Department of Metabolism and Endocrinology Tokyo University of Science Tokyo Japan ; Center for Molecular Diabetology Tokyo University of Science Tokyo Japan.
Department of Metabolism and Endocrinology Tokyo University of Science Tokyo Japan.
J Diabetes Investig. 2013 May 6;4(3):297-303. doi: 10.1111/jdi.12032. Epub 2013 Feb 13.
AIMS/INTRODUCTION: The distinct effects of different statins on glycemic control have not been fully evaluated. In this open-label, prospective, cross-over clinical trial, we compared the effects of pitavastatin and atorvastatin on glycemic control in type 2 diabetic patients with hypercholesterolemia.
A total of 28 Japanese type 2 diabetics with hypercholesterolemia treated with rosuvastatin (2.5 mg/day) for at least 8 weeks were recruited to this quasi-randomized cross-over study. At study entry, the patients assigned to sequence 1 received pitavastatin (2 mg/day) for 12 weeks in period 1 and atorvastatin (10 mg/day) for another 12 weeks in period 2, whereas patients assigned to sequence 2 received atorvastatin (10 mg/day) for 12 weeks in period 1 and pitavastatin (2 mg/day) for another 12 weeks in period 2. Blood samples were collected at three visits (baseline, after 12 and 24 weeks).
Lipid control was similar in both statins. The difference in glycated hemoglobin between pitavastatin and atorvastatin treatments was -0.18 (95% confidence interval -0.34 to -0.02; P = 0.03). Compared with atorvastatin, pitavastatin treatment significantly lowered the levels of glycoalbumin, fasting glucose and homeostasis model assessment of insulin resistance.
Our results showed that treatment with pitavastatin had a more favorable outcome on glycemic control in patients with type 2 diabetes compared with atorvastatin. This trial was registered with UMIN (no. 000003554).
目的/引言:不同他汀类药物对血糖控制的影响尚未得到充分评估。在这项开放标签、前瞻性、交叉临床试验中,我们比较了匹伐他汀和阿托伐他汀对伴有高胆固醇血症的 2 型糖尿病患者血糖控制的影响。
共招募了 28 名日本 2 型糖尿病伴高胆固醇血症患者,他们在至少 8 周内接受瑞舒伐他汀(2.5mg/天)治疗,将这些患者纳入这一准随机交叉研究。在研究开始时,按照顺序 1 分配的患者在第 1 期接受匹伐他汀(2mg/天)治疗 12 周,在第 2 期接受阿托伐他汀(10mg/天)治疗 12 周,而按照顺序 2 分配的患者在第 1 期接受阿托伐他汀(10mg/天)治疗 12 周,在第 2 期接受匹伐他汀(2mg/天)治疗 12 周。在 3 次就诊时(基线、12 周和 24 周)采集血样。
两种他汀类药物的血脂控制相似。与阿托伐他汀治疗相比,匹伐他汀治疗在糖化血红蛋白方面的差异为-0.18(95%置信区间-0.34 至-0.02;P=0.03)。与阿托伐他汀相比,匹伐他汀治疗显著降低了糖化白蛋白、空腹血糖和稳态模型评估的胰岛素抵抗水平。
我们的结果表明,与阿托伐他汀相比,匹伐他汀治疗在 2 型糖尿病患者中对血糖控制有更有利的结果。这项试验已在 UMIN 注册(编号 000003554)。