缬沙坦、氯沙坦和厄贝沙坦在美、英、加、丹受亚硝胺污染召回后的使用情况：描述性队列研究。

Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study.

机构信息

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2023 Apr 17;13(4):e070985. doi: 10.1136/bmjopen-2022-070985.

DOI:10.1136/bmjopen-2022-070985

PMID:37068898

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10111915/

Abstract

OBJECTIVES

To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled.

DESIGN

Retrospective cohort study.

SETTING

USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records.

PARTICIPANTS

Patients aged 18 years and older between January 2014 and December 2020.

INTERVENTION

Valsartan, losartan and irbesartan.

MAIN OUTCOME

Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products.

RESULTS

We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged.

CONCLUSION

The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.

摘要

目的

研究缬沙坦、氯沙坦和厄贝沙坦在美国、英国、加拿大和丹麦的使用和转换模式，这些研究在 2018 年 7 月首例血管紧张素受体阻滞剂（ARB）（缬沙坦）召回之后进行。

设计

回顾性队列研究。

设置

美国、加拿大的行政医疗保健数据、丹麦国家处方登记处和英国初级保健电子健康记录。

参与者

2014 年 1 月至 2020 年 12 月期间年龄在 18 岁及以上的患者。

干预

缬沙坦、氯沙坦和厄贝沙坦。

主要结局

每月单独 ARB 发作、新使用者和转换为另一种 ARB、血管紧张素转换酶抑制剂（ACEI）或含钙通道阻滞剂的产品的百分比。

结果

我们分别在美国、英国、加拿大和丹麦确定了 1080 万、320 万、180 万和 120 万 ARB 用户。在美国，缬沙坦、氯沙坦和厄贝沙坦的使用比例分别为 18.4%、67.9%和 5.2%；在英国，分别为 3.1%、48.3%和 10.2%；在加拿大，分别为 16.3%、11.4%和 18.3%；在丹麦，分别为 1%、93.5%和 0.6%。2018 年 7 月，我们观察到美国和加拿大缬沙坦使用比例急剧下降。在丹麦也观察到了类似的趋势；然而，下降幅度很小。我们没有观察到英国 ARB 使用趋势的变化。缬沙坦的下降伴随着美国、加拿大和丹麦向其他 ARB 的转换增加。与缬沙坦向其他 ARB 的转换相比，ACEI 的转换略有增加。我们还观察到 2019 年在美国和加拿大，其他受影响的 ARB（氯沙坦和厄贝沙坦）向其他 ARB 的使用增加，尽管美国的使用趋势保持不变。