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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bayer, GlaxoSmithKline
Approval Status: Approved September 2003
Treatment Area: Erectile Dysfunction
Levitra (vardenafil), a phosphodiesterase 5 (PDE5) inhibitor, is
an oral medication for the treatment of erectile dysfunction (ED).
It helps increase blood flow to the penis and may help men with ED
get and keep an erection satisfactory for sexual activity. PDE5
inhibitors are a widely accepted and efficacious therapeutic option
for the treatment of erectile dysfunction in men, as a result of
extensive clinical experience with sildenafil and others.
It is available in 2.5 mg, 5 mg, 10 mg, and 20 mg tablets no
more than once a day.
FDA approval of Levitra was based on four multi-center,
double-blind, randomized, placebo controlled, fixed-dose, parallel
design trials. The studies enrolled a total of 2431 men with an
average age of 57 years. The doses investigated were 5 mg, 10 mg,
and 20 mg. An efficacy assessment was based on the Erectile
Function (EF) Domain score of the validated International Index of
Erectile Function (IIEF) Questionnaire and two questions from the
Sexual Encounter Profile (SEP) corresponding to vaginal penetration
achievement (SEP2), and the ability to maintain an erection for
Results demonstrated clinically meaningful and statistically
significant improvements in the EF Domain, SEP2, and SEP3 scores
compared to placebo. The mean baseline EF Domain score in these
trials was 11.8.
In a major North American fixed dose trial, 762 subjects were
evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14
for the Levitra 5 mg, 10 mg, 20 mg and placebo groups,
respectively. There was significant improvement at three months
with Levitra (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg
and 20 mg dose groups, respectively) compared to the placebo group
(EF Domain score of 15). The European trial of 803 subjects
confirmed these results. In the North American trial, Levitra
significantly improved the rates of achieving an erection
sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20
mg compared to placebo (65%, 75%, and 80%, respectively, compared
to a 52% response in the placebo at 3 months. The European trial
confirmed these results.
Adverse events associated with the use of Levitra may include
(but are not limited to) the following:
- Accidental Injury
- Flu Syndrome
Mechanism of Action
Levitra is a selective inhibitor of cyclic guanosine
monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Erection of the penis is initiated by the relaxation of smooth
muscle in the corpus cavernosum, one of a pair of sponge-like
regions in the penis. When aroused, nitric oxide is released from
nerve endings and endothelial cells in the corpus cavernosum.
Nitric oxide activates the enzyme guanylate cyclase resulting in
increased synthesis of cyclic guanosine monophosphate (cGMP) in the
smooth muscle cells of the corpus cavernosum. The cGMP triggers
smooth muscle relaxation, increasing blood flow into the penis,
resulting in erection.
Brock G, Nehra A, Lipshultz LI, Karlin GS et
al.Safety and efficacy of vardenafil for the treatment of
men with erectile dysfunction after radical retropubic
prostatectomy. J Urol. 2003 Oct; 170 (4 Pt 1):
Porst H, Young JM, Schmidt AC, Buvat J.Efficacy
and tolerability of vardenafil for treatment of erectile
dysfunction in patient subgroups. Urology. 2003
Sep;62(3):519-23; discussion 523-4.
Kuthe A.Phosphodiesterase 5 inhibitors in male
sexual dysfunction. Curr Opin Urol. 2003
Junemann KP.How effective are PDE-5 inhibitors?
Urologe A. 2003 Apr; 42(4): 553-8. Epub 2003 Mar 25.