Safety Trial of Diabetes Drug for Use in the Prevention of Oral Cancer Shows Side Effects of Edema, Effect on Lymphocytes and Calcium: Presented at AHNS
8/26/2006 Chicago, IL John Otrompke www.docguide.com Researchers who are evaluating the safety of pioglitazone in nondiabetic patients with precancerous leukoplakia say the drug can be delivered safely for 90 days to non-diabetic people with oral leukoplakia. Nelson Rhodus, MD, professor of oral medicine, department of diagnostic and biological sciences, University of Minnesota, Minneapolis, Minnesota, and colleagues conducted a phase 2a trial to evaluate the safety of pioglitazone in nondiabetic patients with high-risk oropharyngeal leukoplagia. Their findings were presented in a poster session here at the 2006 annual meeting of the American Head and Neck Society (AHNS). Leukoplakia is a precancerous oral condition which affects 1% of the U.S. adult population. Individuals with the condition are at relatively high-risk for conversion to malignancy, with 5% of those with leukoplakia going on to develop oral cancer. By comparison, 1% of those with colonic polyps go on to develop intestinal cancer, the poster said. The researchers undertook this study because the thiazolidinedione class of drugs, commonly used for treatment of type 2 diabetes, bind to peroxisome proliferating-activated receptor (PPAR) gamma nuclear receptors and are therefore theorized to drive dysplastic cells to decrease proliferation and increase maturation. The trial enrolled patients with precancerous leukoplakia but no oral cancer, diabetes, prior radiation to the oral cavity, or serious oral infections between January of 2004 and March of 2006. All patients received 45 mg daily of pioglitazone for 12 weeks. Researchers evaluated laboratory abnormalities using paired Student's t-test and clinical side effects using National Cancer Institute [...]