纤维肌痛患者中加巴喷丁和普瑞巴林与不良心血管事件的关联。

Association of adverse cardiovascular events with gabapentin and pregabalin among patients with fibromyalgia.

机构信息

Computer and Data Science Department, Case Western Reserve University Case School of Engineering, Cleveland, OH, United States of America.

Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of Medicine, Cleveland, OH, United States of America.

出版信息

PLoS One. 2024 Jul 26;19(7):e0307515. doi: 10.1371/journal.pone.0307515. eCollection 2024.

DOI:10.1371/journal.pone.0307515

PMID:39058736

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11280525/

Abstract

OBJECTIVE

Fibromyalgia, a chronic pain disorder, impacts approximately 2% of adults in the US. Gabapentin and pregabalin are common treatments to manage fibromyalgia-related pain. Our recent study showed the risk of adverse cardiovascular events increased in diabetic neuropathy patients who were prescribed gabapentin or pregabalin. Here, we investigated whether the prescription of gabapentin or pregabalin has similar cardiovascular risk in patients with fibromyalgia.

METHODS

This retrospective cohort study leveraged electronic health records from 64 US healthcare organizations with 112 million patients. The study population included 105,602 patients first diagnosed with fibromyalgia and followed by a prescription of gabapentin, pregabalin, or other FDA-approved drugs for treating fibromyalgia from 2010 to 2019. Outcomes were deep venous thrombosis (DVT), myocardial infarcts (MI), peripheral vascular disease (PVD), strokes, heart failure, and pulmonary embolism (PE). In propensity-score-matched cohorts, 1-year and 5-year hazard ratios (HRs) were computed with their respective 95% confidence intervals (CIs). Additionally, we conducted sensitivity analyses on the subpopulations without other possible indications.

RESULTS

For 5-year follow-up, gabapentin increased the risk of PVD (HR = 1.46, 95% CI = 1.17-1.80), MI (HR = 1.31, 95% CI = 1.03-1.66), heart failure (HR = 1.27, 95% CI = 1.10-1.48), DVT (HR = 1.80, 95% CI = 1.33-2.44), and PE (HR = 2.23, 95% CI = 1.62-3.07). Pregabalin increased the risk of DVT (HR = 1.49, 95% CI = 1.01-2.20), and PE (HR = 2.24, 95% CI = 1.43-3.50). For 1-year follow-up, gabapentin increased the risk of PVD (HR = 1.32, 95% CI = 1.11-1.57), DVT (HR = 1.35, 95% CI = 1.09-1.68), and PE (HR = 1.36, 95% CI = 1.17-1.57). Pregabalin increased the risk of PVD (HR = 1.32, 95% CI = 1.06-1.63) and PE (HR = 1.25, 95% CI = 1.03-1.52). Sensitivity analyses showed similar trends.

CONCLUSION

In fibromyalgia patients, the prescription of gabapentin and pregabalin moderately increased the risk of several adverse cardiovascular events. This risk, together with benefits and other adverse reactions, should be considered when prescribing these medications for fibromyalgia patients.

摘要

目的

纤维肌痛是一种慢性疼痛障碍，影响美国约 2%的成年人。加巴喷丁和普瑞巴林是治疗纤维肌痛相关疼痛的常用药物。我们最近的研究表明，在接受加巴喷丁或普瑞巴林治疗的糖尿病周围神经病变患者中，不良心血管事件的风险增加。在这里，我们研究了加巴喷丁或普瑞巴林在纤维肌痛患者中的心血管风险是否相似。

方法

这项回顾性队列研究利用了来自 64 家美国医疗机构的电子健康记录，这些机构拥有 1.12 亿名患者。研究人群包括 2010 年至 2019 年间首次被诊断为纤维肌痛并随后被处方加巴喷丁、普瑞巴林或其他美国食品药品监督管理局批准的药物治疗纤维肌痛的 105602 名患者。结果是深静脉血栓形成（DVT）、心肌梗死（MI）、外周血管疾病（PVD）、中风、心力衰竭和肺栓塞（PE）。在倾向评分匹配队列中，计算了 1 年和 5 年的风险比（HR）及其各自的 95%置信区间（CI）。此外，我们还在没有其他可能指征的亚人群中进行了敏感性分析。

结果

在 5 年的随访中，加巴喷丁增加了 PVD（HR = 1.46，95%CI = 1.17-1.80）、MI（HR = 1.31，95%CI = 1.03-1.66）、心力衰竭（HR = 1.27，95%CI = 1.10-1.48）、DVT（HR = 1.80，95%CI = 1.33-2.44）和 PE（HR = 2.23，95%CI = 1.62-3.07）的风险。普瑞巴林增加了 DVT（HR = 1.49，95%CI = 1.01-2.20）和 PE（HR = 2.24，95%CI = 1.43-3.50）的风险。在 1 年的随访中，加巴喷丁增加了 PVD（HR = 1.32，95%CI = 1.11-1.57）、DVT（HR = 1.35，95%CI = 1.09-1.68）和 PE（HR = 1.36，95%CI = 1.17-1.57）的风险。普瑞巴林增加了 PVD（HR = 1.32，95%CI = 1.06-1.63）和 PE（HR = 1.25，95%CI = 1.03-1.52）的风险。敏感性分析显示出相似的趋势。