Biomedical Center, Edogawa-ku, Tokyo, Japan.
Endocr Res. 2010;35(3):118-27. doi: 10.3109/07435801003762164.
The aim of this study was to evaluate the efficacy of pioglitazone on metabolic parameters in drug-naïve Japanese type 2 diabetic patients with (Diabetes Mellitus Metabolic Syndrome [DMMS] group, n = 36) and without (Diabetes Mellitus non-Metabolic Sundrome [DMNMS] group, n = 36) metabolic syndrome.
The patients received monotherapy of 15-30 mg/day pioglitazone for 3 months. The baseline levels of metabolic parameters were compared with the levels after 3 months.
At baseline, the two groups showed no significant difference in HbA1c (10.05 vs. 9.81%, n.s.) or systolic blood pressure (134.5 vs. 133.0 mmHg, n.s.), but had significant differences in diastolic blood pressure (84.7 vs. 78.9 mmHg, p < 0.05), insulin (14.96 vs. 7.09 microU/mL, p < 0.001), homeostasis model assessment insulin resistance index (HOMA-R) (8.49 vs. 3.96, p < 0.001), triglyceride (TG) (231.4 vs. 131.5 mg/dL, p < 0.0005), high-density lipoprotein (HDL)-C (46.6 vs. 56.1 mg/dL, p < 0.005), body weight (BW) (77.97 vs. 62.52 kg, p < 0.001), and body mass index (BMI) (28.14 vs. 22.86, p < 0.00001). In the DMMS group, significant changes of HbA1c (from 10.05 to 8.01%, p < 0.00001), insulin (-22.7%, p < 0.05), HOMA-R (-48.9%, p < 0.0002), TG (-20.8 %, p < 0.05), HDL-C (+12.0%, p < 0.00001), BW (+1.0 kg/+1.3%, p < 0.05), and BMI (+1.4%, p < 0.02) were observed after 3 months. In the DMNMS group, the reduction of HbA1c (from 9.81 to 8.33%, p < 0.00001) was similar to that in the DMMS group, but the changes of insulin (-4.7%, n.s.), HOMA-R (-15.6%, n.s.), and TG (-12.9%, n.s.) were smaller and not significant. Significant increases of HDL-C (+9.2%, p < 0.02), BW (+0.64 kg/+1.0%, p < 0.05), and BMI (+1.0%, p < 0.02) were observed, but these changes were also smaller than the respective changes in the DMMS group. Based on the change of each parameter relative to its baseline value, significant intergroup differences were found for TG, insulin, or HOMA-R, whereas no such differences were observed for HDL-C, BW, and BMI. No subjects showed any clinically significant adverse events.
These results suggest that the glucose-lowering effect of pioglitazone is comparable in patients with type 2 diabetes with or without metabolic syndrome, but that the drug has different effects on nonglycemic parameters including TG, insulin and HOMA-R in the two groups of patients.
本研究旨在评估吡格列酮对伴有（糖尿病代谢综合征[DMMS]组，n=36）和不伴有（糖尿病非代谢综合征[DMNMS]组，n=36）代谢综合征的初治日本 2 型糖尿病患者代谢参数的疗效。
患者接受吡格列酮 15-30mg/天单药治疗 3 个月。比较基线代谢参数水平与治疗 3 个月后的水平。
两组患者在糖化血红蛋白（HbA1c）（10.05% vs. 9.81%，无统计学意义）或收缩压（134.5 vs. 133.0mmHg，无统计学意义）方面无显著差异，但在舒张压（84.7 vs. 78.9mmHg，p<0.05）、胰岛素（14.96 vs. 7.09μU/mL，p<0.001）、稳态模型评估胰岛素抵抗指数（HOMA-R）（8.49 vs. 3.96，p<0.001）、三酰甘油（TG）（231.4 vs. 131.5mg/dL，p<0.0005）、高密度脂蛋白（HDL）-C（46.6 vs. 56.1mg/dL，p<0.005）、体重（BW）（77.97 vs. 62.52kg，p<0.001）和体重指数（BMI）（28.14 vs. 22.86，p<0.00001）方面存在显著差异。在 DMMS 组中，HbA1c（从 10.05%降至 8.01%，p<0.00001）、胰岛素（-22.7%，p<0.05）、HOMA-R（-48.9%，p<0.0002）、TG（-20.8%，p<0.05）、HDL-C（+12.0%，p<0.00001）、BW（+1.0kg/+1.3%，p<0.05）和 BMI（+1.4%，p<0.02）均有显著变化。在 DMNMS 组中，HbA1c 降低（从 9.81%降至 8.33%，p<0.00001）与 DMMS 组相似，但胰岛素（-4.7%，无统计学意义）、HOMA-R（-15.6%，无统计学意义）和 TG（-12.9%，无统计学意义）的变化较小且无统计学意义。HDL-C（+9.2%，p<0.02）、BW（+0.64kg/+1.0%，p<0.05）和 BMI（+1.0%，p<0.02）均有显著增加，但这些变化也小于 DMMS 组的相应变化。基于每个参数相对于其基线值的变化，在 TG、胰岛素或 HOMA-R 方面发现了显著的组间差异，而在 HDL-C、BW 和 BMI 方面则没有发现这种差异。没有受试者出现任何临床显著的不良事件。
这些结果表明，吡格列酮对伴有或不伴有代谢综合征的 2 型糖尿病患者的降糖作用相当，但在两组患者中，该药对 TG、胰岛素和 HOMA-R 等非血糖参数的作用不同。
