Focus Will Be on Talking Openly About All Symptoms for Proper Diagnosis and
Treatment
NEW YORK, Oct. 20 /PRNewswire/ -- Cybill Shepherd, the National Women's
Health Resource Center (NWHRC) and Novartis Pharmaceuticals Corporation
announced today that they are working together to launch the educational
campaign Amazing Women.
The campaign is designed to empower women to seek proper diagnosis and
treatment for recurring constipation accompanied by abdominal pain or
discomfort and bloating, the hallmark symptoms of Irritable Bowel Syndrome
(IBS) with constipation, a dysmotility disorder.
IBS with constipation often goes undiagnosed for years. A new RoperASW
survey, IBS with Constipation: The barriers to doctor-diagnosis and treatment,
found that as many as 96 percent of undiagnosed sufferers do not realize they
have IBS with constipation, a treatable medical condition, even though 88
percent of those who had not spoken to their doctor knew about the condition.
Respondents also cited embarrassment about discussing their symptoms as a
reason for failing to communicate openly with family, friends and even their
doctors.
Ms. Shepherd is one of six million Americans who suffer with dysmotility
symptoms associated with IBS with constipation. Until recently, she was like
most of the respondents in the RoperASW survey, in that she didn't realize she
had a treatable medical condition.
"I struggled with recurring constipation, abdominal pain and bloating for
more than 20 years because I didn't talk openly to my doctor about all of my
symptoms," says Ms. Shepherd. "I tried nearly everything, including fiber
supplements and over-the-counter laxatives, but none of these helped relieve
all of my symptoms. Sometimes I was not able to enjoy my free time, including
the activities I did with my kids."
Ms. Shepherd will work with NWHRC and Novartis to engage women who have
been diagnosed with IBS with constipation to encourage them to offer support
to others who are suffering with recurring constipation, abdominal pain and
bloating but who remain undiagnosed. These patient advocates will share
personal stories that led them to the right diagnosis and treatment with
Zelnorm(R) (tegaserod maleate), the first and only medication approved by the
Food and Drug Administration (FDA) for the treatment of women with the
multiple symptoms of IBS with constipation.
"When I finally opened up and told my doctor the whole story, she was able
to diagnose my condition and prescribe Zelnorm, a treatment that finally
helped to relieve all my symptoms," Ms. Shepherd says. "My goal is to urge
all woman to get over their embarrassment, to stop suffering in silence the
way I did, and to talk to their doctors. Getting the right diagnosis and
treatment can help us to be the amazing women we were meant to be."
Seventy percent of the nearly 40 million Americans -- one in five adults -
- who suffer with IBS are women, and it is one of the most common
gastrointestinal disorders. "Yet people are not comfortable talking about
it," says Amy Niles, president and CEO of NWHRC. "In our RoperASW survey, we
found nine out of 10 diagnosed patients initiated the conversation with their
doctor about their combination of symptoms. This demonstrates clearly that
talking candidly with your doctor about all the symptoms -- recurring
constipation, abdominal pain or discomfort and bloating -- is the first step
to getting the right diagnosis."
Susan Lucak, MD, assistant professor of clinical medicine, Division of
Digestive and Liver Disease, Columbia-Presbyterian Medical Center, New York,
says, "Now, it is more important than ever that patients talk to their doctors
about their recurring constipation, abdominal pain and bloating. There is new
research that for the first time has found a difference in the way serotonin
works in the gastrointestinal tract of patients with dysmotility disorders
like IBS compared to those without. Zelnorm is the only treatment available
that mimics serotonin, increasing motility and decreasing pain perception to
improve the dysmotility symptoms of patients with IBS with constipation."
About Amazing Women
The Amazing Women campaign will provide sufferers with new information and
peer support to motivate them to speak openly with their doctors to obtain a
proper diagnosis and appropriate treatment. Materials, including a patient
brochure, are available by visiting http://www.Zwomen.org, or by calling (866)
IBS AND ME (427-2636). The RoperASW survey found that aside from their
doctors, the number one source for information about IBS with constipation was
the Internet. Zwomen.org will also include Cybill's Tips for Talking with
Your Doctor, a printable checklist designed to encourage a comprehensive
symptom-based conversation when they visit their doctor.
The Amazing Women campaign demonstrates Novartis' commitment to
educational programs where more effective dialogues are needed with doctors.
"Patients and physicians need to communicate openly," says Alex Gorsky, chief
operating officer of Novartis Pharmaceuticals. "When they do, the result is
healthier outcomes for patients and the potential for greater satisfaction for
physicians in the management of their patients."
Ms. Shepherd will tour several local markets in 2004, including
Philadelphia, Chicago and Los Angeles, where she will host patient events,
share her personal struggle with IBS with constipation and speak to women
about the importance of talking openly with their doctors about all of their
symptoms.
About IBS with Constipation: The barriers to doctor-diagnosis and
treatment
The findings of the survey are based on telephone interviews conducted by
RoperASW during January and February of 2004 with women who have been
diagnosed by a doctor as having IBS with constipation (213 patients) and women
having the symptoms of IBS but not doctor-diagnosed as having IBS (201
patients). The aim of the survey was to identify and quantify barriers to
doctor-diagnosis and treatment of IBS with constipation. Some highlights of
the survey include:
Diagnosed and Undiagnosed Respondents
* 92 percent of all those surveyed considered their abdominal
pain/discomfort to be very bothersome or somewhat bothersome
* More than half (56 percent) of the diagnosed patients had lived with
the condition for more than 10 years compared to 35 percent of the
undiagnosed patients
* Half of undiagnosed worry their symptoms will lead to something more
serious, whereas fewer diagnosed (42 percent) patients had this worry
Diagnosed Respondents
* 42 percent of sufferers believe there will be no improvement of their
symptoms or their symptoms will get worse
* 47 percent of diagnosed sufferers felt they were very knowledgeable or
somewhat knowledgeable about many aspects of IBS before seeing their
doctor
Undiagnosed Respondents
* Of the 88 percent of sufferers who had heard of IBS, 21 percent have
not talked to their doctor because they didn't believe IBS was a real
medical condition and 14 percent didn't think anything could be done
about it
* Nearly one-third of sufferers believed their symptoms were caused by
poor diet
* Of the patients who self-treat their symptoms, the majority used OTC
remedies. None reported being very satisfied and 38 percent are
dissatisfied with treatments that included laxatives, dietary changes,
fiber supplements, acid reducers, stool softeners, antidiarrheals, gas
relief medications and other medications.
About Dysmotility Disorders
Both IBS with constipation and chronic constipation are considered
disorders of intestinal motility.
IBS is a dysmotility disorder characterized by abdominal pain or
discomfort, bloating and an altered bowel habit (constipation, diarrhea or
alternating between the two). It accounts for approximately 12 percent of all
visits to primary care physicians and 28 percent of visits to
gastroenterologists each year. In addition to the physical impact of IBS, the
condition has a significant economic impact. IBS costs the U.S. healthcare
system up to an estimated $30 billion annually in direct and indirect costs.
Constipation, including that due to other diseases or drugs, is one of the
leading gastrointestinal complaints in the United States, affecting nearly 18
percent of the population, or 37 million people. More than 4.5 million
Americans report they are constipated most of the time. Constipation is
commonly defined as less than three bowel movements a week, but other symptoms
patients complain about most include straining, hard stool, incomplete
evacuation, infrequent defecation, bloating and abdominal discomfort.
Diagnosed cases of constipation are evenly distributed across age groups in
both genders, although slightly more frequent in women.
About the National Women's Health Resource Center (NWHRC)
Since the late 1980s, the NWHRC has helped millions of women educate
themselves about the health topics that concern them the most. The non-profit
organization, dedicated to helping women make informed decisions about their
health, encourages women to embrace healthy lifestyles to promote wellness and
prevent disease. As the national clearinghouse for women's health
information, providing access to health information and resources is the
NWHRC's primary goal. The information they provide is comprehensive,
objective, and supported by an advisory council comprised of the nation's
leading medical and health experts. For more information about the NWHRC
visit http://www.healthywomen.org.
About Zelnorm
As a pro-motility agent, Zelnorm acts as an agonist at 5HT4 (serotonin
type 4) receptors in the gastrointestinal tract and mimics the natural effects
of serotonin by activating 5HT4 receptors, which helps normalize impaired
motility in the GI tract, inhibits visceral sensitivity and stimulates
intestinal secretion. Zelnorm treats the dysmotility symptoms caused by IBS
with constipation and those of chronic constipation.
Zelnorm is indicated for the short-term treatment of women with IBS whose
primary bowel symptom is constipation. The safety and effectiveness of
Zelnorm in men with IBS with constipation have not been established. Zelnorm
is also indicated for chronic idiopathic constipation in male and female
patients less than 65 years of age. The effectiveness of Zelnorm in patients
older than 65 years has not been established.
Overall, safety data is now available in more than 11,600 patients who
have enrolled in clinical trials assessing Zelnorm's safety and efficacy in
various GI conditions.
In IBS with constipation clinical trials, tolerability to Zelnorm was
similar to placebo. The only adverse event reported notably more often with
Zelnorm than with placebo was diarrhea (9 percent vs. 4 percent). The
majority of patients reporting diarrhea had a single episode and in most
cases, diarrhea occurred in the first week of treatment. Typically, it
resolved with continued therapy. Serious consequences of diarrhea, including
hypovolemia, hypotension and syncope, have been reported in the clinical
studies (0.04 percent) and during marketed use of Zelnorm. In some cases,
these complications have required hospitalization for rehydration.
In chronic constipation studies, the incidence of adverse events with
Zelnorm was similar to that of placebo. The only adverse event reported more
often with Zelnorm 6 mg twice-a-day than placebo was diarrhea (6.6 percent vs.
3 percent). Diarrhea rarely led to discontinuation of the study (0.9
percent). Typically, diarrhea was transient, lasting two days, and generally
resolved without rescue medication or interruption of treatment. Data from
the trial that incorporated a 13-month extension study showed Zelnorm to be
generally safe and well tolerated long term.
Zelnorm was developed by Novartis and is also known in some countries as
Zelmac. It is approved in more than 55 countries for IBS with constipation.
Zelnorm also is approved for use in chronic constipation in 10 countries,
including Mexico and Latin America. Zelnorm is being studied as a potential
treatment for other important GI motility disorders, including
gastroesophageal reflux disease (GERD) and dyspepsia.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufacturers
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory
disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation
is an affiliate of Novartis AG (NYSE: NVS), a world leader in pharmaceuticals
and consumer health. In 2003, the Novartis Group's businesses achieved sales
of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested
approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland,
Novartis Group companies employ about 80,000 people and operate in over 140
countries around the world. For further information please consult
http://www.novartis.com.
This release contains certain forward-looking statements relating to the
Company's business, which can be identified by the use of forward-looking
terminology such as "will" or similar terms, or by express or implied
discussions regarding potential additional approvals or potential future sales
of Zelnorm. Such forward-looking statements reflect current views with
respect to future events and are subject to certain risks, uncertainties and
assumptions. There can be no guarantee that Zelnorm will be approved in any
additional countries; that Zelnorm will be approved for the treatment of any
additional indications; or regarding potential future revenues from Zelnorm.
In particular, expectations regarding Zelnorm could be affected by, among
other things, uncertainties relating to unexpected regulatory actions or
delays; government regulation generally; new clinical data; unexpected
clinical trial results; the ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general;
government, industry, and general public pricing pressures; and other risks
and factors referred to in the Novartis AG's current Form 20-F on file with
the Securities and Exchange Commission of the United States. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or expected. The
information in this press release is being provided as of this date and will
not be updated as a result of new information, future events or otherwise.
Amazing Women and Cybill Shepherd's participation are funded by Novartis
Pharmaceuticals Corporation.
CONTACTS:
Beverly Dane
National Women's Health
Resource Center
(802) 626-4294
beverlydame@healthywomen.org
Michelle Dionne
Ruder Finn
(212) 593-6495
(646) 334-0434
dionnem@ruderfinn.com
Carrie Callahan
Novartis Pharmaceuticals Corporation
(862) 778-7065
carrie.callahan@pharma.novartis.com
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