Statin-related neurocognitive disorder: a real-world pharmacovigilance study based on the FDA adverse event reporting system.

IF 3.6 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Review of Clinical Pharmacology Pub Date : 2024-03-01 Epub Date: 2024-01-31 DOI:10.1080/17512433.2024.2311875

Min Xiao, Li Li, Weiwei Zhu, Fengbo Wu, Bin Wu

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引用次数: 0

Abstract

Background: Concerns regarding statin-related neurocognitive disorders have emerged in recent years. However, previous studies have reported inconsistent results. We evaluated the association between statins and neurocognitive disorders using the FDA Adverse Event Reporting System (FAERS).

Research design and methods: Data from 2004 to 2022 were obtained from the FAERS database. After deduplication and standardization of drug names, we extracted neurocognitive disorder event (NCDE) cases reported with statins as the suspected drugs. The significant association between statins and NCDE was evaluated using the reporting odds ratio (ROR) and information component.

Results: In total, 6,959 NCDE cases with statins as the primary suspected drugs were identified. Signals were detected in pravastatin (ROR, 1.49; 95% CI: 1.32-1.67), atorvastatin (ROR, 1.39; 95% CI: 1.34-1.44), and simvastatin (ROR, 1.31; 95% CI: 1.25-1.38). Age-stratified analysis showed that (1) in the population aged 65 years and older, signals were detected for atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, and pitavastatin; and (2) in populations under 65 years of age, signals were detected for atorvastatin, simvastatin, rosuvastatin, pravastatin, and lovastatin.

Conclusions: This study suggests a significant association between the NCDE and statins, including atorvastatin, simvastatin, and pravastatin. The intensity of the association increased with age.

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他汀类药物相关神经认知障碍：基于美国食品药品管理局不良事件报告系统的真实世界药物警戒研究。

背景：近年来，与他汀类药物相关的神经认知障碍问题备受关注。然而，以往研究报告的结果并不一致。我们利用美国食品和药物管理局不良事件报告系统（FAERS）评估了他汀类药物与神经认知障碍之间的关联：我们从FAERS数据库中获取了2004年至2022年的数据。在对药物名称进行重复和标准化处理后，我们提取了以他汀类药物为可疑药物的神经认知障碍事件（NCDE）病例。使用报告几率比（ROR）和信息成分评估他汀类药物与 NCDE 之间的重要关联：结果：共发现了 6,959 例以他汀类药物为主要可疑药物的 NCDE 病例。在普伐他汀（ROR，1.49；95% CI：1.32-1.67）、阿托伐他汀（ROR，1.39；95% CI：1.34-1.44）和辛伐他汀（ROR，1.31；95% CI：1.25-1.38）中发现了信号。年龄分层分析表明：(1) 在 65 岁及以上人群中，阿托伐他汀、辛伐他汀、罗苏伐他汀、普伐他汀、洛伐他汀、氟伐他汀和匹伐他汀检测到信号；(2) 在 65 岁以下人群中，阿托伐他汀、辛伐他汀、罗苏伐他汀、普伐他汀和洛伐他汀检测到信号：这项研究表明，NCDE 与他汀类药物（包括阿托伐他汀、辛伐他汀和普伐他汀）之间存在明显的关联。这种关联的强度随着年龄的增长而增加。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Clinical Pharmacology PHARMACOLOGY & PHARMACY-

CiteScore

7.30

自引率

2.30%

发文量

127

期刊介绍： Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery. Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.