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骨关节炎中抗高血压药物相关不良事件:基于FAERS数据库的大型真实世界样本研究

Antihypertensive drug-associated adverse events in osteoarthritis: a study of a large real-world sample based on the FAERS database.

作者信息

Guo Zijian, Di Jingkai, Zhang Zhibo, Chen Shuai, Mao Xingjia, Wang Zehua, Yan Zehui, Li Xiaoke, Tian Zui, Mu Changjiang, Xiang Changxin, Xiang Chuan

机构信息

Department of Orthopedic, The Second Hospital of Shanxi Medical University, Taiyuan, China.

Department of Basic Medicine Sciences, Department of Orthopaedics of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.

出版信息

Front Pharmacol. 2024 Sep 2;15:1404427. doi: 10.3389/fphar.2024.1404427. eCollection 2024.

Abstract

BACKGROUND

Hypertension is a common complication in patients with osteoarthritis (OA). There is increasing interest in the relationship between hypertension and OA. However, hypertension has been reported to negatively affect symptoms and quality of life in patients with OA. Therefore, treating hypertension is crucial for patients with OA. However, there is a lack of real-world studies on the effects of medications for treating hypertension on OA.

METHODS

Data from the FAERS database from January 2004 to December 2023 were extracted for disproportionality analyses, and proportional reporting ratios (PRRs) were used to assess the association between medications for hypertension and all types of arthritis. Adverse event signals were identified and determined using reporting odds ratios (RORs) Adverse event signals were considered to have occurred if a drug-induced adverse event was recorded more than or equal to 3 and the lower limit of the ROR confidence interval was more than 1. We selected five classes of drugs including, calcium channel blockers (CCBs), angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), thiazide diuretics and β-blockers and representative drugs were analysed for osteoarthritis-related adverse reactions, and age and gender subgroups were analysed for drugs of significance. We also analysed the occurrence of AEs in relation to time using the Weibull distribution.

RESULTS

In terms of overall data, we found significant OA adverse reaction signals only for ARBs among the five drug classes.ARB AEs for spinal osteoarthritis (ROR 4.64, 95% CI 3.62-5.94), osteoarthritis (ROR 3.24 95% CI 2.82-3.72) and gouty arthritis (ROR 3.27 95% CI 1.22-8.75) were the three adverse reactions with the loudest signals. Next, we found that valsartan had strong osteoarthritis adverse reaction signals among the three ARBs, namely, irbesartan, cloxartan, and valsartan. We also analysed age and gender subgroups and found that osteoarthritis signals were strongest in the 18-65 and 65+ population, while females seem to be more prone to valsartan-related OA AEs.

CONCLUSION

ARBs, especially valsartan, have significant positive signals for OA AEs. Therefore, ARB drugs, especially valsartan, should be used with caution when treating patients with OA combined with hypertension.

摘要

背景

高血压是骨关节炎(OA)患者的常见并发症。人们对高血压与OA之间的关系越来越感兴趣。然而,据报道高血压会对OA患者的症状和生活质量产生负面影响。因此,治疗高血压对OA患者至关重要。然而,缺乏关于治疗高血压药物对OA影响的真实世界研究。

方法

提取2004年1月至2023年12月FAERS数据库中的数据进行不成比例分析,使用比例报告比(PRR)评估高血压药物与所有类型关节炎之间的关联。使用报告比值比(ROR)识别和确定不良事件信号。如果记录的药物引起的不良事件大于或等于3且ROR置信区间的下限大于1,则认为发生了不良事件信号。我们选择了五类药物,包括钙通道阻滞剂(CCB)、血管紧张素转换酶抑制剂(ACEI)、血管紧张素受体阻滞剂(ARB)、噻嗪类利尿剂和β受体阻滞剂,并对代表性药物的骨关节炎相关不良反应进行了分析,对有意义的药物按年龄和性别亚组进行了分析。我们还使用威布尔分布分析了不良事件与时间的关系。

结果

就总体数据而言,我们在这五类药物中仅发现ARB有显著的OA不良反应信号。脊柱骨关节炎的ARB不良事件(ROR 4.64,95%CI 3.62 - 5.94)、骨关节炎(ROR 3.24,95%CI 2.82 - 3.72)和痛风性关节炎(ROR 3.27,95%CI 1.22 - 8.75)是信号最强的三种不良反应。接下来,我们发现在三种ARB(厄贝沙坦、氯沙坦和缬沙坦)中,缬沙坦有强烈的骨关节炎不良反应信号。我们还分析了年龄和性别亚组,发现骨关节炎信号在18 - 65岁和65岁以上人群中最强,而女性似乎更容易发生与缬沙坦相关的OA不良事件。

结论

ARB,尤其是缬沙坦,对OA不良事件有显著的阳性信号。因此,在治疗合并高血压的OA患者时,应谨慎使用ARB药物,尤其是缬沙坦。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b87/11402654/ed0420f93689/fphar-15-1404427-g001.jpg

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