Sildenafil, a novel effective oral therapy for male erectile dysfunction

Boolell, Mitra; Gepi-Attee, S.; Gingell, J. C.; Allen, Michael J.

doi:10.1046/j.1464-410x.1996.10220.x

Cited by 564 publications

(349 citation statements)

References 3 publications

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“…This observation likely stems from two reasons: (i) scores on sexual desire in the patient group before treatment were only marginally less than those in the control group; and (ii) sildenafil acts specifically on the peripheral mechanism of erection and has little or no central effects. 6,7 This pattern of results has been observed consistently, and it is noteworthy that no study to date has shown clinically significant increases in sexual desire with sildenafil or other erectogenic agents. …”

Section: Normalization Of Iief Scores With Sildenafil Treatmentmentioning

confidence: 77%

The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction

Rosen¹,

Riley²,

Wagner³

et al. 1997

Urology

5,042

3,524

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The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity. The IIEF was developed in conjunction with the clinical trial program for sildenafil, and has since been adopted as the 'gold standard' measure for efficacy assessment in clinical trials of ED. It has been linguistically validated in 32 languages and used as a primary endpoint in more than 50 clinical trials. This review summarizes early stages in the psychometric validation of the instrument, its subsequent adoption in randomized clinical trials with sildenafil and other ED therapies, and its use in classifying ED severity and prevalence. The IIEF meets psychometric criteria for test reliability and validity, has a high degree of sensitivity and specificity, and correlates well with other measures of treatment outcome. It has demonstrated consistent and robust treatment responsiveness in studies in USA, Europe and Asia, as well as in a wide range of etiological subgroups. Although only one direct comparator trial has been performed to date, the IIEF is also sensitive to therapeutic effects with treatment agents other than sildenafil. A severity classification for ED has recently been developed, in addition to a brief screening version of the instrument. This review includes the strengths as well as limitations of the IIEF, along with some potential areas for future research.

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Section: Normalization Of Iief Scores With Sildenafil Treatmentmentioning

confidence: 77%

The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction

Rosen¹,

Riley²,

Wagner³

et al. 1997

Urology

5,042

3,524

View full text Add to dashboard Cite

show abstract

“…These ®ndings are consistent with those of previous studies with sildena®l, in which the main adverse events were headache, vasodilation and dyspepsia. 8 The majority of our subjects received at least one concomitant medication during the study and there was no evidence of any adverse drug interactions between these drugs and sildena®l. Indeed, few clinically important drug interactions have been identi®ed with sildena®l during the phase III trial programme or in the several interaction studies that have been conducted in healthy volunteers.…”

Section: Discussionmentioning

confidence: 86%

“…In Part I, the duration of erections of 460% and 480% rigidity (an erection 460% rigidity is considered as su cient for penetration 7,8 ) at the base and tip of the penis in response to PVS were recorded 30, 60 and 90 min after drug dosing using penile plethysmography (RigiScan Plus TM ); the vibrator settings used in both cross-over periods were those which had maximised the re¯exogenic erectile response during screening. Sitting BP and pulse rate measurements were performed throughout penile plethysmography and any subject showing a hypertensive dysre¯exic response was immediately withdrawn from the study.…”

Section: Assessments and Statistical Analysesmentioning

confidence: 99%

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A two-part pilot study of sildenafil (VIAGRATM) in men with erectile dysfunction caused by spinal cord injury

Maytom

Derry²,

Dinsmore

et al. 1999

Spinal Cord

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Study design: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, twoway cross-over study comparing a single dose of sildena®l 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildena®l 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. Objectives: To assay the e cacy and safety of sildena®l 50 mg and placebo. Setting: Clinic-and home-based assessments in the United Kingdom. Methods: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the re¯exogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global e cacy, questionniare, diary). Results: In Part I, 17/26 (65%) subjects had erections of 460% rigidity at the penile base (median duration 3.5 min) after sildena®l compared with 2/26 (8%) (median duration 0 min) after placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildena®l and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P50.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P50.02). An analysis of diary data showed no di erence between the groups with respect to the mean number of erections hard enough for penetration (P=0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no signi®cant di erences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildena®l due to adverse events. Conclusion: Sildena®l is an e ective, well-tolerated oral treatment for ED in SCI subjects. Sponsorship: This study was funded by P®zer Inc.

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“…It inhibits the human cGMP-specific phosphodiesterase type 5 enzyme (PDE5) found in human corpus cavernosum. [1][2][3][4] Sildenafil also weakly inhibits phosphodiesterase type 6 (PDE6), that is, one-tenth of its affinity for PDE5. PDE6 is an important component of the phototransduction cascade and is present in high concentrations in cone and rod cells of the retina.…”

Section: Introductionmentioning

confidence: 99%

Effects of sildenafil on blue-on-yellow and white-on-white Humphrey perimetry in 3 months regular use

Dündar

Topaloğlu

Dündar

et al. 2005

Eye

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Sildenafil, a novel effective oral therapy for male erectile dysfunction

Abstract: These results show that sildenafil is a well tolerated and effective oral therapy for male erectile dysfunction with no established organic cause and may represent a new class of peripherally acting drug for the treatment of this condition.

Cited by 564 publications

References 3 publications

The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction

The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction

A two-part pilot study of sildenafil (VIAGRATM) in men with erectile dysfunction caused by spinal cord injury

Effects of sildenafil on blue-on-yellow and white-on-white Humphrey perimetry in 3 months regular use

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