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New Clinical Data Show Patients Receiving Cialis
- Improved Intercourse Success at 24 and 36 Hours After Dosing.
Business Wire
'Marathon Effect' of Impotence Cialis Drug
BBC News
Cialis (tadalafil) -- Approved by European Commission for the
Treatment of Impotence
Business Wire
A Longer Lasting Viagra? Eli Lilly/Icos Developing a Longer
Lasting Competitor to Pfizer's Viagra, Cialis
ABCnews.com
In Two New Studies, Cialis -IC351- Provided an Extended Period
of Responsiveness in Men With Impotence.
Business Wire
Cialis (IC351) Improves Sexual Function In Diabetic Men With
Impotence
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New Clinical Data Show Patients Receiving Cialis - tadalafil
- Improved Intercourse Success at 24 and 36 Hours After Dosing.
Business Wire
According to newly released clinical data on Cialis(TM), an investigational PDE5 inhibitor being 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.
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.
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, 1348 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.
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"Cialis was statistically superior to placebo in enabling men with
impotence 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.
Impotence - Just the Facts
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 and more than 30 million men
in the Europe, with many cases caused by physical conditions, including
cardiovascular disease and diabetes.
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'Marathon Effect' of Impotence Cialis Drug
BBC News
The drug is being developed in the US, impotent men who take a new drug
for the condition may be able to have sex up to 34 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.
Pharmaceutical firm Eli Lilly wants to be able to market Cialis in the US
from the second half of this year. Their trial involved 223 men with moderate
to severe impotence, some of whom were given Cialis, and the rest a dummy
placebo. While the drug group were statistically more likely to achieve
erection, they were also more likely to have successful second sexual encounters
during a 24-hour period.
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 36 hours in patients taking Cialis
and many of the men indicated a sense of freedom and spontaneity."
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Other trials have also suggested that the drug is effective against some forms of impotence. It is estimated that more than 37million 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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Cialis (tadalafil) -- Approved by European Commission
for the Treatment of Impotence
Business Wire
Lilly ICOS LLC announced today that the European Commission has granted
a marketing authorization for Cialis(TM) (tadalafil), an oral PDE5 inhibitor
for the treatment of impotence for all 15-member states of the European
Union. The approval decision follows a positive opinion adopted July 25,
2002, by the European Committee for Proprietary Medicinal Products (CPMP).
Lilly ICOS anticipates launching Cialis in Europe during the first half
of 2003.
The European Commission based its decision on the review and evaluation
of the comprehensive data package of Cialis that comprised results of more
than 60 studies in more than 4,000 people to characterize the safety and
efficacy profile of Cialis. The randomised, placebo-controlled, Phase 3
primary efficacy studies of Cialis involved 1,112 men (804 Cialis, 308 placebo)
with impotence of various causes and severity and evaluated doses including
10 and 20 mg.
"Not only is the approval of Cialis a significant milestone for Lilly ICOS, but we believe it is an important step forward for millions of men in Europe who suffer from impotence," said Paul Clark, ICOS chairman and chief executive officer.
"Cialis will provide an important new treatment option for many of the 31 million men in Europe with impotence," said Richard Pilnik, president of European operations for Lilly.
About Impotence:
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(1). Up to 80 percent of impotence
cases are caused by physiological conditions, including cardiovascular disease
and diabetes, with psychological factors accounting for the remaining 20
percent. In many cases, however, both psychological and physical factors
contribute to the condition.
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A Longer Lasting Viagra? Eli Lilly/Icos Developing
a Longer Lasting Competitor to Pfizer's Viagra, Cialis
ABCnews.com
Cialis, a drug being 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 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 impotence to engage in intercourse
within a 24-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.
Cialis Provides Erections Up to 24 Hours Later:
In one of the studies being reported today, 61 men with mild to severe impotence
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 24 hours later, Padma-Nathan
reports.
Cialis 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 24 hours later, Padma-Nathan found.
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In Two New Studies, Cialis -IC351- Provided an
Extended Period of Responsiveness in Men With Impotence.
Business Wire
According to results of clinical trials released today on Cialis(TM), a new PDE5 inhibitor in development by Lilly ICOS LLC to treat impotence, men reported an improved ability to achieve erections even 24 hours after taking the drug. These data will be presented for the first time at the 96th Annual Meeting of the American Urological Association in Anaheim, California, in June.
"Cialis has the potential to be a valuable new treatment option for men with impotence and their partners," said Dr. Harin Padma-Nathan, urologist and lead investigator of the study. "A therapy that allows a man with impotence to engage in intercourse within a 24-hour window permits the couple to regain spontaneity in their sexual relationship."
Cialis provided extended duration of responsiveness and worked
promptly:
In the first of two trials to measure responsiveness, 610 men with
mild-to-severe impotence were randomized to receive Cialis 10 mg or placebo
in a clinical setting. After taking Cialis, men underwent RigiScan(TM) (a
device for measuring the firmness and duration of erections) evaluations
during exposure to visual sexual stimulation. Men in the Cialis group were
significantly more successful in achieving erections than men in the placebo
group, even when evaluated at 36 hours post Cialis dosing.
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To measure the onset of responsiveness in a more natural setting, 223 men received Cialis (up to 20 mg) or placebo in a second, home-based study. The men were instructed to take the medication immediately before engaging in sexual activity and to use a stopwatch to record the elapsed time until they achieved an erection sufficient for successful intercourse. In this trial, the ability to achieve an erection after sexual stimulation was statistically superior in the group taking Cialis compared with the placebo group at 16 minutes post dosing. Patients on Cialis in this study also recorded statistically significantly more success at second sexual encounters than patients on placebo for a period of up to 24 hours after dosing.
There were no treatment-related serious adverse events. The most commonly reported adverse event was headache. "The side effects in the trials are consistent with other large-scale trials conducted to date with Cialis," said Dr. Padma-Nathan. "Importantly, the extended duration of responsiveness does not appear to increase the rate of side effects or their severity. This is further supported by the fact that very few men chose to discontinue Cialis treatment due to side effects."
Extended duration of responsiveness important to men with impotence
Dr. Padma-Nathan said that these results are especially encouraging
in light of a recent Harris Interactive survey of 256 men with ED in which
88 percent of the men surveyed indicated the duration of responsiveness
was either "very important" or "extremely important"
in selecting a treatment.
Cialis(TM) Phase II/III Studies Encouraging
In a previously released Phase II placebo controlled study, Cialis improved
erectile function in up to 88 percent of men with varying degrees of impotence.
In a placebo controlled Phase III study in men with difficult-to-treat diabetes-related
impotence, up to 64 percent of men reported improved erections. The trials
demonstrated good tolerability over the entire duration of the medication's
effect with headache and dyspepsia (upset stomach) the most commonly reported
side effects. The reported side effects were transient, generally considered
mild to moderate, and their occurrence diminished with continued treatment.
In addition, there were no serious treatment related adverse events.
Impotence is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It 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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First Phase 3 Data Show Cialis -IC351- Improved
Sexual Function in Men With Difficult to Treat, Diabetes-related Impotence.
Business Wire
The first Phase 3 study for Cialis(TM), a new PDE5 inhibitor being developed by Lilly ICOS LLC to treat erectile dysfunction impotence, showed strong results among one of the most difficult to treat populations of men with impotence. 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.
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"The impairment of nerve and blood vessel function that accompanies diabetes makes impotence 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 impotence compounds in patients with diabetes, the 64 percent response rate seen in this Cialis study is impressive.
Sexual
function 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 94 percent of men taking Cialis
20 mg reported significantly enhanced 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 impotence 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.
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Several measures of sexual function and satisfaction indicate Cialis superior to placebo
(sugar pill):
Men participating in both studies completed the International Index of Erectile Function (IIEF), a
standard sexual function questionnaire used by urologists, which includes questions on a man's ability to achieve
and maintain an erection. To evaluate Cialis' effect versus placebo, researchers compared baseline scores with
scores reported after treatment. Additionally, men and their partners completed sexual encounter profile (SEP)
diaries, indicating their perceptions on the success and satisfaction of each sexual attempt. Data reported
to date from Phase 2 and Phase 3 studies show treatment with Cialis significantly increased the number of successful
and satisfying intercourse attempts reported by both men and their partners, relative to placebo. Cialis was
well tolerated and there were no treatment-related serious adverse events.
Impotence 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
impotence. Diabetes can cause vascular complications which, in addition
to impotence, 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.
As a result of these often age-related co-morbidities, there is a higher prevalence of impotence in older
men. Between the ages of 40 and 70 years, for example, the incidence of severe impotence triples from five
percent to 15 percent, while the probability of moderate impotence doubles from 17 to 34 percent.
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