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The Effect of Rosiglitazone on Poorly Controlled Diabetes in Patients Taking Three Oral Antidiabetic Agents

評估添加Rosiglitazone在已經服用三種類降血糖藥物仍血糖控制不良的病人之效價

摘要


背景/目的 此研究在探討添加rosiglitazone在已經服用包括α-glucosidase抑制劑(acarbose)和metformin及胰島素分泌刺激劑等三種類降血糖藥物,仍血糖控制不良的病人之效價。 方法 添加rosiglitazone每日4 mg在已經服用包括acarbose和metformin及胰島素分泌刺激劑等三種類降血糖藥物最大劑量仍血糖控制不良的病人12週,若病人的血糖在4週後仍未改善則增加rosiglitazone至每日8 mg,測量研究前後的空腹血糖值及糖化血色素以評估其效價,糖化血色素改善的情況較好的10位分成一組,另10位分成一組並比較兩組的差異。 結果 整體病人的血糖值及糖化血色素的變化並未達到統計學上有意義的改變,但若依糖化血色素改善的數值分成反應較好組及反應較差組,反應較好組共10人其糖化血色素從9.3±2.2%明顯降至8.1±1.4% (P=0.02),空腹血糖亦從214±36mg/dL降至186±37mg/dL(P=0.01),其中有4人(40%)的糖化血色素值下降超過1%,3人(30%)達到小於或等於7%,反應較差組的血糖值及糖化血色素的變化則未達到統計學上有意義的差異,兩組的基礎體重有明顯差異(53.7±8.8kg vs 71.8±11.8kg, p=0.004)兩組在血糖值(186±37mg/dL vs 238±49mg/dL, p=0.01)及糖化血色素(8.1±1.4% vs 9.8±1.7%, p=0.01)的變化上亦有明顯差異。 結論添加rosiglitazone在最近已經服用包括α-glucosidase抑制劑和metformin及胰島素分泌刺激劑等三種類降血糖藥物最大劑量仍血糖控制不良的病人在統計上並無法改善血糖控制,但體重相對較輕的部分病人的血糖可因此獲得改善。

並列摘要


Background/Purpose. To evaluate the effects of rosiglitazone in treating patients whose type 2 diabetes was poorly controlled with an α-glucosidase inhibitor (i.e., acarbose), a biquanide (i.e., metformin), and an insulin secretagogue. Methods. We studied 20 patients in whom type 2 diabetes was poorly controlled with the combination of acarbose, metformin, and an insulin secretagogue. Rosiglitazone (4 mg/day) was added to the treatment regimen for 12 weeks. The dosage of Rosiglitazone was increased to 8 mg/day in patients whose fasting plasma glucose (FPG) level remained >150 mg/dL during the first 4 weeks of the study. The hemoglobin A1c (HbA1c) and FPG levels were compared before and after starting rosiglitazone. Patients were stratified into two groups (a more-response group (n=10) and a less-response group (n=10)) medially based on changes in HbA1c-level. Differences in HbA1c and FPG levels before and after adding rosiglitazone were compared between the two groups. Results. There were no significant differences in mean FPG levels (222±44 mg/dL vs 211±50 mg/dL, p=0.12) and mean HbA1c-levels (9.3 1.8% vs 9.0 1.7%, p=0.32) before and after adding rosiglitazone, respectively, in the 20 patients. A significant decrease in HbA1c-levels (9.3 2.2% to 8.1 1.4% (p=0.02)) and FPG levels (214±36 mg/dL to 186±37 mg/dL (p=0.01)) was seen in the more-response group. After 12 weeks of administering rosiglitazone, the HbA1c level decreased by more than 1% in four patients (40%) and was lower than 7% in three patients (30%) in this group. Although HbA1c-levels (9.3±1.5% to 9.8±1.7% (p=0.06)) and FPG levels (231±51 mg/dL to 238±49 mg/dL (p=0.54) increased after adding rosiglitazone in the less-response group, the differences were not significant. There were no significant differences in baseline characteristics except for body weight between the two groups (53.7±8.8kg vs 71.8±11.8kg, p=0.004). At the end of the 12-week period, the mean HbA1c level differed significantly between the more-response group and the less-response group (8.1±1.4% vs 9.8±1.7%, p=0.01); the mean FPG level also differed between the two groups (186±37 mg/dL vs 238±49 mg/dL, p=0.01). Conclusion. Administration of rosiglitazone did not lead to a significant improvement in blood glucose levels. However, our results show that rosiglitazone can help improve glycemic control in some patients when it is added to a combination therapy of acarbose, metformin, and an insulin secretagogue. Baseline body weight is a parameter that can predict response to this oral antidiabetic agent.

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