心不全,ササグリプチン,糖尿病:SAVOR-TIMI 53ランダム化試験からの観察

Benjamin M Scirica¹, Eugene Braunwald², Itamar Raz²

¹From the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division (B.M.S., E.B., M.A.C., D.A.M., K.I., A.A.U.-E., D.L.B.) and Department of Pathology (P.J.), Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Diabetes Unit (I.R., O.M.), Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel; Cardiovascular Division (J.A.U.), Women's College Hospital and Toronto General Hospital, University of Toronto, Toronto, Canada; AstraZeneca Research and Development (P.S.P., B.H.), Gaithersburg, MD; Bristol-Myers Squibb (R.F.), Princeton, NJ; Cardiovascular Research Institute (B.S.L.), Lady Davis Carmel Medical Center and Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel; Cardiovascular Medicine (D.K.M.) and Division of Endocrinology, Department of Internal Medicine (J.D.), University of Texas Southwestern Medical Center, Dallas, TX; University Hospital Department (G.S.), Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation, Remodelling), Institut National de la Santé et de la Recherche Médicale (INSERM) Unit 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.), Imperial College, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, London, UK. bscirica@partners.org.

Circulation

|September 6, 2014

まとめ

ササグリプチンは,2型糖尿病患者の心不全のために入院を増加させた. このリスクは,心不全,腎臓病,またはナトリウレチンペプチドの値が上昇した患者で最も高かった.

科学分野:

心臓病学心臓病学
エンドクリノロジーエンドクリノロジー
薬理学薬理学とは

背景:

糖尿病と心不全はしばしば共存する.
末端点として心不全を前向きに評価した糖尿病の臨床試験はほとんどありません.

研究の目的:

2型糖尿病患者の心不全の入院に対するササグリプチンの効果を評価する.
心不全の入院リスクが高い患者のサブグループを特定する.

主な方法:

2型糖尿病と心血管疾患のリスクのある患者16,492人が,ササグリプチンまたはプラセボにランダムに割り当てられました.
平均フォローアップ期間は2.1年; 主要エンドポイントは,心血管疾患による死亡,心筋梗塞,または缺血性脳卒中でした.
心不全による入院は二次的エンドポイントであり,N-ターミナルプロB型ナトリウレチンペプチドが測定されました.

主要な成果:

ササグリプチングループは,心不全の入院率が高かった (3.5%対2.8%; HR, 1.27; P=0.007).
リスクは早期に上昇した (1.9% vs. 12ヶ月で1.3%; HR, 1.46; P=0.002),後の有意な違いはなかった.
前回の心不全,eGFR ≤60mL/min,または高濃度のN端のプロB型ナトリウレチンペプチドを有する患者に最も高いリスクが観察されました.

結論:

ササグリプチンの治療は,心不全のために入院するリスクを増加させた.
この増加したリスクは,ナトリウレチンペプチド値が上昇した患者,心不全の患者,または慢性腎臓疾患の患者で最も顕著でした.

キーワード:

糖尿病・メリトス (糖尿病) について心不全とは,心不全のことです.サクサグリプチン (saxagliptin) とは

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