Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction

Tan, Hui Meng; Moh, Clarence Lei Chang; Mendoza, Jesus Benjamin; Gana, Telesforo E.; Albano, G; Quiroz, Reynaldo de la Cruz; Chye, Peter Lim Huat; Sam, Christopher Cheng Wai

doi:10.1016/s0090-4295(00)00688-9

Cited by 50 publications

(46 citation statements)

References 12 publications

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“…These baseline scores were very similar to the baseline scores observed in the Tan et al study. 18 At 3 months of treatment with flexibledose sildenafil or placebo, mean scores for Q3 and Q4 increased, respectively, to 4.2 and 4.1 for sildenafil vs 3.0 and 2.9 for placebo. The EF domain scores increased to 24.3 for sildenafil and 18.1 for placebo following treatment.…”

Section: Asian Trialsmentioning

confidence: 93%

“…Baseline and posttreatment IIEF scores (Q3, Q4, EF domain) were almost identical in the first US and European studies. 15 -17 Slightly higher post-treatment scores were observed for both drug and placebo conditions in the two Asian studies, 18,19 suggesting that Asian men might be slightly more susceptible to the nonspecific effects of treatment. However, the drugplacebo differences on Q3, Q4, and the EF domain were highly similar to those observed in both the European 16,17 and US 15 studies.…”

Section: Comparison Of Studiesmentioning

confidence: 95%

“…In the first study by Tan et al, 18 254 ED patients of mixed etiology from three Asian countries (Malaysia, Singapore, the Philippines) were randomly assigned to receive either 12 weeks of flexible-dose treatment with sildenafil or double-blind placebo. Mean scores for Q3 and Q4 at baseline were 2.3 and 1.9, respectively.…”

Section: Asian Trialsmentioning

confidence: 99%

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The International Index of Erectile Function (IIEF): a state-of-the-science review

Rosen¹,

Cappelleri

Gendrano³

2002

Int J Impot Res

913

668

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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: Asian Trialsmentioning

confidence: 93%

Section: Comparison Of Studiesmentioning

confidence: 95%

See 1 more Smart Citation

The International Index of Erectile Function (IIEF): a state-of-the-science review

Rosen¹,

Cappelleri

Gendrano³

2002

Int J Impot Res

913

668

View full text Add to dashboard Cite

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“…Numerous studies have reported good efficacy in a variety of Asian populations treated with PDE5 inhibitors; for example, the ASSESS trial included patients from Malaysia, Singapore, and the Philippines. 19,20 However, the present study is the first to investigate the safety and efficacy of a PDE5 inhibitor in an exclusively Japanese population. We have demonstrated that vardenafil taken orally 1 h before sexual intercourse improves key aspects of erectile function in a manner similar to that previously observed in studies in Europe and North America.…”

Section: Discussionmentioning

confidence: 97%

“…Scores were graded on a scale of 1-5, with one for never or almost never, and five for always or almost always, with no intercourse noted as zero. In addition, the IIEF-erectile function (IIEF-EF) domain was also evaluated (the sum of Questions 1-5 plus Question 15), which ranges from severe ( £ 10), to moderate (11)(12)(13)(14)(15)(16), to mild-moderate (17)(18)(19)(20)(21), to mild (22)(23)(24)(25), to normal ( > 25). The 12-week LOCF score was used.…”

Section: Efficacy Parametersmentioning

confidence: 99%

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

et al. 2004

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Aim : Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED.Methods : This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF).Results : All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. Conclusion : Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.

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Sildenafil for Male Erectile Dysfunction

Fink¹,

Donald²,

Rutks³

et al. 2002

Arch Intern Med

224

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Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction

Cited by 50 publications

References 12 publications

The International Index of Erectile Function (IIEF): a state-of-the-science review

The International Index of Erectile Function (IIEF): a state-of-the-science review

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

Sildenafil for Male Erectile Dysfunction

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