Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY Pharmacoepidemiology and Drug Safety Pub Date : 2024-10-01 DOI:10.1002/pds.70040

Cheng Chen, Efe Eworuke, Ashish Rai, Laura Hou, Jenice S Ko, Mary Ross Southworth, José J Hernández-Muñoz, Mingfeng Zhang

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Abstract

Purpose: On August 20, 2020, the United States (U.S.) Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) along with labeling updates to inform the public about a small increased risk of non-melanoma skin cancer (NMSC) associated with hydrochlorothiazide (HCTZ) use. This study aims to assess whether the DSC impacted HCTZ use in the U.S.

Methods: We conducted a trend analysis in the Sentinel Distributed Database using national healthcare administrative data from January 2017 to November 2022. We identified two cohorts each month: An overall cohort of all enrollees and a skin cancer cohort of those with a history of NMSC. For each cohort, we plotted the monthly proportion of patients receiving HCTZ-containing products among those receiving any thiazide diuretics. We performed interrupted time series analyses to quantify the impact of the DSC on these monthly proportions. Secondary analyses were conducted on the proportion of HCTZ users among patients receiving any antihypertensives.

Results: In the overall cohort, the DSC was only associated with a statistically significant but clinically negligible trend change of monthly HCTZ proportion within this cohort (0.018%; 95% CI, 0.012%-0.025%). Similar results were observed in the skin cancer cohort. The secondary analysis found no significant level change or trend change in the monthly proportion of HCTZ use among antihypertensive users.

Conclusions: We did not observe significant changes in HCTZ use following the DSC about its NMSC risk, among the overall population and those with a history of NMSC. Our findings were in accordance with the DSC recommendation.

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关于皮肤癌风险的标签更新后美国氢氯噻嗪的使用情况。

目的：2020年8月20日，美国食品和药物管理局（FDA）发布了《药物安全通报》（DSC）以及标签更新，告知公众使用氢氯噻嗪（HCTZ）会导致非黑素瘤皮肤癌（NMSC）风险小幅增加。本研究旨在评估 DSC 是否影响了 HCTZ 在美国的使用：我们利用 2017 年 1 月至 2022 年 11 月的全国医疗保健管理数据对哨兵分布式数据库进行了趋势分析。我们每月确定两个队列：一个是所有参保者的总体队列，另一个是有 NMSC 病史的皮肤癌队列。对于每个队列，我们绘制了接受任何噻嗪类利尿剂的患者中每月接受含 HCTZ 产品的比例。我们进行了间断时间序列分析，以量化 DSC 对这些月比例的影响。我们还对服用任何降压药的患者中使用 HCTZ 的比例进行了二次分析：结果：在整个队列中，DSC 只与队列中 HCTZ 每月使用比例的趋势变化（0.018%；95% CI，0.012%-0.025%）有统计学意义，但临床上可忽略不计。皮肤癌队列中也观察到类似的结果。二次分析发现，降压药使用者每月使用 HCTZ 的比例没有明显的水平变化或趋势变化：结论：我们没有观察到在关于 HCTZ NMSC 风险的 DSC 发布后，HCTZ 的使用在总体人群和有 NMSC 病史的人群中发生了重大变化。我们的研究结果符合 DSC 的建议。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.