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.     

Medical management of erectile dysfunction in aging males： is it too late to treat？

Erectile dysfunction （ED） is a common disorder among aging males. However, most aging males refuse to seek medical help and believe that ED is an irreversible event in the aging process. The purpose of this study was to describe the current medical management of ED in aging males and to examine whether it is too late to treat this disorder in these elderly men. From 2007 to 2008, 4507 patients diagnosed with ED were gathered from 46 centers in China; 4241 completed the study, 3837 of whom were treated with sildenafil. The 3837 patients were divided into five groups based on age （group A： 20-30 years; group B： 31-40 years; group C： 41-50 years; group D： 51-60 years; and group E： 〉60 years）. After comparing pre- and posttreatment International Index of Erectile Function-Erectile Function domain （IIEF-EF） questionnaires, Erection Hardness Scale （EHS）, and IIEF Q13 （＂How satisfied have you been with your overall sex life？＂）, we discovered that the aging males had worse erectile function, erection hardness, and sexual satisfaction than the younger males （P〈 0.001）. After treatment, the improvement rates in the IIEF-EF, EHS, and IIEF Q13 scores were 107.0%, 83.1%, and 116.5%, respectively. The magnitude of these changes demonstrated significant differences among groups （P 〈 0.001）. Accordingly, aging males are likely to benefit more from medical treatment. We propose that aging males should be informed that age is not a limiting factor for medical ED management, and it is never too late to treat.     

Evaluation of an alternative dosing regimen with tadalafil, three times per week, for men with erectile dysfunction： SURE study in Italy

Aim： To examine the preference for two dosing regimens of 20 mg of tadalafil, on demand or three times per week, in men affected with erectile dysfunction （ED） in Italy. Methods： Scheduled Use versus on demand Regimen Evaluation （SURE） is a multicenter, crossover and open-label study, involving 94 urology centers in Italy. Patients aged 18 years or older affected with ED for at least 3 months were enrolled and randomized to 20 mg of tadalafil treatment on demand or three times per week for 5-6 weeks. After a 1-week washout, patients were crossed over to the alternate regimen for 5-6 weeks. A treatment preference question was used to determine the preferred treatment regimen. International Index of Erectile Function （IIEF） and Sexual Encounter Profile （SEP） questionnaire were used as efficacy measures. Results： A total of 1 058 men （mean age 54.8 years）, were randomized to treatment. Overall, 59.1% of patients preferred the on-demand regimen and 41.9% preferred the three times per week dosing. Both regimens were efficacious and well tolerated. Although a statistically higher improvement of the IIEF erectile function （IIEF-EF） domain score and the SEP questionnaire was reported for the three times per week compared to the ondemand treatment regimen, this difference was numerically minimal and lacking in clinical significance. Conclusion： Tadalafil is effective and well tolerated whether used on demand or three times per week. Patients should be given the option to choose the best treatment regimen according to personal needs and preferences.     

The role of statins in erectile dysfunction： a systematic review and meta-analysis

To evaluate the effect of statins for erectile dysfunction （ED）, a systematic review of the literature was conducted in the Cochrane Library, Embase and PubMed from the inception of each database to June 2013. Only randomized controlled trials （RCTs） comparing treatment for ED with statins were identified. Placebo RCTs with the International Index of Erectile Function （IIEF） as the outcome measure were eligible for meta-analysis. A total of seven RCTs including two statins with a total of 586 patients strictly met our criteria for systematic review and five of them qualified for the meta-analysis. A meta-analysis using a random effects model showed that statins were associated with a significant increase in IIEF-5 scores （mean difference （MD）： 3.27; 95% confidential interval （CI）：1.51 to 5.02; P〈 0.01） and an overall improvement of lipid profiles including total cholesterol （MD： -1.08; 95% Ch -1.68 to -0.48; P 〈 0.01）, low-density lipoprotein （LDL） cholesterol （MD： -1.43; 95% Ch -2.07 to -0.79; P 〈 0.01）, high-density lipoprotein （HDL） cholesterol （MD： 0.24; 95% Ch 0.13 to 0.35; P〈 0.01） and triglycerides （TGs） （MD. -0.55; 95% Ch -0.61 to -0.48; P 〈 0.01）. In summary, our study revealed positive consequences of these lipid-lowering drugs on erectile function, especially for nonresponders to phosphodiesterase type 5 inhibitors （PDE51s）. However, it has been reported that statin therapy may reduce levels of testosterone and aggravate symptoms of ED. Therefore, larger, well-designed RCTs are needed to investigate the double-edged role of statins in the treatment of ED.     

The effect of α-blocker therapy on erectile functions in patients with lower urinary tract symptoms due to benign prostate hyperplasia

In this study we aimed to evaluate the impact of doxazosin treatment on erectile functions in patients with lower urinary tract symptoms （LUTS） and having erectile dysfunction （ED） at baseline. Fifty-three patients with LUTS （IPSS score 〉 7） whose maximum flow rate （Qmax） 〈 15 mL s-1 and PSA 〈 4 ng dL^-1 were enrolled in the study. Patients received doxazosin 4 nag once daily for 6 weeks. Subjective efficacy was assessed by IPSS, IPSS- Quality of Life （IPSS-QoL） for LUTS and efficacy was assessed by International Index of Erectile Function （IIEF） for erectile functions at baseline and sixth weeks. The objective efficacy was assessed by Q The patients were classified according to their self reported erectile status： group I had ED and group II did not have ED. At the endpoint, doxazosin significantly improved the total IPSS score （-7.7 ±6.1, P = 0.006）, IPSS-QoL score （-1.5 ± 1.5, P = 0.024） and Qmax （3.2 ± 4.6 mL s^-1, P = 0.002） over baseline. Mean decrease in IPSS and IPSS-QoL scores after the treatment period were 6.9 ＋ 6.4 （P 〈 0.001） and 0.95 4- 1.80 （P 〈 0.05） in group I, whereas 8.2 4- 5.8 （P 〈 0.001） and 1.9 4- 1.1 in group IX （P 〈 0.001）, respectively. Mean changes of Qmax values were 2.3 4- 3.3 mL s^-1 in group I （P 〈 0.05） and 3.7 4- 5.3 mL s-1 in group II （P 〈 0.001）. The improvement of IIEF-EF scores after the treatment period was only significant for group I. The efficacy of a-blocker therapy for LUTS was better by means of symptomatic relief for patients who did not have ED when compared with patients who had ED at baseline. However, slight improvement in erectile functions with a-blocker therapy was only seen in LUTS patients with ED.     

Evaluation of tetrahydrobiopterin （BH4） as a potential therapeutic agent to treat erectile dysfunction

Aim： Nitric oxide （NO）-mediated smooth muscle relaxation causes penile erections. The endothelial NO synthase （eNOS） coenzyme tetrahydrobiopterin （BH4） converts eNOS-mediated catalytic activity from oxygen radical to NO production, improving endothelial function and vascular smooth muscle relaxation. Methods： Using quantitative immunohistochemistry, 8-isoprostane and nitrotyrosine concentrations were compared in cavernosal tissue from 17 potent and 7 impotent men, and the effect of single oral doses of BH4 on penile rigidity and tumescence was investigated. The pharmacodynamic effect of single oral doses of BH4 on penile rigidity and tumescence was investigated in a randomized, placebo-controlled, double-blind cross-over fashion in 18 patients with erectile dysfunction （ED） while receiving visual sexual stimulation. Results： 8-isoprostane content in endothelium and smooth muscle was signifi- cantly higher in impotent patient samples; the level of nitrotyrosine was unchanged in ED patients. Relative to placebo, a single dose of 200 mg BH4 led to a mean increase in duration of 〉 60% penile rigidity （33.5 rain [95% confidence interval （CI）： 13.1-49.3] at base and 29.4 rain [95% CI： 8.9-42,2] at tip）. A 500-mg dose increased the relative duration of 〉 60% penile rigidity by 36. I rain （95% CI： 16.3-51.8） at the base and 33.7 rain （95% CI： 11.4-43.9） at the tip. Treatments were well tolerated. Conclusion： BH4 treatment is suggested to switch eNOS catalytic activity from super-oxide to NO formation, leading to a reduced formation of free radical reaction product 8-isoprostane without alteration of nitrotyrosine. The observed results make BH4 a suitable candidate as an ED treatment through reconstitution of altered catalytic activity of the eNOS. （Asian JAndro12006 Mar; 8： 159-167）     

Treatment preferences in men with erectile dysfunction： an open label study in Korean men switching from sildenafil citrate to tadalafil

To evaluate patient preferences for sildenafil citrate or tadalafil （PDE-5 inhibitors available for the treatment of erectile dysfunction [ED]） and assess potential reasons for these preferences. Methods： This open-label study was conducted on Korean men taking sildenafil, at least 6 weeks prior to study entry, for ED. Following screening, patients continued sildenafil treatment for 4 weeks, then after a 1-week washout period, switched to tadalafil for 8 weeks. Patients then continued with their treatment of choice during an extension phase. Psychosocial factors （time concern, spontaneity, sexual self-confidence） were evaluated using Psychological and Interpersonal Relation- ship Scales （PAIRS）, while timing of dose to sexual attempt patterns were assessed from patient diaries. Results： The present study enrolled 160 Korean men （mean age 55 years） with prior median sildenafil use of 585 days. During the extension phase, 73.7% of patients elected to take tadalafil, whereas 26.3% chose sildenafil （P 〈 0.001）. After switching from sildenafil to tadalafil, mean PAIRS time concern scores decreased from 2.54 to 2.42 （P = 0.002）, with no statistically significant differences observed between the sildenafil and tadalafil assessment phases in sexual spontaneity and self-confidence scores. Sexual attempts made 〉 4 h to 〈 36 h post-dose occurred in 4.5% of patients during the sildenafil assessment phase compared with 17.5% during the tadalafil assessment phase. Conclusion： After experiencing both sildenafil and tadalafil, the majority of patients exhibited a preference for tadalafil. This preference might be influenced by psychosocial factors, such as decreased time concerns, and a broader window of opportunity available for sexual activity.     

Efficacy and limits of sildenafil citrate in patients with arterial erectile dysfunction： role of peripheral arterial disease and cardiovascular comorbidities

Aim： To evaluate whether the response to sildenafil administration in patients with arterial erectile dysfunction （ED） was related to their peak systolic velocity （PSV）, peripheral atherosclerosis, cardiovascular risk factors （RF） and/or comorbidities at low cardiovascular risk. Methods： We enrolled 97 patients with 1-2 RF and comorbidities, combined with arterial ED alone （group A, n = 27）, ED plus atherosclerotic carotid artery （group B, n = 23）, ED plus lower limb artery abnormalities （group C, n = 25）, and ED plus carotid and lower limb artery abnormalities （group D, n = 22）. Sildenafil efficacy （100 mg twice a week for 12 weeks） was also examined in patients with ≥ 3 RF, peripheral a（herosclerosis and no cardiovascular comorbidities （group E, n = 20）. Results： Median PSV was 24.1, 21.0, 19.3, 14.5 and 17.5 cm/s in groups A, B, C, D and E, respectively. Sildenafil response was higher in group A patients （77.8%）, intermediate in groups B and C （65.2% and 56%） and lowest in groups D （45.4%） and E （50%）, and the response in latter two groups was significantly lower than in the other three groups. In addition, sildenafil response was nega- tively influenced by： 〉 3 RF, peripheral atherosclerosis and no systemic comorbidity, or presence of 1-2 RF associated with extended atherosclerosis and comorbidities. The number of comorbidifies was positively related to atherosclerosis localization or extension （25, 35, 38 and 47 in groups A, B, C and D, respectively）. Conclusion： Low sildenafil efficacy in patients with arterial ED was associated with extended atherosclerosis. These patients should undergo extensive ultrasonography and a full cardiovascular examination.     

Different hemodynamic responses by color Doppler ultrasonography studies between sildenafil non-responders and responders

Aim： To determine if there are different penile hemodynamic patterns between sildenafil non-responders and responders by using color Doppler ultrasonography. Methods： A total of 69 erectile dysfunction （ED） patients aged 22-79 years were enrolled into the present study. Thirty-eight （55.1%） men with ED who did not respond to four attempts of treatment with 100 mg sildenafil after re-education were classified as sildenafil non-responders. A com- bination of three vasodilator drugs, 1.25 mg papaverine, 0.4 mg phentolamine and 5 ug prostaglandin E1, was given by intracavernous injection before penile Doppler ultrasonography was carried out. The erectile response to intracavernous injection and vascular parameters including peak systolic velocity （PSV）, resistance index （RI）, end diastolic velocity （EDV） and cavernosa artery diameter （CD） were measured and the results between sildenafil nonresponders and responders were compared. Results： No statistical difference in vascular parameters measured by Doppler ultrasonography studies between non-responders and responders was noted. Sildenafil non-responders had a poorer penile rigidity response to intracavernous injection than responders （P 〈 0.05）. Among patients with adequate PSV （〉 30 cm/s） and abnormal EDV （〉 5 cm/s）, individuals in the non-responder group had fewer positive responses to intracavernous vasodilator injection than in the responder group （35.3% vs. 72.2%, P 〈 0.05）. Advanced age and comorbidity with diabetes mellitus were significantly associated with sildenafil non-response （P 〈 0.05）. Conclusion： Sildenafil non-responders were characterized by a poorer penile rigidity response to intracavernous injection and had an associated impaired veno-occlusive mechanism. Advanced age and comorbidity with diabetes mellitus were two common factors associated with non-response.     

Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction： a randomized double-blind, parallel, placebo-controlled clinical study

Aim： To assess the efficacy and safety of tadalafil in comparison to a placebo, when taken on demand for 12 weeks by East/Southeast Asian men with erectile dysfunction （ED）, Methods： This multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August 2002 and February 2003. Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive a placebo or 20 mg of tadalafil taken as needed （maximum once daily）. Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile diary and Global Assessment Questions. Results： Tadalafil significantly improved erectile function as compared to the placebo （P 〈 0.001）. At the endpoint, the patients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts （Sexual Encounter Profile question 3： 70.9% compared to 33.5% in the placebo） and a greater proportion of improved erections （Global Assessment Question： 86.2% compared to 30.1%）. Most （≥3%） treatment emergent adverse events were mild or moderate. The most common treatment emergent adverse events were headache, back pain, dizziness and dyspepsia. Conclusion： Tadalafil was an effective and well-tolerated treatment for ED in East and Southeast Asian men.     

Long-term treatment of erectile dysfunction with a phosphodiesterase-5 inhibitor and dose optimization based on nocturnal penile tumescence

Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands

OBJECTIVE

To test the hypothesis that a variable dosage of the oral phosphodiesterase type 5 (PDE5) inhibitor sildenafil (25, 50, 100 mg) or vardenafil (5, 10, 25 mg) determined according to results obtained from nocturnal penile tumescence and rigidity (NPTR, RigiScan), given nightly for 1 year, can improve spontaneous erectile function (EF) in men with mild‐to‐moderate arteriogenic erectile dysfunction (ED); this regimen was compared with a fixed daily dosage of sildenafil 25 mg or vardenafil 5 mg.

PATIENTS AND METHODS

In a prospective open‐label, parallel‐group trial 154 men with ED were randomized either to fixed low‐dose sildenafil 25 mg or vardenafil 5 mg (group 1) or to the lowest erectile dosage of sildenafil (25, 50 or 100 mg) or vardenafil (5, 10 or 20 mg) (group 2) provoking an erectile event as measured by NPTR nightly for 1 year. The EF domain of the International Index of Erectile Function (IIEF) was assessed before and 1 year after the beginning of treatment, and at 4 weeks after ending treatment.

RESULTS

After 1 year, 27 of 63 (64%) evaluable men in group 1 had an EF domain score in the normal range, vs 46 of 61 (75%) men in group 2. After the subsequent 4‐week wash‐out phase, both groups continued to have improved EF domain scores; 22 of 63 (35%) men in group 1 still had a score in the normal range, whereas 38 of 61 (62%) in group 2 had a normal score. The EF domain score in group 1 and 2 improved significantly after 1 year of treatment, from 13.6 to 18.9, and 15.1 to 23.9, respectively (P < 0.01). After the subsequent 4‐week wash‐out phase, men from both groups maintained this significant level of EF, at 17.1 and 22.4, respectively (P < 0.05).

CONCLUSION

Nightly PDE5‐inhibitor treatment 1 year in a dosage determined by NPTR measurements results in better EF than giving a fixed dosage of sildenafil (25 mg) or vardenafil (5 mg). This improvement persisted for >4 weeks beyond the end of treatment. The results from this open‐label, randomized trial warrant verification under double‐blind, placebo‐controlled conditions.     

Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction

OBJECTIVE: Tadalafil (Cialis) is an inhibitor of phosphodiesterase type 5, which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection. The purpose of this multicentre, randomized, double-blind, parallel group, placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-demand Cialis in men with mild-to-severe erectile dysfunction (ED). METHODS: Following a 4-week treatment-free run in period, patients stratified into three severity groups by the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score were randomized to receive either placebo or Cialis 20 mg taken on demand over a 12-week period. Efficacy endpoints were change from baseline in IIEF EF domain scores, responses to Sexual Encounter Profile diary (SEP) questions, and responses to the Global Assessment Questions (GAQ). Treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire in two of seven participating countries where validated translations were available. RESULTS: Of the 443 men who entered the trial, 409 (mean age, 52 years) formed the intent-to-treat population. Mean baseline demographics and ED severity measures were balanced between treatment groups except for a higher percentage of patients na?ve to sildenafil in the tadalafil group compared to placebo (50% versus 36%). The percentage of patients in each IIEF EF severity class (mild, moderate and severe) was 47%, 30% and 23% for placebo patients and 48%, 29% and 23% for tadalafil patients, respectively. Tadalafil was significantly superior to placebo on all primary efficacy measures (IIEF EF domain scores, SEP15, GAQ1; p < 0.001); notably 64% of tadalafil patients achieved a normal IIEF EF domain score at endpoint compared to 16% of placebo patients (p < 0.001). Of the 185 patients completing the EDITS questionnaire (137 receiving Cialis and 48 receiving placebo), tadalafil-treated patients had a median EDITS score of 84 (95%CI 80, 86), which was significantly higher than the median score for placebo-treated patients of 41 (95%CI 32, 59; p < 0.001; Wilcoxon test). The proportion of patients satisfied with treatment (defined as final EDITS score greater than 50) was 87% for the tadalafil-treated group and 46% for the placebo-treated group (p < 0.001; exact test). Adverse events were significantly more common with tadalafil than placebo (p < 0.01) and included primarily headache (7.2% versus 1.9%) and flushing (4.6% versus 0%). One patient discontinued tadalafil treatment due to back pain. CONCLUSION: In men with mild-to-severe ED, tadalafil 20 mg significantly improves erectile function, demonstrates superior treatment satisfaction relative to placebo, and is well tolerated. This is the first study to yield efficacy data on tadalafil in an Eastern European population of men with erectile dysfunction, and the first to measure satisfaction with the EDITS questionnaire in any study population of men with this condition using tadalafil.     

Risk factors in predicting a poor response to sildenafil citrate in elderly men with erectile dysfunction

OBJECTIVE: To assess the clinical efficacy of sildenafil and the potential predictors of poor response to sildenafil in elderly patients with erectile dysfunction (ED). PATIENTS AND METHODS: The study included 162 patients (aged > or = 60 years) treated with sildenafil for at least 8 weeks; all patients were evaluated with a history, physical examination, measurement of total testosterone and a pharmacological erection test. Sexual function before and 8 weeks after treatment was assessed using the self-administered International Index of Erectile Function (IIEF). Treatment was considered successful when the patient attained a higher grade on the erectile function (EF) domain score, and an affirmative response to the overall assessment question. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis. RESULTS: The overall efficacy with sildenafil was 47% (76/162). On univariate analysis, uncontrolled diabetes, current smoking, hypogonadism (<3 microg/L testosterone) and low pretreatment EF domain score (<17) were selected as predictors of a poor response. On multivariate logistic regression, a low pretreatment EF domain score was the strongest independent prognostic factor for a poor response (odds ratio 2.25, 95% confidence interval, 1.45-7.33), and this was followed by hypogonadism (1.89, 1.12-3.16) and current smoking (1.34, 1.04-3.52). CONCLUSION: In a real clinical setting, sildenafil was effective for about half of the elderly men. The baseline EF domain score, hypogonadism and current smoking were significantly associated with failure of sildenafil. These results suggest that modifying reversible risk factors, e.g. stopping smoking and replacing testosterone, would be beneficial in augmenting the efficacy of sildenafil in elderly men.     

Sildenafil reduces bother associated with erectile dysfunction: pooled analysis of five randomized, double-blind trials

Improvement in bother associated with erectile dysfunction (ED) is an important aspect of successful treatment of ED. Changes in erectile function and the bother associated with ED were assessed in this analysis of pooled data from five 12-week, multicenter, randomized, double-blind, placebo-controlled, flexible-dose studies of sildenafil. Men who received sildenafil (n=578, vs placebo, n=550) had significantly greater (least squares mean+/-s.e.) improvement in erectile function (EF) domain scores of the international index of erectile function (IIEF) (10.0+/-0.3 vs 1.0+/-0.3, P<0.0001) and in erection distress scale (EDS) total transformed score (18.8+/-0.8 vs 4.8+/-0.9, P<0.0001). Scores on individual questions of the EDS were 24-65% higher after treatment with sildenafil (vs 8-12%, for placebo). The change in EF domain score correlated positively with the change in total transformed EDS score (0.43, P<0.0001). Successful treatment of ED with sildenafil may reduce the bother associated with ED.     

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.     

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

     

Efficacy, tolerability and satisfaction with sildenafil citrate 100-mg titration compared with continued 50-mg dose treatment in men with erectile dysfunction

OBJECTIVE

To evaluate the efficacy, tolerability, and treatment satisfaction after initiating treatment with sildenafil 50 mg and later titrating to 100 mg, compared with continuing treatment with sildenafil 50 mg, in men with erectile dysfunction (ED).

PATIENTS AND METHODS

A multicentre, parallel‐group trial was conducted in two 4‐week periods. In period 1, patients received 50‐mg doses of sildenafil single‐blinded for 4 weeks. In period 2, patients were randomized to double‐blind, placebo‐controlled treatment with sildenafil 50 mg or sildenafil 100 mg for 4 weeks. All patients were aged ≥18 years with a documented clinical diagnosis of ED (score of ≤25 on the International Index of Erectile Function, IIEF, Erectile Function, EF, domain), and met the prescribing criteria for sildenafil 50 mg and 100 mg.

RESULTS

Of 492 enrolled patients (mean age 53 years, sd 11), 476 (97%) completed period 1 and 473 (96%) completed period 2. Patients receiving sildenafil 50 mg in period 1 had an increase in the mean (sd ) baseline EF domain score from 12.8 (5.2) to 22.5 (6.6) (P < 0.001), and improved scores on the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX‐Q). The IIEF EF domain scores were similar in the two groups at baseline and randomization. Patients titrated to the 100‐mg dose (237 men) showed a significantly greater improvement than those who continued on the 50‐mg dose (240; P < 0.001). There was a significant increase in QEQ and SEX‐Q scores in patients titrated to sildenafil 100 mg compared with patients continuing at sildenafil 50 mg. At either sildenafil dose, headache, flushing and hot flushes were the most common adverse events. Neither the frequency nor the severity of adverse events increased with titration to sildenafil 100 mg.

CONCLUSIONS

After initial treatment with sildenafil 50 mg, patients titrated to 100 mg showed further increases in efficacy and satisfaction with no increase in the number or severity of adverse events than in those remaining on the starting dose.     

Positive effect of counseling and dose adjustment in patients with erectile dysfunction who failed treatment with sildenafil

OBJECTIVE: Many patients with erectile dysfunction (ED) stop using sildenafil due to subjective failure. This study examined whether counseling and maximal dosing (100 mg) could achieve better treatment compliance and could possibly improve treatment outcome. MATERIAL AND METHODS: Patients were recruited by newspaper advertisements and referred to 5 ED centers throughout the country. Details about their previous experiences with sildenafil were recorded and following an explicit explanation about the nature and action of the drug, were offered to enter the study. Instructions on drug use were provided during each visit in which four 100 mg Sildenafil tablets were provided. Treatment outcomes were assessed by the international index of erectile function (IIEF) questionnaire after taking 4 and 8 tablets. In 2 ED centers a short video with sexual counseling content was added in between visits. RESULTS: The study cohort was comprised of 220 patients aged 27-88 years. The majority reported having received limited or no instructions on drug use when sildenafil was first prescribed. A significant increase in IIEF erectile function domain scores (EFDS) between visits 1, 2 and 3 was observed (10.96+/-0.40, 16.73+/-0.51 and 17.82+/-0.55 mean+/-SE, respectively), with 23.6% of the study patients achieving normal erectile function at the end of the study. The parameters of age and initial severity of ED most influenced treatment success. CONCLUSIONS: Counseling and dose adjustment were directly influential in achieving an excellent response to a second trial of sildenafil in patients with ED who had previously failed treatment with the drug, and obviated their needing to seek more invasive measures.     

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.     

Severity of erectile dysfunction in married impotent patients: Interrelationship with anthropometry, hormones, metabolic profiles and lifestyle

OBJECTIVE: This study was designed to evaluate the effects of risk factors for erectile dysfunction (ED) or cardiovascular disease on the disease severity in impotent men. METHODS: A total of 87 men, 25-75 years old (mean age, 53.4) were included in the study. Patients were evaluated with anthropometry, hormones, metabolic profiles and lifestyle. Baseline erectile function (EF) was evaluated using the International Index of Erectile Function (IIEF). The severity of ED was classified into the following four grades based on the six-item EF domain of the IIEF: severe (6-10); moderate (11-16); mild to moderate (17-21); and mild (22-25). Patients were deemed to have metabolic syndrome (MS) if they had three or more of five criteria according to National Cholesterol Education Program, with some modification. RESULTS: Of 87 patients, 15 patients (17.2%) had mild, 11 (12.6%) had mild to moderate, 33 (37.9%) had moderate and 28 (32.3%) had severe ED. There was no correlation between scores of IIEF or EF domain and continuous parameters. On the multivariate model used, hypertensive patients had 26-fold higher risk (odds ratio, 26.195; 95% confidence interval, 1.463-46.072; P = 0.027) of severe ED than those without hypertension. Other factors were not significant. CONCLUSION: The results of the study indicate that MS might not influence the severity of ED in impotent men. However, our findings suggest that hypertension plays a role in the disease severity in these patients.