London (ots/PRNewswire) -
- Patients with moderate-to-severe ED and comorbid conditions
respond to Cialis
Cialis(R)(1) (tadalafil) may effectively treat erectile
dysfunction (ED) in men with a variety of comorbidities that can make
the condition more difficult to manage, according to new studies
released at the 7th Annual Congress of the European Society for
Sexual Medicine (ESSM). In the studies, Cialis was shown to
significantly improve erectile function in men suffering from ED and
comorbid clinical depression or comorbid diabetes mellitus. Cialis
also showed efficacy in improving erectile function in men who
developed ED as a result of traumatic spinal cord injuries.
"Erectile dysfunction on its own can be difficult for men to cope
with and treat. Comorbid conditions such as clinical depression or
diabetes, or ED caused by a traumatic spinal cord injury, can make
treating ED more challenging," said Allen D. Seftel, MD, Department
of Urology, Case Western Reserve University, Cleveland, Ohio, U.S.A.
"These studies show that Cialis works in patients with
moderate-to-severe ED and other disorders, and that it is an
important treatment option to consider."
Treating ED in Men with Comorbid Clinical Depression
A multicentre, open-label study demonstrated that 89 percent of
men who had ED along with clinical depression reported improved
erections after taking 20 mg Cialis, based on the question of whether
the treatment they were taking improved their erections.
- 86 percent of men reported successful penetration after
treatment, while 77 percent reported successful completion of
- Of those men able to complete intercourse (positive response to
SEP question 3), in 87 percent of the episodes they were satisfied
with the hardness of their erections and in 82 percent of the
episodes they reported satisfaction with the overall sexual
experience while using Cialis
The data were based on a subset of 178 patients who were
identified as having a diagnosis of clinical depression at the time
of their first visit to their doctor to participate in the trial.
This group was one of the prospectively recruited populations of a
multicentre, open label trial of 1,911 men with ED. Men were given 12
weeks of treatment with 20 mg Cialis and asked to record responses to
the Sexual Encounter Profile (SEP)(2), as well as the International
Index of Erectile Function (IIEF)(3) and the Global Assessment
Questionnaire (GAQ).(4) The most common treatment emergent side
effects were headache (8 percent), flushing (4 percent), upset
stomach (3 percent), flu (3 percent), nasal congestion (3 percent),
and back pain (3 percent).
ED and Diabetes
In a retrospective analysis of data from 12 placebo-controlled,
clinical trials among a population of 637 men with ED and diabetes
and 1,681 men with ED but without diabetes, 10 mg and 20 mg Cialis
each demonstrated an improvement in IIEF scores in both groups.
Improvement also was noted in the SEP, question 3 (regarding
Importantly, although men with diabetes had more severe ED than
those men who did not have diabetes at the beginning of the trials,
both groups showed significant improvement after taking Cialis,
regardless of whether they took 10 mg or 20 mg Cialis. In terms of
efficacy, neither dose of Cialis was influenced by the patients'
glycosated haemoglobin levels (higher levels indicate more severe or
less controlled diabetes) or by diabetes medications, including
insulin or other oral agents. The most commonly reported adverse
events were headache, upset stomach, back pain, muscle ache and runny
ED in Men With Traumatic Spinal Cord Injuries
A multicentre, open-label exploratory study of 49 patients
demonstrated that 88 percent of men who developed ED as a result of
traumatic spinal cord injuries reported improved erections after
taking 20 mg Cialis, based on the GAQ.
- In the study, 73 percent of patients indicated that they were
able to successfully achieve penetration of their partner, while 64
percent reported the ability to maintain an erection through
- The most commonly reported treatment-emergent adverse events
with Cialis in the study were headache (12 percent), upset stomach (2
percent), and flushing (2 percent)
This study, which was a subgroup of a larger study that attracted
1,911 men with various comorbidities, examined men with ED due to
traumatic spinal cord injury, including men with paraplegia and
tetraplegia (quadriplegia). The trial consisted of a four-week run-in
period to determine baseline measurements, followed by a 12-week
treatment period with 20 mg Cialis. Men were asked questions from the
IIEF, as well as for their responses to SEP, questions 2 (regarding
penetration)(6) and 3 (regarding successful intercourse). Men were
also asked GAQ questions about whether they experienced improved
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.(7) 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.(8,9)
In many cases, however, both psychological and physical factors
contribute to the condition.(10)
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) The Sexual Encounter Profile, SEP, is a patient self-administered
diary completed by clinical trial participants after each sexual
(3) The International Index of Erectile Function, IIEF, is an
international scale that assesses erectile function in cross-cultural
settings by measuring treatment-related responses in patients.
(4) The Global Assessment Questionnaire, GAQ, is a self-administered
questionnaire that allows patients to rate improvement in erectile
(5) SEP 3 - "Did your erection last long enough for you to successfully
(6) SEP 2 - "Were you able to achieve an erection sufficient to achieve
penetration with your partner?"
(7) Data were extrapolated from Feldman HA, Goldstein I, Hatzichistou 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 Revisions) with indirect standardization.
(8) Shabsigh R (2002). Back to Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(9) Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp . Data accessed 11.20.03
(10) 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,
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO, PRN Photo