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Asacol(R)(Mesalamine) Sponsors ScriptAssist Nurse Call-Back Program to Address Critical Issue of Medication Adherence

Posted on: Wednesday, 17 January 2007, 12:00 CST

CINCINNATI, Jan. 17 /PRNewswire-FirstCall/ -- Procter & Gamble Pharmaceuticals, Inc. has partnered with ScriptAssist to offer a Nurse Call- Back Program for patients prescribed Asacol. This nationwide program will encourage patient adherence to medication through education and support. The personalized, six-month, no-cost, confidential program is offered to all patients currently taking Asacol to treat their ulcerative colitis (UC), a form of inflammatory bowel disease (IBD).

According to the World Health Organization (WHO), poor adherence to treatment of chronic disease is a "worldwide problem of striking magnitude." The WHO estimates that in developed nations, half of patients do not take medicines for chronic diseases in the prescribed manner.(1) In a survey of 588 patients taking chronic medications, 56 percent reported missing a dose.(2) Further, a recent analysis of 1,680 UC patients who initiated 5-ASA treatment showed that approximately one-third of patients were no longer on their 5-ASA therapy at three months.(3)

"New data show that there continues to be a steady decline in patient adherence to ulcerative colitis medication, regardless of drug formulation and dosing regimen," said Sunanda Kane, M.D., associate professor of medicine, section of gastroenterology and nutrition at the University of Chicago. "A program that encourages patients through a personalized approach is an effective way to encourage patients' adherence to their UC medication."

Patients enrolled in the ScriptAssist Nurse Call-Back Program for Asacol are paired with a ScriptAssist registered nurse who, after an initial welcome call to discuss the program and adherence, periodically follows up by phone to ensure the patient is complying with his or her Asacol regimen. After each follow-up call, reports are sent to the patient's physician to update him or her about the patient's progress with the program.

"The Crohn's and Colitis Foundation of America (CCFA) is committed to improving the lives of those affected by digestive diseases through education and support. We are encouraged by the ScriptAssist Program for Asacol which can provide a valuable service to patients," said Kimberly Frederick, CCFA Vice President of Patient & Professional Services. Neglecting to take prescribed medication for a chronic disease, such as ulcerative colitis, can lead to clinical recurrence of disease symptoms.(4)

The ScriptAssist Nurse Call-Back Program for Asacol launched this past summer in New York and is now available in all 50 states.

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 all 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 see accompanying full prescribing information or visit http://www.pgpharma.com/pi/US-Asacol.pdf.

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, Asacol, Enablex, Prilosec OTC, Metamucil, Fibersure, Align, Pepto-Bismol, Vicks, ThermaCare, PUR, Crest and Oral-B. The P&G community consists of almost 140,000 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) "Adherence to Long-Term Therapies: Evidence for Action," World Health Organization Report, 2003. (2) Data from a survey conducted by National Family Opinion, 2004. (3) Magowan, S.H., et.al Am. J. Gastroenterology, Sept. 2006, Vol. 101, Issue 52, p. S447.4 (4) Kane S., et al. Am J Med. 2003; 114:39-43.

Procter & Gamble

CONTACT: Corporate Media Center, +1-866-PROCTER, (+1-866-776-2837);Elaine Plummer, P&G Pharmaceuticals, Inc., +1-513-622-3662

Web site: http://www.pg.com/http://www.pgpharma.com/pi/US-Asacol.pdf

Source: PRNewswire-FirstCall

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