higher frequency reported in patients receiving phentolamine than sildenafil (41% vs 33%), with the exception of headache, which was reported more frequently in sildenafil users. Overall, sildenafil was more effective and appeared to be better tolerated than phentolamine for the treatment of erectile dysfunction.     

An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction

Two papers in this section deal with well‐known pharmacological agents used to treat male erectile dysfunction. In the first of these, authors from the UK compared the efficacy and safety of sildenafil and apomorphine in such patients. This open‐label crossover trial suggested that sildenafil was better than apomorphine, where the primary endpoint was the erectile function domain of the International Index of Erectile Function. The second paper is an update on the efficacy and safety of tadalafil. It describes the results of its use in a large number of men with erectile dysfunction, compared to placebo. Once again, the erectile function domain was one of the primary endpoints. Tadalafil was an effective and well tolerated treatment for this condition.

OBJECTIVE

To compare the efficacy and safety of sildenafil and apomorphine in the treatment of men with erectile dysfunction (ED).

PATIENTS AND METHODS

In all, 139 men with ED who were naïve to treatment were entered into an open‐label crossover trial with two treatment periods, each of 8 weeks, separated by a 2‐week washout period. Men were randomized to receive either sildenafil then apomorphine or apomorphine then sildenafil, and were allowed to titrate the dose on both drugs. The primary endpoint was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and other endpoints included diary data, the other domains of the IIEF, overall assessment questions and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire.

RESULTS

The EF domain score after treatment was 25.2 for sildenafil and 15.9 for apomorphine. The treatment difference of the adjusted means was 9.3 points (95% confidence interval 7.6–11.1; P < 0.001). After sildenafil the successful intercourse rate was 75%, vs 35% for apomorphine (P < 0.001), and the EDITS scores were 82.5 for sildenafil and 46.8 for apomorphine (P < 0.001). Of the men, 96% expressed a preference for sildenafil as a treatment for their ED. The side‐effect profiles for both drugs were in keeping with published data.

CONCLUSION

By all measurable endpoints sildenafil was superior to apomorphine in this open‐label crossover study of men with ED who were naïve to therapy