Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. Efficacy and safety of tadalafil for erectile dysfunction in patients with multiple sclerosis. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. 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 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. Effects of three-times-per-week versus on-demand tadalafil treatment on erectile function and continence recovery following bilateral nerve sparing radical prostatectomy: results of a prospective, randomized, and single-center study. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. A randomized clinical trial investigating treatment choice in Chinese men receiving sildenafil citrate and tadalafil for treating erectile dysfunction Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: a multicenter, randomized, double-blind, placebo-controlled clinical trial. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction.
INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least " better " using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs.  placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated INTRODUCTION Data are sparse concerning the effects of phosphodiesterase type 5 ( PDE5 ) inhibitors for erectile dysfunction ( ED ) in subjects with multiple sclerosis ( MS ) . AIM To evaluate the efficacy and safety of tadalafil use in subjects with ED because of MS . METHODS Ninety-six MS patients with ED after a 4-week treatment-free period were given tadalafil  10 mg . All patients were re-evaluated after 4 weeks . Those with a score lower than 26 on the International Index of Erectile Function ( IIEF-15 ) and with less than 75 % of total successful sexual attempts assessed by the Sexual Encounter Profile Questions 2 and 3 ( SEP2 - 3 ) had their dosage of tadalafil increased to 20 mg , whereas responding subjects continued with 10 mg . Subsequently , all patients had a final follow-up visit after 8 weeks . MAIN OUTCOME MEASURES SEP2 - 3 , IIEF-15 question naire . The Life Satisfaction Checklist ( LSC ) question naire composed of eight questions was used prior to starting tadalafil and at the end of the 12-week treatment . RESULTS Ninety-two subjects completed the study . Seventy-two responded , 30 of whom used 10 mg . Two subjects discontinued the therapy because of moderate side effects : one suffered from headache and one from tachycardia . Responding patients reached a significant statistical improvement in all follow-ups compared with baseline on the erectile domain and overall sexual satisfaction scores of the IIEF-15 using the Wilcoxon test P < 0.01 . Furthermore , they showed statistical improvement through the Wilcoxon test P < 0.01 on the sexual life , family life , and partner relationship questions of the LSC compared with baseline . CONCLUSION Tadalafil is an effective and safe treatment for males with MS suffering from ED . Further studies are needed on MS patients to evaluate the efficacy and safety of long-term use , and to detect predictable parameters for the success of PDE5 inhibitors INTRODUCTION An optimal outcome of an erectile dysfunction ( ED ) treatment is to enable a return to normal erectile function ( as defined by an International Index of Erectile Function-Erectile Function [ IIEF-EF ] domain score ≥ 26 ) . As-needed ( PRN ) phosphodiesterase type 5 ( PDE5 ) inhibitor treatment does not always result in a return-to-normal erectile function . AIM The combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment . METHODS Men were ≥ 18 years of age , sexually active , reported a ≥ 3-month history of ED , and had been taking the maximum dose of sildenafil citrate , vardenafil , or tadalafil PRN . R and omization to once-daily therapy with tadalafil 2.5 mg to 5 mg ( N = 207 ) , tadalafil 5 mg ( N = 207 ) , or placebo  ( N = 209 ) for 12 weeks followed a 4-week maximum dose PRN PDE5 treatment and 4-week nondrug lead periods . Two identical double-blind , r and omized , placebo-controlled studies were conducted ; combined results are reported . MAIN OUTCOME MEASURE The main outcome measure was the percentage of subjects with a return-to-normal erectile function ( IIEF-EF domain score ≥ 26 ) when treated with tadalafil once daily compared with placebo . RESULTS In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor , a higher percentage of subjects treated with tadalafil  had an IIEF-EF domain score ≥ 26 at end point ( tadalafil 2.5- to 5-mg group [ 39 % ] ; tadalafil 5-mg group [ 40 % ] ) compared with the placebo group ( 12.1 % ; P < 0.001 ) . Tadalafil was generally well tolerated and adverse events observed were consistent with previous reports of tadalafil once daily . CONCLUSIONS Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment 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 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 Erectile dysfunction ( ED ) and urinary incontinence after bilateral nerve-sparing radical prostatectomy ( BNSRP ) still remain major causes of morbidity . Phosphodiesterase type 5 inhibitors ( PDE5-Is ) have a role in the treatment of ED after BNSRP . Several studies in patients with ED and lower urinary tract symptoms demonstrated that PDE5-Is could improve both erectile function and urinary symptoms . The aim of this study was to compare the efficacies of two dosing regimens of 20 mg tadalafil ( on-dem and and 3 times per week ) and to assess the role of tadalafil in recovery of erectile function and continence after BNSRP . We conducted a single-center , prospect i ve , r and omized controlled trial of three times per week versus on-dem and tadalafil 20 mg and a control group after BNSRP . A total of 129 preoperatively potent and continent patients were included in the study . The patients were evaluated at 6 weeks and 12 months postoperatively for erectile function and continence status . There was no significant difference between all three groups with respect to erectile function at 6 weeks after the surgery . Twelve months after the surgery , the International Index of Erectile Function score was significantly higher in the group using tadalafil 20 mg three times per week . However , there was no significant difference between the treated groups and the control group with respect to the continence status at 12 months after the surgery . There was no correlation between incontinence and ED after the surgery in all groups . Tadalafil 20 mg three times per week is an efficacious and well-tolerated treatment option for ED after BNSRP . Treatment with 20 mg tadalafil either three times per week or on dem and can not improve continence recovery after BNSRP compared with the control group BACKGROUND To date , no data have been available from large , well- design ed trials comparing on dem and and nightly dosing of phosphodiesterase type 5 ( PDE5 ) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction ( ED ) . OBJECTIVE To investigate the effect of early postoperative dosing with vardenafil , administered either nightly or on dem and , compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy ( NSRP ) surgery . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , double-dummy , multicentre , parallel group study conducted at 87 centres across Europe , Canada , South Africa , and the United States . For inclusion , patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain ( IIEF-EF ) score of > or = 26 at screening . A total of 628 men , aged 18 - 64 yr , were r and omised to treatment . Study design consisted of a 9-mo double-blind treatment period , a 2-mo single-blind washout period , and an optional 2-mo open-label period . INTERVENTION Patients received placebo , nightly vardenafil , or on dem and vardenafil . MEASUREMENTS Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or = 22 after the 2-mo washout period . Secondary variables included mean per-patient success rates for Sexual Encounter Profile ( SEP ) questions 2 and 3 . RESULTS AND LIMITATIONS No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or = 22 or in SEP3 success rates after the washout period . On-dem and vardenafil treatment result ed in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period . CONCLUSIONS In this study of men with ED following bilateral NSRP , vardenafil was efficacious when used on dem and , supporting a paradigm shift towards on dem and dosing with PDE5 inhibitors in this patient group . TRIAL REGISTRATION European clinical trials data base ( EudraCT ; available at http://eudract.emea.europa.eu/ ) . TRIAL REGISTRATION NUMBER 11336 Sildenafil and tadalafil are efficacious and well tolerated in Chinese men with erectile dysfunction ( ED ) . Recent study results indicate that men with ED in China who were naïve to phosphodiesterase inhibitor type 5 ( PDE5 ) therapy prefer tadalafil 20-mg ( on-dem and ) versus sildenafil 100-mg ( on-dem and ) . Differences in psychosocial outcomes may help to explain treatment preference in favor of tadalafil . This open-label , r and omized , crossover study compared psychosocial outcomes and drug attribute choices between tadalafil and sildenafil in Chinese men with ED naïve to PDE5 inhibitor therapy . Eligible patients were r and omized to sequential 20-mg tadalafil/100-mg sildenafil ( n = 190 ) or 100-mg sildenafil/20-mg tadalafil ( n = 193 ) for 8 weeks each and were asked which treatment they preferred to take for the 8-week extension phase . Psychosocial outcomes were assessed using the Psychological and Interpersonal Relationship Scale ( PAIRS ) , Drug Attributes Question naire ( DRAQ ) , and Sexual Life Quality Question naire ( SLQQ ) . When taking tadalafil versus sildenafil , men had a higher mean endpoint score on the PAIRS Spontaneity Domain  ( tadalafil = 2.86 vs sildenafil = 2.72 ; P < 0.001 ) , and a lower mean endpoint score on the Time Concerns Domain ( tadalafil = 2.41 vs sildenafil = 2.55 ; P < 0.001 ) . A numerical increase in the Sexual Self-Confidence Domain was observed when taking tadalafil versus sildenafil ( tadalafil = 2.76 vs sildenafil = 2.72 ; P = 0.102 ) . The most frequently chosen drug attributes explaining treatment preference were able to get an erection long after having drug , and ability to get an erection every time . SLQQ results were comparable between treatment groups . These psychosocial outcomes may explain why more Chinese men preferred tadalafil versus sildenafil for the treatment of ED in this clinical trial INTRODUCTION Mirodenafil is a newly developed selective phosphodiesterase type 5 ( PDE5 ) inhibitor for the treatment of erectile dysfunction ( ED ) . AIM To evaluate the efficacy , safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes . METHODS A multicenter , r and omized , double-blind , placebo-controlled , parallel-group , fixed-dose study was conducted with 112 subjects who were r and omized to either placebo or mirodenafil 100 mg on dem and for 12 weeks . MAIN OUTCOME MEASURES Primary efficacy variable was the erectile function ( EF ) domain scores of the International Index of Erectile Dysfunction ( IIEF ) question naire . Secondary efficacy variables included change in the scores of IIEF question 3 and 4 ( IIEF Q3 and Q4 ) from baseline , change in all domain scores in the IIEF from baseline , Sexual Encounter Profile questions 2 and 3 ( SEP2 and SEP3 ) , the Global Assessment Question ( GAQ ) and the Life Satisfaction Checklist ( LSC ) . RESULTS After 12 weeks of treatment , mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group ( 9.3 vs. 1.4 , P < 0.0001 ) . The changes from baseline in the mirodenafil group in IIEF Q3 ( 1.7 vs. 0.4 , P < 0.0001 ) and Q4 ( 1.7 vs. 0.3 , P < 0.0001 ) were higher compared with the placebo group . Differences between the mirodenafil and placebo groups were significant in the SEP2 ( 82.0 % vs. 55.2 % , P = 0.0003 ) , SEP3 ( 68.9 % vs. 22.3 % , P < 0.0001 ) . Difference in GAQ " YES " responses was also significant ( 76.9 % vs. 19.1 % , P < 0.0001 ) . Normal EF domain scores ( ≥ 26 ) at study end were achieved by 32.7 % and 9.4 % in the mirodeniafl and placebo groups , respectively ( P = 0.0031 ) . As for the LSC scores , the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group . Most treatment-associated AEs were mild that resolved spontaneously . CONCLUSIONS Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea AIM To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day ( OaD ) vs. tadalafil 20 mg or sildenafil 100 mg as needed ( pro re nata [ PRN ] ) in patients with erectile dysfunction ( ED ) . METHODS A r and omized , open-label , crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 ( PDE5 ) inhibitor PRN . Data were analyzed with a mixed effects model for crossover design . MAIN OUTCOME MEASURES The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales ( PAIRS ) between tadalafil OaD and sildenafil PRN . SECONDARY OUTCOMES INCLUDED : Time Concerns and Spontaneity domains of PAIRS , and the Self-Esteem and Relationship ( SEAR ) scale . RESULTS Men naive to tadalafil OaD were enrolled ( N = 378 ) , with 61 - 69 % prior PDE5 inhibitor use . There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN ( P < 0.001 ) . The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD , 0.5 ± 0.72 for tadalafil PRN , and 0.39 ± 0.67 for sildenafil PRN . The difference in least-squares mean was 0.12 ± 0.04 ( confidence interval [ CI ] = 0.04 , 0.19 ; P = 0.001 ) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 ( CI = -0.06 , 0.08 ; P = 0.872 ) between tadalafil OaD and tadalafil PRN . The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN ( P < 0.001 ) . There were no differences in SEAR scores between treatments . CONCLUSIONS Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence , Time Concerns , and Spontaneity . There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN . Changes in SEAR , the erectile function domain of the International Index of Erectile Function , and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar
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 .