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Zelnorm Study Shows Significant Improvement in Work Productivity

Posted on: Wednesday, 3 November 2004, 09:00 CST

ORLANDO, Fla., Nov. 3 /PRNewswire/ -- A new health economic study for Zelnorm(R) (tegaserod maleate) shows a significant improvement in overall work productivity in employed women who suffer with Irritable Bowel Syndrome (IBS) with constipation.

The data demonstrated that women receiving Zelnorm showed a decrease in absenteeism (missed time at work) and presenteeism (reduced on-the-job effectiveness). On average, patients receiving Zelnorm were able to work two-and-one-half hours more per week compared to patients receiving placebo.

The productivity results -- assessed as part of a randomized, double-blind, placebo-controlled, multi-center clinical trial of Zelnorm compared to placebo in 2,650 women -- were presented today during the 69th annual meeting of the American College of Gastroenterology (ACG). Positive results were seen in work productivity early on and those benefits were maintained until the end of the four-week trial period with the pro-motility agent, Zelnorm.

"It is exciting to see an intervention produce clinical benefit and also demonstrate a significant improvement in patients' ability to work and conduct daily activities," says Margaret Reilly, who conducted the study and is a health economic analyst and president of Margaret Reilly Associates, Inc., New York. "Data of this type helps patients, employers, physicians, the medical community, and insurers because it begins to quantify the contribution a therapy can make on a personal and health economic level."

For employed patients with IBS, direct medical and indirect productivity costs to the employer have been estimated to be 50 percent higher than for employees without IBS(1). It is estimated in the United States alone that the annual costs of IBS are $30 billion, with indirect costs, including lost days at work, estimated at $20 billion(1),(2),(3). These costs do not include partial day absences, or reduced on-the-job effectiveness.

The productivity results at the end of four weeks found Zelnorm significantly reduced absenteeism by 2.6 percent (p= <0.004), presenteeism by 5.4 percent (p = <0.0001), overall work productivity loss by 6.3 percent (p = <0.0001), and daily activity impairment by 5.8 percent (p = <0.0001). The health economic endpoints were assessed by the validated Work Productivity and Activity Impairment Questionnaire for IBS (WPAI-IBS); the validation of which was published in August 2004 in Alimentary Pharmacology and Therapeutics(4). The WPAI measures absenteeism, presenteeism, and impairment with daily activities in the past seven days. Daily activities included but were not limited to housework, shopping, childcare, exercising and studying.

The clinical trial included a two-week baseline period followed by a four-week placebo-controlled treatment period. Women in the trial met the accepted diagnostic (Rome II) criteria for IBS with constipation. Those in the Zelnorm arm took 6 mg of Zelnorm twice a day. Of the 1,675 employed study patients, the mean age was 40.8 years and the mean duration of IBS symptoms was 13 years. In the Zelnorm group, 63.8 percent were employed compared to 59.4 percent in the placebo group. Prior to study enrollment, patients reported absenteeism (51 percent), presenteeism (92 percent), and limitations in daily activities due to IBS with constipation (87 percent).

"We know that recurring constipation, abdominal pain and bloating associated with IBS with constipation can significantly reduce a person's quality of life," says Alex Gorsky, chief operating officer of Novartis Pharmaceuticals Corporation. "It is gratifying for us to learn that treatment with Zelnorm can help patients feel good enough to be more productive at work."

Zelnorm Significantly Reduced Healthcare Resource Utilization in Managed Care for Patients with IBS with Constipation

A second study presented at ACG of 3,365 new Zelnorm users and 3,364 matched non-Zelnorm users carried out by a large geographically diverse managed care organization found that effective treatment with Zelnorm reduced the use of GI-related medical healthcare resources that included physician office visits, emergency room (ER) visits, hospitalizations and diagnostic procedures.

The study found that during the six-month study period, all GI-related medical resource categories showed significant (p<0.01) absolute decreases in utilization, with a relative decrease between 20 and 40 percent for Zelnorm users that was not observed consistently for non-Zelnorm users. GI drug use did not change significantly for Zelnorm users; however, there was a statistically significant, 15 percent relative increase, (p<0.01) for non-Zelnorm users.

Zelnorm reduced the number of GI-related physician office visits by 22 percent (-0.42 visits), hospitalizations by 33 percent (-0.02 hospitalizations), ER visits by 40 percent (-0.04 visits), endoscopic procedures by 21 percent (-0.08 procedures), and non-endoscopic procedures by 31 percent (-0.16 procedures), when compared to the use of these resources during the six months prior to taking Zelnorm for IBS or a GI-related disorder. Eighty-two percent of Zelnorm users had diagnostic claims consistent with IBS, or one or more of the cardinal symptoms of IBS: IBS (48 percent), abdominal pain (40 percent), bloating (11 percent), or constipation (38 percent) during the study period.

This retrospective, longitudinal study used medical and pharmacy claims using ICD-9-CM codes to identify Zelnorm users and matched non-Zelnorm users who were continuously enrolled, benefit-eligible patients. GI-related resource use was compared for the six months prior to and following use of Zelnorm. In comparing post utilization to pre utilization, all GI-related medical resource categories showed a significant decrease (p<0.01) for Zelnorm users that was not seen consistently in the control group.

About Zelnorm

As a pro-motility agent, Zelnorm acts as an agonist at 5HT4 (serotonin type 4) receptors in the GI tract and 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. Zelnorm treats dysmotility symptoms caused by chronic constipation and IBS with 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 also is indicated for the treatment of patients less than 65 years of age with chronic idiopathic constipation, a condition that affects up to 4.5 million Americans. Effectiveness of Zelnorm in patients 65 years or older with this condition has not been established.

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.

Zelnorm Safety Data

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, Zelnorm was generally well tolerated. 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 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.

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 "can make,""can help,""potential treatment," or similar expressions, or by express or implied discussions regarding potential new approvals or new indications or future sales of Zelnorm. Such forward-looking statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee regarding potential future revenues from Zelnorm or that Zelnorm will be approved for any additional indications or in any additional countries. In particular, management's expectations could be affected, among other things, by 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 Company'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. Novartis is providing the information in this news release as of this date and does not undertake any obligation to update any forward-looking statements contained in this news release as a result of new information, future events or otherwise.

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 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com/.

For more information and for a copy of the complete prescribing information, please contact: Carrie Callahan (862) 778-7065, or via email at carrie.callahan@pharma.novartis.com.

References

1. Leong SA, Barghout V, Birnbaum HG, et al. The economic consequences of

irritable bowel syndrome: a US employer perspective. Arch Intern Med

2003; 163: 929-35.

2. Martin R, Barron JJ, Zacker C. Irritable bowel syndrome: toward a

cost-effective management approach. Am J Manage Care 2001; 7(Suppl.

8): S268-75.

3. American Gastroenterological Association. The burden of

gastrointestinal diseases, 2001.

4. Reilly MC, et al. The validity and accuracy of the work productivity

and activity impairment questionnaire- irritable bowel syndrome

version. Aliment Pharmacol Ther 2004; 20: 1-9.

Contacts

Carrie Callahan

Novartis Pharmaceuticals Corporation

Tel 862 778 7065 (direct)

or 917 348 9437 (mobile)

carrie.callahan@pharma.novartis.com

John Gilardi

Novartis Global Media Relations

Tel +41 61 324 30 18 (direct)

or +41 79 593 42 91 (mobile)

john.gilardi@group.novartis.com

Kevin Bannon

Ruder Finn Public Relations

Tel 212 715 1621 (direct)

or 917 679 9126 (mobile)

bannonk@ruderfinn.com

Novartis Pharmaceuticals Corporation

CONTACT: Carrie Callahan of Novartis Pharmaceuticals Corporation,+1-862-778-7065, or mobile, +1-917-348-9437,carrie.callahan@pharma.novartis.com, or John Gilardi of Novartis Global MediaRelations, +41-61-324-30-18, or mobile, +41-79-593-42-91,john.gilardi@group.novartis.com; or Kevin Bannon of Ruder Finn PublicRelations, +1-212-715-1621, or mobile, +1-917-679-9126, bannonk@ruderfinn.com

Web site: http://www.novartis.com/

Source: PRNewswire

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