Thiazolidinedione use and ulcerative colitis-related flares: an exploratory analysis of administrative data.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that affects nearly 500,000 Americans.1,2 The clinical course is typically relapsing and remitting: patients experience flares of their illness with symptoms of abdominal pain, diarrhea, rectal bleeding, and extra-intestinal manifestations, followed by periods of remission. Thus, the goals of therapy are twofold: 1) to treat disease flares (induction of remission) and 2) to prolong the length of time between flares (maintenance of remission). Despite the morbidity and mortality associated with UC,3 limited treatment options exist and additional therapeutic agents are needed. Thiazolidinediones, inhibitors of PPAR gamma,4 were introduced to the US market in 1997. Although currently indicated for the treatment of type 2 diabetes mellitus (“diabetes”),5 preclinical data and a recent randomized controlled trial have demonstrated the efficacy of rosiglitazone (one member of the thiazolidinedione class) for the induction of remission in UC patients with active disease.6–9 Yet the effectiveness of thiazolidinediones in the maintenance of UC remission has not been comprehensively evaluated. Diabetes is one of the most common chronic illnesses in the US, with a prevalence of 8%.10 Based on the combined prevalence of UC and diabetes, a substantial percentage of Americans may be affected by both conditions. UC may be particularly problematic in patients with coexisting diabetes because oral steroids, a mainstay of UC treatment, can exacerbate hyperglycemia. Therefore, preventing UC flares in these patients is of particular importance. Thiazolidinediones are considered second-line oral medications, reserved for diabetics who fail to achieve metabolic goals on metformin therapy. However, if thiazolidinediones are effective in maintaining UC remission in diabetic patients, there would be a strong argument to move this class to first-line therapy in diabetic patients with UC. Additionally, since few medications have been shown to maintain remission in UC, thiazolidinediones could have a role in the primary treatment of UC patients with or without diabetes. Therefore, we performed an exploratory retrospective cohort study using administrative data to examine the association between thiazolidinedione use and UC flares in patients with UC and diabetes.