| Item type |
文献 / Documents(1) |
| 公開日 |
2020-11-26 |
| アクセス権 |
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|
アクセス権 |
open access |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1186/s12933-016-0381-x |
|
|
言語 |
ja |
|
|
関連名称 |
10.1186/s12933-016-0381-x |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
Rationale and design of a randomized trial to test the safety and non‑inferiority of canagliflozin in patients with diabetes with chronic heart failure : the CANDLE trial |
|
言語 |
en |
| 著者 |
タナカ, アツシ
イノウエ, テルオ
キタカゼ, マサフミ
オヤマ, ジュンイチ
佐田, 政隆
タグチ, イサオ
シミズ, ワタル
ワタダ, ヒロタカ
トミヤマ, ヒロフミ
アコ, ジュンヤ
サカタ, ヤスシ
アンザイ, トシヒサ
ウエマツ, マサアキ
スズキ, マコト
エグチ, カズオ
ヤマシナ, アキラ
サイトウ, ヨシヒコ
サトウ, ヤスノリ
ウエダ, シンイチロウ
ムロハラ, トヨアキ
ノデ, コウイチ
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Background: Because type 2 diabetes mellitus is associated strongly with an increased risk of cardiovascular diseases, the number of patients with diabetes with chronic heart failure is increasing steadily. However, clinical evidence of therapeutic strategies in such patients is still lacking. A recent randomized, placebo-controlled trial in patients with type 2 diabetes with high cardiovascular risk demonstrated that the SGLT2 inhibitor, empagliflozin, reduced the incidence of hospitalization for heart failure. Because SGLT2 inhibitors cause a reduction in body weight and blood pressure in addition to improving glycemic control, they have the potential to exert beneficial effects on the clinical pathophysiology of heart failure. The aim of the ongoing CANDLE trial is to test the safety and non-inferiority of canagliflozin, another SGLT2 inhibitor, compared with glimepiride, a sulfonylurea agent, in patients with type 2 diabetes mellitus and chronic heart failure.
Methods: A total of 250 patients with type 2 diabetes who are drug-naïve or taking any anti-diabetic agents and suffering from chronic heart failure with a New York Heart Association classification I to III will be randomized centrally into either canagliflozin or glimepiride groups (1: 1) using the dynamic allocation method stratified by age (<65, ≥65 year), HbA1c level (<6.5, ≥6.5 %), and left ventricular ejection fraction (<40, ≥40 %). After randomization, all the participants will be given the add-on study drug for 24 weeks in addition to their background therapy. The primary endpoint is the percentage change from baseline in NT-proBNP after 24 weeks of treatment. The key secondary endpoints after 24 weeks of treatment are the change from baseline in glycemic control, blood pressure, body weight, lipid profile, quality of life score related to heart failure, and cardiac and renal function.
Discussion: The CANDLE trial is the first to assess the safety and non-inferiority of canagliflozin in comparison with glimepiride in patients with type 2 diabetes with chronic heart failure. This trial has the potential to evaluate the clinical safety and efficacy of canagliflozin on heart failure. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Canagliflozin |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Chronic heart failure |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Glimepiride |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Non-inferiority |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
NT-proBNP |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Safety |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
SGLT2 inhibitor |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Type 2 diabetes mellitus |
| 書誌情報 |
en : Cardiovascular Diabetology
巻 15,
p. 57,
発行日 2016-04-04
|
| 収録物ID |
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|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
14752840 |
| 出版者 |
|
|
出版者 |
Springer Nature |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
BioMed Central |
|
言語 |
en |
| 権利情報 |
|
|
言語 |
en |
|
権利情報 |
© 2016 Tanaka et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| EID |
|
|
識別子 |
310419 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
cardiab_15_57.pdf (950 KB)
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