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Marathon Effect' of Cialis
Impotence Drug
BBC News
August, 2007
New Phase III Study Shows,
Cialis -- IC351 -- 20 mg Improved Erections in 85 Percent of Men With
Erectile Dysfunction Regardless of ED Severity.
Business Wire
June 14, 2007
New Clinical Data Show
Patients Receiving Cialis - tadalafil - Improved Intercourse Success at
24 and 36 Hours After Dosing.
Business Wire
May 25, 2007
First Phase 3 Data Show
Cialis Improved Sexual Function in Men With Difficult to Treat,
Diabetes-related ED.
Business Wire
April 6, 2007
Lilly, Bayer Ready Drugs to
Take On Pfizer's Viagra
WALL STREET JOURNAL
July 24, 2007
A Longer Lasting Viagra?
Eli Lilly Lycos Developing a Longer Lasting Competitor to Pfizer's
Viagra
ABCnews.com
June, 2007
Marathon Effect' of Cialis Impotence Drug
BBC News
August, 2007
New erection enhancement drug allows men to have enhanced erections
to have sex up to 36 hours later, claims the maker Cialis, a medication
trying to gain a foothold in the lucrative
anti-impotence market created by
Viagra, is being tested by doctors.
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Dr Harin Padma-Nathan, a professor of urology at
the University of Southern California, who led the study, acknowledged
that other
impotence drugs had not been tested for
this longevity of effect. However, he said: "We saw a huge clinical
difference within 24 hours in patients taking Cialis and many of the men
indicated a sense of freedom and spontaneity."
Other trials have also suggested that the drug is
even more effective effective against some other forms of
erectile dysfunction (impotence).
It is estimated that more than 7m men worldwide have taken the original
impotence drug, Viagra, since it came
onto the market in 1998. Almost £400m has been spent paying for the
treatment.
It is not freely available on the NHS, although
men with a range of conditions which cause
impotence as a side-effect are given a
fixed number of pills on prescription. Approximately 300,000 NHS
prescriptions for the drug are handed out every year.
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New Phase III Study Shows, Cialis 20
mg Improved Erections in 85 Percent of Men With Erectile Dysfunction
Regardless of ED Severity.
Business Wire
June 14, 2001
Clinical trials with Cialis, a new PDE5
inhibitor in development by Lilly ICOS LLC to treat
erectile dysfunction (impotence),
have shown strong results among men with mild to severe cases of the
condition. Results from several late-stage studies will be highlighted
at this week's 6th Annual Latin American Society for
Impotence Research in Rio de Janeiro.
In one Phase III study, 85 percent of men taking
Cialis 20 mg reported improved erections, regardless of the severity of
their
erectile dysfunction (impotence).
In another study, men reported improved ability to achieve erections
with sexual stimulation even up to 36 hours after taking the drug. The
PDE5 inhibitor currently available to treat
erectile dysfunction is known to enable
a man to achieve an erection within a four or five hour period after the
drug has taken effect.
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"Based on a collective review of the data
presented at this meeting -- the strong response rate among men even
with severe forms of ED, the duration and tolerability -- Cialis has the
potential to be a valuable new medical treatment option for men
suffering from ED," said Miguel Rivero, MD, chief of the andrology
service, Hospital Militar Central in Buenos Aires, Argentina. "A new
therapy that also allows a man with ED to have a window of opportunity
for intercourse anytime within a 24-hour period would help him and his
partner regain spontaneity in their sexual relationship."
Cialis significantly improved erections in men
with mild-to-severe
Impotence
The Phase III study examined the safety and
efficacy of "on-demand" Cialis treatment in 196 men suffering from
mild-to-severe
erectile dysfunction. Men in the study
were randomized to receive up to 20 mg of Cialis or placebo over a
12-week period. Men were free to take their study medication without
restrictions on food or alcohol consumption and to have sex with their
partners at the time of their choosing after each dose.
Results showed that 95 percent of men taking
Cialis 20 mg reported significantly improved erections compared with
baseline. In addition, 78 percent of intercourse attempts recorded by
all men on Cialis 20 mg were successful. Importantly, 73 percent of men
with
erectile dysfunction
treated with Cialis 20 mg achieved an erectile function score experts
consider "normal" for healthy men as measured by the International Index
of Erectile Function (IIEF).
On the 10 mg dose, 92 percent of men reported
improved erections, and 70 percent of intercourse attempts were
successful. Forty-two percent of men taking the 10 mg dose achieved IIEF
scores in the normal range. Fifty-four percent of patients on placebo in
the study reported improved erections, while 43 percent of their
attempts were successful. Twenty percent of men taking placebo attained
IIEF scores in the "normal" range.
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Cialis provided extended duration of
responsiveness and worked promptly
Erectile
dysfunction or
impotence is defined as the consistent
inability to attain and maintain an erection sufficient for sexual
intercourse.
impotence affects an estimated 152
million men and their partners worldwide with many cases caused by
physical conditions, including cardiovascular disease and diabetes.
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New Clinical Data Show Patients Receiving
Cialis - tadalafil - Improved Intercourse Success at 24 and 36 Hours
After Dosing.
Business Wire
May 25, 2007
According to newly released clinical data on
Cialis, PDE5 inhibitor developed by Lilly ICOS LLC for the
treatment of erectile dysfunction (ED), men with ED reported a
statistically significant improvement in successful intercourse attempts
at 24 and 36 hours after taking the drug, compared to placebo.
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These and other new findings - including a summary
of cardiovascular safety data that showed no increased incidence of
cardiovascular events during clinical studies - are being presented at
the 97th Annual Meeting of the American Urological Association in
Orlando, Florida.
Cialis Period of Effectiveness - Key Study
Findings
In a Phase III clinical study designed to
evaluate the efficacy of Cialis at specific time points after dosing,
348 men with mild-to-severe ED were randomly assigned to receive Cialis
20 mg (n=175) or placebo (n=173) over approximately an eight-week
period. Patients were instructed to attempt intercourse with their
partners on four specific occasions: on two occasions at 24 hours after
dosing and on two occasions at 36 hours after dosing. The primary
endpoint was the percentage of successful sexual intercourse attempts.
"Cialis was statistically superior to placebo
in enabling men with ED to have successful intercourse at 24 or 36 hours
after taking the drug and showed a consistent effect at both time
points," said Raymond Rosen, Ph.D., study author and director of the
Program in Human Sexuality at the University of Medicine and Dentistry
of New Jersey and professor of psychiatry, Robert Wood Johnson Medical
School, Piscataway, New Jersey. "Also, in this study, the duration of
effectiveness did not appear to influence the incidence or severity of
side effects."
In addition, study results show
that in secondary measures of efficacy - including ability to penetrate,
satisfaction with hardness of erection and overall satisfaction - Cialis
was statistically superior to placebo at 24 and 36 hours.
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First Phase 3 Data Show Cialis
Improved Sexual Function in Men With Difficult to Treat,
Diabetes-related ED.
Business Wire
April 6, 2007
The first Phase 3 study for Cialis, a new PDE5
inhibitor being developed by Lilly ICOS LLC to treat erectile
dysfunction (ED), showed strong results among one of the most difficult
to treat populations of men with ED. The findings--to be released
tomorrow at the European Association of Urology Meeting
(EAU)--demonstrated that 64 percent of men with diabetes-related
impotence
taking Cialis 20 mg on demand reported improved erections.
"The impairment of nerve and blood vessel
function that accompanies diabetes makes ED prevalent and particularly
difficult to treat in this population," said Professor Inigo Saenz de
Tejada, of the Foundation for Research and Development in Andrology in
Madrid, Spain. "This study, alongside previously released data, suggests
on demand Cialis may help most men with
impotence
regain sexual function, regardless of cause or severity." Tejada noted
that while direct comparisons cannot be made to the clinical trial
results of other ED compounds in patients with diabetes, the 74 percent
response rate seen in this Cialis study is impressive.
Sexual function or enhanced erections
significantly improved across all study endpoints
In this Phase 3 study, 216 men with mild-to-severe
diabetes-related
impotence were randomized to receive
either placebo or Cialis at doses of up to 20 mg for 12 weeks. Results
indicated 74 percent of men taking Cialis 20 mg reported improved
erections, compared to 25 percent for placebo. Treatment with Cialis
significantly improved sexual function compared to placebo across all
primary and secondary study endpoints, regardless of patient age,
duration and severity of
impotence or diabetes.
Importantly, study participants reflected a broad
cross-section of men with diabetes and included those with poor glucose
control, diabetic retinopathy
(damage to the retina in the eyes), and diabetic
kidney disease. Despite including men with these diabetes-related
complications, few side effects were reported in this study. Headache
and dyspepsia (indigestion) were the only side effects reported by
greater than five percent of study participants. Researchers observed no
significant changes in clinical laboratory values, ECGs
(electrocardiograms) or blood pressure in this trial. In addition,
Cialis use was not associated with
disturbances in color vision for men in the study, including those with
diabetic retinopathy. Of the side effects that were reported, the
majority were mild-to-moderate and appeared to diminish with continued
treatment. Few patients discontinued treatment due to side effects.
Additional results from the Cialis
global Phase 3 program will be presented at scientific meetings later
this year.
Phase 2: Up to 88 percent of men with ED of
varying etiologies reported improvement
Findings from a Cialis Phase 2 study are also to
be presented at this meeting. In this study, a broad population of
impotence sufferers of varying severity
and causes (including men with diabetes) took Cialis on demand at doses
of up to 25 mg for eight weeks. Results indicated that up to 88 percent
of men taking Cialis reported significantly improved erections, compared
with 28 percent of those taking placebo. Headache and dyspepsia were the
only side effects reported by greater than five percent of all
Cialis-treated study participants.
Several measures of sexual function and
satisfaction indicate Cialis superior to placebo
Erectile Dysfunction is a Common
Complication in Men With Diabetes
It is estimated that 150 million adults worldwide
have diabetes(1). Experts suggest that between 25-75 percent of men with
diabetes also have ED. Diabetes can cause vascular complications which,
in addition to ED, can lead to blindness, kidney failure, heart disease
and nerve damage.
According to a recently published study in the
British Journal of Urology,
impotence
is a highly prevalent condition that affects an estimated 152 million
men worldwide(2). This includes an estimated 90 million men combined in
the United States, France, Germany, Italy, Spain, the United Kingdom,
Japan, and Brazil(3). The disorder is associated with a range of
behavioral risk factors, such as cigarette smoking and excessive alcohol
consumption, as well as numerous other medical conditions, notably
diabetes and cardiovascular disease.
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Lilly, Bayer Ready Drugs to Take on Pfizer's Viagra
WALL STREET JOURNAL
July 24, 2007
When people think impotence, they think Viagra.
Soon, that may change.
Two "sons of Viagra" are close to reaching the
market, and doctors say these new drugs may have some definitive
advantages. They work in a similar way, but they seem to act faster and
cause fewer of the trademark Viagra side effects: headaches, nasal
congestion, flushed faces and blue vision.
To tout the new drugs' advantages, their makers
can unleash some serious marketing firepower -- sufficient to give
Pfizer Inc., which effectively created the pharmaceutical market for
alleviating erectile dysfunction when it launched Viagra a few years ago
-- a run for its money. A lot of money is at stake. Viagra's sales
totaled $1.3 billion last year and are projected to rise to $1.6 billion
this year.
Cialis and vardenafil act in the same way as
Viagra, by blocking an enzyme called phosphodiesterase-5, or PDE-5, and
in the process relaxing smooth muscle cells in the penis and elsewhere.
In causing these muscles to relax, the drugs effectively increase blood
flow to the penis.
Though they work in similar ways, Cialis,
vardenafil and Viagra are distinctly different chemical entities. Some
urologists say vardenafil and Cialis are more effective at blocking the
PDE-5 enzyme and hence potentially more potent than Viagra. This means
they could act as well as, or better than, Viagra at smaller doses. They
also interact with fewer other molecules and hence might have fewer side
effects.
In the looming marketing battle, Viagra starts out
with some advantages, Pfizer argues. The company has conducted more than
80 studies of Viagra, says Michael Widlitz, a vice president at Pfizer,
and "no competitor can hope to ascend this mountain of efficacy and
safety data."
Drug-industry executives estimate that 30 million
European men suffer from
No one can make a definitive comparison between
the drugs because there have been no public head-to-head clinical
trials. But the newcomers are already zeroing in on what they believe
are their drugs' advantages over Viagra. Cialis, for instance, gave
men improved ability to have sex for up to 36 hours, according to
results from a study presented at a medical conference recently. In
contrast, Pfizer recommends that men have sex within four hours of
taking Viagra.
"Patients should not have to worry about
watching the clock and planning their sex life around the time they take
a drug," says Paul Clark, chief executive officer of Icos. "Cialis
allows you to have a more spontaneous relationship."
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In addition, Cialis and vardenafil may take
effect faster than Viagra, urologists say. Pfizer advises patients to
take Viagra an hour before attempting sexual intercourse. In a clinical
trial, a majority of patients who took Cialis were able to engage in
sexual intercourse within 30 minutes of taking the drug. Bayer hasn't
conducted a similar trial to test how quickly vardenafil acts, but Irwin
Goldstein, a professor of urology at Boston University School of
Medicine who has conducted clinical investigations of Cialis, says his
patients seem to experience a faster onset than Viagra.
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Some urologists say patients who have used
Cialis seem to experience fewer side effects. Dr. Goldstein says,
"There's no question patients find Cialis better than Viagra."A
Pfizer spokesman says the company won't respond to assertions about the
other drugs because it hasn't seen details of the studies. He says the
company prefers to stand by Viagra's record so far as a safe and
effective drug.
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A Longer Lasting Viagra? Eli Lilly/Icos
Developing a Longer Lasting Competitor to Pfizer's Viagra
ABCnews.com
June, 2002
Cialis, a drug developed by Eli Lilly and Co.
and Icos Corp., may be able to give men erections for 24 hours after
they take the drug, or approximately 20 hours longer than Viagra can. "Cialis
has the potential to be a valuable new treatment option for men with
impotence
[erectile dysfunction] and their partners," says Dr. Harin Padma-Nathan,
a urologist with the University of Southern California and lead
investigator of two studies testing the drug for the companies.
"A therapy that allows a man with ED to engage in intercourse within a
36-hour window permits the couple to regain spontaneity in their sexual
relationship." Viagra's manufacturer, Pfizer, Inc., recommends men take
Viagra about one hour before engaging in sexual activity. The drug helps
men get an erection if they are sexually excited in about 30 minutes,
and it lasts up to four hours, the company says.
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Erections Up to 36 Hours Later
In one of the studies being reported today, 61 men
with mild to severe erectile dysfunction received either Cialis or a
placebo in a clinical setting. The doctors were not aware which patients
received the drug or the placebo until after the data was collected.
After taking the drug and looking at sexual images, the doctors
measured the men's response with a RigiScan, or a device that measures
the firmness and duration of erections. The men taking the Cialis were
more successful at achieving erections, even up to 36 hours later, Padma-Nathan
reports.
Sixteen Minutes to Action?
In another study, 223 men took the drug or a
placebo at home, in a more natural setting. The men were instructed to
take the drug before engaging in sexual activity and to use a stopwatch
to record the time it took to achieve an erection. Men were able to get
an erection as early as 16 minutes after taking the drug and could have
a second sexual encounter up to 36 hours later, Padma-Nathan found.
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