Ulcerative Colitis :: Adherence to ulcerative colitis medications is not affected by drug formulation or dosing regimen

Poor adherence to medication is a recognized medical problem, costing an estimated $100 billion a year in the United States.(i) New data show that while there is a steady decline in adherence to medications for ulcerative colitis (UC), drug formulation and the number of pills taken each day do not affect long-term adherence. The data were presented today at the annual scientific meeting of the American College of Gastroenterology by University of Chicago researcher Sunanda Kane, M.D.

“This new study not only reaffirms that adherence to medication is a critical issue in the treatment of UC, but also demonstrates for the first time that long-term adherence is independent of drug formulation and dosing regimen,” said co-author Dr. Kane, associate professor of medicine, section of gastroenterology and nutrition at the University of Chicago. “This study demonstrates that taking a range of four to 16 pills a day does not affect adherence to UC treatment. However, additional studies are needed to further understand the multiple factors that prevent patients from adhering to treatment regimens long term.”

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.(ii)

Adherence to medication among UC patients has not been examined in a large-scale study until this analysis. The retrospective study analyzed records of 1,680 UC patients from health plans across the country. These patients initiated therapy with 5-aminosalycylic acid (5-ASA) medications. Physicians use 5-ASA medications both acutely and as maintenance therapy to avoid UC flare-ups, during which the rectum and/or colon become inflamed.

Patients of any age and sex with diagnosed UC were included in the study, but those with 5-ASA therapy in the previous six months were excluded. Patients’ medication refill rates were measured in three-month intervals over a 12-month period. The majority of patients (62%) were initiated on treatment with Asacol (delayed-release mesalamine, median dose 2.4 grams/day). The remaining patients were on the following 5-ASA treatments and median daily doses: sulfasalazine 2.0 grams (17.5%), Colazal (Salix Pharmaceuticals) (balsalazide disodium) 6.75 grams (12.6%) and Pentasa (Shire) (controlled- release mesalamine) 4.0 grams (7.6%).

The purpose of the study was to observe in a real-world setting patients’ adherence to their treatment by examining refill rates of the four 5-ASA therapies, all of which had different median daily dosing regimens: delayed- release mesalamine (6 pills), sulfasalazine (4 pills), balsalazide (9 pills) and controlled-release mesalamine (16 pills).

The study found that there was a steady decline in medication refill rates, particularly during the first three months of therapy. After three months, medication refills continued to decline at about 1 percent each month with similar medication refill rates for the four 5-ASA therapies.

About Ulcerative Colitis

Ulcerative colitis 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.

It 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 ulcerative colitis is a lifelong condition, flares can be controlled with medication.

Ulcerative colitis affects people of all ages, but often is 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%), and eructation (16% vs 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs 50%), rhinitis (42% vs 36%), and diarrhea (35% vs 50%).

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. As with other mesalamine-containing products, serious adverse events may occur with Asacol.

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(i) O’Conner, P, Improving Medication Adherence, Archives of Internal
Medicine 2006, 166: 1802-1804.
(ii) Adherence to Long-Term Therapies: Evidence for Action, World Health
Organization Report, 2003.

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Ulcerative Colitis :: Adherence to ulcerative colitis medications is not affected by drug formulation or dosing regimen
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