Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study
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초록

We investigated the efficacy and safety of pioglitazone compared to dapagliflozin when added to metformin plus alogliptin for patients with type 2 diabetes. The patients (n = 133) were randomized to receive pioglitazone (n = 65) or dapagliflozin (n = 68) in addition to metformin and alogliptin therapy for 26 weeks. The primary endpoint was a change in HbA1c. The non-inferiority margin for HbA1c reduction was 0.4%. The adjusted mean change of HbA1c at week 26 was - 0.75% with pioglitazone and - 0.88% with dapagliflozin (mean difference: 0.12% [95% CI - 0.09 to 0.34]). The adjusted mean change of HOMA-IR at week 26 was - 1.55 with pioglitazone and - 1.96 with dapagliflozin (mean difference: 0.41 [95% CI - 0.01 to 0.83]). Lipid profiles were similar between the groups. The proportion of patients achieving HbA1c < 6.5% was similar between groups. Pioglitazone added to metformin and alogliptin significantly improved glycemic control in patients with type 2 diabetes, and was non-inferior to dapagliflozin. This study suggests that pioglitazone could be an effective and safe option for patients with inadequate glycemic control on metformin and DPP4i.

키워드

Dipeptidyl-peptidase IV inhibitorsDrug therapyCombinationSodium-glucose transporter 2 inhibitorsThiazolidinedionesTYPE-2THIAZOLIDINEDIONESROSIGLITAZONEGLICLAZIDERESISTANCEEVENTSTRIAL
제목
Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study
저자
Kim, KyuhoKo, Seung-HyunYun, Jae-SeungLee, Kwan-WooKim, Eun SookJeong, In-KyungKim, Jae HyeonKim, Sang YongWon, Kyu ChangKim, MikyungCha, Bong-SooKim, SungraeChoi, Sung HeeRhee, Eun-JungKim, Sin GonKim, Bo HyunPark, Kang SeoJu, Young-CheolHeo, Tae-WonAhn, Yu-Bae
DOI
10.1038/s41598-025-30882-w
발행일
2025-12-11
유형
Article
저널명
Scientific Reports
16
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