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32-OR: The Bexagliflozin Efficacy and Safety Trial (BEST): A Randomized, Double-Blind, Placebo-Controlled, Phase IIII, Clinical Trial

医学 狼牙棒 内科学 安慰剂 临床终点 心肌梗塞 心力衰竭 冲程(发动机) 不稳定型心绞痛 2型糖尿病 比例危险模型 心脏病学 糖尿病 随机对照试验 内分泌学 传统PCI 替代医学 病理 工程类 机械工程
作者
John J.V. McMurray,Mason W. Freeman,Joseph M. Massaro,Scott D. Solomon,Paul Lock,Matthew C. Riddle,Eldrin F. Lewis,Yuan‐Di C. Halvorsen
出处
期刊:Diabetes [American Diabetes Association]
卷期号:69 (Supplement_1) 被引量:11
标识
DOI:10.2337/db20-32-or
摘要

Bexagliflozin (bexa) is a potent and selective inhibitor of SGLT2. To demonstrate its effects in patients (pts) at increased risk of cardiovascular (CV) events, pts with type 2 diabetes (T2D) ≥40 years old with HbA1c 7.5-11 % and eGFR ≥45 were enrolled in 1 of 3 groups: 1) established atherosclerotic CVD 2) heart failure (HF) or 3) ≥55 years with ≥2 CV risk factors. The primary endpoint was change in HbA1c at wk 24. Secondary endpoints included change in SBP at 24 wks in pts with SBP ≥140 mmHg, weight loss at 48 wks in pts with BMI ≥25 kg/m2, and time to hospitalization for HF or CV death. MACE+ (CV death, myocardial infarction, stroke, or unstable angina) was tested in a non-inferiority analysis to demonstrate upper 95% CI <1.8. Pts were randomized 2:1 to bexa 20 mg or placebo qd. Follow-up continued until all pts completed ≥52 wks and when ≥134 subjects had a MACE+ event. CV endpoints and deaths were adjudicated and analyzed using Cox proportional hazards regression. Placebo-corrected changes from baseline in HbA1c, weight and SBP were analyzed using a mixed model repeated measures approach to account for missing data. 1700 pts were enrolled (62.6% Group1, 14.5% Group 2, 22.9% in Group 3) and followed for a median of 30 months. At baseline mean (SD) HbA1c was 8.32 (0.91)%; BMI 32.6 (6.0) kg/m2 (92%≥25); SBP 134 (16) mmHg (39% ≥140); eGFR 77.9 (19.5) (19% <60). The primary endpoint showed a placebo-corrected reduction in HbA1c of 0.48% (95% CI -0.56, -0.39), p<0.0001; SBP fell 3.0 mmHg (- 5.5, -0.4), p=0.02; and weight declined 2.7kg (-3.1, -2.2), p<0.0001. CV death or HF hosp. occurred in 48 (4.2%) pts on bexa and 31 (5.5%) on placebo: HR 0.74 (0.47, 1.17). MACE+ occurred in 90/1133 (7.9%) pts on bexa and 57/567 (10.1%) on placebo: HR 0.79 (95%CI 0.56, 1.09). In high-risk T2D pts, bexagliflozin was well tolerated and improved HbA1c, SBP, and weight. Non-inferiority was demonstrated for MACE+, with point-estimates for MACE+ and CV death or HF hosp similar to other SGLT2 inhibitors. Disclosure J.J.V. McMurray: Other Relationship; Self; AbbVie Inc., Alnylam Pharmaceuticals, Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Bristol-Myers Squibb, Cardurion, GlaxoSmithKline plc., Novartis Pharmaceuticals Corporation, Theracos, Inc. M.W. Freeman: Research Support; Self; Theracos, Inc. J. Massaro: Consultant; Self; Theracos, Inc. S. Solomon: Consultant; Self; AstraZeneca, Theracos, Inc. Research Support; Self; AstraZeneca, Theracos, Inc. P. Lock: None. M.C. Riddle: Consultant; Self; ADOCIA, Dance Biopharm Holdings, Inc., GlaxoSmithKline plc., Sanofi US, Theracos, Inc. Research Support; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk Inc. E. Lewis: Consultant; Self; Novartis Pharmaceuticals Corporation. Research Support; Self; Amgen, Novartis Pharmaceuticals Corporation, Theracos, Inc. Y.C. Halvorsen: Research Support; Self; Theracos, Inc.

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