Clinical
Data Shows Lilly ICOS' Cialis (Tadalafil) Improves
Erectile Function in ED Patients with Significant
June 15, 2005
Erectile Dysfunction Treatment SAN ANTONIO, Texas, May 23, 2005 / PRNewswire-FirstCall
via COMTEX/ - Lilly ICOS LLC (NYSE: LLY and NASDAQ:
ICOS) announced data today from anlabel clinical
trial showing Cialis® (Tadalafil)(1) improved
erections in more than three- quarters of men who
were suffering from erectile dysfunction (ED) and
one or more comorbid conditions. These comorbidities
include cardiovascular disease (including hypertension),
diabetes, depression, hyperlipidemia, and prostate
disease (including those who had undergone prostatectomy).
On average, nearly 50 percent of all attempts resulted
in an erection that lasted long enough to have successful
sexual intercourse when patients were treated with
Cialis 20 mg. This is compared to approximately 17
percent of attempts at baseline for this patient group.
These data will be presented today at the 100th Annual
Meeting of the American Urological Association (AUA).
"Treatment of ED in men with
comorbid conditions is a challenge. It is exciting
to see such positive results in this group of patients,
who had a relatively high degree of severe ED and
many of whom had multiple comorbidities," said
Irwin Goldstein, M.D., Professor of Urology and Gynecology
at the Boston University School of Medicine. "The
findings confirm that Cialis improved erectile function
in men with ED even when associated with significant
comorbid conditions. Also, these patients tolerated
treatment with Cialis very well."
Study Design and Key Findings The MOMENTUS study (Multiple Observations
in Men with ED in National Tadalafil Study in the
United States) is a multi-center,label study
that evaluated the efficacy and safety of Cialis 20
mg in 1,911 American men with ED who were enrolled
into eight predefined groups. In this study, after
a four-week treatment-free period to determine baseline
ED, patients were instructed to take Cialis 20 mg
as needed prior to sexual activity (not more than
one dose a day) for a period of 12 weeks. The subgroup
discussed here included 155 patients, mean age 65,
who had significant comorbid conditions; many of these
patients also had severe ED at baseline (51.9 percent).
This subgroup comprised patients who met the enrollment
criteria for the MOMENTUS trial but who could not
be included in any other predefined group.
In the subgroup, 77.4 percent of
patients reported an improvement in their erections
after taking Cialis 20 mg based on the Global Assessment
Questions (GAQ)(2), question one (Has the treatment
you've been taking during this study improved your
erections?). They also showed a 7.6 point improvement
from the baseline score of 11.48 in the Erectile Function
(EF) Domain Score of the International Index of Erectile
Function (IIEF)(3). It is generally considered that
an improvement of four points or more in the EF domain
score reflects a clinically meaningful change (4).
After taking Cialis 20 mg, patients
reported an increase from baseline in erections that
resulted in "successful sexual intercourse"
based on positive per patient response to Sexual Encounter
Profile (SEP)(5) question three (Did your erection
last long enough for you to have successful sexual
intercourse?). On an average, half (49.4 percent)
of the attempts resulted in an erection that lasted
long enough for successful sexual intercourse, compared
to the percentage at baseline of 16.9.
"Cialis provides a meaningful
therapeutic benefit with regards to erectile function
in men suffering from ED and significant comorbid
conditions," said Sanjeev Ahuja, M.D., Associate
Medical Director, Eli Lilly and Company. "Men
who have ED should visit their doctor to discuss their
sexual health and their overall health. This will
give their doctor the opportunity to do a complete
exam, during which significant health problems may
be detected and addressed, and treatment options for
ED can be discussed."
The most commonly reported side effects
in the patients in this group were headache, flushing,
nasal congestion, back pain, and upset stomach. Discontinuations
due to adverse events in this group were three percent
and similar to previously reported discontinuation
rates in Cialis clinical trials. Not included in this
clinical trial were patients with certain serious
underlying cardiovascular conditions, including recent
myocardial infarction, uncontrolled arrhythmias, hypotension
(<90/50 mm Hg), uncontrolled hypertension (>170/100
mm Hg), unstable angina or angina occurring during
sexual intercourse, or those who recently suffered
a stroke or had severe heart failure.
Study Population The table below depicts the baseline characteristics
of age, severity of ED, and comorbid conditions among
this subgroup of patients.
Baseline Characteristics
Study group
AGE:
Mean age (years)
65
ED SEVERITY:
Severe ED (%)
51.9%
IIEF EF Domain
Score
12.2
COMORBID CONDITIONS:
Diabetes (%)
Cardiovascular
disease* (%)
72.3%
*60.6 percent
of patients had hypertension
67.1%
Hyperlipidemia
(%)
49.0%
Benign Prostatic
Hyperplasia/Prostatectomy
(%)
36.8%
Depression (%)
38.1%
MULTIPLE COMORBIDITIES:
Have two or
more comorbid conditions
84.5%
About Erectile Dysfunction Erectile Dysfunction is defined as the consistent
inability to attain and maintain an erection sufficient
for sexual intercourse. ED affects an estimated 189
million men worldwide (6). Experts believe that 80
- 90 percent of ED cases are related to a physical
or medical condition, like diabetes, cardiovascular
diseases, and prostate cancer treatment, while 10
- 20 percent are due to psychological causes (7,8).
In many cases, however, both psychological and physical
factors contribute to the condition (9).
About Cialis Cialis was approved by the FDA in November
2003 for the treatment of erectile dysfunction. Cialis
is widely available throughout the world, including
Australia, Brazil, Mexico, Canada, the United States
and countries throughout Europe. More than 4.5 million
patients worldwide have been treated with Cialis since
its first introduction in February 2003.
Cialis is available by prescription
only and is not for everyone. Men taking nitrates,
often used for chest pain, should not take Cialis.
Such a combination could cause a sudden, unsafe drop
in blood pressure.
Men should discuss their medical
conditions and medications, including alpha blockers
for prostate problems or high blood pressure, with
their doctors to ensure Cialis is right for them and
that they are healthy enough for sexual activity.
The most common side effects with Cialis were headache,
upset stomach, delayed backache or muscle ache. Although
rare, men who experience an erection for more than
four hours (priapism) should seek immediate medical
attention. Men should not drink alcohol in excess
with Cialis. Cialis does not protect a man or his
partner from sexually transmitted diseases, including
HIV. The standard recommended starting dose of Cialis
for most patients is 10 mg. Patients with certain
medical conditions or taking concomitant medications
may need to start at a lower dose.
Individual results may vary. Cialis
studies were not designed to assess multiple intercourse
attempts after a single dose. For full patient information,
visit www.cialis.com
About Lilly ICOS LLC Lilly ICOS LLC, a joint venture between ICOS
Corporation (NASDAQ: ICOS) and Eli Lilly and Company
(NYSE: LLY), developed Tadalafil for the treatment
of erectile dysfunction.
ICOS Corporation, a biotechnology
company headquartered in Bothell, Washington, is dedicated
to bringing innovative therapeutics to patients. ICOS
is marketing its product, Cialis (Tadalafil), through
Lilly ICOS LLC, for the treatment of erectile dysfunction.
ICOS is working to develop treatments for serious
unmet medical conditions such as benign prostatic
hyperplasia, pulmonary arterial hypertension, cancer
and inflammatory diseases. Additional information
about ICOS is available at www.ICOS.com .
Lilly, a leading innovation-driven
corporation is developing a growing portfolio of first-in-class
and best-in-class 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 www.lilly.com
P-LLY Except for historical information contained
herein, this press release contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking
statements are based on current expectations, estimates
and projections about the industry, management beliefs
and certain assumptions made by the management of
ICOS and Lilly. Investors are cautioned that matters
subject to forward-looking statements involve risks
and uncertainties, including economic, competitive,
governmental, technological, legal and other factors
discussed in the two companies' respective filings
with the Securities and Exchange Commission, which
may affect the business and prospects of the two companies
and Lilly ICOS. Results and the timing and outcome
of events may differ materially from those expressed
or implied by the forward-looking statements in this
press release. More specifically, there can be no
assurance that Cialis will achieve commercial success
or that competing products will not pre-empt market
opportunities that might exist for the product.
Cialis® is a registered trademark of Lilly
ICOS LLC.
The GAQ is a self-administered questionnaire
that allows patients to rate improvement in
erections.
The IIEF is a validated scale that assesses
erectile function by measuring treatment-related
responses in patients.
Mulhall J. Deciphering Erectile Dysfunction
Drug Trials, Journal of Urology. Vol. 170, 353-358;
August 2003
The SEP diaries contain five patient diary
questions that allow patients to record responses
following sexual events.
Data were extrapolated from Feldman HA, Goldstein
I, Hatzichristou DG, Krane RJ. Impotence and
its Medical and Psychosocial Correlates: Results
of the Massachusetts Male Aging Study, Journal
of Urology. Vol. 151, 54-61, January 1994 and
World Population Projection Program Of United
Nations (2002 Revision) with indirect standardization.
Shabsigh, R. (2002). Back To Great Sex: Overcome
ED and Reclaim Lost Intimacy. New York: Kensington.
Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp Data
accessed 11.20.03
Lue, Tom F. Erectile Dysfunction. N Engl J
Med 2000; 342: 1802-1813.
