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| |  DG DISPATCH - ADA: Troglitazone Safe And Effective In Triple Therapy By Cameron Johnston Special to DG News SAN DIEGO, CA -- June 21, 1999 -- A study of 178 patients with type 2 diabetes has found that troglitazone (Rezulin, Parke-Davis) works well as triple therapy for patients who were considered poor responders to metformin and sulfonylurea alone. In the study, which was conducted at the Metabolic Day Centre of the Royal Victoria Hospital, in Montreal, Canada, patients showed a mean HbA1c of 8.5 percent, meaning they were not even close to having adequate glycemic control. However, significant changes were recorded in fasting plasma glucose (FPG) and glycated hemoglobin when they added 400 mg of troglitazone daily to their existing metformin dose of 1500 mg/day and the maximum allowable dose of sulfonylurea. In addition, there was a modest reduction in the amount of insulin the patients were using each day. The results were presented at the American Diabetes Association’s 59th Annual Scientific Sessions by Dr. Jean-Francois Yale, director of the Metabolic Day Centre at the hospital. Metformin and sulfonylurea have been used in combination to treat type 2 diabetics for many years, although there has always been a risk of daytime hypoglycemia which would necessitate lowering the dose of sulfonylurea and, therefore, reducing the efficacy of the two drugs. Whereas metformin’s target is the liver and sulfonylurea’s is the beta cells in the pancreas, troglitazone improves insulin sensitivity by exerting its action directly on the muscles that are supposed to burn insulin. At the start of the Montreal study, the patients’ mean baseline measures for FPG was 232 mg/dl; their HbA1c was 9.7 percent and their mean daily dose of insulin was a relatively small 14.1 units. Over the course of the six-month trial, mean FPG declined by 43 mg/dl compared with a reduction of just 5 mg/dl in the group who received a placebo. Similarly, there was a statistically significant reduction in HbA1c of 1.3 percent versus 0.1 percent in the placebo group. Daily insulin dose the patients were taking declined by a modest 2.5 units, which was still statistically significant compared with the placebo group. There was also a notable decline in triglyceride levels of 26 mg/dl versus an increase of 41 percent in the placebo group. There were no significant differences in adverse events, including hepatotoxicity between the study group and the placebo groups. There were more hypoglycemic reactions reported in the troglitazone group, although according to the investigators, none required treatment as a result. A significant, though unreported percentage of patients in the triple therapy trial achieved American Diabetes Association goals for good glycemic control, said Dr. Yale
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