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他汀类药物对血压的影响:FDA 发布的不良事件分析。

Effect of statins on blood pressure: Analysis on adverse events released by FDA.

机构信息

a Department of Cardiovascular , Surgery of Gansu Provincial Hospital , Lanzhou City , Gansu Province , China.

b School of Basic Medical Science , Lanzhou University , Lanzhou City , Gansu Province , China.

出版信息

Clin Exp Hypertens. 2017;39(4):325-329. doi: 10.1080/10641963.2016.1254224. Epub 2017 May 17.

DOI:10.1080/10641963.2016.1254224
PMID:28513233
Abstract

OBJECTIVE

As a class of cholesterol-lowering drugs, statins have been reported to cause unexpected decrease in blood pressure (BP). However, most studies in this issue were subject to inadequate study design or very small sample size. The present study was designed to examine the BP-lowering effect of various statins.

METHODS

Here we retrieved 5.9 million clinical reports submitted to FDA Adverse Event Reporting System (FAERS) from 2004 to 2015. Meta-analysis was performed to estimate the overall reporting odds ratio (ROR) of hypotension adverse events concurrent with various statins (i.e., atorvastatin, simvastatin, and rosuvastatin).

RESULTS

Comparing the reporting rate of hypotension event between statins and other drugs found that atorvastatin (pooled ROR = 1.26, adjusted p-value = 8.60 × 10) and simvastatin (pooled ROR = 1.94, adjusted p-value = 4.16 × 10) were significantly associated with reduction in BP. On the other hand, the association between rosuvastatin and hypotension was observed to be nonsignificant (adjusted p-value = 0.65).

CONCLUSION

To our knowledge, this is the first pooled analysis on large-scale data of adverse events to identify the BP-lowering effect of statins. The results will contribute to the development of novel statin-based antihypertensive therapies. In addition, the differential effects of individual statins can warrant subsequent research on the underlying mechanisms of BP control.

摘要

目的

他汀类药物作为一类降脂药物,据报道会导致血压(BP)意外下降。然而,该问题中的大多数研究都存在研究设计不当或样本量很小的问题。本研究旨在检验各种他汀类药物的降压效果。

方法

我们从 2004 年至 2015 年检索了向 FDA 不良事件报告系统(FAERS)提交的 590 万份临床报告。进行荟萃分析以估计各种他汀类药物(即阿托伐他汀、辛伐他汀和瑞舒伐他汀)同时发生低血压不良事件的总体报告比值比(ROR)。

结果

比较他汀类药物和其他药物的低血压事件报告率发现,阿托伐他汀(汇总 ROR = 1.26,调整后的 p 值= 8.60×10)和辛伐他汀(汇总 ROR = 1.94,调整后的 p 值= 4.16×10)与血压降低显著相关。另一方面,瑞舒伐他汀与低血压之间的关联被观察到不显著(调整后的 p 值= 0.65)。

结论

据我们所知,这是首次对不良事件进行大规模数据的汇总分析,以确定他汀类药物的降压作用。研究结果将有助于开发新型基于他汀类药物的降压疗法。此外,个体他汀类药物的差异作用可以保证对血压控制的潜在机制进行后续研究。

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