Cialis is a phosphodiesterase type 5 inhibitor approved by the Food and
Drug Administration (FDA) for erectile dysfunction (ED), the signs and
symptoms of benign prostatic hyperplasia (BPH) and both ED and the signs
and symptoms of BPH (ED+BPH).
"PDE5 inhibitors are highly effective for most men when taken as-needed,
but responses can range from minimal change to a return to normal
erectile function," said Dr. Edward D. Kim, MD, of the Division of
Urology, Department of Surgery, University of Tennessee Graduate School
of Medicine and lead author of the study. "We believe the study outcome
will help prescribers make better informed decisions when treating their
patients."
It is important to note that Cialis is not to be taken with medicines
called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate
which are often prescribed for chest pain; or with recreational drugs
called "poppers" like amyl or butyl nitrite, as the combination may
cause an unsafe drop in blood pressure; or if allergic to Cialis or
Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences
any symptoms of an allergic reaction, such as rash, hives, swelling of
the lips, tongue or throat, or difficulty breathing or swallowing,
should call a healthcare provider or get help right away.
The randomized, double-blind, parallel, placebo-controlled trial was
conducted in 51 sites in the United States and Canada. The study
enrolled men with ED aged 18 years and older who had some response
(IIEF-EF > /= 17) but were unable to reach normal erectile function
(IIEF-EF < 26) while on a maximum dose of an as-needed PDE5 inhibitor
treatment. The study assessed whether Cialis for once daily use is
superior to placebo in returning these men to normal erectile function. A
total of 623 subjects were randomly assigned to receive treatment with
Cialis for once daily use or placebo.
The primary objective was to determine whether a significantly greater
percentage of incomplete responders had a return to normal erectile
function when treated with tadalafil 2.5 titrated to 5 mg and 5 mg once
daily compared to placebo. The key secondary objective was evaluation of
the efficacy of tadalafil 2.5 titrated to 5 mg and 5 mg once daily
compared to placebo, as measured by change from baseline to endpoint in
IIEF-EF.
The International Index of Erectile Function-Erectile Function Domain
(IIEF-EF) is a questionnaire evaluating sexual function where higher
scores indicate better erectile function.
