"Speed of Relief" a Key Factor in Selecting Ulcerative Colitis Treatment: New Study

    Canadian ulcerative colitis patients and gastroenterologists say speed to
    symptom relief and few side effects are the most important factors in
    choosing treatment options

    TORONTO, May 4 /CNW/ - A Canadian study examining patient needs in the
management of ulcerative colitis (UC) has been published by the journal
Alimentary Pharmacology and Therapeutics. The study showed that among patients
with UC, speed to symptom relief and few side effects are the most important
attributes when considering a medication(1). With 88,500 Canadians living with
UC, Canada has one of the highest reported prevalences of UC in the world.
There are approximately 4,100 new cases of UC reported in Canada every
    The study, "Treatment of ulcerative colitis from the patient's
perspective: a survey of preferences and satisfaction with therapy," which
surveyed 100 Canadian UC patients, found that speed to symptom relief was
cited as a preferred medication attribute by 84 per cent of patients. Few side
effects was cited by 75 per cent of patients as a preferred attribute(1).
Patients were also asked to rate the importance of factors related to dosing
regimen (i.e., dosing frequency, number of pills), cost and formulary
    "These findings are valuable for those who are treating UC patients, as
we need to understand what patients are looking for in terms of treatment
options," said the study's lead author, Dr. James Gray, Clinical Assistant
Professor of Gastroenterology, University of British Columbia. "This being
said, every patient is different, so it's important for healthcare
professionals to work closely with their patients to find the right strategy
and treatment for their particular case."

    Physician Preference - Cost, dosing considerations also play a role

    A follow-up survey of 61 Canadian gastroenterologists found that speed to
symptom relief and few side effects are also the most important to physicians
(84 per cent and 63 per cent respectively)(3). Physicians (more than half)
were also more concerned than patients (about one-third) regarding cost and
formulary coverage when prescribing drugs to their patients(3). Neither
patients (35 per cent) nor physicians (32 per cent) cited a strong preference
toward once-daily dosing(3).

    Patients and Physicians Need to Work Together

    "Once a patient finds something that works well for them, they may be
reluctant to switch to a new treatment," said Dr. Gray. "However, it is
important for physicians to maintain an ongoing dialogue with their patients
to determine whether another treatment option might work even better than the
tried and true. There is always new information and studies coming out that
can benefit patients, and we should take advantage of any new knowledge."
    For example, a recent analysis of two different doses of mesalamine in
moderate UC patients found faster symptom relief with one. Asacol 800 at 4.8
g/day provided 10-day faster symptom relief than Asacol (400 mg tablet) at 2.4
g/day based on the composite endpoint of rectal bleeding and stool frequency,
Asacol 800 provides fast relief of rectal bleeding and stool frequency,(4) in
addition to the added convenience of taking 50% fewer pills every day.

    About the Studies

    The study "Treatment of ulcerative colitis from the patient's
perspective: a survey of preferences and satisfaction with therapy" was
conducted with 100 Canadian UC patients on topics including: educational
resources used to learn about the disease, medication attributes that are more
valued and preferred by the patient, and satisfaction with current therapy.
The physician preference study was conducted among 61 Canadian
gastroenterologists. Both studies were sponsored by Procter & Gamble
Pharmaceuticals, Inc.

    About Asacol 800

    Asacol 800 is indicated for the treatment of moderately active ulcerative
colitis. The recommended daily adult dose for Asacol 800 is six tablets, taken
orally in divided doses. The Asacol 400 mg tablet used in the 2.4 g/day arm of
the ASCEND I trial was approved in Canada in 1985. Asacol 400 mg tablet is
indicated for the treatment of mild to moderate active ulcerative colitis and
for the maintenance of remission of mild to moderate ulcerative colitis.
    Asacol 800 at 4.8 g/day demonstrated superior efficacy in patients with
moderately active ulcerative colitis compared to patients taking Asacol at 2.4
g/day, with a similar safety profile. Asacol 800 at 4.8 g/day demonstrated an
overall incidence of adverse events comparable to Asacol dosed at 2.4 g/day.
Reported adverse events were generally mild and transient, and seldom resulted
in discontinuation of treatment. Most commonly reported adverse events for
Asacol 800 were nausea (6.1%), headache (5.4%), vomiting (4.1%) and flatulence
(4.1%) while those for Asacol were headache (5.8%), abdominal pain (4.5%), and
ulcerative colitis (3.9%). Patients should be made aware that ulcerative
colitis rarely remits completely. Abrupt discontinuation of mesalamine therapy
is not recommended and may result in relapse. Caution should be exercised in
patients with hepatic dysfunction or history of renal disease. Asacol 800 is
not recommended for use in patients with renal impairment.
    It is recommended that all patients have an evaluation of renal function
prior to initiation of Asacol 800 tablets and periodically while on Asacol 800
therapy. Please refer to the Asacol 800 Product Monograph for a complete list
of adverse events.

    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), a division of The Procter & Gamble Company
(NYSE:   P&G), 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). P&GP
employs a Connect & Develop model for new product development and in-licenses
or acquires all of its new drug candidates from biotech and pharmaceutical
industry relationships. P&GP is committed to leveraging this model to build
brands to address unmeet needs in the areas of gastrointestinal,
musculoskeletal and women's health. 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.

    Three billion times a day, P&G brands touch the lives of people around
the world. P&G has one of the strongest portfolios of quality, leadership
brands in consumer health and wellness, including Align(R), Always(R),
Crest(R), Metamucil(R), Oral-B(R), Pepto-Bismol(R), Prilosec OTC(R), Scope(R),
Tampax(R), and Vicks(R), in addition to its trusted consumer brands, including
Ariel(R), Braun(R), Bounty(R), Charmin(R), Dawn(R), Downy(R), Duracell(R),
Folgers(R), Gillette(R), Head & Shoulders(R), Iams(R), Lenor(R), Mach3(R),
Olay(R), Pantene(R), Pampers(R), Pringles(R), Tide(R), Wella(R), and
Whisper(R). The P&G community consists of over 135,000 employees working in
over 80 countries worldwide. Please visit http://www.pg.com for the latest
news and in-depth information about P&G and its brands.

    (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 Feb 16. (Epub ahead of print)
        Available from:
    (2) Crohn's and Colitis Foundation of Canada. The Burden of Inflammatory
        Bowel Disease (IBD) in Canada. Available from:
29th%20EN.pdf. Accessed March 16, 2009.
    (3) Asacol Physician Preference Study - Summary. Procter & Gamble
        Pharmaceuticals, Toronto, ON January 19, 2009.
    (4) Asacol 800 Product Monograph, Jan. 14, 2009. Procter & Gamble
        Pharmaceuticals, Toronto, ON.

For further information:

For further information: Media Contacts: Laura Grice, MS&L, (416)
847-1319, laura.grice@mslworldwide.com

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