London (ots/PRNewswire) -
- 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
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
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,
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.
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
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.
@@start.t1@@ (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.@@end@@
ots Originaltext: Lilly ICOS LLC
Im Internet recherchierbar: http://www.newsaktuell.ch
Jane Calloway of Lilly, +1-317-651-5870; or Lacy Fitzpatrick of ICOS,
bin/prnh/20040122/LILLYICOSLOGO, PRN Photo Desk,