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Var3.6

Vardenafil (Levitra) Research

Mostly mechanism / observationalModerate safety

6 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Vardenafil (Levitra) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from mixed-quality meta-analyses and randomised trials published 2001–2019.

Based on 6 studies · 1 meta-analysis · 4 RCTs

Confidence

Moderate

By outcome

Erectile function
Mostly mechanism / observational5 studies
Safety profile
Mostly mechanism / observational3 studies
Cardiovascular & vascular
Too few graded studies1 study

Older research base

Newest study from 2019 · Latest meta-analysis: 2019

200120102019

1RCT2001

All vardenafil doses improved all IIEF domains compared to placebo (P<0.001) in this first large-scale at-home trial.

Porst, Rosen, Padma-Nathan, Goldstein, Giuliano, Ulbrich, Bandel · International Journal of Impotence Research (2001)

Multicentre, randomized, double-blind, placebo-controlled at-home trial in 601 men with mild-to-severe erectile dysfunction
12 weeks of placebo or vardenafil 5, 10, or 20 mg; dose-dependent improvement in penetration and maintenance of erections
All vardenafil doses improved every IIEF domain versus placebo

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2RCT2003

Vardenafil significantly improved erectile function in men with diabetes — a population in which erectile dysfunction is typically harder to treat.

Goldstein, Young, Fischer, Bangerter, Segerson, Taylor · Diabetes Care (2003)

Prospective multicenter double-blind placebo-controlled fixed-dose RCT in men with diabetes and erectile dysfunction
Vardenafil 10 and 20 mg improved IIEF erectile-function scores and rates of successful intercourse versus placebo
Demonstrated efficacy in a difficult-to-treat diabetic population

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3RCT2003

Vardenafil was safe and effective for erectile dysfunction following bilateral nerve-sparing radical retropubic prostatectomy.

Brock, Nehra, Lipshultz, Karlin, Gleave, Seger, Padma-Nathan · The Journal of Urology (2003)

Randomized, double-blind, placebo-controlled trial in men with erectile dysfunction after radical retropubic prostatectomy
Vardenafil 10 and 20 mg improved erectile function versus placebo in nerve-sparing patients
Established efficacy in a post-surgical population where erectile dysfunction is difficult to treat

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4Meta-Analysis2019

PDE5 inhibitors were generally efficacious and well tolerated in diabetic men, with vardenafil among the top-ranked on-demand regimens.

Liao, Qiu, Bao, Wang, Yang, Wei · World Journal of Urology (2019)

Bayesian network meta-analysis of 15 randomized trials (5,274 patients) of PDE5 inhibitors in diabetic men
Compared on-demand and regular regimens on GAQ response, IIEF erectile-function scores, and adverse events
Vardenafil on-demand ranked highly across efficacy and tolerability endpoints

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5RCT2004

Therapeutic and supratherapeutic doses produced only small increases in the QTcF interval, which were considered to be clinically irrelevant ... vardenafil and sildenafil produced no increase of absolute QT and only similar, small increases of the QTc interval.

Morganroth, Ilson, Shaddinger, Dabiri, Patel, Boyle, Sethuraman, Montague · The American Journal of Cardiology (2004)

Randomized study of the effects of vardenafil and sildenafil on QT and corrected-QT (QTc) duration
Vardenafil (8 ms at 10 mg) and sildenafil (6 ms at 50 mg) produced only small, comparable placebo-corrected QTcF increases; neither increased absolute QT
Characterizes the class QT effect; informs the caution with Class IA/III antiarrhythmics and other QT-prolonging drugs

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6Review2012

On-demand vardenafil ODT 10 mg was efficacious for erectile dysfunction in the POTENT I and II studies, with a pharmacokinetic profile distinct from the film-coated tablet.

Sanford · Drugs (2012)

Review of the vardenafil orodispersible (Staxyn ODT) formulation, its pharmacokinetics, efficacy, and tolerability
ODT provides greater systemic exposure than the film-coated tablet, so the formulations are not interchangeable
Efficacy of on-demand ODT 10 mg established in the POTENT I and II trials

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View in Research Library

Vardenafil (Levitra) Research

Mostly mechanism / observational

The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial.

Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study.

Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy.

Comparative efficacy and safety of phosphodiesterase type 5 inhibitors for erectile dysfunction in diabetic men: a Bayesian network meta-analysis of randomized controlled trials.

Evaluation of vardenafil and sildenafil on cardiac repolarization.

Vardenafil orodispersible tablet.