Study demonstrates once-daily dose of Asacol(R) (mesalamine) is comparable to
twice-daily dose for maintaining remission of ulcerative colitis (UC)

    
    Largest prospective controlled trial in UC meets primary endpoint of non-
    inferiority for maintaining remission in UC patients
    

TORONTO , Oct. 28 /CNW/ - Results from the largest prospective controlled ulcerative colitis (UC) trial conducted to date, called the QD dosing investigation for efficacy IN UC maintenance (QDIEM), found that once-daily dosing of Asacol(R) (mesalamine) delayed-release 400 mg tablets at 1.6-2.4 g/day was comparable to twice-daily dosing for the maintenance of remission in patients with UC. The study, which met its primary endpoint of non-inferiority, found that 90.5 per cent of patients taking Asacol once-daily remained in remission at six months compared to 91.8 per cent of patients taking Asacol twice-daily. These findings were announced at the American College of Gastroenterology (ACG) Annual Scientific Meeting in San Diego , California.

At 12 months, approximately 85 per cent of patients maintained remission irrespective of whether they took Asacol once- or twice-daily. The number of serious adverse events and withdrawals due to adverse events were similar for patients in the once-daily and twice-daily Asacol dosing regimens.

"While Asacol is currently indicated for divided dosing, it is encouraging to see that in this study, when Asacol was taken once-daily, the results were comparable to when it was taken twice-daily," said Dr. Pierre Paré, Director of Clinical Research in Gastroenterology, Centre Hospitalier Affilie Universitaire de Québec. "UC is a chronic condition, so it is extremely important that patients take their medication as prescribed, and work together with their physician to determine how to best manage their symptoms and maintain disease remission."

Two recent Canadian studies, comparing preferred medication attributes among UC patients and physicians found that while speed to symptom relief and few side effects are the most important attributes in choosing a treatment option, 35 per cent of patients and 32 per cent of physicians rate once-daily dosing as a preferred medication attribute.(1),(2)

Additional Study Details

The QDIEM study was a multi-centre, randomized, investigator-blinded, 12-month parallel-group study that included 1,027 patients. The study was designed to assess the non-inferiority of once-daily dosing versus twice-daily dosing of Asacol for maintaining clinical remission in patients with UC. Patients were randomized to either the once-daily or twice-daily dosing regimen at the same total daily dose (ranging from 1.6 to 2.4 g/day) that they had taken to maintain remission prior to entering the study. Clinical remission was defined as a Simple Clinical Colitis Activity Index (SCCAI) score of two or less points. Relapse was defined as an SCCAI score greater than or equal to five points. Relapse rates were assessed over the 12-month period using the Cox proportional hazards model. Patients who had not relapsed were considered to be in remission.

About Asacol

Asacol (400 mg tablet) is indicated for the treatment of mildly to moderately active ulcerative colitis and the maintenance of remission of mild to moderate ulcerative colitis. Asacol is generally well tolerated. The most commonly reported side effects included nausea, diarrhea, abdominal pain and headache.

About Ulcerative Colitis

Ulcerative colitis (UC) is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). UC involves inflammation of the lining of the colon and rectum and it is characterized by flares, which can vary in duration and intensity, followed by periods of remission throughout a lifetime. During a flare, the rectum and/or colon become inflamed and an increase in symptoms such as diarrhea, rectal bleeding, abdominal cramping, and an urgent need to go to the bathroom are experienced.

UC varies in clinical severity with patients having mild, moderate or severe disease. The severity of disease is used to determine the appropriate approach to therapy. While ulcerative colitis is a lifelong condition, flares can be controlled with medication. The causes of this condition are unknown, but may involve heredity, infection or the immune system.

The Crohn's and Colitis Foundation of Canada reports an estimated 88,500 men and women suffer from UC in Canada . The condition affects people of all ages, but is frequently diagnosed between the ages of 15-25, or 45-55. Most people experience periods of remission and flare-ups of the disease, often requiring long-term medication, hospitalization or surgery. Although UC is found throughout the world, it seems to be more common in North America and northern Europe . Canada is believed to have one of the highest incidence rates of UC in the world.

About P&G Pharmaceuticals

P&G Pharmaceuticals (P&GP) has successfully developed and marketed a wide range of prescription products since the 1980s, including Actonel(R), Asacol(R), Enablex(R), Entex(R), Dantrium(R), Didronel(R), Macrobid(R), and Ziac(R). The P&GP community consists of more than 3,000 employees working in over 22 countries worldwide. For more information on P&GP and its prescription product portfolio, please visit www.pgpharma.com.

    
    References
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    (1) Gray JR, Leung E, Scales J. Treatment of ulcerative colitis from the
        patient's perspective: a survey of preferences and satisfaction with
        therapy. Aliment Pharmacol Ther. 2009; 29(1):1114-20.
    (2) Asacol Physician Preference Study - Summary. Procter & Gamble
        Pharmaceuticals, Toronto, ON January 19, 2009.
    

For further information: Collin Matanowitsch, MS&L, [phone], [email protected]