New Study of Cialis® (tadalafil) Tablets Co-administered with Finasteride
Meets Primary Endpoint in Men with Lower Urinary Tract Symptoms of Benign
Phase 3 data presented at European Association of Urology Congress
INDIANAPOLIS, March 18, 2013
INDIANAPOLIS, March 18, 2013 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
presented results today at the annual European Association of Urology (EAU)
Congress in Milan, Italy, of a study that showed Cialis 5 mg once daily
co-administered with finasteride significantly improved scores on the
International Prostate Symptom Score (IPSS), compared to placebo/finasteride,
in men with lower urinary tract symptoms of benign prostatic hyperplasia
(LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure,
Cialis/finasteride also improved erectile function scores versus
placebo/finasteride in those men who had both LUTS/BPH and erectile
dysfunction (ED) at baseline.
This is the first study to report co-administration of Cialis and finasteride
in men with LUTS/BPH. Cialis is a phosphodiesterase type 5 inhibitor approved
by the Food and Drug Administration (FDA) for the signs and symptoms of BPH
and both ED and the signs and symptoms of BPH (ED+BPH). Finasteride is a type
II 5alpha-reductase inhibitor (5-ARI) approved by the FDA for the treatment of
BPH in men with an enlarged prostate.
"Symptomatic improvement with 5-ARI therapy (finasteride) is observed after
six to twelve months of treatment; therefore, the study aimed to understand if
men with prostatic enlargement experience earlier improvement of BPH symptoms
when tadalafil is co-administered with a 5-ARI therapy," said Claus Roehrborn,
MD, chairman, Department of Urology, The University of Texas Southwestern
Medical Center, who presented the results during the EAU Congress. "These
results can help prescribers make better informed decisions when treating
About the Study
The randomized, double-blind, placebo-controlled, 26-week trial assessed the
efficacy and safety of Cialis 5 mg for once daily use or placebo
co-administered with finasteride in 696 men aged 45 years and older with an
International Prostate Symptom Score (IPSS) of at least 13, a urine flow rate
(Qmax) of 4 millimeters per second (mL/sec) to 15 mL/sec and a prostate volume
at least 30 mL.
The primary measure was the International Prostate Symptom Score (IPSS), a
questionnaire evaluating lower urinary tract symptoms (LUTS) occurring during
the preceding month where lower scores indicate less severe LUTS.
Pre-specified secondary measures included the International Index of Erectile
Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual
function where higher scores indicate better erectile function, and the
Treatment Satisfaction Scale-Benign Prostatic Hyperplasia (TSS-BPH), a
validated, disease-specific 13-item questionnaire used to assess patients'
perceptions of satisfaction with efficacy, dosing and side effects, with lower
scores indicating greater satisfaction with treatment.
Cialis/finasteride met the primary endpoint, significantly improving IPSS
total scores through 12 weeks versus placebo/finasteride (-5.2 versus -3.8, p
= 0.001). Cialis/finasteride also significantly improved IPSS total scores
versus placebo/finasteride at 4 weeks (-3.9 versus -2.3, p<0.001) and 26 weeks
(-5.5 versus -4.5, p=0.022).
On the key secondary measure, Cialis/finasteride improved IIEF-EF scores in
sexually active men with ED versus placebo/finasteride at Week 4 (2.7 versus
-1.4, p<0.001), Week 12 (4.2 versus 0.5, p<0.001) and Week 26 (3.9 versus
The TSS-BPH improved with Cialis/finasteride versus placebo/finasteride at 26
weeks (2.0 versus 2.1, p=0.031), driven by satisfaction with efficacy
(p=0.025), with no significant difference for dosing or side effects.
The most common treatment-emergent adverse events (TEAEs) were headache
(Cialis/finasteride 12 [3%]; placebo/finaseteride 12 [3 %]), indigestion
(Cialis/finasteride 8 [2%]; placebo/finaseteride 2 [.5 %]) and back pain
(Cialis/finasteride 1 [.3%]; placebo/finaseteride 0 [0 %]).
About BPH and ED
Benign prostatic hyperplasia (BPH) is a condition where the prostate enlarges,
which can cause urinary symptoms like needing to go urgently and frequently.
ED is a condition where the penis does not fill with enough blood to harden
and expand when a man is sexually excited, or when he cannot keep an erection.
BPH and ED are conditions that may occur in the same patient. Several studies
have shown that many men with ED also experience the symptoms of
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
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/medwatchor 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.pdfand Prescribing Information at
http://pi.lilly.com/us/cialis-pi.pdf, or visit www.cialis.comfor 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
This press release contains forward-looking statements about the use of Cialis
for the treatment of benign prostatic hyperplasia and 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
^ Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E, et al. Lower
urinary tract symptoms and male sexual dysfunction: the multinational survey
of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649.
^ Brookes ST, Link CL, Donovan JL, and McKinlay JB. Relationship between
lower urinary tract symptoms and erectile dysfunction: results from the Boston
Area community Health Survey. J Urol 2008;179:250-255.
^ Gacci M, et al. Critical analysis of the relationship between sexual
dysfunctions and lower urinary tract symptoms due to benign prostatic
hyperplasia. In press. Eur Urol 2011; doi:10.1016/j.eururo.2011.06.037.
Refer to: Teresa Shewman, (317) 433-1888 (office), (317) 292-8940 (mobile),
SOURCE Eli Lilly and Company
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