PubMed日本語 - 2型糖尿病のジペプチジル・ペプチダーゼ-4抑制薬の効能と安全性:展望研究。―QLifePro医療翻訳医療翻訳 QLifePro



Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis.

Published date 2012 Nov 7

Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis.


Published date



Haesuk Park, Chanhyun Park, Yoona Kim, Karen L Rascati


Health Outcomes and Pharmacy Practice Division, College of Pharmacy, The University of Texas, Austin, TX, USA.


BACKGROUND: An up-to-date assessment of dipeptidyl peptidase-4 (DPP-4) inhibitors is needed to include newly available data.


OBJECTIVE: To assess the efficacy and safety of DPP-4 inhibitors, including sitagliptin, saxagliptin, vildagliptin, and linagliptin, in type 2 diabetes.


METHODS: We conducted a search of MEDLINE for randomized controlled trials (RCTs) of DPP-4 inhibitors in type 2 diabetes through November 2011, using the key terms sitagliptin, saxagliptin, vildagliptin, and linagliptin. We also searched for completed, but unpublished, trials at relevant web sites. RCTs were selected for meta-analysis if they (1) compared DPP-4 inhibitors with placebo or an antihyperglycemic agent; (2) had study duration of 12 or more weeks; (3) had 1 or more baseline and posttreatment efficacy and/or safety outcome; and (4) were published in English.


RESULTS: In 62 evaluated articles, DPP-4 inhibitors lowered hemoglobin A(1c) (A1C) significantly more than placebo (weighted mean difference [WMD] -0.76%; 95% CI -0.83 to -0.68); however, heterogeneity was substantial (I(2) = 82%). Exclusion of Japanese trials (n = 7) resulted in a reduction of heterogeneity (I(2) = 59%). In the non-Japanese RCTs (n = 55), DPP-4 inhibitors were associated with a reduction in A1C (WMD -0.65%; 95% CI -0.71 to -0.60) but higher risk of hypoglycemia (odds ratio [OR] 1.30; 95% CI 1.00 to 1.68) compared to placebo. The 7 Japanese-specific RCTs showed a greater reduction in A1C (WMD -1.67%; 95% CI -1.89 to -1.44) and a nonsignificant increase in risk of hypoglycemia (OR 1.41; 95% CI 0.51 to 3.88) with DPP-4 inhibitors versus placebo. When comparing DPP-4 inhibitors to active comparators, the I(2) was still high after deleting Japanese studies. In these 17 active comparator trials, there was no significant difference in A1C reduction (WMD 0.04%; 95% CI -0.09 to 0.16) or risk of hypoglycemia (OR 0.60; 95% CI 0.22 to 1.61) for DPP-4 inhibitors compared to other antihyperglycemics. There were similar odds of any or serious adverse events with DPP-4 inhibitors compared to placebo, but a decreased risk compared to other antihyperglycemics.


CONCLUSIONS: DPP-4 inhibitors were associated with a reduction in A1C with comparable safety profiles compared to placebo, but no significant difference in A1C compared to other hyperglycemics. Differences in efficacy and safety were observed between Japanese and non-Japanese patients.




RCTは、展望研究もしものために選択された彼ら(1)プラセボまたは抗高血糖薬剤を使った比較されたDPP-4抑制薬; (2) 12週以上の研究長さを持った; (3) 1つ以上のベースラインおよび治療後有効性および/または安全結果があった;そして、(4)英語で発表された。

結果62の評価された論文では、DPP-4抑制薬は、プラセボ(加重平均差[WMD]-0.76%; 95%CI-0.83~-0.68)より有意に、ヘモグロビンA(1c)(A1C)を降ろした;しかしながら、異質性は相当だった(= 82%私(2))。
日本の試験(n = 7)の除外は、異質性(= 59%私(2))の減少に帰着した。
非日本のRCT(n = 55)では、DPP-4抑制薬はA1C(WMD-0.65%; 95%CI-0.71~-0.60)の減少と関係していたが、プラセボと比較した低血糖(オッズ比[OR]1.30; 95%CI 1.00~1.68)でより危険性が高かった。
7件の日本人に特有のRCTは、A1C(WMD-1.67%; 95%CI-1.89~-1.44)のより大きな減少とDPP-4抑制薬対プラセボによる低血糖(OR 1.41; 95%CI 0.51~3.88)のリスクの有意でない増加を示した。
これらの17件の活発なコンパラトール試験では、有意差が他のantihyperglycemicsと比較してDPP-4抑制薬のためにA1C減少(WMD 0.04%; 95%CI-0.09~0.16)または低血糖(OR 0.60; 95%CI 0.22~1.61)のリスクになかった。


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