The Efficacy and Safety of Tadalafil in United States and Puerto Rican Men With Erectile Dysfunction

Seftel, Allen D.; Wilson, Steven K.; Knapp, Peter M.; Shin, Janey; Wang, W. Christine; Ahuja, Sanjeev

doi:10.1097/01.ju.0000132857.39680.ce

Cited by 40 publications

(27 citation statements)

References 8 publications

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“…Patients who received 20 mg tadalafil in this analysis had, on average, an IIEF-EF domain score of 23.0 at the end point, corresponding to mild ED as defined by Cappelleri et al [18]. The mean success rate for intercourse attempts (SEP3) with 20 mg tadalafil was 70.5%, which is comparable to results reported in Japan (69.4%) [25], the US and Puerto Rico (67.6%) [24], Canada (61.5%) [22], and Western Europe (73.9%) [23].…”

Section: Discussionsupporting

confidence: 77%

“…This integrated analysis of 1 046 Asian men with ED showed that treatment with tadalafil at 10 mg or 20 mg improves The improvements in erectile function observed in this Asian population mirror those observed in earlier studies in Western populations [22][23][24]. Patients who received 20 mg tadalafil in this analysis had, on average, an IIEF-EF domain score of 23.0 at the end point, corresponding to mild ED as defined by Cappelleri et al [18].…”

Section: Discussionsupporting

confidence: 56%

“…In this report, approximately one quarter of the patients with ED had at least one of the three most common comorbid conditions: cardiovascular disease, diabetes, and hypertension. This frequency of diabetes is higher than that reported in Western ED populations [23,24] and is largely due to the high frequency of diabetes in Indian patients with ED (63% in Study H6D-MC-LVDX of this analysis). As expected, baseline erectile function scores were numerically lower for patients with comorbid diabetes, hypertension, and cardiovascular disease; however, the magnitude of improvement with treatment was not impaired.…”

Section: Discussioncontrasting

confidence: 48%

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Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

Guo¹,

Viswanathan²,

Chiang³

et al. 2009

Asian J Androl

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We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351). Efficacy assessments included the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary and Global Assessment Question (GAQ). Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) domain score in all clinical sub-populations analyzed, compared with patients receiving placebo (P < 0.001). The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts (SEP3, successful intercourse), respectively, compared with 33.4% in the placebo group (P < 0.001), and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group (P < 0.001). Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionsupporting

confidence: 56%

Section: Discussioncontrasting

confidence: 48%

See 1 more Smart Citation

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

Guo¹,

Viswanathan²,

Chiang³

et al. 2009

Asian J Androl

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“…The IIEF has been shown to be valid cross-culturally, 16 and its adaptation to Asian languages has not been associated with problems of comprehension. 13 All three measures have been widely used in clinical studies to assess the efficacy of ED therapy Mild (17)(18)(19)(20)(21)(22)(23)(24)(25) Moderate (11)(12)(13)(14)(15)(16) Severe (1)(2)(3)(4)(5)(6)(7)(8)(9)(10) and are complementary to each other. Tadalafil at doses of 10-mg and 20-mg resulted in consistent and robust improvements in erectile function in South-East Asian men with ED based on all three measures.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of on‐demand tadalafil for the treatment of erectile dysfunction in South‐East Asian men

et al. 2006

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Aim : Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of ondemand tadalafil for the treatment of ED in South-East Asian men. Methods : This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo ( n = 122), tadalafil 10 mg ( n = 120), or tadalafil 20 mg ( n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results : Men from China, Singapore, and the Philippines participated in this trial ( n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes ( P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group ( P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group ( P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. Conclusions : Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.

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“…131 In a trial of 207 US and Puerto Rican men, it was shown that the most successful intercourse attempts occurred between 4 and 36 h after taking tadalafil with 83% of men taking tadalafil reporting improved erections vs 20% placebo. 132 Another study confirmed the efficacy and adverse effect profile with tadalafil, and also showed that patients and their sexual partners were more satisfied than those given placebo. 133 Improved sexual satisfaction with tadalafil 10 and 20 mg has also been reported in men with mild, moderate and severe ED.…”

Section: Clinical Trials With Tadalafilmentioning

confidence: 76%

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

Doggrell

2006

Int J Impot Res

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Erectile dysfunction (ED) affects up to 50% of men between the ages of 40 and 70 years of age. Sildenafil, vardenafil and tadalafil have all been shown to be similarly effective in the treatment of men with ED of vary etiologies, to have similar adverse effects profiles, and to improve quality-oflife by similar amounts. As these phosphodiesterase 5 (PDE5) inhibitors all increase the hypotensive effects of nitrates, they are not suitable for use in patients taking nitrates for the treatment of ischaemic heart disease. All three inhibitors must be used with caution in patients taking a 1 -adrenoceptors antagonists for benign prostatic hyperplasia. Although nonarteritic anterior ischaemic neuropathy has been reported in some users of the PDE5 inhibitors, there is no conclusive evidence that PDE5 inhibitors cause this rare effect. Tadalafil has a longer half-life than sildenafil or vardenafil, and a longer duration of action than sildenafil and vardenafil. Most preference studies have shown tadalafil to be preferred, but there are serious limitations to some of these studies. One approach to treatment is to give each patient a short-and long-acting agent, and for individuals to decide their preference.

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The Efficacy and Safety of Tadalafil in United States and Puerto Rican Men With Erectile Dysfunction

Abstract: Tadalafil (20 mg) significantly improved erectile function and patients did not closely temporally link sexual intercourse attempts with taking tadalafil. Tadalafil was also well tolerated in both groups of men with mild to severe ED.

Cited by 40 publications

References 8 publications

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

Efficacy and safety of on‐demand tadalafil for the treatment of erectile dysfunction in South‐East Asian men

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

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