Contreras-Salinas Homero, Barajas-Hernández Mariana, Baiza-Durán Leopoldo Martín, Vázquez-Álvarez Alan Omar, Bautista-Castro Manuel Alejandro, Rodríguez-Herrera Lourdes Yolotzin
Pharmacovigilance Department, Laboratorios Sophia, S.A. de C.V, Zapopan, Jalisco, México.
School of Medicine and Health Science, Tecnológico de Monterrey, Guadalajara, Jalisco, México.
Clin Ophthalmol. 2021 Feb 16;15:583-590. doi: 10.2147/OPTH.S288180. eCollection 2021.
In this study active pharmacovigilance was used in an uncontrolled population to enrich the safety profile and canvass the Adverse Drug Reactions (ADRs) associated with the use of a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (TBD).
Active pharmacovigilance consisting of 3 follow-up calls within 60 days was used to monitor the product's safety and identify new risks by searching for unexpected ADRs and increased incidence, tolerability, drug interactions and special population-related ADRs.
Ninety-four ADRs were reported by a total of 246 patients (0.38 ADRs/patient); all of them were classified as "mild". We found an increased risk of ADRs with a Relative Risk (RR) for simultaneous use of TBD + ophthalmic ciprofloxacin and TBD + oral atorvastatin; 2.0309 (95% CI, 1.2467-3.3083) and 1.8864 (95% CI, 1.0543-3.3754), respectively. Two unexpected ADRs were discovered, both of which presented belonged to the System Organ Class (SOC) of "infections and infestations" and the preferred term (PT) of "nasopharyngitis.".
Three safety signals were identified, two of them corresponded to an increase in the incidence of ADRs and the last one is associated with 2 unexpected ADR. Nevertheless, we found a good tolerability profile for TBD in the study population.
在本研究中，主动药物警戒应用于非对照人群，以完善安全性概况并探究与使用0.5%噻吗洛尔+0.2%溴莫尼定+2.0%多佐胺固定复方制剂（TBD）相关的药物不良反应（ADR）。
主动药物警戒包括在60天内进行3次随访电话，用于监测产品安全性，并通过查找意外ADR以及增加的发生率、耐受性、药物相互作用和特殊人群相关ADR来识别新风险。
总共246例患者报告了94例ADR（0.38例ADR/患者）；所有ADR均被分类为“轻度”。我们发现同时使用TBD+环丙沙星滴眼液和TBD+阿托伐他汀口服制剂时ADR风险增加，相对风险（RR）分别为2.0309（95%置信区间，1.2467 - 3.3083）和1.8864（95%置信区间，1.0543 - 可见3.3754）。发现了2例意外ADR，均属于“感染和侵染”系统器官分类（SOC），首选术语（PT）为“鼻咽炎”。
识别出3个安全信号，其中2个对应ADR发生率增加，最后1个与2例意外ADR相关。然而，我们在研究人群中发现TBD具有良好的耐受性。
