Mizranita Vinci, Pratisto Eko Harry
Department of Pharmacy, Sebelas Maret University, Surakarta, Indonesia.
Department of Information Technology, Sebelas Maret University, Surakarta, Indonesia.
Int J Clin Pharm. 2015 Oct;37(5):844-50. doi: 10.1007/s11096-015-0128-x. Epub 2015 May 5.
Statins are a class of medication indicated for atherosclerotic diseases and dyslipidemia. Since their appearance, many adverse events have been associated with their use. Ocular disorders are rare but serious adverse events of statins.
To report the association between statins and ocular adverse events (blurred vision, visual impairment, visual field defect, reduced visual acuity, myopia, hypermetropia, presbyopia, and astigmatism) which might be associated with muscle or liver problems by examining the frequency of ocular adverse events among the reported adverse drug reactions from the Food and Drug Administration (FDA) and Adverse Drug Reactions Advisory Committee (ADRAC) data. Setting The FDA USA and ADRAC Australia databases.
We conducted a retrospective study of statin-associated ocular adverse events reported to FDA between 1988 and 2013 and ADRAC between 1988 and 2011. The recoded data included: patient's age, gender, suspected drug and dosage, concomitant drug, adverse events, duration of therapy, dechallenge and rechallenge therapy. The differences in the adverse events profiles between each of the statins and atorvastatin were performed using Chi square and multivariate (logistic regression) statistical tests.
Percentages of subjects correlated with each Ocular adverse events.
Among 131,755 cases of patients taking statins in the FDA, there were 2325 cases reported ocular adverse events after using statins (1.8%). The Chi square statistic showed that the proportions of ocular adverse events varied significantly (p < 0.0001) across the different statin drugs. The most highly reported ocular adverse events associated with statins were blurred vision (48.4%) and visual impairment (25.7%). Results from logistic regression indicated that the ocular problems formed a greater proportion of the adverse events for subjects taking atorvastatin (2.1%). Of the 1.8%, ocular adverse events mostly occurred alone (60.9%), followed by 30.3% where muscle adverse events also were involved. The ADRAC data held 136 cases of statins associated ocular adverse events (47 patients reported blurred vision and 64 reported vision impairment).
All statins were associated with ocular side effects, with atorvastatin showed a higher incidence of ocular side effects in conjunction with muscle and liver problems.
他汀类药物是一类用于治疗动脉粥样硬化疾病和血脂异常的药物。自其出现以来，许多不良事件与其使用相关。眼部疾病是他汀类药物罕见但严重的不良事件。
通过检查美国食品药品监督管理局（FDA）和澳大利亚药物不良反应咨询委员会（ADRAC）报告的药物不良反应中眼部不良事件的发生频率，报告他汀类药物与可能与肌肉或肝脏问题相关的眼部不良事件（视力模糊、视觉障碍、视野缺损、视力下降、近视、远视、老花眼和散光）之间的关联。研究地点为美国FDA和澳大利亚ADRAC数据库。
我们对1988年至2013年向FDA报告的他汀类药物相关眼部不良事件以及1988年至2011年向ADRAC报告的此类事件进行了回顾性研究。编码数据包括：患者年龄、性别、可疑药物及剂量、伴随用药、不良事件、治疗持续时间、撤药和再激发治疗。使用卡方检验和多变量（逻辑回归）统计检验对每种他汀类药物与阿托伐他汀之间的不良事件特征差异进行分析。
与每种眼部不良事件相关的受试者百分比。
在FDA的131755例服用他汀类药物的患者中，有2325例报告在使用他汀类药物后出现眼部不良事件（1.8%）。卡方统计显示，不同他汀类药物的眼部不良事件比例差异显著（p < 0.0001）。与他汀类药物相关的报告最多的眼部不良事件是视力模糊（48.4%）和视觉障碍（25.7%）。逻辑回归结果表明，眼部问题在服用阿托伐他汀的受试者不良事件中占比更大（2.1%）。在这1.8%的眼部不良事件中，大多数单独发生（60.9%），其次是30.3%同时伴有肌肉不良事件。ADRAC数据中有136例他汀类药物相关眼部不良事件（47例患者报告视力模糊，64例报告视觉障碍）。
所有他汀类药物均与眼部副作用相关，阿托伐他汀在伴有肌肉和肝脏问题时眼部副作用发生率更高。
