Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction

Tan, Hui Meng; Chin, Chong Min; Chua, Chong Beng; Gatchalian, Edsal; Kongkanand, Apichat; Moh, Clarence Lei Chang; Ng, Foo Cheong; Ratana-Olarn, K; Serrano, Dennis P.; Taher, Akmal; Tambi, Ismail; Tantiwong, Anupan; Chen, Michael Wong Yuet; Yip, Wai Chun Andrew

doi:10.1111/j.1745-7262.2008.00388.x

Cited by 9 publications

(6 citation statements)

References 30 publications

(36 reference statements)

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“…In agreement with this study, a recent meta-analysis found that, in a pooled analysis of PDE5 inhibitors, treatment was more effective in Caucasians compared with Asians 36 . However, a smaller (N = 334 patients; 264 vardenafil, 70 placebo) study investigating vardenafil efficacy in Asian men reported a significant increase in IIEF-EF score, which was similar to that seen in previous studies in Caucasians 37 . Direct comparisons between studies are difficult to make owing to differences in protocols; thus, further investigation is warranted to explore these potential ethnic differences and their causes.…”

Section: Discussionsupporting

confidence: 88%

REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome

Shabsigh

Mattern

2016

Sexual Medicine

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IntroductionErectile dysfunction (ED) is prevalent in men with metabolic syndrome (MetS); therefore, it is important to characterize ED treatments in this population.AimsTo investigate the safety and effectiveness of vardenafil in men with ED and MetS in a clinical setting.MethodsREVITALISE is an international, prospective, single-arm, observational study in men with ED and MetS newly prescribed vardenafil. Vardenafil was prescribed at the discretion of the treating physician in line with the marketing authorization. Treatment effectiveness (International Index of Erectile Function [IIEF]) and health-related quality of life (Aging Males' Symptoms Scale) were assessed at treatment initiation, at an optional dose adjustment visit after approximately 4 weeks, and at the end of the observation period (approximately 12 weeks).Main Outcome MeasuresThe primary outcome was an intraindividual improvement in erectile function (EF), defined as an increase of at least four points in the EF domain of the IIEF. Secondary outcomes included assessing normal EF (IIEF-EF score ≥ 26), mild ED (IIEF-EF score = 22–25), and health-related quality of life. Treatment-emergent adverse events were monitored.ResultsIn the intent-to-treat population (n = 1,832, mean age = 54.0 years, mean body mass index = 31.82 kg/m2, Asian 36.8%, white 49.9%, 20.4% with severe ED, 75.6% with mild or moderate ED, 4.0% without ED), 82.4% reported an increase of at least four points in IIEF-EF score. Median IIEF-EF score increased from 15.0 (baseline) to 25.0 at 12 weeks (P < .0001). After treatment, 45.4% and 29.4% (intent-to-treat population) had normal EF and mild ED, respectively. Improvements in the sexual, psychological, and somatic subscales of the Aging Males' Symptoms Scale were found (P < .0001). Treatment-emergent adverse events were reported by 7.19% of patients; there were no serious adverse events related to vardenafil.ConclusionIn a clinical setting, men with ED and MetS treated with vardenafil reported improvements in EF and health-related quality of life; and the safety profile of vardenafil was acceptable. REVITALISE demonstrates that vardenafil represents a good treatment option for men with ED and MetS.

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Section: Discussionsupporting

confidence: 88%

REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome

Shabsigh

Mattern

2016

Sexual Medicine

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“…Although side effects do occur with vardenafil (most notably headache, flushing, indigestion and nasal congestion), providing that the drug is used in line with the labeling recommendations, there is no convincing evidence in the literature of any significant safety issue, including cardiovascular, visual and aural safety [105–127].…”

Section: Drugs Which Are Effective When Administered Systemicallymentioning

confidence: 99%

Pharmacotherapy for Erectile Dysfunction

Eardley

Donatucci

Corbin

et al. 2010

The Journal of Sexual Medicine

175

150

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Introduction Pharmacotherapy is the usual initial therapy for most men with erectile dysfunction. Aim To review the current data relating to the efficacy, tolerability and safety of drugs used in the treatment of men with erectile dysfunction. Methods A critical review of the literature relating to the use of pharmacotherapeutic agents was undertaken by a committee of eight experts from five countries, building on prior reviews. Main Outcome Measures Expert opinion and recommendations were based on grading of evidence-based literature, internal committee dialogue, open presentation, and debate. Results Almost all currently available evidence relates to sildenafil, tadalafil, and vardenafil. Phosphodiesterase type 5 (PDE5) inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use. There is no evidence of significant differences in efficacy, safety, and tolerability between the PDE5 inhibitors and apomorphine. Intracavernosal injection therapy with alprostadil should be offered to patients as second line therapy for erectile dysfunction. Intraurethral alprostadil is a less effective treatment than intracavernosal alprostadil for the treatment of men with erectile dysfunction. Conclusions PDE5 inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction. Apomorphine, intracavernosal injection therapy with alprostadil, and intraurethral alprostadil are all effective and well-tolerated treatments for men with erectile dysfunction. We recommend some standardization of the assessment of psychosocial outcomes within clinical trials in the field of erectile dysfunction.

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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%

“…35,36 The first such study was performed in six countries or regions: Malaysia, Singapore, Thailand, the Philippines, Hong Kong (China) and Indonesia. 35 In this study, 358 men with ED were randomly assigned to receive vardenafil 10 mg or placebo for 12 weeks. The primary efficacy variables were the IIEF-EF and the sexual encounter profile (SEP) questions related to penetration (SEP2) and intercourse completion (SEP3).…”

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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Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction

Abstract: Vardenafil (10 mg) is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.

Cited by 9 publications

References 30 publications

REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome

REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome

Pharmacotherapy for Erectile Dysfunction

Prevalence and medical management of erectile dysfunction in Asia

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