M Abe1, K Okada, F Kikuchi, K Matsumoto. 1. Division of Nephrology, Hypertension and Endocrinology, Department of Medicine, Nihon University School of Medicine, Itabashi-ku, Tokyo, Japan. mabe@med.nihon-u.ac.jp
Abstract
AIMS: Type 2 diabetes is characterized by a combination of insulin resistance, dyslipidemia, and increased blood pressure. In this study, we evaluated the clinical efficacy of pioglitazone in the treatment of diabetic patients with hypertension undergoing hemodialysis (HD). METHODS: An open-label, randomized study was performed using 40 subjects assigned to two groups: one group (pioglitazone group) was administered an add-on pioglitazone therapy (fixed dose, 30 mg) plus conventional oral antidiabetic agents, and the other group (control group) was administered conventional oral agents alone. The treatment efficacy was determined by monitoring the glycemic control and insulin resistance, which were assessed based on the homeostasis model assessment for insulin resistance (HOMA-IR). The safety of and tolerance to the drug were determined by monitoring clinical and laboratory parameters. RESULTS:Pioglitazone was effective in reducing the plasma glucose and hemoglobin A1c levels from the baseline values, beginning at 4 weeks of treatment. It was also effective in reducing the triglyceride levels. The HOMA-IR decreased significantly in the pioglitazone group, and this decrease was maintained until the last measurement, which was at 24 weeks. The systolic and diastolic blood pressure values were statistically lower in the pioglitazone group than in the control group. No serious adverse effects were observed in any of the patients. CONCLUSIONS:Pioglitazone is safe and effective for the treatment of Type 2-diabetic patients undergoing HD therapy. A daily dose of 30 mg pioglitazone is sufficient for treating HD patients, regardless of whether or not they are obese. Furthermore, pioglitazone reduced the systolic and diastolic blood pressure in our patients, and this effect requires further investigation.
RCT Entities:
AIMS: Type 2 diabetes is characterized by a combination of insulin resistance, dyslipidemia, and increased blood pressure. In this study, we evaluated the clinical efficacy of pioglitazone in the treatment of diabeticpatients with hypertension undergoing hemodialysis (HD). METHODS: An open-label, randomized study was performed using 40 subjects assigned to two groups: one group (pioglitazone group) was administered an add-on pioglitazone therapy (fixed dose, 30 mg) plus conventional oral antidiabetic agents, and the other group (control group) was administered conventional oral agents alone. The treatment efficacy was determined by monitoring the glycemic control and insulin resistance, which were assessed based on the homeostasis model assessment for insulin resistance (HOMA-IR). The safety of and tolerance to the drug were determined by monitoring clinical and laboratory parameters. RESULTS:Pioglitazone was effective in reducing the plasma glucose and hemoglobin A1c levels from the baseline values, beginning at 4 weeks of treatment. It was also effective in reducing the triglyceride levels. The HOMA-IR decreased significantly in the pioglitazone group, and this decrease was maintained until the last measurement, which was at 24 weeks. The systolic and diastolic blood pressure values were statistically lower in the pioglitazone group than in the control group. No serious adverse effects were observed in any of the patients. CONCLUSIONS:Pioglitazone is safe and effective for the treatment of Type 2-diabeticpatients undergoing HD therapy. A daily dose of 30 mg pioglitazone is sufficient for treating HDpatients, regardless of whether or not they are obese. Furthermore, pioglitazone reduced the systolic and diastolic blood pressure in our patients, and this effect requires further investigation.
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