Survey Finds 43 Percent of Americans Suffer With Common GI Disorders

EAST HANOVER, N.J. -- A new survey of 1,000 people provided insights on the most common barriers chronic constipation and Irritable Bowel Syndrome with Constipation (IBS-C) sufferers experience in seeking effective care. According to the survey, 43 percent of respondents suffer with recurring constipation, abdominal pain or discomfort and bloating, yet 87 percent of these symptomatic respondents were undiagnosed by their doctor.

This may be due to the fact that 78 percent of all undiagnosed symptomatic respondents admitted they didn't discuss their symptoms' effect on their life. The survey also found that when patients made specific appointments to discuss their symptoms (as opposed to bringing them up in the course of a routine checkup), the discussion was more likely to take 10 minutes or longer and patients were more likely to receive a proper diagnosis.

"For more than 20 years, I suffered with the symptoms of chronic constipation. I told my doctor about my symptoms, but I often felt embarrassed. It was difficult to communicate just how much they all affected me," says Joanna Pedrosa Gonzalez, chronic constipation patient of Brooklyn, N.Y. "Now I have been properly diagnosed and I found a treatment that works for me. I know how important it is to talk to your doctor without embarrassment. By speaking out, and encouraging others to do the same, I hope to help those who are suffering with the symptoms of chronic constipation."

The survey findings led Novartis Pharmaceuticals Corporation to work together with the National Women's Health Resource Center (NWHRC) to launch the "Take 10 for GI Health" campaign, as part of NWHRC's year-long "Take 10 to Talk" campaign. "Take 10 for Gastrointestinal Health" aims to help sufferers with chronic constipation and IBS-C get effective care. "Take 10 for GI Health" encourages patients to make the most of their medical visits by spending 10 minutes with their doctor, openly discussing their chronic constipation and IBS-C symptoms and the impact they have on their lives.

"By taking 10 minutes to have a focused discussion with their doctor, patients can describe the impact of all their symptoms -- how they effect their work, their family and their social lives," says Amy Niles, president and chief executive officer of the National Women's Health Resource Center (NWHRC), and the study's co-sponsor. "I recommend sufferers of recurring constipation, abdominal discomfort and bloating prepare for their doctor's visit in advance in order to overcome the embarrassment of their symptoms."

Patients can visit www.Take10forGIHealth.org to download "Take Ten: Tips for Talking with Your Doctor about GI Health," an educational tool they can print and bring to their next appointment. The tool includes tips and questions designed to help sufferers prepare for their appointment and improve the productivity of their visit.

"When the overwhelming prevalence of these conditions is considered, the need for improved communication becomes clear. More than 31 million Americans suffer from constipation and up to 6 million suffer with IBS-C. Contrast these numbers with the survey statistics and a sufferer's inability to obtain the right diagnosis becomes a huge issue," said Christine Frissora, MD, assistant professor of medicine at the Weill Medical College of Cornell University.

For many patients encountering difficulty in receiving effective care, embarrassment is a primary barrier. "Too often, patients wait until their doctor is halfway out the door before even mentioning an embarrassing symptom -- if they bring it up at all," continued Frissora. "It is critical that sufferers speak openly about all their symptoms. As a physician, my goal is to provide my patients with the best possible care. Knowing more about their symptoms, the impact those symptoms have on their lives and the unsuccessful treatments they have tried before enable me to do this."

Of those surveyed taking medication for their symptoms, most used over-the-counter fiber and laxatives; these treatments are not approved for the multiple symptoms of chronic constipation and IBS-C.

Like the many sufferers surveyed, Pedrosa tried numerous treatments to help manage all of her symptoms. "Before my doctor and I found a treatment that worked for me, I relied on laxatives for my constipation. I also tried fiber, lots of fiber, but nothing helped with all my symptoms. I'd get so bloated my clothing often didn't fit comfortably, and I spent way too much time in the bathroom," Pedrosa continues. "After speaking with my doctor, he prescribed Zelnorm. Zelnorm helped to relieve all of my symptoms."

Zelnorm is the first and only medicine approved for men and women less than 65 years of age with chronic constipation (constipation lasting more than six months with no known cause) and for women with IBS with constipation.

About the Roper ASW Survey
The GI Health Survey was conducted in April 2005 by RoperASW. The sample group consisted of 1,000 randomly selected men and women 18 to 64 years of age. Rome II criteria for diagnosing the two conditions were used to ask questions and evaluate answers. The sampling frame was a national random-digit dialing system that included all telephone households within the United States. The number surveyed provided statistically significant findings for the patient population represented with the margin for error plus or minus three percentage points for the total sample. For additional survey findings, contact those listed below to obtain a copy of the GI Health Survey fact sheet, or view it online at www.HealthyWomen.org.

About the "Take 10 for GI Health" Campaign
The National Women's Health Resource Center (NWHRC) and Novartis Pharmaceuticals Corporation are working together to launch the "Take 10 for GI Health" campaign. "Take 10 for Gastrointestinal Health" will help sufferers with symptoms of chronic constipation and IBS-C get proper diagnosis and treatment. "Take 10" encourages patients to make the most of their medical visit by spending 10 minutes openly discussing all of their symptoms with their doctor.

About the National Women's Health Resource Center
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.

About Zelnorm
Zelnorm is indicated for the treatment of men and women less than 65 years of age with chronic idiopathic constipation. The effectiveness of Zelnorm in patients 65 years or older with chronic idiopathic constipation has not been established. Zelnorm is also indicated for the short-term treatment of women with IBS whose primary symptom is constipation. The safety and effectiveness of Zelnorm in men with IBS-C have not been established. Zelnorm is the first in a novel class of drugs that act as an agonist at 5HT4 (serotonin type 4) receptors. Zelnorm mimics the natural effects of serotonin by activating 5HT4 receptors, which normalizes impaired motility in the GI tract, inhibits visceral sensitivity and stimulates intestinal secretion.

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.

In IBS-C clinical trials, Zelnorm was generally well tolerated. The only adverse events reported notably more often with Zelnorm than with placebo were diarrhea (9 percent vs. 4 percent) and headache (15 percent vs. 12 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. Ischemic colitis and other forms of intestinal ischemia have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm and these events has not been established.

Zelnorm was developed by Novartis and is also known in some countries as Zelmac. Approximately 3 million patients worldwide have been treated with Zelnorm to date. It is approved in more than 55 countries for IBS with constipation. Zelnorm also is approved for use in chronic constipation in more than 15 countries, including Mexico and many of the Latin American countries.

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.

Source: Novartis Pharmaceuticals Corporation

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