Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study

Yip, Wai Chun Andrew; Chiang, Han-Sun; Mendoza, Jesus Benjamin; Tan, Hui‐Meng; Li, Man-Kay; Wang, Wei Christine; Kopernicky, Vladimir

doi:10.1111/j.1745-7262.2006.00213.x

Cited by 22 publications

(23 citation statements)

References 21 publications

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“…The studies were conducted across nine Asian countries at 50 study sites between October 2000 and December 2003. The details of the study design have been published earlier [13][14][15][16]. In brief, the studies included a 4-week baseline period and a 12-week double-blind treatment period.…”

Section: Methodsmentioning

confidence: 99%

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: Methodsmentioning

confidence: 99%

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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“…These included four RCTs of sildenafil, [31][32][33][34] two RCTs of vardenafil, 35,36 four RCTs of tadalafil, [37][38][39][40] two RCTs of udenafil 41,42 and two RCTs of mirodenafil. 43,44 The efficacy and safety of two novel PDE-5 inhibitors, mirodenafil and udenafil, were evaluated only in Korean men.…”

Section: Medical Treatment Of Ed In Asiamentioning

confidence: 99%

“…36 Treatment with vardenafil produced significant improvement in the main efficacy measures of IIEF-EF score and SEP2 and SEP3 as well as the GAQ. The efficacy [31][32][33][34][35][36][37][38][39][40][41][42][43][44] Prevalence and management of ED in Asia K Park et al 547…”

Section: Efficacy and Safety Of Sildenafilmentioning

confidence: 99%

“…45,46 Efficacy and safety of tadalafil Tadalafil is considered an effective, well-tolerated therapy for Asian men with ED of broad-spectrum severity and aetiology. [37][38][39][40]47 Yip et al 37 assessed the efficacy and safety of tadalafil as compared with a placebo in a multicentre, randomized, double-blind, parallel-group, placebo-controlled study conducted at 17 centres across East and Southeast Asia: Hong Kong (China) (one site, 38 patients), Indonesia (two sites, 21 patients), Malaysia (three sites, 32 patients), the Philippines (four sites, 40 patients), Singapore (three sites, 30 patients) and Taiwan (China) (four sites, 81 patients). In this study, men older than 18 years with mild to severe ED of various aetiologies were randomly assigned to receive a placebo or 20 mg tadalafil taken as needed.…”

Section: Efficacy and Safety Of Sildenafilmentioning

confidence: 99%

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Prevalence and medical management of erectile dysfunction in Asia

Park¹,

Hwang²,

Kim³

2011

Asian J Androl

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Erectile dysfunction (ED) is an important worldwide health issue that has a significant negative impact on the quality of life and life satisfaction of both the affected individual and his partner. Here we review the prevalence of ED in Asia, associated factors that may influence sexual attitudes and sexual behaviours, and randomized clinical trials (RCTs) of phosphodiesterase-5 (PDE-5) inhibitors to evaluate the clinical efficacy and safety of PDE-5 inhibitors in Asian men. We searched for English-language articles in MEDLINE and PubMed from January 2000 to September 2010. Our results showed that the overall reported prevalence rate of ED in Asia ranged widely, from 2% to 88%. This finding indicates that ED is a common and major health problem in this region. However, sociocultural and economic factors in Asia prevent people from seeking and obtaining appropriate medical care. We found reports on five kinds of PDE-5 inhibitors for the management of ED: sildenafil, vardenafil, tadalafil, udenafil and mirodenafil. The results of RCTs showed that these five PDE-5 inhibitors are more effective than placebo in improving erectile function in Asian men with ED and that these drugs have similar efficacy and safety profiles. INTRODUCTIONErectile dysfunction (ED) has been defined as the inability to achieve or maintain an erection sufficiently rigid for achieving satisfying sexual intercourse.1 ED is an important worldwide health issue that affects nearly half of men over the age of 40 years, and it has a significant negative impact on the quality of life and life satisfaction of the affected individual as well as his partner.2,3 One of the most frequently cited epidemiological surveys reporting prevalence data for ED is the Massachusetts Male Aging Study.2 The Massachusetts Male Aging Study-the first longitudinal, community-based, randomized, widescale epidemiological study of ED-included 1709 men between the ages of 40 and 70 years who completed a self-reported ED questionnaire. Over that age range, the probabilities of minimal, moderate and complete ED were 16.5%, 17.5% and 4.9%, respectively, at age of 40 years, and 18%, 34% and 15% at age of 70 years, showing that the prevalence of ED increases with age.Another pivotal epidemiological study of sexual dysfunction was the Global Study of Sexual Attitudes and Behaviors (GSSAB), which included 27 500 men and women aged 40-80 years in 29 countries.

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“…However, there is no report so far on the effectiveness of tadalafil (Yip et al, 2006;Mirone et al, 2007), another new type of PDE5 inhibitor, in treating CRF-related ED. By observing the effects of CRF on cGMP concentration in the corpus cavernosum of rabbits and the effects of tadalafil on the relaxation of corpus cavernosal smooth muscle in CRF rabbits, the present research is in an attempt to provide theoretical basis for the use of tadalafil in clinical treatment of CRF-related ED.…”

Section: Introductionmentioning

confidence: 99%

Effect of tadalafil in chronic renal failure rabbits: relevance to erectile dysfunction

Zhang

Bian

2011

J. Zhejiang Univ. Sci. B

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It is of great importance to investigate an effective and reliable medication against chronic renal failure (CRF)-related erectile dysfunction (ED), which aims to improve patients' life qualities. The concentrations of cyclic guanosine monophosphate (cGMP) in the corpus cavernosal smooth muscle of both CRF and control rabbits were measured. The effects of various concentrations of tadalafil, papaverine, and sodium nitroprusside on the relaxation responses of corpus cavernosal smooth muscle pre-contracted with phenylephrine in CRF rabbits were observed. There was significant difference in the concentration of cGMP between CRF and control rabbits (P<0.01). Tadalafil had the greatest impacts on CRF rabbits when given the same concentration of papaverine or sodium nitroprusside and particularly significant differences were identified under the concentration levels of 10 −5 and 10 −4 mol/L (P<0.01). The results suggest that the cGMP concentrations of the corpus cavernosum had been greatly reduced in CRF rabbits compared with control rabbits and that tadalafil may be an ideal medication for use in the treatment of CRF-related ED.

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Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study

Abstract: Tadalafil was an effective and well-tolerated treatment for ED in East and Southeast Asian men.

Cited by 22 publications

References 21 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

Prevalence and medical management of erectile dysfunction in Asia

Effect of tadalafil in chronic renal failure rabbits: relevance to erectile dysfunction

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