Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. A dose‐escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction. Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa Sildenafil citrate (Viagra®) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra®) in the treatment of erectile dysfunction in Brazilian and Mexican men Evaluation of the safety and efficacy of sildenafil citrate for erectile dysfunction in men with multiple sclerosis: a double-blind, placebo controlled, randomized study. Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors.
OBJECTIVES To assess the efficacy and safety of Viagra ( sildenafil citrate ) in male out patients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ) . METHODS A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a r and omized , double-blind , parallel-group , multicenter study conducted at outpatient clinics . Patients receiving oral sildenafil ( 25 , 50 , and 100 mg ) were compared with patients receiving placebo during a 12-week period . The principal efficacy measures were responses to question 3 ( ability to achieve an erection ) and question 4 ( ability to maintain an erection ) on the International Index of Erectile Function and three global efficacy questions . Patient and partner satisfaction with treatment were assessed , for the first time , using the EDITS question naire . RESULTS Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo ( P < 0.001 ) . Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo ( P < 0.001 ) . Adverse events were chiefly mild or moderate . Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events . CONCLUSIONS Sildenafil was an effective , well-tolerated treatment for erectile dysfunction in an outpatient setting . Partner evaluations corroborated patient assessment s. The results from the EDITS question naire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo Objective To assess the efficacy and safety of sildenafil citrate ( Viagra ® , Pfizer Inc. , USA ) in a double‐blind , placebo‐controlled , dose‐escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology BACKGROUND Erectile dysfunction is a common , multi-factorial disorder . AIMS To evaluate the efficacy , tolerability and frequency of use of sildenafil citrate in men with mild to moderate erectile dysfunction of no established organic cause . METHOD This double-blind , r and omised , placebo-controlled , flexible-dose , two-way crossover study was conducted at four centres in the UK in 44 men with mild to moderate erectile dysfunction of no clinical ly obvious organic cause . The study included two 28-day treatment periods , during which time sildenafil or placebo ( 25 - 75 mg , based on efficacy ) was taken as required . RESULTS Compared with placebo , sildenafil was associated with increases in frequency of use , erections adequate for sexual intercourse and level of sexual satisfaction ( P:<0.0001 ) . More patients receiving sildenafil stated they would use the treatment again compared with those receiving placebo ( P:<0.0001 ) . There were no discontinuations due to sildenafil treatment . CONCLUSIONS Sildenafil is effective and well tolerated in men with mild to moderate erectile dysfunction of no clinical ly identifiable organic cause PURPOSE We assess the clinical efficacy of sildenafil citrate and predictors of satisfactory outcome . MATERIAL S AND METHODS All patients treated with sildenafil citrate within the first 6 weeks of its release were evaluated with a self-administered question naire before and at completion of therapy to assess etiology of erectile dysfunction , level of sexual function , libido , response to previous therapies , response to therapy with sildenafil citrate and quality of life . Sexual function was measured before and during therapy using an abbreviated version of the International Index of Erectile Function , with a successful outcome defined as a level of satisfaction of 4 or 5 on a 5-point scale . RESULTS Followup was obtained in 267 of the 308 patients who entered the study . Mean age plus or minus st and ard deviation was 61+/-9.6 years and duration of erectile dysfunction was 4.1+/-3 years .  Overall satisfaction with sildenafil citrate for the entire patient population was 65 % and response to prior therapies did not affect satisfaction . There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41 % satisfaction rate . Etiology of erectile dysfunction had a significant impact on satisfaction rate , with neurogenic causes of erectile dysfunction ( diabetes , prostate surgery and so forth ) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction . CONCLUSIONS Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice . The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction . However , we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy . Therefore , all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction ( ED ) from Colombia , Ecuador , and Venezuela . One hundred and fifty-eight out patients with ED participated in a double-blind , flexible-dose , r and omized-controlled trial . Efficacy measures included question 3 ( achieving an erection ) and question 4 ( maintaining an erection ) from the International Index of Erectile Function ( IIEF ) , the five functional domains of the IIEF , a global efficacy question , and patient event log . Sildenafil increased patients ' ability to achieve/maintain erections ( P<0.01 ) . Seventy-seven per cent of sildenafil- vs 46 % of placebo-treated patients reported improved erections ( P<0.001 ) . Sixty-five percent and 35 % of intercourse attempts were successful among sildenafil and placebo patients , respectively ( P<0.05 ) . Sildenafil patients showed significant improvements in three of the five IIEF functional domains ( P<0.05 ) . Adverse events were reported for 51 % and 33 % of sildenafil and placebo patients , respectively . It can be concluded that sildenafil is an effective , well-tolerated treatment for ED in patients from Latin America PURPOSE We assessed the efficacy and safety of sildenafil citrate as treatment for erectile dysfunction . MATERIAL S AND METHODS A total of 433 completely evaluated men with chronic erectile dysfunction were treated with sildenafil citrate . Response was assessed prospect ively by baseline and followup physician interviews , and by a patient self-administered 15-item question naire on the domains of patient treatment response and satisfaction , partner treatment satisfaction , comparative previous treatment satisfaction , adverse effects , and patient and partner quality of life . RESULTS Of the 304 men ( 70.2 % ) who completed the question naire 278 received sildenafil , including 186 who previously had undergone treatment for erectile dysfunction , principally involving intracavernous injection therapy . A response was elicited by a median dose of 100 mg . in 188 patients ( 67.6 % ) who achieved erection suitable for sexual intercourse . Those with psychogenic erectile dysfunction responded significantly better than those with organic dysfunction ( p < 0.001 ) . Erection suitable for intercourse was attained by 30.8 % of patients with erectile dysfunction after radical prostatectomy and 80 % with cavernous veno-occlusive dysfunction . Of previous intracavernous injection responders 29.9 % were refractory to sildenafil , while 33 . 3 % of previous intracavernous injection nonresponders responded to sildenafil . The sildenafil response was considered inferior to the intracavernous injection response by 43.6 % of the men who previously responded to intracavernous injection , of whom 51.5 % continued to receive intracavernous injection as the only treatment ( 19.5 % ) or as an alternative to sildenafil ( 32 % ) . Adverse effects in 53.6 % of cases were assessed as mild in 56.4 % , moderate in 38.3 % and severe in 5.3 % . Multiple adverse effects were reported by 62.4 % of patients , while 17 ( 6.1 % ) discontinued sildenafil as a direct result of intolerable adverse effects . The most common adverse effects were facial flushing in 33.5 % of cases , headaches in 23.4 % , nasal congestion in 12.6 % , dyspepsia in 10.1 % and dizziness in 10.8 % . Baseline patient and partner quality of life scores significantly improved after sildenafil treatment ( p < 0.001 ) , while significantly improved quality of life was noticed by 51.5 % and 43.1 % , respectively . CONCLUSIONS Sildenafil citrate is effective oral first line treatment for erectile dysfunction . Although more than 50 % of men reported adverse effects , most were considered mild and rarely result ed in treatment cessation . There was a trend in those on intracavernous injection who responded to sildenafil to continue intracavernous injection as the only therapy or as an alternative to sildenafil . Also , we noted that some cases refractory to sildenafil responded to intracavernous injection . These findings imply that intracavernous injection remains an effective erectile dysfunction treatment option The efficacy of sildenafil citrate ( Viagra ® ) , an oral agent for the treatment of erectile dysfunction ( ED ) , has been demonstrated in global studies . This 12-week r and omized , double-blind , placebo-controlled , parallel-group , flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa . Men with ED of varied etiology were r and omized to receive sildenafil 50 mg ( n=128 ) or placebo ( n=126 ) ; doses could be adjusted to 100 or 25 mg . Questions from the International Index of Erectile Function ( IIEF ) assessing the ability to achieve ( Q3 ) and maintain ( Q4 ) erections demonstrated a significant improvement with sildenafil compared with placebo ( P<0.0001 ) . Improved erections were reported by 74 % of patients receiving sildenafil and 27 % of those receiving placebo ( P<0.0001 ) . Headache , dyspepsia , and flushing were the most common adverse events in sildenafil-treated patients . These results are consistent with clinical trials in other countries . We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa Our objectives were : ( 1 ) to determine the efficacy , safety , and tolerability of sildenafil citrate ( Viagra ® ) administered to men with broad-spectrum erectile dysfunction ( ED ) in southern Latin America ; and ( 2 ) to correlate Rigiscan ® measurements assessing ED etiology with the investigator 's assessment . A total of 141 men with broad-spectrum ED ( mean age 57 ) were enrolled in a r and omized , 12-week , double-blind , placebo-controlled , flexible-dose escalation study of sildenafil . After the 12-week treatment period , the mean score for the primary efficacy variables had risen significantly : for the sildenafil group , 66.2 % from baseline for question 3 of the International Index of Erectile Function and 77.6 % for question 4 , vs 15.1 % and 21.2 % for the placebo group , respectively ( P<0.0001 ) . Rigiscan ® data confirmed investigator assessment s of etiology . Headache and flushing , usually mild and transient , were the most common adverse events . Sildenafil was an effective , well-tolerated treatment for men in southern Latin America with broad-spectrum ED A 12-week , double-blind , placebo-controlled , multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate ( Viagra ® ) treatment ( 25 , 50 or 100 mg ) in Brazilian and Mexican men with erectile dysfunction ( ED ) of broad-spectrum etiology . Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function ( IIEF ) question naire , completed at baseline and after 12 weeks of treatment . At end point , mean scores for all IIEF domains of sexual function ( erectile function , orgasmic function , sexual desire , intercourse satisfaction and overall satisfaction ) were significantly ( P<0.0001 ) higher in the sildenafil group ( n=109 ) than in the placebo group ( n=105 ) . These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously . Sildenafil treatment was well tolerated . The most common adverse events were headache and flushing . In conclusion , sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men PURPOSE We evaluated the safety and efficacy of sildenafil citrate for treating erectile dysfunction in patients with multiple sclerosis . MATERIAL S AND METHODS A total of 203 patients with multiple sclerosis ( age range 18 to 50 years old ) with erectile dysfunction were r and omly assigned to receive 50 to 100 mg sildenafil ( 102 patients in group 1 ) or a similar regimen of placebo ( 101 patients in group 2 ) 45 minutes to 2 hours before sexual stimulation . Patients were asked to use at least 24 doses/attempts at home . Primary outcome measures consisted of responses to questions 3 and 4 from the International Index of Erectile Function question naires well as responses to Sexual Encounter Profile diary questions 2 and 3 . We also assessed the number of attempts at sexual intercourse , the number of attempts that were successful and adverse drug effects . RESULTS Improved erections ( positive response to the Global Assessment Question naire ) were reported by 32.8 % of patients receiving sildenafil and 17.6 % of those receiving placebo ( p = 0.04 ) . For Sexual Encounter Profile question 2 ( successful penetration ) the increase from baseline in mean per patient percentage of yes responses was 29.4 % after sildenafil vs 18.8 % after placebo ( p = 0.04 ) . The proportion of successful sexual attempts ranged from 12 % to 26 % for sildenafil and from 9 % to 21 % for placebo , respectively ( p = 0.044 ) . Of patients taking sildenafil and placebo 24 ( 23.5 % ) and 9 ( 8.9 % ) experienced 81 and 31 adverse events , respectively ( p = 0.01 ) . CONCLUSIONS Compared with placebo , sildenafil has little effect on multiple sclerosis emergent erectile dysfunction and , therefore , can not be recommended for the routine treatment of erectile dysfunction in patients with multiple sclerosis . This finding implies that there must be other mechanisms that are not affected by sildenafil or are resistant to the effects of sildenafil 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
In data pooled from 6 parallel-group , fixed-dose trials , efficacy appeared slightly greater at higher doses .
Treatment response appeared to vary between patient subgroups , although relative to placebo , sildenafil significantly improved erectile function in all evaluated subgroups .
In trials with parallel-group design and flexible dosing , men r and omized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality .
Sildenafil was not significantly associated with serious cardiovascular events or death .
CONCLUSIONS Sildenafil improves erectile function and is generally well tolerated .
Treatment response seems to vary between patient subgroups , although sildenafil has greater efficacy than placebo in all evaluated subgroups
OBJECTIVE To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction .