种族对每周一次艾塞那肽的心脏代谢反应的影响：来自艾塞那肽心血管事件降低研究（EXSCEL）的见解。
Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
机构信息
Medical School, University of Western Australia, Fremantle Hospital, P.O. Box 480, Fremantle, WA, Australia.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
出版信息
Cardiovasc Diabetol. 2022 Jun 27;21(1):116. doi: 10.1186/s12933-022-01555-z.
BACKGROUND
To determine whether there were racial differences in short-term cardiometabolic responses to once-weekly exenatide (EQW) in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
METHODS
EXSCEL enrolled 14,752 patients with type 2 diabetes (hemoglobin A (HbA) 6.5-10.0% [48-86 mmol/mol]) with or without cardiovascular disease who were randomized double-blind to EQW or placebo. Background glucose-lowering/other cardiovascular therapies were unaltered for 6 months post-randomization unless clinically essential, facilitating comparison of EQW-associated effects in 14,665 evaluable participants self-identifying as White (n = 11,113), Asian (n = 1444), Black (n = 870), or Other Race (n = 1,238. Placebo-adjusted 6 month absolute changes in cardiometabolic variables were assessed using generalized linear models.
RESULTS
Mean 6-month placebo-adjusted HbA reductions were similar in the four groups (range 0.54-0.67% [5.9 to 7.3 mmol/mol], P = 0.11 for race×treatment interaction), with no significant difference in Asians (reference) versus other groups after covariate adjustment (all P ≥ 0.10). Six-month placebo-adjusted mean changes in systolic (-1.8 to 0.0 mmHg) and diastolic (0.2 to 1.2 mmHg) blood pressure, serum LDL (- 0.06 to 0.02 mmol/L) and HDL (0.00 to 0.01 mmol/L) cholesterol, and serum triglycerides (-0.1 to 0.0 mmol/L) were similar in the racial groups (P ≥ 0.19 for race×treatment interaction and all P ≥ 0.13 for comparisons of Asians with other races). Resting pulse rate increased more in Asians (4 beats/min) than in other groups (≤ 3 beats/min, P = 0.016 for race×treatment interaction and all P ≤ 0.050 for comparisons of Asians with other races).
CONCLUSIONS
Short-term cardiometabolic responses to EQW were similar in the main racial groups in EXSCEL, apart from a greater pulse rate increase in Asians.
TRIAL REGISTRATION
https://clinicaltrials.gov NCT01144338.
背景
为了确定每周一次艾塞那肽（EQW）在心血管事件降低的艾塞那肽研究（EXSCEL）中的短期心脏代谢反应是否存在种族差异。
方法
EXSCEL 纳入了 14752 名患有 2 型糖尿病（血红蛋白 A（HbA）6.5-10.0%[48-86mmol/mol]）的患者，这些患者有或没有心血管疾病，他们被随机双盲分配至 EQW 或安慰剂组。在随机分组后 6 个月内，除非临床必需，否则不改变背景下的降糖/其他心血管治疗，从而有利于在 14665 名自认为是白人（n=11113）、亚洲人（n=1444）、黑人（n=870）或其他种族（n=1238）的可评估参与者中比较 EQW 相关的影响。使用广义线性模型评估心脏代谢变量的 6 个月安慰剂调整后的绝对变化。
结果
在四个组中，6 个月时的平均安慰剂调整后的 HbA 降低幅度相似（范围 0.54-0.67%[5.9 至 7.3mmol/mol]，P=0.11 用于种族与治疗的交互作用），在调整了协变量后，亚洲人（参考）与其他组之间没有显著差异（所有 P≥0.10）。6 个月时的安慰剂调整后平均收缩压（-1.8 至 0.0mmHg）和舒张压（0.2 至 1.2mmHg）、血清 LDL（-0.06 至 0.02mmol/L）和 HDL（0.00 至 0.01mmol/L）胆固醇以及血清甘油三酯（-0.1 至 0.0mmol/L）在种族群体中相似（种族与治疗的交互作用 P≥0.19，所有 P≥0.13 用于亚洲人与其他种族之间的比较）。在亚洲人中，静息脉搏率增加更多（4 次/分钟），而在其他组中增加较少（≤3 次/分钟，种族与治疗的交互作用 P=0.016，所有 P≤0.050 用于亚洲人与其他种族之间的比较）。
结论
除了亚洲人的脉搏率增加更多外，EXSCEL 中的主要种族群体对 EQW 的短期心脏代谢反应相似。
试验注册
https://clinicaltrials.gov NCT01144338。
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