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Cybill Shepherd Leads Amazing Women Campaign to Help IBS Sufferers Get Relief

Posted on: Wednesday, 20 October 2004, 08:00 CDT

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 , 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

Novartis Pharmaceuticals Corporation

National Women's Health Resource Center;

CONTACT: Beverly Dane of National Women's Health Resource Center,+1-802-626-4294, beverlydame@healthywomen.org; or Michelle Dionne of RuderFinn, +1-212-593-6495, or +1-646-334-0434, dionnem@ruderfinn.com, for NationalWomen's Health Resource Center, and Novartis Pharmaceuticals Corporation; orCarrie Callahan of Novartis Pharmaceuticals Corporation, +1-862-778-7065,carrie.callahan@pharma.novartis.com

Web site: http://www.novartis.com/http://www.healthywomen.org/http://www.zwomen.org/

Source: PRNewswire

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