直近一年間の累計
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ID 115096
著者
Tanaka, Atsushi Saga University
Hisauchi, Itaru Dokkyo Medical University
Taguchi, Isao Dokkyo Medical University
Sezai, Akira Nihon University
Toyoda, Shigeru Dokkyo Medical University
Tomiyama, Hirofumi Tokyo Medical University
Ueda, Shinichiro University of the Ryukyus
Oyama, Jun-ichi Saga University
Kitakaze, Masafumi National Cerebral and Cardiovascular Center
Murohara, Toyoaki Nagoya University
Node, Koichi Saga University
キーワード
Type 2 diabetes
Heart failure
SGLT2 inhibitor
NT-proBNP
Non-inferiority
Glimepiride
資料タイプ
学術雑誌論文
抄録
Aims
Little is known about the impact of sodium glucose co‐transporter 2 (SGLT2) inhibitors on cardiac biomarkers, such as natriuretic peptides, in type 2 diabetes (T2D) patients with concomitant chronic heart failure (CHF). We compared the effect of canagliflozin with glimepiride, based on changes in N‐terminal pro‐brain natriuretic peptide (NT‐proBNP), in that patient population.
Methods and results
Patients with T2D and stable CHF, randomized to receive canagliflozin 100 mg or glimepiride (starting‐dose: 0.5 mg), were examined using the primary endpoint of non‐inferiority of canagliflozin vs. glimepiride, defined as a margin of 1.1 in the upper limit of the two‐sided 95% confidence interval (CI) for the group ratio of percentage change in NT‐proBNP at 24 weeks. Data analysis of 233 patients showed mean left ventricular ejection fraction (LVEF) at randomization was 57.6 ± 14.6%, with 71% of patients having a preserved LVEF (≥50%). Ratio of NT‐proBNP percentage change was 0.48 (95% CI, −0.13 to 1.59, P = 0.226) and therefore did not meet the prespecified non‐inferiority margin. However, NT‐proBNP levels did show a non‐significant trend lower in the canagliflozin group [adjusted group difference; −74.7 pg/mL (95% CI, −159.3 to 10.9), P = 0.087] and also in the subgroup with preserved LVEF [−58.3 (95% CI, −127.6 to 11.0, P = 0.098]).
Conclusions
This study did not meet the predefined primary endpoint of changes in NT‐proBNP levels, with 24 weeks of treatment with canagliflozin vs. glimepiride. Further research is warranted to determine whether patients with heart failure with preserved ejection fraction, regardless of diabetes status, could potentially benefit from treatment with SGLT2 inhibitors.
掲載誌名
ESC Heart Failure
ISSN
20555822
出版者
The Heart Failure Association of the European Society of Cardiology|Wiley
7
4
開始ページ
1585
終了ページ
1594
発行日
2020-04-29
権利情報
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License(https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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出版社版DOI
出版社版URL
フルテキストファイル
言語
eng
著者版フラグ
出版社版
部局
医学系