台灣第二型糖尿病患使用Dipeptidyl Peptidase-4 Inhibitors之效益預測因子分析

Abstract

背景與目的：Dipeptidyl Peptidase-4 (DPP-4) inhibitors是十五年來最受歡迎的口服降血糖藥物。它主要是靠抑制DPP-4這個胜肽酶，去提升內生性腸泌素，進而使胰島素增加分泌及減少昇糖素的分泌，達成降低血糖的效果。使用此藥物其低血糖的風險較低、降糖化血紅素的效果中等(下降ΔHbA1c: 0.5-0.9%)、對體重不太會有改變、方便使用(大多是一天一顆)、及很少有嚴重的副作用。在台灣目前還不清楚何種類的患者使用DPP-4 Inhibitors會受益。本研究的目的想要分析台灣第二型糖尿病患初次使用DPP-4 Inhibitors之效益預測因子。 方法：本研究為回溯觀察性研究，收錄193位(122為男性)第二型糖尿病患初次使用DPP-4 Inhibitors，其平均年齡58.0 ± 12.6歲，患病時間5.4 ± 4.7年，身體質量指數26.1 ± 4.3 kg/m2，預測腎絲球過濾率95.9 ± 27.0 mL/min/1.73M2，觀察其使用後六個月的HbA1c的變化。 結果：這193位使用者大都是將DPP-4 Inhibitors放在第二或第三線的治療 (平均使用2.8 ± 0.7種口服降糖藥)、其平均基準HbA1c: 8.4 ± 1.4%，經過六個月的使用後，平均下降HbA1c 1.1 ± 1.2% (P <0.01)。統計分析下，基準HbA1c較高的組群有較顯著的HbA1c下降效果(ΔHbA1c ≥0.5%)。簡單線性回歸分析發現六個月治療後HbA1c的改變與患者的基準HbA1c呈正相關(R = 0.71, P <0.001)。多元線性回歸分析發現較高基準HbA1c level、較低身體質量指數、較短糖尿病患病時間、使用較少種類的口服降糖藥是降低HbA1c的貢獻因子。 結論：本研究發現較高基準HbA1c level、較低身體質量指數、較短糖尿病患病時間、較少使用口服降糖藥是台灣第二型糖尿病患使用DPP-4 Inhibitors效益預測因子，尤其是基準HbA1c level在有效療效(ΔHbA1c ≥0.5%)中起著最重要的作用。

Background/purpose: Dipeptidyl peptidase-4 (DPP-4) inhibitors are the most popular oral antidiabetic drugs (OADs) in recent 15 years because of lower risk of hypoglycemia, intermediate efficacy to lower glycated hemoglobin (ΔHbA1c): 0.5-0.9%, neutral effect on body weight change, convenience for usage (mostly once daily), and rare occurrence of major side effects. It had not been established which patients would benefit from the treatment of DPP-4 inhibitors in Taiwan. The purpose of this study was to investigate the predictors of the efficacy of naïve use of DPP-4 inhibitors in Taiwanese patients with type 2 diabetes mellitus (T2D). Methods: A retrospective observational study was conducted. Of the T2D patients, 193 (122 men) naïve DPP-4 inhibitor users with an age of 58.0 ± 12.6 years, disease duration of 5.4 ± 4.7 years, body mass index (BMI) of 26.1 ± 4.3 kg/m2, and estimated glomerular filtration rate of 95.9 ± 27.0 mL/min/1.73M2 were assessed for change of HbA1c in 6 months. Results: After 6 months of DPP-4 inhibitors use, mostly as second- or third-line of oral antidiabetic drugs (2.8 ± 0.7 kinds of OADs), 193 T2D patients (mean baseline HbA1c: 8.4 ± 1.4%) had reduction of HbA1c 1.1 ± 1.2% on average (P <0.01). The group with a higher baseline HbA1c level had better efficacy (defined asΔHbA1c ≥0.5%) in lowering HbA1c. Single regression analysis showed that the change in HbA1c after 6 months of treatment was positively associated with the baseline HbA1c level (R = 0.71, P <0.001). In addition, multiple regression analysis showed that the contributors to reduction of HbA1c level after 6 months were higher baseline HbA1c level, lower BMI, shorter T2D duration, and use of fewer kinds of OADs. Conclusion: Our study suggested that higher baseline HbA1c level, lower BMI, shorter T2D duration, and use of fewer kinds of OADs were the predictors of the efficacy of DPP-4 inhibitors in Taiwanese patients with T2D. The baseline HbA1c level, in particular, played the most important role in predicting efficacy (ΔHbA1c ≥0.5% at 6 months).