Duke University Medical Center, Durham, NC.
Duke Clinical Research Institute, Duke University, Durham, NC.
Diabetes Care. 2024 Jan 1;47(1):81-88. doi: 10.2337/dc23-0749.
Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events.
ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome.
Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83-1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72-2.16]; P = 0.772).
This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population.
患有糖尿病（DM）和动脉粥样硬化性心血管疾病（ASCVD）的患者必须使用最有效的剂量的阿司匹林，以降低未来不良心血管事件的风险。
ADAPTABLE 是一项开放性、实用性研究，将稳定的慢性 ASCVD 患者随机分为每日 81 毫克或 325 毫克的阿司匹林。评估阿司匹林剂量对主要有效性结局（全因死亡、心肌梗死住院或中风住院的复合结局）和主要安全性结局（大出血住院）的影响。在这项预设分析中，我们使用 Cox 比例风险模型比较了有和无糖尿病患者的主要有效性和安全性结局的阿司匹林剂量。
在 15076 名患者中，5676 名（39%）患有 DM，其中 2820 名（49.7%）被分配到 81 毫克阿司匹林组，2856 名（50.3%）被分配到 325 毫克阿司匹林组。有和无糖尿病的患者复合心血管结局的发生率更高（9.6%比 5.9%；P < 0.001）和出血事件发生率更高（0.78%比 0.50%；P < 0.001）。比较 81 毫克和 325 毫克的阿司匹林，有糖尿病的患者在主要有效性结局方面没有差异（9.3%比 10.0%；风险比[HR]0.98[95%可信区间 0.83-1.16]；P = 0.265）或安全性结局（0.87%比 0.69%；亚分布 HR 1.25[95%可信区间 0.72-2.16]；P = 0.772）。
本研究证实了无论阿司匹林剂量如何，患有糖尿病的患者的风险都更高。我们的研究结果表明，更高剂量的阿司匹林并不能带来额外的临床获益，即使在更脆弱的人群中也是如此。
