Data_Sheet_1_Cardiovascular adverse reactions associated with escitalopram in patients with underlying cardiovascular diseases: a systematic review and meta-analysis.DOCX

BackgroundDespite the anticipated efficacy of escitalopram in treating depression and anxiety in individuals with preexisting cardiovascular conditions, persistent concerns regarding its adverse effects have emerged. In this systematic review, we aimed to evaluate the cardiovascular safety profile of escitalopram compared with that of placebo in patients with underlying cardiovascular disease.
MethodsWe used a predefined search strategy in PubMed, Cochrane Central Register of Controlled Trials, Embase, International Clinical Trials Registry Platform, and ClinicalTrials.gov to identify studies evaluating adverse cardiovascular reactions to escitalopram in patients with underlying cardiovascular disease. Randomized controlled trials (RCTs) that provided results on cardiovascular safety outcomes were included. Two independent reviewers screened the abstracts and full texts of the individual studies. The risk of bias was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation approach.
ResultsThe primary outcomes were the frequency of major adverse cardiovascular events (MACE), QTc prolongation, and discontinuation of study medication. We identified 5 RCTs with 773 participants who met the inclusion criteria. Escitalopram was not associated with significantly increased risk of MACE (risk ratio [RR] = 1.85; 95% confidence interval [CI] 0.80 to 4.26; I2 0%; 5 RCTs; n = 773, moderate certainty of evidence), discontinuation of study medication (RR = 1.03; 95% CI 0.84–1.26; I2 0%; 5 RCTs; n = 773, low certainty of evidence), and QTc prolongation (RR = 1.20; 95% CI 0.76–1.90; I2 0%; 4 RCTs; n = 646, low certainty of evidence).
ConclusionEscitalopram does not significantly increase the risk of cardiovascular adverse reactions compared with placebo in patients with underlying cardiovascular disease. However, the presence of wide CIs and the limited number of included studies highlight the need for further studies with larger sample sizes to enhance the precision and reliability of these findings.
Systematic review registration: International Prospective Register of Systematic Reviews [CRD42022298181].

背景 尽管艾司西酞普兰（escitalopram）在治疗合并基础心血管疾病患者的抑郁与焦虑方面被预期具有疗效，但关于其不良反应的持续担忧仍层出不穷。本项系统综述旨在评估与安慰剂（placebo）相比，艾司西酞普兰在基础心血管疾病患者中的心血管安全性特征。
方法 我们在PubMed、考克兰对照试验中心注册库（Cochrane Central Register of Controlled Trials）、Embase数据库、国际临床试验注册平台（International Clinical Trials Registry Platform）以及ClinicalTrials.gov中采用预先设定的检索策略，以筛选评估基础心血管疾病患者使用艾司西酞普兰后心血管不良反应的相关研究。纳入提供心血管安全性结局数据的随机对照试验（RCTs）。由两名独立研究者逐一筛查文献摘要与全文。采用考克兰随机试验偏倚风险评估工具V2.0评估偏倚风险，并采用推荐分级的评估、制定与评价（GRADE）系统评估证据确定性。
结果 本研究的主要结局指标包括主要不良心血管事件（MACE）发生频率、QT间期延长（QTc prolongation）情况以及研究药物停用率。最终纳入符合纳入标准的5项RCT，共涉及773名受试者。与安慰剂相比，艾司西酞普兰并未显著增加主要不良心血管事件风险（风险比[RR]=1.85；95%置信区间[CI] 0.80~4.26；I²=0%；5项RCT；n=773，证据确定性为中等）、研究药物停用风险（RR=1.03；95%CI 0.84~1.26；I²=0%；5项RCT；n=773，证据确定性为低）以及QT间期延长风险（RR=1.20；95%CI 0.76~1.90；I²=0%；4项RCT；n=646，证据确定性为低）。
结论 在基础心血管疾病患者中，与安慰剂相比，艾司西酞普兰并未显著增加心血管不良反应风险。然而，置信区间较宽以及纳入研究数量有限的局限性提示，仍需开展更大样本量的后续研究，以提升本研究结果的精准性与可靠性。
系统综述注册信息 国际系统综述前瞻性注册库（International Prospective Register of Systematic Reviews）[CRD42022298181]。