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转换为低剂量瑞舒伐他汀(5毫克/天)对日本2型糖尿病合并血脂异常患者糖代谢及血脂谱的影响:一项单臂、前瞻性干预试验。

Effects of switching to low-dose rosuvastatin (5 mg/day) on glucose metabolism and lipid profiles in Japanese patients with type 2 diabetes and dyslipidemia: a single-arm, prospective, interventional trial.

作者信息

Kameda Akiko, Nakamura Akinobu, Kondo Yoshinobu, Kimura Mari, Terauchi Yasuo

机构信息

1Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan.

Division of Endocrinology and Metabolism, Fujisawa Shounandai Hospital, 2345 Takakura, Fujisawa, 252-0802 Japan.

出版信息

Diabetol Int. 2017 Jul 5;8(4):383-391. doi: 10.1007/s13340-017-0328-9. eCollection 2017 Nov.

Abstract

AIMS

We investigated the effects of switching from other statins, such as pravastatin (5 or 10 mg/day), rosuvastatin (2.5 mg/day), or pitavastatin (1 or 2 mg/day), to low-dose rosuvastatin (5 mg/day) on glucose metabolism and lipid profiles in Japanese patients with type 2 diabetes and dyslipidemia.

METHODS

This was a prospective, two-center, open-label, single-arm, interventional trial. Several clinical parameters were analyzed at baseline and 24 weeks after switching from other statins to rosuvastatin at 5 mg/day. The primary endpoints were changes in hemoglobin (Hb) A1c level and lipid profile.

RESULTS

Forty-five patients were enrolled in the trial. The mean HbA1c level increased significantly from 7.1 ± 0.7 to 7.5 ± 0.9% ( < 0.001), whereas the mean low-density lipoprotein cholesterol (LDL-C) level decreased significantly from 108.9 ± 16.5 to 91.6 ± 24.5 mg/dL ( < 0.001). Multiple linear regression analysis showed that changes in HbA1c levels were significantly and positively correlated with fasting plasma glucose (FPG) levels at baseline. Receiver operating characteristic (ROC) curve analysis examining the relationship between HbA1c and FPG showed that FPG was a significant predictor of changes in HbA1c levels (area under the curve, 0.72). The cutoff FPG value of 168 mg/dL had a sensitivity of 47% and a specificity of 93%.

CONCLUSIONS

Switching to a low dose of rosuvastatin impaired glucose metabolism in Japanese patients with type 2 diabetes and dyslipidemia. Patients with high FPG levels were particularly prone to an exacerbation of glucose metabolism.

摘要

目的

我们研究了从其他他汀类药物,如普伐他汀(5或10毫克/天)、瑞舒伐他汀(2.5毫克/天)或匹伐他汀(1或2毫克/天)换用低剂量瑞舒伐他汀(5毫克/天)对日本2型糖尿病和血脂异常患者糖代谢及血脂谱的影响。

方法

这是一项前瞻性、两中心、开放标签、单臂干预试验。在基线时以及从其他他汀类药物换用5毫克/天瑞舒伐他汀24周后,对多个临床参数进行了分析。主要终点是糖化血红蛋白(Hb)A1c水平和血脂谱的变化。

结果

45名患者纳入该试验。平均HbA1c水平从7.1±0.7显著升至7.5±0.9%(<0.001),而平均低密度脂蛋白胆固醇(LDL-C)水平从108.9±16.5显著降至91.6±24.5毫克/分升(<0.001)。多元线性回归分析显示,HbA1c水平的变化与基线时的空腹血糖(FPG)水平显著正相关。检验HbA1c与FPG之间关系的受试者工作特征(ROC)曲线分析表明,FPG是HbA1c水平变化的显著预测指标(曲线下面积,0.72)。FPG值为168毫克/分升时,敏感性为47%,特异性为93%。

结论

换用低剂量瑞舒伐他汀会损害日本2型糖尿病和血脂异常患者的糖代谢。FPG水平高的患者尤其容易出现糖代谢恶化。

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