Efficacy and safety of mitiglinide in diabetic patients on maintenance hemodialysis.

Mitiglinide is a rapid- and short-acting insulinotropic sulfonylurea receptor ligand and features rapid hypoglycemic action. To date, no prospective study has evaluated the use of mitiglinide in diabetic patients receiving hemodialysis (HD). In this study we evaluated the efficacy and safety of mitiglinide in diabetic patients on HD. Following an 8-week baseline period, we enrolled a study population of poorly controlled diabetic HD patients who had mean hemoglobin (Hb)A(1c) levels greater than 6.5% at baseline and who were not receiving insulin injection therapy. Patients were administered mitiglinide, 15 mg for those who were younger than 70 years and 7.5 mg for those who were 70 years and older, daily with each meal for the first 8 weeks. Subsequently, the doses were titrated by dose-doubling to a maximum of 30 mg/day if no adverse effects appeared. The efficacy was determined by monitoring glycemic control (plasma glucose, HbA(1c), and glycated albumin levels). Safety and tolerance were determined by monitoring clinical and laboratory parameters during the 24-week study period. The average final dose of mitiglinide was 20.0 +/- 8.6 mg daily. Mitiglinide was effective in reducing not only HbA(1c) and glycated albumin but also fasting plasma glucose levels from baseline from week 4 after the start of treatment. The agent was also effective in reducing triglyceride levels. No serious adverse effects such as hypoglycemia or liver impairment were observed in any patient. However, we could not completely rule out the possibility of a hypoglycemic episode, including silent hypoglycemia due to autonomic neuropathy, and therefore further clinical studies are required. It is necessary to adjust the dose of mitiglinide according to the status of glycemic control or hypoglycemic symptoms of individual patients. Although mitiglinide was effective as a treatment for diabetic patients on HD therapy, it should be initiated at a lower dose in the HD population, compared with the general population of diabetic patients. Mitiglinide can be safely used for diabetic patients on HD, if careful attention is paid to hypoglycemia.