Reynolds L Raymond, Kingsley Felicia J, Karounos Dennis G, Tannock Lisa R
Lexington Veterans Administration Medical Center, University of Kentucky College of Medicine, Department of Internal Medicine, Lexington, KY, United States.
Diabetes Res Clin Pract. 2007 Aug;77(2):180-7. doi: 10.1016/j.diabres.2006.12.011. Epub 2007 Jan 18.
Type 2 diabetes remains a difficult clinical challenge characterized by progressive insulin deficiency and frequent cardiovascular events requiring multiple therapeutic decisions. In this randomized clinical trial, we assessed the comparative effects of rosiglitazone (RSG) and insulin glargine (IG) on inflammatory biomarkers, glycemic control, and lipids. Forty subjects with type 2 diabetes and inadequate glycemic control on sulfonylurea and metformin therapy received 24 weeks of add-on therapy with either RSG 4mg daily or IG 10 units daily. Subjects on RSG with fasting glucose values >120mg/dl at 12 weeks were increased from 4 to 8mg. Subjects on IG increased insulin doses until fasting glucose was <120mg/dl. Markers of glycemic control and inflammation including HbA1c, hsCRP, PAI-1, plasma F2-isoprostanes, and lipids were measured at baseline, 12, 18, and 24 weeks. RSG and IG demonstrated similar efficacy in reducing HbA1c levels by 1.5 and 1.4%, respectively, with greater weight gain with RSG. Hypoglycemic events occurred with equal frequency. IG did not reduce hsCRP, but RSG reduced hsCRP levels 45% from baseline. Both IG and RSG reduced F2-isoprostanes similarly. IG did not affect PAI-1 levels, but did reduce total, LDL, and non-HDL cholesterol levels. Despite similar HbA1c reductions with RSG and IG, differential effects were found on inflammatory biomarkers and lipids that deserve consideration in the clinical decision process of selecting a therapeutic agent.
2型糖尿病仍然是一项艰巨的临床挑战，其特征为进行性胰岛素缺乏以及频繁发生的心血管事件，这需要做出多种治疗决策。在这项随机临床试验中，我们评估了罗格列酮（RSG）和甘精胰岛素（IG）对炎症生物标志物、血糖控制和血脂的比较效果。40例接受磺脲类药物和二甲双胍治疗但血糖控制不佳的2型糖尿病患者接受了为期24周的附加治疗，分别为每日服用4mg RSG或每日注射10单位IG。接受RSG治疗且在12周时空腹血糖值>120mg/dl的患者，其剂量从4mg增加至8mg。接受IG治疗的患者增加胰岛素剂量，直至空腹血糖<120mg/dl。在基线、12周、18周和24周时测量血糖控制和炎症的标志物，包括糖化血红蛋白（HbA1c）、高敏C反应蛋白（hsCRP）、纤溶酶原激活物抑制剂1（PAI-1）、血浆F2-异前列腺素和血脂。RSG和IG在降低HbA1c水平方面显示出相似的疗效，分别降低了1.5%和1.4%，但RSG组体重增加更多。低血糖事件发生频率相同。IG未降低hsCRP，但RSG使hsCRP水平较基线降低了45%。IG和RSG对F2-异前列腺素的降低作用相似。IG不影响PAI-1水平，但降低了总胆固醇、低密度脂蛋白胆固醇和非高密度脂蛋白胆固醇水平。尽管RSG和IG降低HbA1c的效果相似，但在炎症生物标志物和血脂方面发现了不同的作用，这在选择治疗药物的临床决策过程中值得考虑。
