Is Vardenafil “Noninferior” or Superior to Sildenafil in the Management of Erectile Dysfunction? Revisiting the Biochemical, Physiological, and Clinical Evidence

Traish, Abdulmaged M.; Kim, Noel N.

doi:10.1111/j.1743-6109.2007.00719.x

Cited by 3 publications

(3 citation statements)

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“…Direct comparison between different PDE5 inhibitors gave contradictory results: a randomized, double‐blind, head‐to‐head trial in ED patients with cardiovascular risk factors demonstrated the non‐inferiority of vardenafil for overall preference with respect to sildenafil [22,23]. In the same report, vardenafil achieved a nominal statistical superiority over sildenafil for several frequently used efficacy measures.…”

Section: Discussionmentioning

confidence: 99%

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The ENDOTRIAL Study: A Spontaneous, Open-Label, Randomized, Multicenter, Crossover Study on the Efficacy of Sildenafil, Tadalafil, and Vardenafil in the Treatment of Erectile Dysfunction

Jannini

Isidori

Gravina

et al. 2009

The Journal of Sexual Medicine

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Introduction The three effective, commercially available drugs for the treatment of erectile dysfunction—sildenafil, vardenafil, and tadalafil—inhibit the same substrate, the erectolytic enzyme phosphodiesterase type 5 (PDE5). Although there are pharmacological differences between these three compounds, few comparative studies have been conducted to date. Aim The aim of this study was to determine the efficacy of sildenafil, tadalafil, and vardenafil in a randomly assigned 8-week fixed regimen. Methods This was a spontaneous, open-label, randomized, multicenter, crossover study where the patients were randomized to receive sildenafil 50 mg, sildenafil 100 mg, tadalafil 20 mg, or vardenafil 20 mg. Main Outcome Measures The primary outcome included the posttreatment analysis of erectile function domains of the abridged International Index of Erectile Function (IIEF5+1). The secondary objectives included the analysis of peak-systolic velocities (PSVs), end-diastolic velocities (EDVs), and resistive index (RI), and the estimate of the percentage of men with normal penile hemodynamic parameters after each treatment. Results In all groups of patients taking sildenafil 50 mg, sildenafil 100 mg, tadalafil 20 mg, and vardenafil 20 mg at a frequency reflecting the common treatment regimens in real life, there was a statistically significant baseline-to-end point improvement in subjective perception of erectile function measured by IIEF5+1. When the four groups were compared, the treatments were not different in modifying IIEF5+1 and penile flow parameters. However, the within-group analysis showed that PSV improved in the sildenafil 50 mg group and that PSV together with RI significantly ameliorated in patients receiving 100 mg of sildenafil. Regression analysis confirmed an independent effect of sildenafil on hemodynamic efficacy parameters. Conclusions An overall equivalence was demonstrated in the subjective perception of treatment benefits for all the PDE5i tested. However, sildenafil, in a dose-dependent manner, was the unique PDE5i able to ameliorate some of the penile flow parameters within the 8-week treatment period. These findings should be interpreted conservatively because of the observational nature of the study.

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Section: Discussionmentioning

confidence: 99%

“…In the vast majority of cases, they were self-reported, such as through patient logs, self-administered questionnaires, [10] or structured interview [11]. Both behavioral [38] and psychological [23] dimensions have been explored.…”

Section: Pde5 Inhibitors By Definition Vasoactive Drugsmentioning

confidence: 99%

The ENDOTRIAL Study: A Spontaneous, Open-Label, Randomized, Multicenter, Crossover Study on the Efficacy of Sildenafil, Tadalafil, and Vardenafil in the Treatment of Erectile Dysfunction

Jannini

Isidori

Gravina

et al. 2009

The Journal of Sexual Medicine

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“…Since the introduction of the first phosphodiesterase type 5 (PDE5) inhibitor, sildenafil, several other effective oral treatments for ED have become available. Vardenafil, launched in 2004 in Japan, is more selective for PDE5 and more biochemically potent than sildenafil in in vitro and in vivo studies when tested under the same conditions, and has been shown to be efficacious in the general population of men with ED, as well as in those having co‐morbid conditions associated with more severe ED [7–16]. While it is reported that diabetic men with ED tend to be more difficult‐to‐treat with PDE5 inhibitors because of the more complex and multifactorial pathogenesis of diabetes‐associated ED, a recent report in Japanese men with DM and ED showed that 10 mg and 20 mg vardenafil improved erectile function with incremental clinical benefit and exhibited comparable safety profiles between doses [17–19].…”

Section: Introductionmentioning

confidence: 99%

Vardenafil Allows Successful Intercourse initiated Rapidly After Dosing in Japanese Patients with Diabetes Mellitus and Erectile Dysfunction

Nagao

Kobayashi

Fujikawa

et al. 2009

The Journal of Sexual Medicine

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Introduction Vardenafil is reported to improve success rates in the maintenance of an erection sufficient for completion of intercourse (SEP-3) compared with placebo in erectile dysfunction (ED) patients who attempted intercourse from as early as 15 minutes after dosing. However, these data were based on general ED patients, using time from administration to initiation of intercourse. It is unclear whether the results can be applied to difficult-to-treat ED patients, such as those with diabetes mellitus (DM), with the time between dosing and insertion into vagina. Aim To determine whether early onset of activity with vardenafil is also achievable in ED patients with DM. Methods Data from a 12-week Phase III clinical trial (randomized, placebo-controlled, double-blind, parallel-group comparison) in Japanese men with ED and DM was used for analysis. In this study, patients received vardenafil 10 mg, 20 mg, or placebo, and were instructed to start sexual activity 1 hour after dosing. Mean per-patient SEP-3 success rates (intent-to-treat; ITT population), based on patient diary question, were calculated by the time between dosing and insertion. The least-squares means and nominal P values for differences versus placebo were derived by analysis of covariance with terms for baseline. Main Outcome Measures SEP-3 success rates in each time interval. Results The majority of inserts occurred between 60–90 minutes after dosing, but 100 of inserts in 52 patients occurred in the first 30 minutes. SEP-3 success rates in patients who inserted in each interval from 0–15 minutes (P = 0.0268), 15–30 minutes (P = 0.0094) through > 120 minutes were all higher in vardenafil-treated patients than those in placebo. Conclusions In this retrospective analysis, a rapid onset of activity was also demonstrated in difficult-to-treat ED patients. Vardenafil improved successful intercourse rates compared with placebo in Japanese DM patients who inserted from as early as 15 minutes to >120 minutes after dosing.

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Mise au point thérapeutique : la dysfonction érectile chez le diabétique

Bondil

Halimi

2010

Médecine des Maladies Métaboliques

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Is Vardenafil “Noninferior” or Superior to Sildenafil in the Management of Erectile Dysfunction? Revisiting the Biochemical, Physiological, and Clinical Evidence

Cited by 3 publications

References 43 publications

The ENDOTRIAL Study: A Spontaneous, Open-Label, Randomized, Multicenter, Crossover Study on the Efficacy of Sildenafil, Tadalafil, and Vardenafil in the Treatment of Erectile Dysfunction

The ENDOTRIAL Study: A Spontaneous, Open-Label, Randomized, Multicenter, Crossover Study on the Efficacy of Sildenafil, Tadalafil, and Vardenafil in the Treatment of Erectile Dysfunction

Vardenafil Allows Successful Intercourse initiated Rapidly After Dosing in Japanese Patients with Diabetes Mellitus and Erectile Dysfunction

Mise au point thérapeutique : la dysfonction érectile chez le diabétique

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