Physical activity and PDE5 inhibitors in the treatment of erectile dysfunction: results of a randomized controlled study. Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction A 6-month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction The multinational Men's Attitudes to Life Events and Sexuality (MALES) Study Phase II: understanding PDE5 inhibitor treatment seeking patterns, among men with erectile dysfunction. Effects of daily low-dose treatment with phosphodiesterase type 5 inhibitor on cognition, depression, somatization and erectile function in patients with erectile dysfunction: a double-blind, placebo-controlled study Erectile dysfunction as a predictor of cardiovascular events and death in diabetic patients with angiographically proven asymptomatic coronary artery disease: a potential protective role for statins and 5-phosphodiesterase inhibitors. Combination therapy with selective serotonin reuptake inhibitors and phosphodiesterase‐5 inhibitors in the treatment of premature ejaculation Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. Phosphodiesterase inhibitors in the treatment of erectile dysfunction in spinal cord-injured men Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Efficacy of Tadalafil De-Escalation in the Treatment of Psychogenic Erectile Dysfunction The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction. Sexual function, satisfaction, and association of erectile dysfunction with cardiovascular disease and risk factors in cardiovascular high-risk patients: substudy of the ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNT Study in ACE-IN
INTRODUCTION Physical activity ( PhA ) has proven to be a protective factor for normal erectile function in numerous epidemiological studies . AIM The aim of this study was to establish if PhA could have a therapeutic role in the treatment of  erectile dysfunction ( ED ) . METHODS This was a r and omized , open-label study . A total of 60 patients complaining of ED were studied . Patients were assessed at baseline and after 3 months of study treatment . At baseline , patients were r and omized to receive phosphodiesterase type 5 inhibitor ( PDE5i ) alone ( group A ) or PDE5i plus regular ( ≥3 hours/week ) , aerobic , non-agonistic PhA ( group B ) . MAIN OUTCOME MEASURES All subjects completed the International Index of Erectile Function ( IIEF-15 ) question naire and performed total testosterone ( TT ) . RESULTS Mean PhA was 3.4 hours/week in group B vs. 0.43 in group A ; mean energy expenditure in group B was 1,868 kcal/ week or 22.8 metabolic equivalent (MET)/week . IIEF restoration of ED occurred in 77.8 % ( intervention group ) vs. 39.3 % ( control ) ( P < 0.004 ) . The IIEF-15 score result ed in statistical improvement in intervention group in all the domains but one ( orgasm ) : erectile function 24.7 vs. 26.8 ( P = 0.003 ) ; confidence ( Q15 ) 3.53 vs. 4.07 ( P = 0.006 ) ; sexual desire 6.46 vs. 7.18 ( P = 0.028 ) ; intercourse satisfaction 9.85 vs. 11.25 ( P = 0.001 ) ; total satisfaction 7.17 vs. 8.07 ( P = 0.009 ) ; total score 56.2 vs. 61.07 ( P = 0.007 ) . TT was statistically similar in the two groups ; separate analysis in each group showed statistical increase in group B 4.24 vs. 4.55 ( P = 0.012 ) . At multivariate logistic regression analysis , PhA was the only independent variable for normal erection ( P = 0.010 ) ( 95 % confidence interval [ CI ] 0.036 - 0.643 ) , higher sexual satisfaction ( P = 0.022 ) ( 95 % CI 0.084 - 0.821 ) and normal total IIEF-15 score ( P = 0.023 ) ( 95 % CI 0.85 - 0.837 ) . CONCLUSION In this r and omized controlled pilot study , PDE5i plus PhA was more effective than PDE5i alone in the treatment of ED Abstract Background : Phosphodiesterase type 5 ( PDE5 ) inhibitors have discontinuation rates as high as 60 % in men with erectile dysfunction . Treatment satisfaction has been significantly associated with treatment continuation . Underst and ing key characteristics in terms of treatment preference , relationship , and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally . Objective : The objective was to identify subgroups of interest in the pooled data base of two observational studies conducted in Latin America ( LA ) and Middle East/North Africa ( MENA ) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline . Methods : Two identical prospect i ve , non-interventional , observational , studies in MENA ( N = 493 ) and LA ( N = 511 ) treated men with an ‘ on dem and ’ ( pro re nata , PRN ) PDE5 inhibitor ( sildenafil , tadalafil , vardenafil , or lodenafil ) during 6 months . In this post-hoc meta- analysis of two observational studies with equal design , pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations , satisfaction , self-esteem , and patient – partner relationships . Decision tree analyses , with and without weighting , were used to identify and describe key features . Results : In each analysis of patient expectations , patient – partner relationship , and self-esteem , we describe the two major subgroups at baseline for each decision tree . Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors ( 59 % ) highlighted the importance of treatment effect duration , second to partner satisfaction with treatment , while patients prescribed short-acting PDE5 inhibitors ( 32 % ) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion . Further insights regarding patients , partner relationship characteristics , and treatment expectations were identified . Conclusion : Our analyses have described key characteristics , such as self- and partner perceptions , sexual attitudes , and treatment expectations in relation to the patients ’ country and prescribed treatment , which might guide treatment decisions in MENA and LA men with ED Abstract Background : Erectile dysfunction ( ED ) negatively impacts quality of life .  Phosphodiesterase type 5 inhibitors ( PDE5Is ) are effective in treating ED ; however , rates of discontinuation remain high . Objectives : To assess on-dem and PDE5I treatment persistence and adherence through 6 months in Middle Eastern and North African ( MENA ) men with ED in a prospect i ve , non-interventional , observational trial . Research design and methods : Enrolled men were ≥18 years old from Saudi Arabia , Egypt , and the United Arab Emirates , PDE5I naïve , and sexually active .  PDE5Is were selected per routine clinical practice . Persistence was defined as use of ≥1 dose during the prior 4 weeks , adherence as compliance with dosing instructions during the most recent dose . Logistic regression models were used to identify factors associated with persistence and adherence . Main outcome measures : Persistence and Adherence Question naire ; Partner Relationship Question naire ; Self-Esteem and Relationship Question naire ; International Index of Erectile Function ( IIEF ) ; Erectile Dysfunction Inventory of Treatment Satisfaction . Results : Patients ’ ( n = 493 ) mean age was 49.8 years , mean BMI was 29.3 , and the majority ( n = 354 , 71.8 % ) were from Saudi Arabia .  Tadalafil was the most prescribed PDE5I ( 69.6 % ) , versus sildenafil ( 15.4 % ) , or vardenafil ( 15.0 % ) . Patients ’ mean IIEF – Erectile Function scores improved from moderate to mild and Erection Hardness Scores ( SD ) improved from 1.8 ( 1.0 ) at baseline to 3.5 ( 0.7 ) at 6 months . At 6 months , 64.9 % of patients were treatment persistent ( tadalafil , 68.8 % , sildenafil , 65.8 % , and vardenafil , 45.9 % ) and 59.6 % were adherent . Factors significantly predictive ( p < 0.05 ) of persistence at 6 months included age , employment status , and ED severity . Factors significantly predictive of adherence were age , employment status , and duration of ED . Interpretation of differences between drugs was limited by substantial differences in prescription rates between countries . Conclusions : At 6 months , 64.9 % of men were treatment persistent . In this study , age , employment status , ED severity , and duration of ED were associated with persistence and /or adherence OBJECTIVE The aim of Phase II of the Men 's Attitudes to Life Events and Sexuality ( MALES ) Study is to explore PDE5 inhibitor treatment seeking among men with erectile dysfunction ( ED ) . METHODS Phase II of the MALES study involved 2,912 men , aged 20 - 75 years , from 8 countries ( U.S. , U.K. , Germany , France , Italy , Spain , Mexico , and Brazil ) , who reported ED . Participants were recruited from the MALES Phase I sample [ 1 ] and via booster methods ( e.g. , physician referral , street interception ) , and completed self-report question naires concerning the characteristics of their ED , their efforts to seek PDE5 inhibitor treatment for their sexual dysfunction , and attitudinal and referent influences that potentially affect treatment-seeking . Statistical analyses focus on identification of correlates of PDE5 inhibitor treatment seeking . RESULTS PDE5 inhibitor utilization is strongly associated with ED sufferers ' assessment of the severity of their sexual dysfunction , with their belief that medication for ED is dangerous , and with their perceptions of whether physicians , other professionals , and spouses or family members are supportive of their seeking treatment . ED sufferers who evaluate their sexual dysfunction as severe , who believe that medication for ED is not dangerous , and who perceive support for treatment seeking from referent others , are more likely to utilize PDE5 inhibitor treatment . CONCLUSION Findings indicate that perceived ED severity , beliefs about ED medication , and referent influences are strongly correlated with utilization of PDE5 inhibitor therapy . These findings aid our underst and ing of factors that may incline men with ED to seek-or to avoid-PDE5 inhibitor therapy for their sexual dysfunction , and provide a basis for clinical and educational interventions to assist men with ED to seek appropriate treatment Phosphodiesterase type 5 ( PDE5 ) inhibitors have recently been shown to have cognitive-enhancing effects in animal models and in our previous pilot study . To investigate the efficacy of daily low-dose treatment with a PDE5 inhibitor on cognitive function , depression and somatization in patients with erectile dysfunction ( ED ) , 8-week , double-blind , placebo-controlled study enrolled 60 male patients with ED for ≥3 months without cognitive impairment . Forty-nine patients completed the study . Patients were r and omized to receive either daily low-dose udenafil 50 mg or placebo for 2 months . The International Index of Erectile Function-5 ( IIEF-5 ) , the Korean version of the Mini-Mental State Examination ( K-MMSE ) for general cognitive function and the Seoul Neuropsychological Screening Battery for comprehensive neuropsychological examination , the Physical Health Question naire-9 ( PHQ-9 ) for depression and the Physical Health Question naire-15 ( PHQ-15 ) for somatization were administered at baseline and at 2 months . The change in the mean IIEF-5 was significantly higher in the udenafil group than the placebo group ( 6.08±4.72 vs 2.20±3.50 , P=0.008 ) . The changes in the PHQ-9 and PHQ-15 were −2.04±3.14 and −2.17±2.87 in the udenafil group , and 1.20±1.63 and 0.56±2.48 in the placebo group ( both , P<0.001 ) . The changes in the K-MMSE and Digit Span Forward were 1.25±1.26 and 0.92±1.02 in the udenafil group , and −0.52±1.19 and −0.24±1.13 in the placebo group ( both , P<0.001 ) . However , there were no differences in the other neuropsychological tests . Daily dosing with a PDE5 inhibitor seems to improve cognitive function , depression and somatization , as well as erectile function , in patients with ED OBJECTIVES We sought to investigate whether erectile dysfunction ( ED ) is a predictor of future cardiovascular events and death in diabetic patients with silent coronary artery disease ( CAD ) and whether there are predictors of cardiovascular events and death among CAD diabetic patients with ED . BACKGROUND Case-control studies showed that ED is associated with CAD in diabetic patients , but no prospect i ve study is available . METHODS Type 2 diabetic men ( n = 291 ) with silent CAD angiographically documented were recruited .  Erectile dysfunction  was assessed by the International Index Erectile Function-5 question naire .  RESULTS During a follow-up period of 47.2 + /- 21.8 months ( range 4 to 82 months ) , 49 patients experienced major adverse cardiac events ( MACE ) . The difference in ED prevalence between patients with and those without MACE was significant ( 61.2 % vs. 36.4 % ; p = 0.001 ) . Cox regression analysis showed that ED predicted MACE ( hazard ratio [ HR ] 2.1 ; 95 % confidence interval [ CI ] 1.6 to 2.6 ; p < 0.001 ) . Among patients with CAD and ED , the Kaplan-Meier method showed that the statin ( Mantel log-rank test : 3.921 ; p = 0.048 ) and 5-phosphodiesterase ( 5-PDE ) inhibitor use ( Mantel log-rank test : 4.608 ; p = 0.032 ) were associated with a lower rate of MACE . Cox regression analysis showed that statin use ( HR 0.66 ; 95 % CI 0.46 to 0.97 ; p = 0.036 ) reduced MACE . Treatment with 5-PDE inhibitors did not enter the model , but its p value was very near to the significant level ( HR 0.68 ; 95 % CI 0.46 to 1.01 ; p = 0.056 ) . CONCLUSIONS Our data first show that ED is a powerful predictor of cardiovascular morbidity and mortality in diabetic patients with silent CAD and that the treatment with statins and 5-PDE inhibitors might reduce the occurrence of MACE among CAD diabetic patients with ED We aim ed to evaluate the effectiveness of paroxetine and tadalafil combination in the treatment of  premature ejaculation ( PE ) . A total of 150 primary (lifelong)PE patients were r and omly distributed into three groups of 50 patients each . Group 1 received 20 mg paroxetine every day for 1 month , Group 2 received 20 mg tadalafil on dem and 2 h before intercourse , and Group 3 received paroxetine and tadalafil on dem and 2 h before intercourse . Intravaginal ejaculatory latency times ( IELT ) scores were evaluated at baseline , at the end of the first month of therapy and 1 month after discontinuation of the treatment , while International Index of Erectile Function ( IIEF ) question naire scores were evaluated both prior to and after the treatment . At the end of the first month of therapy , IELT scores were compared with the basal values and statistically significant changes were detected ( 60.6 ± 30.2–117.3 ± 67.3 , 68.5 ± 21.4–110.2 ± 37.3 , 71.56 ± 40.23–175.2 ± 60.2)(P < 0.01 ) . IELT scores after discontinuation of treatment were found to be close to the baseline IELT scores ( P > 0.05 ) . IIEF scores were evaluated both prior to and after the treatment , and no statistically significant difference was detected ( P > 0.05 ) . It is concluded that utilisation of selective serotonin reuptake inhibitors ( SSRI ) and phosphodiesterase‐5 inhibitors ( PDE5i ) combination before intercourse seems to provide significantly longer ejaculatory latency times as compared with SSRI alone for a long time in patients with PE Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes . In this multicenter , open-label study , men with ED , naïve to PDE5I , were r and omized to tadalafil 5 mg once-a-day ( OaD ; N=257 ) , 10 mg on dem and ( PRN ; N=252 ) or sildenafil-citrate ( sildenafil ) 50 mg PRN ( N=261 ) for 8 weeks ( dose adjustments allowed ) , followed by 16 weeks of pragmatic treatment ( switching between PDE5I allowed ) . Primary outcomes ( treatment-adherence ) were reported previously . Here , we report effects on : Psychological and Interpersonal Relationship Scales , Self-Esteem and Relationship ( SEAR ) question naire , ED Inventory of Treatment Satisfaction ( EDITS ) , International Index of Erectile Function ( IIEF ) , Sexual Encounter Profile ( SEP ) and Global Assessment Questions ( GAQ ) . Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline ; GAQ-responses were evaluated by logistic regression . Analyses were adjusted for treatment , country , ED-severity , baseline and baseline-by-treatment interaction . Patients r and omized to tadalafil OaD or PRN reported greater improvement ( least-square mean ( s.e . ) change ) in Sexual Self-Confidence ( OaD + 0.90 ( 0.048 ) , PRN + 0.93 ( 0.050 ) , vs + 0.73 ( 0.049 ) ; P=0.006 and P=0.001 ) and Spontaneity ( OaD + 0.11 ( 0.035 ) , PRN + 0.13 ( 0.035 ) , vs + 0.02 ( 0.035 ) ; P=0.044 and P=0.010 ) compared with sildenafil . Improvements in GAQ and SEP responses , IIEF-EF , orgasmic function , sexual desire , overall satisfaction domains , SEAR and EDITS scores did not differ significantly between treatment groups INTRODUCTION Mirodenafil is a newly developed oral phosphodiesterase type 5 inhibitor , currently under investigation as a treatment for erectile dysfunction ( ED ) . AIM We investigated the efficacy and safety of on dem and mirodenafil therapy at fixed doses ( 50 and 100 mg ) in Korean men with a broad range of ED . METHODS A multicenter , r and omized , double-blind , placebo-controlled , parallel-group , fixed-dose study was conducted with 223 subjects who were r and omized to placebo or mirodenafil at fixed doses of 50 or 100 mg for 12 weeks on an " as needed " basis . MAIN OUTCOME MEASURES Primary efficacy measures were scores on the International Index of Erectile Function ( IIEF ) Question 3 ( Q3 ) and Question 4 ( Q4 ) . Secondary efficacy measures included all domain scores of the IIEF , Sexual Encounter Profile Question 2 ( SEP2 ) , Sexual Encounter Profile Question 3 ( SEP3 ) , the Global Assessment Question ( GAQ ) , and the Life Satisfaction Checklist ( LSC ) . Safety assessment s included laboratory tests , vital signs , physical examination , 12-lead electrocardiogram recordings , and patients ' reporting of adverse events . RESULTS Mirodenafil 50 and 100 mg groups showed a significantly greater increase in IIEF Q3 ( P = 0.0001 , P < 0.0001 , respectively ) and Q4 scores ( both P < 0.0001 ) at the end point compared with the placebo group . And mirodenafil in both doses significantly improved the scores of all five domains of the IIEF , SEP2 , and SEP3 as well as the percentages of patients responding positively to the GAQ compared with the placebo group . As for LSC scores , the two mirodenafil groups showed significantly greater improvements in items regarding life as a whole , sexual life , and partner relationship than the placebo group . Most treatment-associated adverse events were of mild intensity , resolving spontaneously . CONCLUSIONS Mirodenafil , in doses of 50 or 100 mg , significantly improved erectile function and were well tolerated in a representative population of Korean men with broad-spectrum ED of various etiologies and severities Study design : Open , before – after study . Objective : To assess the efficacy and safety of phosphodiesterase type 5 ( PDE5 ) inhibitors for erectile dysfunction ( ED ) in spinal cord-injured ( SCI ) patients . Setting : Home- and clinic-based assessment s in the outpatient department at the Centre Bouffard Vercelli , Cerbère France . Methods : Clinic trials with Sildenafil ( Viagra ® )  on 120 patients , Tadalafil ( Cialis ® ) on 54 patients and Vardenafil ( Levitra ® ) on 66 patients were performed . Flexible doses of PDE5 inhibitors were given depending on efficacy and tolerability , from 50 to 100 mg for Sildenafil , and from 10 to 20 mg for Vardenafil and Tadalafil . Each trial was performed after a week 's interval . The efficacy was self-assessed by the patients on a six-point quantitative scale assessment . The response to treatment was assessed at home in 90 patients ( 57 patients on Sildenafil , 12 patients on Vardenafil and 21 patients on Tadalafil )  using the International Index of Erectile Function ( IIEF ) . Results : In clinic trials , PDE5 inhibitors were effective ( rigidity enough for penetration ) in 85 % of the patients on Sildenafil , 74 % of the patients on Vardenafil and 72 % of the patients on Tadalafil .  The mean duration of erection was 34 , 28 and 26 min , respectively . Adverse effects were mild , usually attenuated with continued dosing . More than 70 % of the patients on Vardenafil and Tadalafil required higher doses of 20 mg , whereas 50 mg of Sildenafil was effective in 55 % of the patients . Two-thirds of our patients on Tadalafil reported a duration of action longer than 24 h. The presence of an upper motor neuron lesion was significantly associated with therapeutic success , lower motor neuron lesions and cauda equina patients were poor responders . Other variables such as completeness of lesion had no impact . In the follow-up visits , the IIEF global scores and three IIEF domains ( erectile function , intercourse satisfaction and overall satisfaction ) were significantly improved in all patients . Patients on Sildenafil showed a significant improvement of orgasmic function , ejaculation ( Question 9 ) and orgasm ( Question 10 ) . Conclusion : Sildenafil , Vardenafil and Tadalafil are all effective and well-tolerated treatments for ED in SCI patients . Although no statistical analysis could be applied on these data , these results might indicate that Sildenafil is more effective in treating ED . Clinic trials are important for proper dose titration and appropriate education of the patients INTRODUCTION Alpha1-blockers ( AB ) are the first-line monotherapy for lower urinary tract symptoms ( LUTS ) .  Phosphodiesterase type 5 ( PDE5 ) inhibitors are the first-line treatment for erectile dysfunction ( ED ) . Numerous studies have supposed a significant association between ED and LUTS , but a causal relationship can not be established . AIM The aim was to evaluate the efficacy of a combined therapy with an AB ( alfuzosin ) and PDE5 inhibitors ( tadalafil ) in patients with LUTS and ED . METHODS This was a r and omized , open-label , three-arm study . A total of 66 men complaining of ED and LUTS were included in the study . Patients were assessed at baseline and after 12 weeks of study treatment , and then underwent r and omized allocation to either alfuzosin 10 mg once a day ( 22 patients ) or tadalafil 20 mg on alternative days ( 21 patients ) , or a combination of both ( 23 patients ) . MAIN OUTCOME MEASURES All participants completed the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) and the International Prostatic Symptom Score ( IPSS ) . Other efficacy variables included maximum urinary flow rate ( Qmax ) and medium urinary flow rate ( Qave ) . RESULTS IIEF-EF tended to improve with alfuzosin alone ( + 15 % ) , while it was clearly improved with tadalafil alone ( + 36.3 % ) . The greatest improvement was experienced with the combination therapy ( + 37.6 % ) . Improvement in Qmax was observed in all groups , but patients receiving combination therapy had greater improvement ( 29.6 % ) than patients receiving either only alfuzosin ( 21.7 % ) or only tadalafil ( 9.5 % ) . IPSS was significantly improved in alfuzosin group ( 27.2 % ) , was more marked with the combination therapy ( 41.6 % ) , and a small increase , although not significant , was also observed with tadalafil ( 8.4 % ) . CONCLUSIONS Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores . A significant improvement was also observed in quality of life assessment s. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED , although present , were smaller The study was to compare treatment preference , efficacy , and tolerability of sildenafil citrate ( sildenafil ) and tadalafil for treating erectile dysfunction ( ED ) in Chinese men naοve to phosphodiesterase 5 ( PDE5 ) inhibitor therapies .  This multicenter , r and omized , open-label , crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil . After a 4 weeks baseline assessment , 383 eligible patients were r and omized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension . Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Question naire ( PITPQ ) . Secondary efficacy was analyzed by PITPQ Question 2 , the International Index of Erectile Function ( IIEF ) erectile function ( EF ) domain , sexual encounter profile ( SEP ) Questions 2 and 3 , and the Drug Attributes Question naire . Three hundred and fifty men ( 91 % ) completed the r and omized treatment phase . Two hundred and forty-two per 350 ( 69.1 % ) patients preferred 20-mg tadalafil , and 108/350 ( 30.9 % ) preferred 100-mg sildenafil ( P < 0.001 ) as their treatment in the 8 weeks extension . Ninety-two per 242 ( 38 % ) patients strongly preferred tadalafil and 37/108 ( 34.3 % ) strongly the preferred sildenafil . The SEP2 ( penetration ) , SEP3 ( successful intercourse ) , and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups . For patients who preferred tadalafil , getting an erection long after taking the medication was the most reported reason for tadalafil preference . The only treatment-emergent adverse event reported by > 2 % of men was headache . After tadalafil and sildenafil treatments , more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil . Both sildenafil and tadalafil treatments were effective and safe Sildenafil ( Viagra , UK-92,480 ) is a novel oral agent under development for the treatment of  penile erectile dysfunction .  Erection is dependent on nitric oxide and its second messenger , cyclic guanosine monophosphate ( cGMP ) . However , the relative importance of phosphodiesterase ( PDE ) isozymes is not clear . We have identified both cGMP- and cyclic adenosine monophosphate-specific phosphodiesterases ( PDEs ) in human corpora cavernosa in vitro . The main PDE activity in this tissue was due to PDE5 , with PDE2 and 3 also identified . Sildenafil is a selective inhibitor of PDE5 with a mean IC50 of 0.0039 microM. In human volunteers , we have shown sildenafil to have suitable pharmacokinetic and pharmacodynamic properties ( rapid absorption , relatively short half-life , no significant effect on heart rate and blood pressure ) for an oral agent to be taken , as required , prior to sexual activity . Moreover , in a clinical study of 12 patients with erectile dysfunction without an established organic cause , we have shown sildenafil to enhance the erectile response ( duration and rigidity of erection ) to visual sexual stimulation , thus highlighting the important role of PDE5 in human penile erection . Sildenafil holds promise as a new effective oral treatment for penile erectile dysfunction BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology . Current analyses were based on 17 clinical trials of tadalafil . Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies . CONCLUSIONS The context ualization of treatment-related changes in terms of clinical ly relevant improvement is essential to underst and ing treatment efficacy , to interpreting results across studies , and to managing patients effectively . This analysis provides , for the first time , anchor-based estimates of MCIDs in the EF domain score of the IIEF Objectives : To assess the efficacy of tadalafil de-escalation in the therapeutic effects of psychogenic erectile dysfunction ( ED ) during the 3 months extension phase . Methods : A total of 90 men with mild to severe psychogenic ED were r and omly divided into 2 groups : tadalafil 5 mg group and tadalafil de-escalation group . Efficacy assessment s included the 5-item version of International Index of Erectile Function ( IIEF-5 ) , the Sexual Encounter Profile ( SEP ) question naires , Psychological and Interpersonal Relationship Scales ( PAIRS ) , Erection Hardness Score ( EHS ) . Results : Compared with the baseline , tadalafil 5 mg and de-escalation groups enhanced all efficacy outcomes . Patients receiving tadalafil 5 mg and de-escalation experienced a significant mean improvement in the psychogenic erectile function domain of the IIEF-5 from the baseline ( p < 0.01 ) . The mean change from baseline was significantly higher for the tadalafil de-escalation group than for the tadalafil 5 mg group ( p < 0.05 ) . Response to SEP3 , PAIRS and EHS was significantly higher in the tadalafil de-escalation group than in the tadalafil 5 mg group ( p < 0.05 ) . The severity of ED in the tadalafil de-escalation group had reduced after treatment . It was also significantly better than those in the tadalafil 5 mg group ( p < 0.05 ) . Conclusion : Tadalafil de-escalation significantly improved the erectile function among psychogenic ED patients . This implies that tadalafil de-escalation treatment for psychogenic ED is worthy of further clinical practice and research INTRODUCTION Udenafil is a potent selective phosphodiesterase type 5 ( PDE5 ) inhibitor newly developed for the treatment of erectile dysfunction ( ED ) . AIM This study was performed to evaluate the efficacy and safety of udenafil therapy in patients with ED . METHODS In this multicenter , double-blind , placebo-controlled , fixed-dose , parallel-group phase III trial , 167 patients with ED of diverse origin and severity were r and omized to take placebo or udenafil at fixed doses of 100 or 200 mg as needed for 12 weeks . MAIN OUTCOME MEASURES Primary efficacy variable was change from baseline in erectile function ( EF ) domain scores of the International Index of Erectile Dysfunction ( IIEF ) question naire . Secondary efficacy variables include change from baseline in scores on the IIEF Questions 3 and 4 ( IIEF Q3 and Q4 ) , change from baseline in all domain scores of the IIEF , patients ' responses to questions 2 and 3 of the Sexual Encounter Profile ( SEP2 and SEP3 ) , and patients ' responses to the Global Assessment Question ( GAQ ) . Any adverse events were also recorded during the trial . RESULTS After 12 weeks of treatment , the patients treated with udenafil showed significantly greater change from baseline in the IIEF-EF domain score compared with placebo ( placebo , 0.20 ; 100-mg udenafil , 7.52 ; and 200-mg udenafil , 9.93 , respectively ) ( P < 0.0001 ) . Compared with placebo , udenafil significantly enhanced the rates of successful penetration ( SEP Q2 ) and maintenance of erection ( SEP Q3 ) ( P < 0.0001 ) . Furthermore , significantly greater proportions of udenafil treatment groups responded positively to the GAQ compared with the placebo group ( GAQ : placebo , 25.9 % ; 100-mg udenafil , 81.5 % ; and 200-mg udenafil , 88.5 % , respectively ) ( P < 0.0001 ) . Treatment-related adverse events were generally mild to moderate with facial flushing and headache being the most common . CONCLUSIONS Udenafil is an effective and well-tolerated therapy for ED of broad-spectrum etiology and severity BACKGROUND Erectile dysfunction ( ED ) is a common disorder in middle-aged men and is significantly influenced by cardiovascular risk factors ( CVRFs ) and cardiovascular disease . The sub study of the ONTARGET/TRANSCEND trials evaluates the relationship of erectile function to baseline characteristics and current treatment in cardiovascular high-risk patients who have been enrolled in these trials . The effects of treatment with telmisartan and ramipril , alone or in combination , including a telmisartan versus placebo arm will be determined prospect ively during a follow-up of 4 years . METHODS One thous and three hundred fifty-seven patients were evaluated in 13 countries at baseline , 2 years , and 4 years , with ED determined using the ED score of the Cologne Male Survey ( Kölner [ Cologne ] Evaluation of Erectile Dysfunction ) and the 5-item International Index of Erectile Function . Erectile dysfunction scores were related to CVRF and the use of cardiovascular drugs . RESULTS Prevalence of ED was 50.7 % ( Kölner [ Cologne ] Evaluation of Erectile Dysfunction ) and 54.3 % ( 5-item International Index of Erectile Function ) , respectively , with a decline of sexual activity after the diagnosis of cardiovascular disease . In multivariate analysis , diabetes mellitus ( P < .00001 ) , stroke ( P = .00026 ) , pelvic surgery ( P = .025 ) , and age of > 65 years ( P < .00001 ) correlated with the degree of ED . No significant associations were observed for cholesterol levels , hypertension , and smoking status as well as current treatment with angiotensin-converting enzyme inhibitors , angiotensin I antagonists , diuretics , beta-blockers , or calcium-channel blockers . CONCLUSIONS The ONTARGET/TRANSCEND-ED sub study shows a significant influence of cardiovascular disease on erectile function . In contrast to prior smaller studies , drug therapy and CVRF seem to play a minor role in cardiovascular high-risk patients . Follow-up data will provide information whether angiotensin-converting enzyme inhibitors , angiotensin I antagonists , or a combination thereof are able to improve erectile function
The results of the included studies are inconclusive , though they show a trend towards a larger effect of combined treatment compared with PI or PDE5-I treatment alone .
The meta- analysis found that , overall , combined treatment was more efficacious for ED symptoms than PDE5-I treatment or PI alone .
Combined treatment was more efficacious than PDE5-I use alone on sexual satisfaction .
No differences were found between PDE5-Is and PI as st and -alone treatments .
The combination of PI and PDE5-Is is a promising strategy for a favorable outcome in ED and can be considered as a first-choice option for ED patients .
INTRODUCTION Erectile dysfunction ( ED ) is an increasing health problem that dem and s effective treatment .
There is evidence that phosphodiesterase-5 inhibitors ( PDE5-Is ) and psychological intervention ( PI ) are effective treatment options ; however , little is known about their comparative efficacy and the efficacy of combined treatments .
AIM The aim of this systematic review and meta- analysis is to evaluate the comparative efficacy of PI , PDE5-Is , and their combination in the treatment of ED .
MAIN OUTCOME MEASURES Primary outcome was ED symptoms , and secondary outcome was sexual satisfaction of the patient .