Jovanovic Lois, Hassman David R, Gooch Brent, Jain Rajeev, Greco Susan, Khutoryansky Naum, Hale Paula M
Sansum Medical Research Institute, 2219 Bath Street, Santa Barbara, CA 93105, USA.
Diabetes Res Clin Pract. 2004 Feb;63(2):127-34. doi: 10.1016/j.diabres.2003.09.004.
The efficacy and safety of combination therapy (repaglinide plus pioglitazone) was compared to repaglinide or pioglitazone in 24-week treatment of type 2 diabetes. This randomized, multicenter, open-label, parallel-group study enrolled 246 adults (age 24-85) who had shown inadequate response in previous sulfonylurea or metformin monotherapy (HbA(1c) > 7%). Prior therapy was withdrawn for 2 weeks, followed by randomization to repaglinide, pioglitazone, or repaglinide/pioglitazone. In the first 12 weeks of treatment, repaglinide doses were optimized, followed by 12 weeks of maintenance therapy. Pioglitazone dosage was fixed at 30 mg per day. Baseline HbA(1c) values were comparable (9.0% for repaglinide, 9.1% for pioglitazone, 9.3% for combination). Mean changes in HbA(1c) values at the end of treatment were -1.76% for repaglinide/pioglitazone, -0.18% for repaglinide, +0.32% for pioglitazone. Fasting plasma glucose reductions were -82 mg/dl for combination therapy, -34 mg/dl for repaglinide, -18 mg/dl for pioglitazone. Minor hypoglycemia occurred in 5% of patients for the combination, 8% for repaglinide, and 3% for pioglitazone. Weight gains for combination therapy were correlated to individual HbA(1c) reductions. In summary, for patients who had previously failed oral antidiabetic monotherapy, the combination repaglinide/pioglitazone had acceptable safety, with greater reductions of glycemic parameters than therapy using either agent alone.
在2型糖尿病的24周治疗中，比较了联合治疗（瑞格列奈加吡格列酮）与瑞格列奈或吡格列酮的疗效和安全性。这项随机、多中心、开放标签、平行组研究纳入了246名成年人（年龄24 - 85岁），这些人在先前的磺脲类药物或二甲双胍单药治疗中反应不佳（糖化血红蛋白>7%）。先前的治疗停药2周，然后随机分为瑞格列奈组、吡格列酮组或瑞格列奈/吡格列酮组。在治疗的前12周优化瑞格列奈剂量，随后进行12周的维持治疗。吡格列酮剂量固定为每日30毫克。基线糖化血红蛋白值相当（瑞格列奈组为9.0%，吡格列酮组为9.1%，联合治疗组为9.3%）。治疗结束时糖化血红蛋白值的平均变化为：瑞格列奈/吡格列酮组为 -1.76%，瑞格列奈组为 -0.18%，吡格列酮组为 +0.32%。联合治疗组空腹血糖降低82毫克/分升，瑞格列奈组降低34毫克/分升，吡格列酮组降低18毫克/分升。联合治疗组5%的患者发生轻度低血糖，瑞格列奈组为8%，吡格列酮组为3%。联合治疗组的体重增加与个体糖化血红蛋白降低相关。总之，对于先前口服抗糖尿病单药治疗失败的患者，瑞格列奈/吡格列酮联合治疗具有可接受的安全性，与单独使用任一药物相比，血糖参数降低幅度更大。
