New Study Shows Men Taking Cialis® (tadalafil) Tablets Once Daily Returned to
Normal Erectile Function after Incomplete Response to As-Needed PDE5 Inhibitor
Data published in the Journal of Sexual Medicine
INDIANAPOLIS, July 16, 2013
INDIANAPOLIS, July 16, 2013 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
announced today that study results published in the Journal of Sexual Medicine
showed a greater percentage of men who had an incomplete response to as-needed
PDE5 inhibitor treatment returned to normal erectile function when given
Cialis once daily, compared to placebo, as measured by the erectile function
domain of the International Index of Erectile Function (IIEF-EF). In a
pre-specified secondary measure, Cialis significantly improved erectile
function scores versus placebo in those men who had an incomplete response to
as-needed PDE5 treatment.
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
"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
About the Study
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.
Treatment with Cialis 2.5 mg to 5 mg and 5 mg met the primary endpoint,
resulting in significantly higher percentages of men (38.7 percent and 39.6
percent, respectively) with IIEF-EF domain scores in the normal range (>/= 26)
through 12 weeks versus placebo (12.1 percent; both, p<.001). At week 4,
significantly greater percentages of men being treated with Cialis 2.5 to 5 mg
and 5 mg (33.5 percent and 41.1 percent, respectively) had experienced a
return to normal erectile function (placebo, 8.5 percent; both, p<.001).
For the key secondary objective, improvements in the IIEF-EF domain score were
statistically significant for the tadalafil 2.5- to 5-mg group (8.1) and the
tadalafil 5-mg group (8.0), compared to the placebo group (1.9; both, p<.001).
The most common treatment-emergent adverse events observed in the study were
consistent with other Cialis studies and included headache, back pain and
upset stomach. Three Cialis 2.5 mg to 5 mg subjects, three Cialis 5 mg
subjects and two placebo subjects discontinued study participation due to an
adverse event (AE). Nasal congestion was the only AE leading to
discontinuation reported by more thanone subject (two subjects in the
tadalafil 2.5 to 5 mg group).
Cialis is indicated for the treatment of men with erectile dysfunction (ED),
men with the signs and symptoms of benign prostatic hyperplasia (BPH), and men
with both ED and the signs and symptoms of BPH.
Cialis is not for women or children.
Important Safety Information for Cialis^® (tadalafil) tablets
What Is The Most Important Information I Should Know About Cialis?
Do not take Cialis if you:
otake medicines called "nitrates" such as isosorbide dinitrate or
isosorbide mononitrate which are often prescribed for chest pain as the
combination may cause an unsafe drop in blood pressure
ouse recreational drugs called "poppers" like amyl nitrite and butyl
oare allergic to Cialis or Adcirca^® (tadalafil), or any of its
ingredients. Call your healthcare provider or get help right away if you
experience any symptoms of an allergic reaction, such as rash, hives,
swelling of the lips, tongue or throat, or difficulty breathing or
After taking a single tablet, some of the active ingredient of Cialis remains
in your body for more than 2 days. The active ingredient can remain longer if
you have problems with your kidneys or liver, or you are taking certain other
Stop sexual activity and get medical help right away if you get symptoms such
as chest pain, dizziness, or nausea during sex. Sexual activity can put an
extra strain on your heart, especially if your heart is already weak from a
heart attack or heart disease.
What Should I Tell My Healthcare Provider Before Taking Cialis?
Cialis is not right for everyone. Only your healthcare provider and you can
decide if Cialis is right for you. Ask your healthcare provider if your heart
is healthy enough for you to have sexual activity. You should not take Cialis
if your healthcare provider has told you not to have sexual activity because
of your health problems. Before taking Cialis, tell your healthcare provider
about all your medical problems, particularly if you have or ever had:
oheart problems such as chest pain (angina), heart failure, irregular
heartbeats, or have had a heart attack
ohigh or low blood pressure or have high blood pressure that is not
oliver or kidney problems or require dialysis
oretinitis pigmentosa, a rare genetic (runs in families) eye disease
osevere vision loss, including a condition called NAION
ostomach ulcers or a bleeding problem
oa deformed penis shape or Peyronie's disease
oan erection that lasted more than 4 hours
oblood cell problems such as sickle cell anemia, multiple myeloma, or
Can Other Medicines Affect Cialis?
Tell your healthcare provider about all the medicines you take especially if
omedicines called "nitrates" which are often prescribed for chest pain
oalpha-blockers often prescribed for prostate problems
oblood pressure medications
omedicines for HIV or some types of oral antifungal medications
osome types of antibiotics such as clarithromycin, telithromycin,
erythromycin (several brand names exist, please contact your healthcare
provider to determine if you are taking this medicine)
oother medicines or treatments for erectile dysfunction (ED)
oCialis is also marketed as Adcirca for the treatment of pulmonary arterial
hypertension. Do not take both Cialis and Adcirca. Do not take sildenafil
citrate (Revatio^®)* with Cialis.
What Should I Avoid While Taking Cialis?
oDo not use other ED medicines or ED treatments while taking Cialis.
oDo not drink too much alcohol when taking Cialis (for example, 5 glasses
of wine or 5 shots of whiskey). Drinking too much alcohol can increase
your chances of getting a headache or getting dizzy, increasing your heart
rate, or lowering your blood pressure.
What Are The Possible Side Effects Of Cialis?
The most common side effects with Cialis are: headache, indigestion, back
pain, muscle aches, flushing, and stuffy or runny nose. These side effects
usually go away after a few hours. Men who get back pain and muscle aches
usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches
usually go away within 2 days. Call your healthcare provider if you get any
side effect that bothers you or one that does not go away.
Uncommon but serious side effects include:
An erection that won't go away: If you get an erection lasting more than 4
hours, seek immediate medical help to avoid long-term injury.
In rare instances, men taking prescription ED tablets, including Cialis,
reported a sudden decrease or loss of vision or hearing (sometimes with
ringing in the ears and dizziness). It's not possible to determine if these
events are related directly to the ED tablets or to other factors. If you have
a sudden decrease or loss of vision or hearing, stop taking any ED tablet,
including Cialis and call a healthcare provider right away.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Cialis does not:
oincrease a man's sexual desire
oprotect a man or his partner from sexually transmitted diseases, including
oserve as a male form of birth control
Cialis is available by prescription only. For additional information, talk to
your doctor and see full Patient Information at
http://pi.lilly.com/us/cialis-ppi.pdf and Prescribing Information at
http://pi.lilly.com/us/cialis-pi.pdf, or visit www.cialis.com for more
* The brand listed is a trademark of its respective owner and is not a
trademark of Eli Lilly and Company. The maker of this brand is not affiliated
with and does not endorse Eli Lilly and Company or its products.
TD Con-F ISI 03FEB2012
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers –
through medicines and information – for some of the world's most urgent
medical needs. Additional information about Lilly is available at
This press release contains forward-looking statements about the use of Cialis
for the treatment of erectile dysfunction reflects Lilly's current beliefs.
However, as with any pharmaceutical product under development, there are
substantial risks and uncertainties in the process of development,
commercialization, and regulatory review. There is no guarantee that the
product will receive additional regulatory approvals. There is also no
guarantee that the product will continue to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with theUnited States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Refer to: Kelly Hoffman, (317) 631-6400 (office), 317-459-7826 (mobile,
Morry Smulevitz, (317) 651-5567 (office), (317) 457-3294 (mobile),
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
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