New Data Show Cialis(R) (tadalafil) is Effective in Treating Erectile Dysfunction Caused by Traumatic Spinal Cord Injury
07 April 2006 - 12:45AM
PR Newswire (US)
Patients Report Improved Erections and Erectile Function BOTHELL,
Wash. and INDIANAPOLIS, April 6 /PRNewswire-FirstCall/ -- Data
presented today at the 21st Congress of the European Association of
Urology (EAU) show that when patients who had erectile dysfunction
(ED) secondary to traumatic spinal cord injury (SCI) were treated
with Cialis(R) (tadalafil)(1) (N=140), their International Index of
Erectile Function (IIEF) Erectile Function (EF) Domain(2) scores
improved from a mean baseline score of 13.5 to a score of 22.6 at
endpoint. This is compared with placebo treated patients (N=44)
with a mean baseline score of 13.0 and a score of 13.6 at endpoint.
It is generally considered that an improvement of 4.0 points or
more in the IIEF domain score reflects a clinically meaningful
change.(3) Further, 54 percent of SCI patients treated with Cialis
reported "normal" erectile function at the end of the treatment
phase, as measured by the IIEF EF (IIEF EF domain score greater
than or equal to 26).(4) Study Analysis and Results The efficacy of
Cialis in patients with SCI was assessed by their scores on the
IIEF EF domain, responses to the Sexual Encounter Profile (SEP)(5)
diary question two (successful penetration) and question three
(successful intercourse), and the Global Assessment
Questionnaire(6) (GAQ) question one (improved erections).
Tolerability was evaluated using treatment-emergent adverse events
and vital signs collected at each assessment phase in the trial.
According to SEP diary question two(7), on average, patients
receiving Cialis (N=139) reported the ability to penetrate their
partner in 75.4 percent of attempts (43.6 percent at baseline). In
patients receiving placebo (N=42), successful penetration was
reported, on average, in 41.1 percent of attempts (44.9 percent at
baseline). For SEP diary question three(8), on average, patients
receiving Cialis (N=139) reported successful intercourse in 47.6
percent of attempts (10.8 percent at baseline). For patients
receiving placebo (N=42), successful intercourse was reported, on
average, in 16.8 percent of attempts (8.6 percent at baseline). For
those patients receiving Cialis, the SEP diary questions two and
three post-baseline scores were significantly different (p <
0.001) versus placebo. According to GAQ question one (improved
erections), 84.6 percent of patients (N=115) in the study reported
improved erections after treatment with Cialis, whereas 19.5
percent of placebo treated patients (N=8) reported improved
erections after treatment. "Treating men for ED caused by a spinal
cord injury is a complicated task. These results are encouraging
for men who suffer from spinal cord injury," said Francois
Giuliano, MD, PhD, Neuro-Urology Unit, Department of Physical
Medicine and Rehabilitation, Raymond Poincare Hospital, Garches and
Medical University of Paris West, France. "Tadalafil was not only
effective in improving erections, it enabled more than half the men
receiving tadalafil in the trial to achieve a normal erectile
function score." Study Design In this study, 186 patients with a
mean age of 38 were randomized to receive placebo or Cialis in a
double-blind, parallel, flexible-dose study in four European
countries (France, Germany, Italy and Spain). Patients were treated
for 12 weeks with assessments after each four-week interval.
Following a four-week, treatment-free run-in period, patients were
randomized to 10 mg Cialis or placebo. After this first treatment
interval, patients receiving 10 mg Cialis were either increased to
20 mg Cialis or left unchanged based on patient response to the 10
mg Cialis dose. After the second treatment interval, Cialis dosing
was increased, decreased, or unchanged, based on patient response
to the first treatment interval. The study population included
patients with varying degrees of SCI severity. As determined by the
American Spinal Injury Association (ASIA) scale, 69.4 percent
(N=186) of patients had a complete spinal cord lesion, reflecting
the greatest degree of neurological impairment. Further, patients
with all levels of the spinal lesion (N=179, 84.3 percent thoracic
or lumbo- sacral lesions) and all degrees of erectile dysfunction
(N=184, 69 percent of patients had moderate to severe ED) were
included. Study results show that Cialis improved all efficacy
endpoints when compared with placebo (p < 0.001). Cialis was
generally well tolerated with mild or moderate treatment-emergent
adverse events. The most common treatment-emergent adverse events
(greater than or equal to 5 percent incidence) were headache (8.5
percent Cialis; 4.5 percent placebo) and urinary tract infection
(7.7 percent Cialis; 6.8 percent placebo). Discontinuation due to
an adverse event occurred in 2.8 percent of the patients receiving
tadalafil and 2.3 percent of those receiving placebo. 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.(9) 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.(10,11) In
many cases, however, both psychological and physical factors
contribute to the condition.(12) About Cialis Cialis(R) (tadalafil)
was approved by the FDA in November 2003 for the treatment of
erectile dysfunction. 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. The most common side effects
with Cialis were headache, upset stomach, delayed backache or
muscle ache. As with any ED tablet, in the rare event of priapism
(an erection lasting more than four hours), men should seek
immediate medical attention to avoid long-term injury. Men should
not drink alcohol in excess with Cialis. Cialis does not protect a
man or his partner from sexually transmitted diseases, including
HIV. In rare instances, men taking prescription ED tablets
(including Cialis) reported a sudden decrease or loss of vision.
It's not possible to determine if these events are related directly
to the ED tablets or to other factors. If a man has a sudden
decrease or loss of vision, he should stop taking any ED tablet and
seek immediate medical attention. Men should discuss their medical
conditions and all medications with their doctors to ensure Cialis
is right for them and that they are healthy enough for sexual
activity. 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.
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 working to develop treatments for serious unmet
medical conditions such as benign prostatic hyperplasia,
hypertension, 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 IIEF
is a validated scale that assesses erectile function by measuring
treatment-related responses in patients. (3) Mulhall J. Deciphering
Erectile Dysfunction Drug Trials, Journal of Urology. Vol. 170,
353-358; August 2003. (4) Cappelleri JC, Rosen RC, Smith MD, Mishra
A, Osterloh IH. Diagnostic evaluation of the erectile function
domain of the International Index of Erectile Function. Urol,
1999:54; 346-351. (5) The SEP diaries contain five patient diary
questions that allow patients to record responses following sexual
events. (6) The Global Assessment Questionnaire, GAQ, is a
self-administered questionnaire that allows patients to rate
improvement in erectile function. (7) Were you able to insert your
penis into your partner's vagina? (8) Did your erection last long
enough for you to have successful intercourse? (9) 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. (10)
Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim
Lost Intimacy. New York: Kensington. (11) Diseases and Conditions:
Impotence, http://www.impotence.org/FAQ/index.asp. Data accessed
11.20.03 (12) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000;
342: 1802-1813. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
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
Copyright
Icos (NASDAQ:ICOS)
Historical Stock Chart
From May 2024 to Jun 2024
Icos (NASDAQ:ICOS)
Historical Stock Chart
From Jun 2023 to Jun 2024