加勒比地区两种阿司匹林配方的药效学比较：ARC 研究。
IF 3
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
引用次数: 0
摘要
研究简介这项前瞻性、单臂、交叉药效学研究评估了拜耳®低剂量阿司匹林81毫克肠溶片（LD EC-ASA）（拜耳股份公司，德国北威州勒沃库森）与Vazalore®低剂量磷脂阿司匹林81毫克液体填充胶囊（LD PL-ASA）（PLx Pharma Inc：方法：招募了 47 名健康志愿者。使用 VerifyNow™ ARU 分析仪（Werfen，美国马萨诸塞州贝德福德）评估血小板功能，并在开始每天服用拜耳® LD EC-ASA 14 天后进行评估，28 天为冲洗期，然后每天服用 Vazalore® LD PL-ASA 14 天，之后再次进行 ARU 测试：服用低剂量EC-ASA的患者平均ARU评分为426分，其中19.1%的患者ARU大于550分；服用低剂量PL-ASA的患者平均ARU评分为435分，其中14.9%的患者ARU大于550分。不同配方（拜耳® LD EC-ASA 与 Vazalore® LD PL-ASA）的阿司匹林耐药性（ARU > 550）没有明显差异。无论使用哪种配方，阿司匹林耐药性都与种族无关。此外，体表面积（BSA）与拜耳® LD EC-ASA ARU 值（p 值 0.788）或 Vazalore® LD PL-ASA ARU 值（p 值 0.477）之间无明显关联。没有患者出现任何严重不良事件或治疗突发不良事件：拜耳® LD EC-ASA和Vazalore® LD PL-ASA在阿司匹林耐药性方面没有明显差异。这项专门的药效学研究可能具有参考价值，适用于接受双重抗血小板疗法（DAPT）的特立尼达患者。还需要进一步的研究来证实这些探索性发现：试验注册：ClinicalTrials.gov标识符，NCT06228820，2024年1月18日前瞻性注册。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Pharmacodynamic Comparison of Two Aspirin Formulations in the Caribbean: The ARC Study.
Introduction: This prospective, single-arm, crossover pharmacodynamic study assessed the effect of Bayer® low-dose enteric-coated aspirin 81 mg tablets (LD EC-ASA) (Bayer AG, Leverkusen, North Rhine-Westphalia, Germany) compared to Vazalore® low-dose phospholipid-aspirin liquid-filled 81 mg capsules (LD PL-ASA) (PLx Pharma Inc., Sparta, NJ, USA) on platelet reactivity with respect to aspirin reaction units (ARU).
Methods: Forty-seven healthy volunteers were recruited. Platelet function was evaluated with the VerifyNow™ ARU assay (Werfen, Bedford, MA, USA) and assessed post-initiation of Bayer® LD EC-ASA daily for 14 days, with a washout period of 28 days, followed by Vazalore® LD PL-ASA daily for 14 days, again followed by ARU testing.
Results: Participants on LD EC-ASA had a mean ARU score of 426, with 19.1% of participants having an ARU > 550; patients on LD PL-ASA derived a mean ARU score of 435, with 14.9% achieving an ARU > 550. There were no significant differences in aspirin resistance (ARU > 550) according to the formulation (Bayer® LD EC-ASA vs. Vazalore® LD PL-ASA) used. Aspirin resistance was independent of ethnicity regardless of the formulation used. In addition, there were no significant associations between body surface area (BSA) and Bayer® LD EC-ASA ARU value (p value 0.788) or Vazalore® LD PL-ASA ARU value (p value 0.477). No patients experienced any serious adverse events or treatment-emergent adverse events.
Conclusions: There were no significant differences in aspirin resistance between Bayer® LD EC-ASA and Vazalore® LD PL-ASA. This dedicated pharmacodynamic study could potentially be informative and applicable for Trinidadian patients on dual antiplatelet therapy (DAPT). Further studies are required to confirm these exploratory findings.
Trial registration: ClinicalTrials.gov identifier, NCT06228820, prospectively registered 1/18/2024.
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来源期刊
Cardiology and Therapy
CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
5.30
自引率
0.00%
发文量
38
审稿时长
6 weeks
期刊介绍：
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Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged.
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