Combination therapy with selective serotonin reuptake inhibitors and phosphodiesterase‐5 inhibitors in the treatment of premature ejaculation The efficacy of duloxetine in the treatment of premature ejaculation Relevance of serum nitric oxide levels and the efficacy of selective serotonin reuptake inhibitors treatment on premature ejaculation: decreased nitric oxide is associated with premature ejaculation PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double‐blind, placebo‐controlled study Efficacy of sertraline hydrochloride in treatment of premature ejaculation: a placebo-controlled study using a validated questionnaire Improved ejaculatory latency, control and sexual satisfaction when PSD502 is applied topically in men with premature ejaculation: results of a phase III, double-blind, placebo-controlled study. Comparison Between Tadalafil Plus Paroxetine and Paroxetine Alone in the Treatment of Premature Ejaculation 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 Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline. 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 Physical activity and PDE5 inhibitors in the treatment of erectile dysfunction: results of a randomized controlled study. A 6-month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction Effect on Sexual Function of Long-Term Treatment With Selective Serotonin Reuptake Inhibitors in Depressed Patients Treated in Primary Care 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. 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. Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors.
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 Abstract Aim : Though premature ejaculation ( PE ) has been overshadowed by current attention given to erectile dysfunction , it is the most widespread form of male sexual dysfunction . Delayed or inhibited ejaculation , a known side effect of selective serotonin reuptake inhibitors ( SSRIs ) , has made SSRIs potentially useful in the treatment of this disorder . In the present study , we examined the efficacy of duloxetine , an SSRI , in the treatment of PE . Method : The study included 20 married patients diagnosed with PE . The patients were r and omly assigned to two groups , duloxetine ( group I ) and placebo ( group II ) , each consisting of 10 patients . The effects on the ejaculatory function were estimated by the intravaginal ejaculation latency time . All patients were evaluated by using clinical global impression-improvement Scale ( CGI-I ) . Results : The increase in the intravaginal ejaculation latency time in the duloxetine group was statistically significant than that of placebo group . Of group I patients , four ( 40 % ) were considered as “ very much improved ” and four ( 40 % ) “ much improved ” by CGI-I and only one of group II patients ( 10 % ) showed “ much improved ” . Conclusion : Duloxetine appears to be superior to placebo in the pharmacological treatment of PE when administered on a chronic basis The aim of the present study was to determine the relevance of serum nitric oxide levels and the efficacy of selective serotonin reuptake inhibitors ( SSRI ) treatment on  premature ejaculation . Sixty married men ( aged 20–50 ) with lifelong premature ejaculation and forty healthy men ( aged 24–48 ) as control group were included in this study . The patients were evaluated by  intravaginal ejaculation latency time ( IELT ) for premature ejaculation ( PE ) . IELT<1 min is accepted PE . Patients with diabetes mellitus , chronic disorders or erectile dysfunction and heavy smokers were excluded . All patients were evaluated with history , physical examination , International Index of Erectile Dysfunction‐5 ( IIEF‐5 ) score and IELT by stopwatch  method . Nitric oxide levels were measured by Griess reaction , and all sample s were frozen at −80 ° C . Patients were r and omly categorised 4 group to receive fluoxetine 20 mg day−1 ( Group 1 ) , paroxetine 20 mg day−1 ( Group 2 ) , sertraline 50 mg day−1 ( Group 3 ) and healthy control ( Group 4 ) for 4 weeks . Baseline and post‐treatment findings were compared between the four groups . At the end of 4 weeks , in fluoxetine , paroxetine , sertraline  groups mean IELT values showed a statistically significant improvement from the baseline values ( P < 0.001 , P < 0.001 , P = 0.03 ; respectively ) . Baseline and 1st month follow‐up mean IIEF scores were 24.5 and 23.05 , 24.70 and 23.60 ( P < 0.05 ) in group 1 and group 3 respectively ; also 23.09 and 23.32 ( P > 0.05 ) in group 2 . Baseline serum NO levels were 31.8 , 30.44 , 30.8 and 42.84 in fluoxetine , paroxetine , sertraline and healthy control groups respectively . NO levels were statistically lower in patients with PE . After treatment of fluoxetine , paroxetine and sertraline , NO levels were increased baseline ( 35.8 , 36.4 , 38.08 ) ( P < 0.05 ) . Our findings indicated that PE is associated with decreased serum NO levels . After the SSRI treatment increased , NO may retard ejaculation presumably by central peripheral mechanism . Further studies are needed to confirm this suggestion and the role of NO in pathophysiology and treatment for premature ejaculation To determine the effect of PSD502 applied topically 5 min before intercourse on the Index of Premature Ejaculation ( IPE ) and intravaginal ejaculatory latency time ( IELT ) of men with lifelong premature ejaculation ( PE ) defined according to the International Society of Sexual Medicine ( ISSM ) definition ; secondary objectives were to evaluate the safety and tolerability of PSD502 in patients with PE , and their sexual partners Selective serotonin reuptake inhibitors ( SSRIs ) are increasingly used to treat premature ejaculation . We report a large prospect i ve placebo-controlled crossover study of sertraline in premature ejaculation ( PE ) using Arabic Index of Premature Ejaculation ( AIPE ) . One hundred and forty-seven men suffering from PE were enrolled in a r and omized single-blinded crossover study of sertraline hydrochloride and placebo .  Patients were r and omized into group 1 ( n=77 ) and group 2 ( n=70 ) . Both groups received sertraline and placebo interchangeably for 4 weeks . Overall , 127 ( 81 % ) of 157 subjects experienced a significant increase in their AIPE total score after sertraline treatment . Sixty-six ( 66 % ) of 100 patients available for follow-up experienced relapse of PE within 6 months after sertraline withdrawal . The active drug was generally well tolerated . Our relatively large study , using a vali date d question naire ( AIPE ) , confirmed the useful effect of sertraline on PE INTRODUCTION PSD502 is a novel aerosolized , lidocaine-prilocaine , spray being developed for the treatment of lifelong premature ejaculation . The clinical profile of PSD502 is described in one of two double-blind , placebo-controlled , phase III studies . AIM To determine the effect of PSD502 on the Index of Premature Ejaculation ( IPE ) and intravaginal ejaculatory latency ( IELT ) of men with lifelong PE . METHODS Men with lifelong PE who documented an IELT ≤ 1 minute with two or more of the first three sexual encounters during a 4-week baseline period were r and omized to receive double-blind treatment with PSD502 or placebo for 3 months . Patients completed IPE and Premature Ejaculation Profile question naires at entry and monthly visits , and recorded stop-watch timed IELT during each encounter . Safety was assessed by collecting adverse event data and st and ard safety measures . MAIN OUTCOME MEASURES Stopwatch timed IELT recordings and a patient-reported outcome question naire the IPE were used in this study to determine the effect of PSD502 applied topically 5 minutes before intercourse . RESULTS Two hundred fifty-six men with PE were r and omized from 38 centers in the U.S. , Canada , and Pol and .  The geometric mean IELT over the 3-month treatment period increased from a baseline of 0.56 minute and 0.53 minute in the PSD502 and placebo group respectively to 2.60 and 0.80 minute . There were significantly greater increases in the scores for the IPE domains of ejaculatory control , sexual satisfaction and distress in the PSD502 group than in the placebo group , with a mean 5.0 point difference between treatments in change from baseline in the IPE domain for ejaculatory control , 4.6 point difference in change from baseline in the IPE domain for sexual satisfaction , and a 2.5 point difference in change from baseline in the IPE domain for distress . This was supported by improvements in all secondary endpoints . CONCLUSION In this study , PSD502 applied topically to the glans penis 5 minutes before intercourse showed significantly improved ejaculatory latency , ejaculatory control , sexual satisfaction and distress and was shown to be well tolerated by patients and partners Background : Several recent studies have investigated the therapeutic role of phosphodiesterase type 5 ( PDE5 ) inhibitors in premature ejaculation ( PE ) used in the treatment of erectile dysfunction . Objectives : In the present research , the efficacy of paroxetine alone and paroxetine plus tadalafil was compared in patients referred because of premature ejaculation . Patients and Methods : This quasi-experimental study was performed on 100 consecutive 17 to 49-year-old potent men with premature ejaculation and without any clear organic disease . All patients had lifelong PE with an intravaginal ejaculation latency time ( IELT ) shorter than 1.5 minutes . Informed consent was obtained from all patients who were r and omly divided into two groups using a computer-generated r and om tabulation list . In group A , patients received 10 mg paroxetine daily , in addition to four hours before planned sexual activity . In group B , 10 mg paroxetine was taken daily , plus 10 mg tadalafil one hour before planned sexual activity . The duration of the intervention was six months and patients were evaluated for IELT three and six months after the beginning of therapy . Results : The mean age of patients in groups A and B were 33 ± 9.6 and 31.2 ± 9.3 years , respectively ( P = 0.368 ) . The mean number of intercourses were 1.08 ± 0.6 and 1.12 ± 0.6 per week in groups A and B , respectively ( P = 0.791 ) . Mean IELT at the 3-month follow up in groups A and B was 4.5 ± 1.5 and 5 ± 2.4 minutes , respectively ( P = 0.285 ) and at the 6-month follow up was 4.8 ± 1 and 5.3 ± 2 minutes , respectively ( P = 0.278 ) . Conclusions : The results of the study show that tadalafil can increase the mean IELT and can be used for treatment of premature ejaculation in combination with paroxetine 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 Depression is a common cause of sexual dysfunction , but also antidepressant medication is often associated with sexual side effects . This article includes two related studies . The first double-blind , placebo-controlled study was conducted in men with lifelong rapid ejaculation and aim ed to assess putative differences between the major selective serotonin reuptake inhibitors ( SSRIs ) ( fluoxetine , fluvoxamine , paroxetine , and sertraline ) with regard to their ejaculation-delaying effect .  Sixty men with an intravaginal ejaculation latency time ( IELT ) of 1 minute or less were r and omly assigned to receive fluoxetine 20 mg/day , fluvoxamine 100 mg/day , paroxetine 20 mg/day , sertraline 50 mg/day , or placebo for 6 weeks . During the 1-month baseline and 6-week treatment periods , the men measured their IELT at home using a stopwatch . The trial was completed by 51 men . During the 6-week treatment period , the geometric mean IELT in the placebo group was constant at approximately 20 seconds . Analysis of variance revealed a between-groups difference in the evolution of IELT delay ( p = 0.0004 ) ; in the paroxetine , fluoxetine , and sertraline groups there was a gradual increase to about 110 seconds , whereas in the fluvoxamine group , IELT was increased to only approximately 40 seconds . The paroxetine , fluoxetine , and sertraline groups differed significantly ( p < 0.001 , p < 0.001 , p = 0.017 , respectively ) from placebo but the fluvoxamine group did not ( p = 0.38 ) . Compared with baseline , paroxetine exerted the strongest delay in ejaculation , followed by fluoxetine and sertraline . There was no clinical ly relevant delay in ejaculation with fluvoxamine . In men with lifelong rapid ejaculation , paroxetine  delayed ejaculation most strongly , whereas fluvoxamine delayed ejaculation the least . The second double-blind , placebo-controlled study was carried out in men with lifelong rapid ejaculation ( IELT < or = 1 minute ) and in men with lifelong less-rapid ejaculation ( IELT > 1 minute ) to investigate whether data about SSRI-induced delayed ejaculation in men with rapid ejaculation may be extrapolated to men with less-rapid ejaculation . After measurement of IELT at home ( using a stopwatch ) during a 1-month baseline assessment , 32 men with an IELT of 1 minute or less ( group 1 ) or more than 1 minute ( group 2 ) were r and omly assigned to receive paroxetine 20 mg/day or placebo for 6 weeks in a double-blind manner . Patients continued to measure their IELTs at home during the 6 weeks of the study . At baseline , 24 patients consistently had IELTs of one minute or less ( group 1 ) , and eight patients had IELTs of more than 1 minute ( group 2 ) . The geometric mean IELT was 14 seconds in group 1 and 83 seconds in group 2 . Twelve patients in group 1 and five in group 2 were r and omized to the paroxetine 20 mg/day . The percentage increase in the geometric mean IELT compared with baseline in patients treated with paroxetine was 420 % ( 95 % confidence interval [ CI ] , 216 - 758 % ) in group 1 and 480 % ( 95 % CI , 177 - 1,118 % ) in group 2 ( p = 0.81 ) . After 6 weeks of treatment with paroxetine , the geometric mean IELT was 92 seconds in group 1 and 602 seconds in group 2 ( p < 0.001 ) . Therefore , the paroxetine-induced percentage increase in IELT seems to be independent of the baseline IELT . This suggests that ejaculation-delaying side effects of some SSRIs investigated in men with lifelong rapid ejaculation may be generalized to men with less-rapid ejaculation 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 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 : 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 The purpose of this study was to prospect ively examine the occurrence and severity of sexual dysfunction symptoms in depressed patients before and after 6 months of treatment with selective serotonin reuptake inhibitors .  The study was part of a r and omized , double-blind , controlled trial of sertraline or citalopram in patients with a DSM-III-R major depressive disorder treated by general practitioners . Three hundred eight patients ( 221 women and 87 men ) were assessed at baseline and after 6 months of treatment by means of the  Montgomery-Åsberg Depression Rating Scale  and five items from the Utvalg for Kliniske Undersogelser ( UKU ) Side Effect Scale covering different aspects of sexual functioning . As measured by the UKU Side Effect Scale , sexual desire and mean total score significantly improved in women , and sexual desire improved in men . Men reported no change in orgasmic dysfunction , erectile dysfunction , or mean total score , but there was a trend toward worsening of ejaculatory dysfunction . However , in the subgroup of women who reported no sexual problems at baseline , 11.8 % reported decreased sexual desire , and 14.3 % reported orgasmic dysfunction at week 24 . The corresponding figures in the same subgroup of men were 16.7 % and 18.9 % , respectively , and as many as 25 % experienced ejaculatory dysfunction after 24 weeks . There were no statistically significant differences between sertraline and citalopram in the magnitude or frequency of adverse sexual side effects 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 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 OBJECTIVE This study was an evaluation of whether sildenafil citrate is effective for the treatment of  erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants . METHOD A retrospective sub analysis of combined data from 10 phase II/III double-blind , placebo-controlled , fixed- and flexible-dose trials ( 12 - 26 weeks ) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil ( N=65 ) or placebo ( N=33 ) and concomitant serotonin-reuptake-inhibiting antidepressants .  Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection , ability to maintain erection , ejaculation frequency , orgasm frequency , and sexual desire . RESULTS Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection , frequency of ejaculation , and orgasm frequency than did patients receiving placebo , without increased sexual desire . CONCLUSIONS Sildenafil significantly improved  erectile dysfunction  in patients taking concomitant serotonergic antidepressants
Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
The combined treatment had better efficacy than PDE5Is or SSRIs alone
Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .