Pop Gabriela, Farcaș Andreea, Butucă Anca, Morgovan Claudiu, Arseniu Anca Maria, Pumnea Manuela, Teodoru Minodora, Gligor Felicia Gabriela
Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Pharmacovigilance Research Center, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.
Pharmaceuticals (Basel). 2022 Dec 10;15(12):1536. doi: 10.3390/ph15121536.
Statins are included in the category of high-frequency prescription drugs, and their use is on an upward trend worldwide. In 2012, the FDA issued a warning about possible cognitive adverse drug reactions (ADRs) related to statins, some of which are listed in the Summary of Product Characteristics, but there are still concerns about their potential risk of psychiatric events. The aim of this research was to investigate spontaneous reports containing psychiatric ADRs associated with statins by analyzing the EudraVigilance (EV) database. From January 2004 to July 2021, a total of 8965 ADRs were reported for the Systems Organ Class (SOC) "psychiatric disorders", of which 88.64% were registered for atorvastatin (3659), simvastatin (2326) and rosuvastatin (1962). Out of a total of 7947 individual case safety reports (ICSRs) of the 3 statins mentioned above, in 36.3% (2885) of them, statins were considered the only suspected drug, and in 42% (3338), no other co-administered drugs were mentioned. Moreover, insomnia has been reported in 19.3% (1536) of cases, being the most frequent adverse reaction. A disproportionality analysis of psychiatric ADRs was performed. The Reporting Odds Ratio (ROR) and 95% confidence interval (95% CI) were calculated for simvastatin, atorvastatin and rosuvastatin compared with antiplatelets and antihypertensive drugs. The reporting probability for most ADRs of these statins compared to antiplatelets was higher. The reporting probability for insomnia, nightmares and depression produced by statins compared to antihypertensive drugs was also higher. The results of this analysis augment the existing data about a possible correlation between the administration of statins and the occurrence of psychiatric side effects.
他汀类药物属于高频处方药类别，其使用在全球范围内呈上升趋势。2012年，美国食品药品监督管理局（FDA）发布了关于他汀类药物可能存在的认知不良药物反应（ADR）的警告，其中一些在产品特性摘要中有列出，但人们仍对其潜在的精神事件风险感到担忧。本研究的目的是通过分析欧洲药物警戒数据库（EudraVigilance，EV）来调查包含与他汀类药物相关的精神性ADR的自发报告。2004年1月至2021年7月，共报告了8965例“精神障碍”系统器官分类（SOC）的ADR，其中88.64%是阿托伐他汀（3659例）、辛伐他汀（2326例）和瑞舒伐他汀（1962例）的注册病例。在上述3种他汀类药物的总共7947份个体病例安全报告（ICSR）中，36.3%（2885份）的报告中他汀类药物被认为是唯一可疑药物，42%（3338份）的报告中未提及其他同时使用的药物。此外，19.3%（1536例）的病例报告了失眠，这是最常见的不良反应。对精神性ADR进行了不成比例分析。计算了辛伐他汀、阿托伐他汀和瑞舒伐他汀与抗血小板药物和抗高血压药物相比的报告比值比（ROR）和95%置信区间（95%CI）。与抗血小板药物相比，这些他汀类药物的大多数ADR的报告概率更高。与抗高血压药物相比，他汀类药物引起的失眠、噩梦和抑郁的报告概率也更高。该分析结果补充了关于他汀类药物给药与精神副作用发生之间可能存在相关性的现有数据。
