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Clinical Data Shows Lilly ICOS' Cialis(R) (tadalafil) Improves
Erectile Function in ED Patients with Significant, Multiple Comorbid Conditions
SAN ANTONIO, Texas, May 23 /PRNewswire-FirstCall/ -- Lilly ICOS LLC
(NYSE:LLYNYSE:andNYSE:Nasdaq:NYSE:ICOS) announced data today from an open-label
clinical trial showing Cialis(R) (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 & Key Findings
The MOMENTUS study (Multiple Observations in Men with ED in National Tadalafil
Study in the United States) is a multi-center, open-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 average, nearly 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 (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 (%) 72.3%
Cardiovascular disease* (%)
*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 ED
ED 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 http://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 http://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 http://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.
(1) Cialis(R) is a registered trademark of Lilly ICOS LLC.
(2) The GAQ is a self-administered questionnaire that allows patients to rate
improvement in erections.
(3) The IIEF is a validated scale that assesses erectile function by measuring
treatment-related responses in patients.
(4) Mulhall J. Deciphering Erectile Dysfunction Drug Trials, Journal of
Urology. Vol. 170, 353-358; August 2003
(5) The SEP diaries contain five patient diary questions that allow patients to
record responses following sexual events.
(6) 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.
(7) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(8) Diseases and Conditions: Impotence, http://www.impotence.org/FAQ/index.asp.
Data accessed 11.20.03
(9) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO
DATASOURCE: Lilly ICOS LLC
CONTACT: Kindra Strupp of Lilly, +1-317-277-5170; or Lacy Fitzpatrick of
ICOS, +1-425-415-2207