替格瑞洛与高强度他汀类药物的肌肉和肾脏安全性:回顾性队列研究结果。

IF 2.8 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics
Therapeutics and Clinical Risk Management Pub Date : 2025-06-08 eCollection Date: 2025-01-01 DOI:10.2147/TCRM.S515732
Abdullah S Alshammari, Amer A Shalwala, Mohammed A Alnuhait, Abdulfattah Y Alhazmi, Refal E Fagieha, Nura Bin Hallabi, Eyad A Alandijani, Mansour A Aloufi, Mudhhi S Alharbi, Reem S Alzahrani, Emad M Elkholy, Mahmoud E Elrggal, Abdulmalik S Alotaibi
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引用次数: 0

摘要

替格瑞洛是一种广泛使用的抗血小板药物,已在包括欧盟和美国在内的70多个国家获得批准,用于减少急性冠脉综合征(ACS)患者的血栓形成事件。在临床实践中,替格瑞洛联合高强度他汀类药物被认为是ACS的标准治疗方法。然而,最近的药效学研究和病例报告表明,潜在的药物-药物相互作用可能增加不良事件的风险,特别是肌肉和肾脏并发症。本研究旨在评估沙特阿拉伯现实世界临床环境中的这些风险。方法:本回顾性观察队列研究在沙特阿拉伯的麦加心脏病学中心进行。该研究纳入成人患者(n = 577),他们服用高强度他汀类药物,同时服用或不服用替格瑞洛。主要结局是他汀类药物相关肌肉并发症(定义为肌痛、肌病、肌炎或横纹肌溶解)和急性肾损伤(AKI)的发生率。从医院信息系统中提取临床资料,对接受他汀类药物单一治疗与联合治疗的患者进行统计比较。结果:该队列以男性患者为主(74.5%)。肌肉相关并发症在同时接受替格瑞洛和他汀类药物治疗组(20.2%)比仅接受他汀类药物治疗组(10.5%)更为常见(P = 0.001)。在合并症中,高血压是唯一与肌肉相关并发症发生率升高显著相关的因素。虽然在联合治疗组中观察到AKI发病率增加的趋势,但这种差异没有达到统计学意义。结论:本研究强调了替格瑞洛和高强度他汀类药物联合使用的潜在安全性问题,特别是肌肉相关并发症的风险增加。虽然AKI的研究结果尚无定论,但结果支持谨慎使用该组合的必要性,并呼吁进行更大规模的前瞻性研究,以进一步评估其安全性并优化治疗策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Muscular and Renal Safety of Ticagrelor with High-Intensity Statins: Retrospective Cohort Findings.

Introduction: Ticagrelor is a widely used antiplatelet agent approved in over 70 countries, including the European Union and the United States, for reducing thrombotic events in patients with acute coronary syndromes (ACS). In clinical practice, combining ticagrelor with high-intensity statins is considered standard therapy for ACS. However, recent pharmacodynamic studies and case reports suggest potential drug-drug interactions that may increase the risk of adverse events, particularly muscular and renal complications. This study aimed to evaluate these risks in a real-world clinical setting in Saudi Arabia.

Methods: This retrospective observational cohort study was conducted at the Makkah Cardiology Center, Saudi Arabia. The study included adult patients (n = 577) who were prescribed high-intensity statins, with or without concurrent ticagrelor. The primary outcomes were the incidence of statin-associated muscular complications-defined as myalgia, myopathy, myositis, or rhabdomyolysis-and acute kidney injury (AKI). Clinical data were extracted from the hospital information system, and statistical comparisons were conducted between patients receiving statin monotherapy and those receiving combination therapy.

Results: The cohort consisted predominantly of male patients (74.5%). Muscle-related complications were significantly more common in the group receiving both ticagrelor and statins (20.2%) compared to the statin-only group (10.5%) (P = 0.001). Among comorbid conditions, hypertension was the only factor significantly associated with a higher incidence of muscle-related complications. Although a trend toward increased AKI incidence was observed in the combination therapy group, this difference did not reach statistical significance.

Conclusion: This study highlights potential safety concerns related to the co-administration of ticagrelor and high-intensity statins, particularly the increased risk of muscle-related complications. While the findings on AKI were inconclusive, the results support the need for cautious use of this combination and call for larger prospective studies to further evaluate its safety profile and optimize treatment strategies.

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来源期刊
Therapeutics and Clinical Risk Management
Therapeutics and Clinical Risk Management HEALTH CARE SCIENCES & SERVICES-
CiteScore
5.30
自引率
3.60%
发文量
139
审稿时长
16 weeks
期刊介绍: Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas. The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature. As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication. The journal does not accept study protocols, animal-based or cell line-based studies.
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