Effectiveness of the medicine: In the
first study, men with erectile dysfunction (ED)
who were taking the oral investigational drug
Levitra reported consistently improved erectile
function the first time they took the drug and
subsequently thereafter. For the three months of
the study involving more than 800 ED patients,
Levitra was reported to consistently improve
rates of successful penetration, intercourse
success and overall satisfaction during the
first and subsequent attempts.
Investigators evaluated the ability of
Levitra to provide reliable efficacy over time
in a broad population of men with ED. They
analyzed data from a phase III, randomized,
double-blind study in which 805 men, including
100 Canadian men with ED and 11 Canadian trial
sites, received Levitra 5, 10 or 20 mg or
placebo for up to 26 weeks. The analysis showed
that at a 20 mg dose: On average men were
successful in 74 per cent of their first
attempts in penetrating their partner compared
with 46 per cent of men taking placebo. Of those
men taking Levitra who were successful the first
time, they continued to achieve successful
penetration in 91 per cent of subsequent
attempts.
Study shows improvement in erection
quality following prostate cancer surgery in
patients taking Levitra. In another study – the
first of its kind to assess the effect of a
phosphodiesterase (PDE-5) inhibitor on erectile
function and depressive symptoms among men with
ED resulting from prostate cancer surgery – men
taking Levitra were more likely to report
improved erections and fewer depressive symptoms
than men taking placebo.
In another phase III clinical trial, 440 men
aged 44 to 77 years with ED following
prostatectomy and who experienced ED for six
months before entering the study, were randomly
assigned to placebo or Levitra (at a dose of 10
or 20 mg) for 12 weeks. This study included 24
Canadian trial sites with 176 patients. After 12
weeks: up to 71 per cent of patients who had
undergone a specific type of prostatectomy,
known as bilateral nerve-sparing prostatectomy,
reported statistically significant improvement
in erections with Levitra 20 mg versus 12 per
cent of men taking placebo. A significant
decrease in depressive symptoms was observed
among a small subset of depressive prostatectomy
patients taking Levitra 20 mg. Men who suffer
from ED following prostatectomy are among the
most difficult to treat because their ED is
typically severe. In these studies, Levitra
related adverse events were reported as
generally mild to moderate in intensity with the
most frequent Levitra adverse events being
headache, flushing and rhinitis.
Side Effects Those involved in the
clinical trials reported mild / moderate side
effects with Levitra, these mostly included
headaches, flushing and rhinitis (nasal
congestion).
Precautions Levitra should not
be taken if you are taking nitrates or nitric
oxide donors (these medications are used to
treat angina or chest pain). Levitra is also
contraindicated in men whom sex is inadvisable
and men older than 75 years old who
concomitantly use potent CYP 3A4 inhibitors
(such as ritonavir, indinavir, ketoconazole and
itraconazole). The safety of Levitra has not
been studied in these subgroups and should not
take Levitra until further studies are
available: severe hepatic (liver system)
impairment, end stage renal disease requiring
dialysis, hypotension, recent history of stroke
or heart attack, unstable angina, and known
hereditary retinal degenerative disorders.
Drug
interactions: Tell your online
doctor of all nonprescription and prescription
medication you may use, especially any nitrate
medications (e.g., nitroglycerin, isosorbide
dinitrate), nitroprusside (any "nitric oxide
donor" medicines), cimetidine, erythromycin,
azole antifungals (e.g., itraconazole,
ketoconazole), mibefradil, rifamycins (e.g.,
rifampin) or high blood pressure medicines.
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