Evidence map›Paper›PMID 37095262›Full record

ArticleEuropean journal of clinical pharmacology2023

A collaborative study of the impact of N-nitrosamines presence and ARB recall on ARB utilization - results from IQVIA™ Disease Analyzer Germany.

Karin Hedenmalm, Chantal Quinten, Xavier Kurz, Marie Bradley, Hana Lee, Efe Eworuke

Open access · hybridAbstract read
In one paragraph

Article in European journal of clinical pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. The consequences of medicine shortages on healthcare utilization and care fragmentation.The European journal of health economics : HEPAC : health economics in prevention and care · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 3 countries.

Karin HedenmalmData Analytics Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
Chantal QuintenData Analytics Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands. chantal.quinten@ema.europa.eu.
Xavier KurzData Analytics Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
Marie BradleyCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.
Hana LeeCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.
Efe EworukeCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, USA.
Center for Drug Evaluation and Research · USEuropean Medicines Agency · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRegulators are increasingly concerned with  the impact of recalls on drug adherence. In 2018, N-nitrosamines impurities were detected in valsartan containing medical products. Concerned products were immediately recalled in July 2018 by regulatory agencies internationally. In Germany, recalls were issued for valsartan, losartan and irbesartan from July 2018 to March 2019. This study examined angiotensin II receptor blocker (ARB) utilization trends and switching patterns in Germany before and after July 2018.

methodsPatients prescribed ARBs from January 2014 to June 2020 in general practices in Germany were included in a collaborative framework common protocol drug utilization study led by the US Food and Drug Administration. Trends in monthly and quarterly proportions of total ARB prescribing were analysed for individual ARBs using descriptive statistics and interrupted time series analysis. The rate of switching to an alternative ARB was analysed before and after the recalls.

resultsThe proportion of valsartan prescriptions immediately decreased from 35.9 to 17.8% following the first recalls in July 2018, mirrored by an increased proportion for candesartan. Increased switching from valsartan to candesartan was observed. No increased switching was observed after losartan recalls, whereas for irbesartan, increased switching was observed 6-12 months after the last recall. Increased switching from ARBs to angiotensin-converting enzyme (ACE) inhibitors or ARB treatment discontinuations were not observed.

conclusionThis study showed that patients were able to continue ARB treatment despite the July 2018-March 2019 recalls, although many patients needed to switch to an alternative ARB. The duration of the impact of ARB recalls appeared to be limited.

Indexed as

HypertensionNitrosaminesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBenzimidazolesBiphenyl CompoundsGermanyHumansIrbesartanLosartanTetrazolesValsartanAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBenzimidazolesBiphenyl CompoundscandesartanIrbesartanLosartanNitrosaminesTetrazolesValsartanAngiotensin receptor blockersDrug recallsDrug utilizationN-nitrosamines

Identifiers

PMID37095262
PMCPMC10229727
OpenAlexW4366824838

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.