| New Analysis Shows
Men Treated With Cialis(R) for ED Report Significant
Satisfaction With Quality of Erection and Overal
December 06, 2004
- Spontaneity and Self-Confidence Cited as
Reasons Why Men Preferred Cialis In Second Study
A recent analysis demonstrated that 80 percent
of men who took 20 mg Cialis(R)(1) (tadalafil)
for the treatment of erectile
dysfunction (ED) and had successful intercourse
reported satisfaction with the hardness of their
erection, and 76 percent indicated satisfaction
with their overall sexual
experience with the drug. The data were
released here today at the 7th Annual Congress
of the European Society for Sexual Medicine
(ESSM).
"As we see from this data, men who use
Cialis to treat their ED continue to be satisfied
with the way the product works and the results
it provides them," said Professor Hartmut
Porst, lead investigator, private urological/andrological
physician in Hamburg, Germany, and associate
professor of urology at the University of Bonn.
"Specifically, that men report such satisfaction
with the quality of their erections and their
overall sexual experience when using Cialis
continues to be encouraging."
Analysis Design and Results
The data are from an integrated analysis of
11 double-blind, placebo-controlled, randomized
ED clinical trials that included 2,102 men receiving
either 10 mg Cialis, 20 mg Cialis or placebo.
After each time a trial participant engaged
in sexual activity, he filled out a Sexual Encounter
Profile (SEP)(2) diary, which included questions
about achievement of successful sexual
intercourse (SEP 3), satisfaction with the
hardness of his erection (SEP 4), and satisfaction
with the overall sexual experience (SEP 5).
Data were only analysed on SEP 4 and SEP 5 when
the response to SEP 3 was positive.
Following positive responses to SEP 3, 80 percent
of men who took 20 mg Cialis (N=1,006) and 66
percent of men who took 10 mg Cialis (N=266)
responded that they were satisfied with the
hardness of their erection compared with 52
percent taking placebo (N=399, p<.001). Further,
76 percent of men taking 20 mg Cialis and 63
percent of men taking 10 mg Cialis indicated
satisfaction with their overall sexual experience
compared with only 48 percent taking placebo
(p<.001). The most common side effects were
headache, upset stomach and back pain.
Patient satisfaction is supported by another
study in which 544 patients of Eastern European
and Mediterranean descent who had been taking
Viagra(R) (sildenafil citrate) for six weeks
or more continued on Viagra for another four
weeks and then switched to Cialis for an eight-week
treatment period. During the final four weeks
of each treatment arm, sexual attempt patterns
were assessed from patient diaries, specifically
looking at the areas of preference between the
two products, time concerns, spontaneity, and
sexual self-confidence. These last three concepts
were measured using the validated questionnaire,
Psychological and Interpersonal Relationship
Scales (PAIRS, scale range 1-4).(3) Men then
continued on their treatment of choice during
an extension phase.
In the study, 83.5 percent of men preferred
Cialis
to Viagra. Investigators noted that once men
began to take Cialis, they also began to take
advantage of the up-to-36-hour extended time
period Cialis offers. The median time between
when men took their medication until they attempted
intercourse changed 1.92 hours (1.08 hours when
men took Viagra
compared with 3.00 hours when men took Cialis).
There was also a 40.2 percent increase in the
number of men who attempted intercourse at a
time point beyond four hours between the two
groups (79 percent of men taking Cialis attempted
intercourse beyond four hours compared with
38.8 percent of men taking Viagra). Further,
once men began to use Cialis, there was a 24
percent increase in the number of men who attempted
intercourse beyond 12 hours (50.6 percent of
men taking Cialis compared with 26.6 percent
of men taking Viagra).
Results from the PAIRS evaluations were equally
illuminating. On a scale of one to four, time
concern scores significantly decreased from
2.55 when subjects took Viagra to 2.33 when
they took Cialis. Also, sexual spontaneity scores
rose (2.94 on Viagra compared with 3.03 on Cialis)
as did sexual self-confidence scores (2.61 on
Viagra compared with 2.80 on Cialis, all p<0.0005).
All changes in scores were statistically significant,
an important distinction when measuring scores
of such low proportion, and all indicate that
men responded better when taking Cialis. The
proportion of patients reporting one or more
treatment-related side effects during Viagra
and Cialis assessment periods were 8.9 percent
and 5.7 percent, respectively.
About Cialis
Cialis is currently available in approximately
100 countries, including Australia, Brazil,
Mexico, Canada, the United States and countries
throughout Europe. More than 3 million patients
worldwide have been treated with Cialis since
its first introduction in February 2003. Cialis
is available by prescription only.
The most commonly reported adverse events with
Cialis are headache, upset stomach, nasal congestion,
backache, muscle ache, dizziness and flushing.
The adverse events reported with Cialis were
transient and generally mild or moderate. As
with other PDE5 inhibitors, the use of Cialis
is contraindicated in patients who are taking
nitrates or for those who have cardiac disease
and for whom sexual activity is not advisable.
About ED
ED is defined as the consistent inability to
attain and maintain an erection sufficient for
sexual intercourse. As of 2004, it is estimated
that approximately 189 million men worldwide
will report having ED.(4) Experts believe that
80 percent to 90 percent of ED cases are related
to a physical or medical condition, such as
diabetes, cardiovascular diseases, and prostate
cancer treatment, while 10 percent to 20 percent
are due to psychological causes.(5,6) In many
cases, however, both psychological and physical
factors contribute to the condition.(7)
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.
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.
ICOS Corporation, a biotechnology company headquartered
in Bothell, Washington, is dedicated to bringing
innovative therapeutics to patients. ICOS is
marketing its first product, Cialis (tadalafil),
through Lilly ICOS LLC. ICOS is working to develop
treatments for serious unmet medical conditions
such as chronic obstructive pulmonary disease,
benign prostatic hyperplasia, cancer and inflammatory
diseases.
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. All other
trademarks are the property of their respective
owners.
(2) Sexual Encounter Profile - SEP is a self-administered
patient diary
completed by clinical trial participants after
each sexual encounter.
(3) PAIRS is an internationally validated patient
questionnaire used to
measure behavioural, psychological and relationship
outcomes
associated with ED and its treatment.
(4) 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.
(5) Shabsigh, R. (2002). Back To Great Sex:
Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(6) Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp . Data
accessed 11.20.03.
(7) Lue, Tom F. Erectile Dysfunction. N Engl
J Med 2000; 342: 1802-1813.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO
)
Lilly ICOS LLC
Jane Calloway of Lilly, +1-317-651-5870; or
Lacy Fitzpatrick of ICOS, +1-425-415-2207/Photo:
http://www.newscom.com/cgi bin/prnh/20040122/LILLYICOSLOGO,
PRN Photo Desk, photodesk@prnewswire.com
source:-http://www.newratings.com
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