Seecheran Naveen, McCallum Penelope, Grimaldos Kathryn, Ramcharan Priya, Kawall Jessica, Katwaroo Arun, Seecheran Valmiki, Jagdeo Cathy-Lee, Rafeeq Salma, Seecheran Rajeev, Quert Abel Leyva, Ali Nafeesah, Peram Lakshmipathi, Khan Shari, Ali Fareed, Motilal Shastri, Bhagwandass Neal, Giddings Stanley, Ramlackhansingh Anil, Sandy Sherry
Department of Clinical Medical Sciences, Faculty of Medical Sciences, The University of the West Indies, 2nd Floor, Building #67, Eric Williams Medical Sciences Complex, Mt. Hope, Trinidad and Tobago.
Department of Medicine, North Central Regional Health Authority, Mt. Hope, Trinidad and Tobago.
Cardiol Ther. 2024 Sep;13(3):593-602. doi: 10.1007/s40119-024-00373-6. Epub 2024 Jul 15.
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).
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.
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.
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.
ClinicalTrials.gov identifier, NCT06228820, prospectively registered 1/18/2024.
这项前瞻性、单臂、交叉药效学研究评估了拜耳低剂量肠溶阿司匹林81毫克片剂（LD EC - ASA）（德国北莱茵 - 威斯特法伦州勒沃库森拜耳股份公司）与Vazalore低剂量磷脂 - 阿司匹林81毫克软胶囊（LD PL - ASA）（美国新泽西州斯巴达PLx制药公司）对血小板反应性（以阿司匹林反应单位（ARU）衡量）的影响。
招募了47名健康志愿者。使用VerifyNow™ ARU检测法（美国马萨诸塞州贝德福德的Werfen公司）评估血小板功能，并在开始每日服用拜耳LD EC - ASA 14天后进行评估，有28天的洗脱期，随后每日服用Vazalore LD PL - ASA 14天，之后再次进行ARU检测。
服用LD EC - ASA的参与者平均ARU评分为426，19.1%的参与者ARU > 550；服用LD PL - ASA的患者平均ARU评分为435，14.9%的患者ARU > 550。根据所使用的制剂（拜耳LD EC - ASA与Vazalore LD PL - ASA），阿司匹林抵抗（ARU > 550）无显著差异。无论使用何种制剂，阿司匹林抵抗均与种族无关。此外，体表面积（BSA）与拜耳LD EC - ASA的ARU值（p值0.788）或Vazalore LD PL - ASA的ARU值（p值0.477）之间无显著关联。没有患者经历任何严重不良事件或治疗中出现的不良事件。
拜耳LD EC - ASA和Vazalore LD PL - ASA在阿司匹林抵抗方面无显著差异。这项专门的药效学研究可能对特立尼达接受双联抗血小板治疗（DAPT）的患者具有参考价值且适用。需要进一步研究来证实这些探索性发现。
ClinicalTrials.gov标识符，NCT06228820，于2024年1月18日进行前瞻性注册。
