Dobrea Carmen Maximiliana, Frum Adina, Butuca Anca, Morgovan Claudiu, Stoicescu Laurentiu, Chis Adriana Aurelia, Arseniu Anca Maria, Rus Luca Liviu, Gligor Felicia Gabriela, Vonica-Tincu Andreea Loredana
Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Internal Medicine Department, Faculty of Medicine, "Iuliu Haţieganu" University of Medicine and Pharmacy, 400000 Cluj-Napoca, Romania.
Pharmaceuticals (Basel). 2024 Sep 26;17(10):1278. doi: 10.3390/ph17101278.
As the most common psychiatric symptom, depression represents a subject of high interest for the medical community. : International guidelines consider selective serotonin reuptake inhibitors (SSRIs) the first-line treatment of depression. Although having better efficacy and tolerability in comparison to tricyclic antidepressants or monoamine oxidase inhibitors, the diversity and potential severity of adverse effects and interactions manifested by SSRIs, combined with the frequency of prescriptions, lead to the necessity of evaluating real-world data. The aim of this study was to identify and evaluate the drug interactions reported in EudraVigilance (EV) for the six SSRIs representatives that are authorized in Europe: fluoxetine (FXT), fluvoxamine (FVM), citalopram (CIT), escitalopram (ESC), paroxetine (PAR) and sertraline (SER). The entire class of SSRIs was examined as a comparator to identify whether one of the representatives was more prone to reporting. : Descriptive analysis and disproportionality analysis were conducted on data extracted from the EV database. : A total of 326,450 adverse reactions (ADRs) were reported for the SSRIs group. Approximately a quarter of these (n = 83,201; 25.46%) were reported for SER and 22.37% (n = 73,131) for PAR. Of the total ADRs reported, 2.12% (n = 6925) represent preferred terms related to drug-drug interactions (DDIs): SER (n = 1474; 22.37%), CIT (n = 1272, 19.86), and FXT (n = 1309, 19.83%). Specific ADRs related to inhibitory activity represent 0.98%, and for potentiating activity, 1.89%. : Although representing a small value of the total ADRs, DDIs may be related to severe outcomes. Awareness should be raised for this category of ADRs that can be reduced by the joined efforts of physicians and pharmacists.
作为最常见的精神症状，抑郁症是医学界高度关注的课题。国际指南将选择性5-羟色胺再摄取抑制剂（SSRI）视为抑郁症的一线治疗药物。尽管与三环类抗抑郁药或单胺氧化酶抑制剂相比，SSRI具有更好的疗效和耐受性，但SSRI表现出的不良反应和相互作用的多样性及潜在严重性，再加上其处方频率，使得评估真实世界数据成为必要。本研究的目的是识别和评估欧洲批准的六种代表性SSRI（氟西汀（FXT）、氟伏沙明（FVM）、西酞普兰（CIT）、艾司西酞普兰（ESC）、帕罗西汀（PAR）和舍曲林（SER））在欧洲药物警戒系统（EV）中报告的药物相互作用。将整个SSRI类别作为对照进行研究，以确定其中一种代表性药物是否更易被报告。对从EV数据库提取的数据进行了描述性分析和不成比例分析。SSRI组共报告了326,450例不良反应（ADR）。其中约四分之一（n = 83,201；25.46%）是SER报告的，PAR报告的占22.37%（n = 73,131）。在报告的ADR总数中，2.12%（n = 6925）是与药物相互作用（DDI）相关的首选术语：SER（n = 1474；22.37%）、CIT（n = 1272，19.86%）和FXT（n = 1309，19.83%）。与抑制活性相关的特定ADR占0.98%，与增强活性相关的占1.89%。尽管DDI在ADR总数中占比小，但可能与严重后果相关。应提高对这类ADR的认识，通过医生和药剂师的共同努力可以减少此类ADR。
