Date of Graduation

Fall 8-10-2013

Degree Type

Capstone Project

Degree Name

Master of Science in Physician Assistant Studies

First Advisor

Robert Rosenow, Pharm.D., OD

Second Advisor

Annjanette Sommers, PA-C, MS

Abstract

Background: Ulcerative colitis (UC), a type of inflammatory bowel disease characterized by diffuse colonic mucosal inflammation, accounts for over 250k physician visits annually with direct medical costs alone exceeding 4 billion dollars annually. The disease, whose etiology is not well understood, can have severe consequences such as colorectal cancer. First-line treatment for mild to moderate disease is topical 5-ASA agents such as mesalamine. Patients refractory to this treatment are candidates for oral steroids, but these can have severe side effects. Budesonide, a second-generation glucocorticoid already used topically for UC, has less systemic effects, but needs an effective delivery mechanism as an oral form to treat areas unreachable via topical solutions. Budesonide multi-matrix (MMX) was just approved January 2013 for treatment. Will it be effective in inducing remission in patients with active, mild to moderate UC?

Methods: An exhaustive literature search using Medline-OVID, CINAHL, EBMR Multifile, and Web of Science using the terms ulcerative colitis and budesonide was conducted. Lists from identified articles were also investigated for further studies. Relevant articles were assessed for quality using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE).

Results: Two study articles were included in the review. CORE 1, a randomized, double-blind, double-dummy study, determined the efficacy of budesonide MMX in inducing remission in ulcerative colitis patients with active disease classified as mild to moderate. The other study was a randomized and double-blind preliminary safety and efficacy study for budesonide MMX. Both studies demonstrated statistically significant rates of remission induction with no increase in side effects

Conclusion: This systematic review indicates this drug as a viable option for patients with active, mild to moderate UC who are refractory to first line therapies. A recommendation for the use of budesonide MMX as an alternative can be given because of the evidence of efficacy, safety of the drug and the already-established use of its two components.

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