Mehta Anita, Shah Urmil, Parikh Keyur, Chag Milan, Baxi Hemang, Chandarana Anish, Naik Ajay, Naik Asha, Shah Kanan, Goyal Ramesh
Lallubhai Motilal College of Pharmacy, Navarangpura, Ahmedabad, GJ 380009, India.
Can J Physiol Pharmacol. 2007 Jun;85(6):628-33. doi: 10.1139/y07-043.
The objective of the study was to demonstrate the effect of pioglitazone and pioglitazone in combination with statin on East Indian patients with hyperinsulinemia and hyperlipidemia. It was a randomized, placebo-controlled, double-blind study with a parallel-group design comprising 83 patients. Patients of either sex with cardiac complications, including hyperlipidemia and (or) diabetes mellitus with or without hyperinsulinemia, were enrolled. Patients over 70 years of age, with renal or hepatic failure, or with severe diabetes mellitus (total glucose >400 mg/dL) were excluded from the study. Enrolled patients were randomly assigned to 4 groups that received placebo, pioglitazone, atorvastatin, or both. Blood samples were collected before and after treatment for analysis of serum glucose, insulin, lipid profile, apolipoprotein (apo) A1, apo B, and fibrinogen. Data were compared with that of patients with normal insulin or hyperinsulinemia. The patients with hyperinsulinemia receiving only pioglitazone showed a significant decrease in insulin levels compared with those with normal insulin levels. These patients also showed a significant increase in HDL levels. However, no significant change was observed in patients treated with both atorvastatin and pioglitazone. Pioglitazone was also found to increase significantly the apo A1 levels in patients with hyperinsulinemia, but there was no significant increase in patients given both atorvastatin and pioglitazone. Our data suggests that pioglitazone should be given preferably to the patients with hyperinsulinemia and statin should not be coadministered.
该研究的目的是证明吡格列酮以及吡格列酮与他汀类药物联合使用对患有高胰岛素血症和高脂血症的东印度患者的影响。这是一项随机、安慰剂对照、双盲研究，采用平行组设计，共有83名患者。纳入了患有心脏并发症的男女患者，包括高脂血症和（或）糖尿病，伴有或不伴有高胰岛素血症。70岁以上、患有肾衰竭或肝功能衰竭、或患有严重糖尿病（总血糖>400mg/dL）的患者被排除在研究之外。纳入的患者被随机分为4组，分别接受安慰剂、吡格列酮、阿托伐他汀或两者。在治疗前后采集血样，以分析血清葡萄糖、胰岛素、血脂谱、载脂蛋白（apo）A1、apo B和纤维蛋白原。将数据与胰岛素正常或高胰岛素血症患者的数据进行比较。与胰岛素水平正常的患者相比，仅接受吡格列酮治疗的高胰岛素血症患者的胰岛素水平显著降低。这些患者的高密度脂蛋白水平也显著升高。然而，同时接受阿托伐他汀和吡格列酮治疗的患者未观察到显著变化。还发现吡格列酮可显著提高高胰岛素血症患者的apo A1水平，但同时接受阿托伐他汀和吡格列酮治疗的患者没有显著升高。我们的数据表明，吡格列酮应优先给予高胰岛素血症患者，不应同时给予他汀类药物。
