Navigation Links
Separate Sets of Research Show Treatment Improved Quality of Life,,,in as Early as Three Weeks; Patient Adherence to Medication is,,,Multifactorial

WASHINGTON, May 22, 2007 /PRNewswire/ -- Results from analyses looking at factors contributing to successful treatment of ulcerative colitis (UC), were presented at Digestive Disease Week (DDW) this week. Both of these studies were funded by Procter & Gamble (P&G) Pharmaceuticals, Inc. Findings from one study offer new information on improvement of quality of life for UC patients treated with Asacol(R) (mesalamine), which is from a class of agents known as 5-ASAs. A separate study looked to pinpoint factors that contributed to non- adherence to medication in patients treated with agents from the 5-ASA class.

"Everyday, UC patients fight to stay on top of their disease. They want to be able to function as close to normal for them as possible. These results should help emphasize to physicians how effective treatment can improve quality of life." said Michel Farhat, PhD, GI Professional & Scientific Relations, P&G Pharmaceuticals. "Additionally, there may not be just one reason why patients have trouble adhering to their medication, and physicians and patients need to examine all potential factors before choosing a treatment."

Asacol Improved Quality of Life in UC Patients in as Early as Three Weeks

The abstract, "Delayed-release mesalamine significantly improved quality of life (QoL) in Patients with Mildly and Moderately Active Ulcerative Colitis (UC)," evaluated QoL in 687 patients with mildly or moderately active UC in patients treated for six weeks with delayed-release mesalamine Asacol 2.4g (marketed 400mg tablet) daily or 4.8g daily (investigational 800mg mesalamine tablet). Data from two multicenter, randomized, double-blind, active- controlled trials were combined and analyzed, and found that patients achieved overall improvement in QoL in as early as three weeks from the start of treatment.

Building on this finding, patients who achieved overall clinical improvement at six weeks (the primary endpoint of the study) experienced a significantly greater mean QoL increase compared to patients with no clinical improvement. The primary endpoint, overall clinical improvement, was defined as improvement from baseline at week 6 in Physician Global Assessment score accompanied by an improvement in at least one other clinical parameter (rectal bleeding, stool frequency, patient functional assessment, or sigmoidoscopy) and no worsening in any of the remaining clinical features.

"The ultimate goals of UC therapy are to treat active disease and prevent relapse, in order to improve patients' quality of life," said lead author E. Jan Irvine, M.D., Head, Division of Gastroenterology, St. Michael's Hospital, Toronto, Ontario and Professor of Medicine at the University of Toronto. "These data show that Asacol did, in fact, improve quality of life in mildly and moderately active UC patients, as early as three weeks after starting therapy."

Patient Compliance to 5-ASA Therapy is Multifactorial

The study, "Predictors of 5-ASA Prescription Persistence in Patients with Ulcerative Colitis," sought to identify factors for 5-ASA therapy non- adherence in patients with UC. Of the more than 3,000 UC patients with 5-ASA prescriptions in the database, 1,530 did not refill their prescription at three months. The study identified that the most significant factors in predicting patient non-adherence at three months were gender (men were less compliant than women), psychiatric history (patients with documented psychiatric illness were less compliant) and co-pay (higher co-payments deterred patients from refilling their prescriptions).

"This study not only reaffirms previous research showing that adherence to medication is a critical issue in the treatment of UC, but also demonstrates that the factors involved in patient compliance are multifactorial," said study lead author Sunanda Kane, M.D., Associate Professor of Medicine, Section of Gastroenterology and Nutrition at the University of Chicago. "This information, adds to the pool of knowledge physicians have surrounding UC treatment to help them better understand and treat their patients."

The retrospective cohort study used records of health service utilization from the Thomson Medstat MarketScan(R) Research database. Treatment initiation was defined as 5-ASA use from October 2002 - September 2004 with no 5-ASA use in the prior six months. 5-ASA prescription refill activity was captured at three months. Parameters of interest at index date and 12 months prior were compared between patients who refilled their prescriptions at three months, and those who did not.

In addition to its well-known consumer brands, P&G develops and markets a gastrointestinal platform that extends across pharmaceutical and over-the- counter brands. One of these brands is Asacol Delayed-Release Tablets, available by prescription only, which is indicated for ulcerative colitis (UC), a form of inflammatory bowel disease (IBD).(1) Additional information about Asacol can be found by visiting

About Ulcerative Colitis

UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease.

UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.

UC affects people of a ll ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system.

About Asacol(R) (mesalamine) Delayed-Release Tablets 400 mg

Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses).

Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs. 36%), abdominal pain (18% vs. 14%), eructation (16% vs. 15%), pain (14% vs. 8%) and nausea (13% vs. 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs. 50%), rhinitis (42% vs. 36%), diarrhea (35% vs. 50%), abdominal pain (32% vs. 44%) and flatulence (24% vs. 30%).

Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol. Please visit for full prescribing information.

About Procter & Gamble

Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel(R), Asacol(R), Enablex(R), Prilosec OTC(R), Metamucil(R), Fibersure(R), Align( R), Pepto-Bismol(R), Vicks(R), ThermaCare(R), PUR(R), Crest(R) and Oral-B(R). The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit for the latest news and in-depth information about P&G and its brands.

About Digestive Disease Week (DDW)

Digestive Disease Week (DDW)(R) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 19-24, 2007 in Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

(1) Data on file: IMS National Prescription Audit, 12 months ending May 2006.

CONTACT: Elaine Plummer of P&G Pharmaceuticals, Inc., +1-513-622-3662, orDanielle Brown of Manning, Selvage & Lee PR, +1-212-468-3194, for Procter &Gamble Pharmaceuticals

Web site:

Ticker Symbol: (NYSE:PG)

Terms and conditions of use apply
Copyright 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Study Shows Advantages of Complete Phase Ib Trial Over Separate Phase I Trials
2. NIEHS Researchers Identify Enzyme Critical in DNA Replication
3. Stanford Researchers Find Brain Pathway of Depression in Rats
4. Suven Life Sciences Presenting Pre-clinical data of their NCE’s SUVN-502 and SUVN-507at International Brain Research Organization (IBRO) 2007 World Congress of Neuroscience
5. From Clinical Cancer Research: Rethinking Therapeutic Cancer Vaccine Trials
6. Researchers Discover Method for Identifying How Cancer Evades the Immune System
7. Infertile Voice Supports Stem Cell Research: RESOLVE Calls for Patient Options in Using Frozen Embryos
8. Fact Sheet: Advancing Stem Cell Research While Respecting Moral Boundaries
9. President Bush Ignores Americas Plea for Support of Stem Cell Research
10. Researchers Discover Gene For Rare Skin Disorder
11. The Christopher and Dana Reeve Foundation Expresses Disappointment Over President Bushs Veto of the Stem Cell Research Enhancement Act
Post Your Comments:
(Date:7/12/2017)... and Company (NYSE: LLY ) has entered into ... litigation in the U.S. District Court for the Eastern District ... (tadalafil) unit dose patent. This patent was previously set ... agreement, Cialis exclusivity is now expected to end at the ... patent for Cialis is valid and infringed by companies seeking ...
(Date:7/11/2017)... 11, 2017  The global market for liquid biopsy ... $394.1 million in 2016.  Although in early stages, the ... in particular as a result of the gradual shift ... recent introduction of a significant number of new liquid ... of tumor biomarkers to guide treatment decisions. ...
(Date:7/11/2017)... July 11, 2017 Oramed Pharmaceuticals Inc. (NASDAQ: ... pharmaceutical company focused on the development of oral drug ... Drug Administration (FDA) has agreed to schedule an End-of-Phase ... IIb trial of its oral insulin capsule ORMD-0801 in ... trial met primary and secondary endpoints by indicating a ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... July 21, 2017 , ... ... students improve their chances of acceptance to a residency in a United States ... earned degrees outside the U.S. , According to data released by the ECFMG®, ...
(Date:7/21/2017)... ... July 21, 2017 , ... West Dermatology is pleased ... Vu, PA-C. Beginning July 17, 2017, Ms. Vu will join West Dermatology’s large network ... experience in dermatology, skin cancer , and more. She graduated from the University ...
(Date:7/21/2017)... ... July 21, 2017 , ... How physicians and ... the rise, say researchers presenting their work at the American Orthopaedic Society ... combination of evaluating the patterns of change in concussion symptom presentation, diagnostic tools ...
(Date:7/20/2017)... ... July 20, 2017 , ... Acute myeloid leukemia (AML) is ... rapidly without treatment. Newly diagnosed patients face intense chemotherapy regimens and a stem ... With such a challenging diagnosis that requires immediate action, patients and caregivers ...
(Date:7/20/2017)... ... ... For individuals with extended hospital stays or who are residents of nursing ... specially designed to accommodate patients with a wide range of ailments or special needs, ... has invented the patent-pending PORTABLE ARM REST, a specially designed armrest that features many ...
Breaking Medicine News(10 mins):