Sitagliptin加入metformin及sulfonylureas合併使用於第二型糖尿病之療效與安全性評估

中文摘要【研究目的】本研究主要是評估sitagliptin (DPP-4 inhibitors) 加入原本已有服用降血糖藥物metformin及sulfonylureas治療之第二型糖尿病病人，探討其療效及安全性。【研究方法】本研究為回溯性研究，收錄2010年1月1日至2011年9月30日期間，併服metformin和sulfonylureas (glimepiride或gliclazide或glipizide)，再加入sitagliptin治療3至6個月之第二型糖尿病門診病人為研究對象。觀察加入sitagliptin治療前、後之糖化血色素(glycosylated hemoglobin; A1C)、空腹血糖值 (fasting plasma glucose; FPG) 和肝腎功能、血脂方面之變化來評估療效和安全性。【結果】研究對象共有201人納入。加入sitagliptin治療前平均年齡為57歲，A1C平均值為8.7 % (8.7 ± 1.52)，FPG平均值為176.52 mg/dL (176.52 ± 50.44)。加入sitagliptin治療3至6個月，整體A1C平均值顯著降低0.72 %，FPG平均值顯著降低22.60 mg/dL。年齡方面，＜50歲組及≧50歲組之A1C平均值各顯著下降0.58 %及0.74 %，＜65歲組及≧65歲組之A1C平均值各顯著下降0.67 %及0.87 %。性別方面，女性及男性之A1C平均值各顯著下降0.85 %及0.53 %。服用不同sulfonylureas的療效結果，使用glimepiride組及使用非glimepiride組 (gliclazide或glipizide) 之A1C平均值各顯著降低0.67 %及0.78 %。安全性方面，整體Scr (serum creatinine) 平均值在治療前後有顯著的下降；治療前後由1.06 mg/dL下降至1.03 mg/dL。Scr平均值在年齡＜50歲組 (－0.04 mg/dL)、≧50歲組 (－0.03 mg/dL) 及＜65歲組 (－0.03 mg/dL) 皆為有顯著的下降。Scr平均值在女性組 (－0.05 mg/dL) 有顯著下降，而男性組Scr平均值 (－0.02 mg/dL) 並無顯著下降。glimepiride組之Scr平均值 (－0.03 mg/dL) 有顯著的下降，非glimepiride組之Scr平均值 (－0.03 mg/dL) 則無顯著下降。整體GPT (glutamic pyruvic transaminase) 在治療後則有顯著上升 (＋3.49 IU/L)，在年齡、性別和sulfonylureas各分組，以≧50歲組 (＋4.93 IU/L)、＜65歲組 (＋4.22 IU/L) 和glimepiride組之GPT平均值 (＋5.16 IU/L) 有顯著上升。【結論】第二型糖尿病人使用metformin併服sulfonylureas (glimepiride或gliclazide或glipizide) 一段時間，之後加入sitagliptin治療3至6個月，確實可使A1C及FPG值下降。在安全性方面，加入sitagliptin治療，其Scr在治療後有顯著下降，尤其在女性特別顯著。GPT在治療後則顯著上升，故應注意GPT之情形。

關鍵字

第二型糖尿病； sitagliptin ； sulfonylureas ； metformin

並列摘要

Abstract 【Objective】 To assess the efficacy and safety of adding sitagliptin in type 2 diabetes mellitus (DM) patients who have been treated metformin and sulfonylureas. 【Methods】 The pharmacy prescription databases dating from January 1, 2010 to September 30, 2011 from a regional teaching hospital in southern Taiwan were used for this retrospective study. Specifically, patients with type 2 DM who have already taking metformin and sulfonylureas were recruited then added sitagliptin for 3 ~ 6 months to assess the safety and efficacy of this medication. The efficacy of sitagliptin was evaluated by a mean change in glycosylated hemoglobin (A1C) and fasting plasma glucose (FPG) levels from baseline at the start of the therapy to 3 ~ 6 months after addition of sitagliptin. Safety of this drug was assessed by including mean changes of the serum creatinine (Scr), total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), glutamic pyruvic transaminase (GPT) and glutamic Oxaloacetic Transaminase (GOP) at same treatment period. 【Results】 201 patients were included in this study and their mean of age was 57 years old. At baseline the mean A1C levels was 8.7 % (8.7 ± 1.52), mean FPG was 176.52 mg/dL (176.52 ± 50.44). After adding sitagliptin 3 ~ 6 months treatment period, the patients A1C and FPG were significantly reduced by 0.72 % and 22.60 mg/dL from the baseline value, respectively. For those patients in the ＜50 and those ≧50 years old groups, their A1C were significantly reduced by 0.58 % and 0.74 %, respectively. For those patients in the＜65 and ≧65 years old groups A1C were significantly reduced 0.67 % and 0.87 %, respectively. According to their gender, the female and male groups A1C were significantly reduced by 0.85 % and 0.53 %, respectively. With respect to different sulfonylureas used, the glimepiride and non-glimepiride groups A1C were significantly reduced 0.67 % and 0.78 %, respectively. With regard to drug safety, all patients’ Scr were significantly reduced. The mean baseline Scr level of 1.06 mg/dL was reduced to 1.03 mg/dL after treatment period. Mean Scr in the ＜50, ≧50 and ＜65 years old patient groups were both were significantly reduced by 0.04 mg/dL, 0.03 mg/dL and 0.03 mg/dL, respectively. Female group Scr was significantly reduced by 0.05 mg/dL, but male group Scr was only reduced 0.02 mg/dL which is not statistically significant. Glimepiride group Scr was significantly reduced by 0.03 mg/dL while even though the non-glimepiride group Scr was also reduced 0.03 mg/dL, but it was not statistically significant. With regarding to changes in GPT levels, all patient groups were significantly increased (＋3.49 IU/L). In assessment of age and different sulfonylureas used regarding their changes in GPT level, we found only those patients in the ≧50 years old, ＜65 years old and glimepiride groups GPT were significantly increased 4.93 IU/L, 4.22 IU/L and 5.16 IU/L, respectively. 【Conclusions】 After 3 ~ 6 months of treatment period for patients with type 2 DM, adding sitagliptin to their ongoing therapy with metformin plus sulfonylureas had led to significant improvements as evidenced by their A1C and FPG levels reduction. In safety, especially those patients in the female groups, their Scr have been significant reduction after treatment. All patients GPT were significantly increased, so their GPT levels must be closely watched.

並列關鍵字

type 2 diabetes mellitus ； sitagliptin ； sulfonylureas ； metformin

參考文獻

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Sitagliptin加入metformin及sulfonylureas合併使用於第二型糖尿病之療效與安全性評估

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