This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Ulcerative Colitis is a disease of dysregulation of the immune system of the colon that results in uncontrolled inflammation. Statin drugs like Lipitor have been shown to decrease inflammation in humans. A series of seven patients with ulcerative colitis have reported significant improvement in their disease after using Lipitor. Lipitor is a once a day, relatively inexpensive, relatively safe drug that could be very helpful for Ulcerative Colitis. We will select patients whose maintenance therapy is not effective, specifically those who have had a disease flare requiring steroids in the past year, or those who continue to have moderate disease activity despite maintenace therapy. We will randomize 36 patients to Lipitor or placebo, evaluate their disease activity at the beginning with lab tests, surveys, and a sigmoidoscopy with biopsies. We will treat patients for 6 months, monitoring their disease activity with lab tests and surveys. At the end of the 6 months, we will repeat the full evaluation with a sigmoidoscopy. The primary endpoint is the decrease in disease activity, as measured by a clinical index known as a Seo Score, which combines symptoms and lab tests into a number that reflects disease severity. We will also be looking at secondary endpoints, including the number of patients who reach mild disease or remission, the number of patients having a flare, improvement in quality of life, whether markers of inflammation in the blood and in colon tissue decrease with drug treatment, and whether this drug appears to act on particular molecules like ras and NF- kappa B to achieve its effect.'
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