Evidence map›Paper›PMID 33057175›Full record

ArticleJournal of human hypertension2021

Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany.

Ulrike Maria Rudolph, Salka Enners, Marita Kieble, Felix Mahfoud, Michael Böhm, Ulrich Laufs, Martin Schulz

Abstract read
In one paragraph

Article in Journal of human hypertension, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
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

18 citing papers in PubMed.

  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
  2. Temporal trends in the prescription of low-dose antithrombotic and anti-inflammatory therapies in Germany (2022-2024).Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. The Utilization of Discharge Prescriptions in Germany.Deutsches Arzteblatt international · 2024
    Article
  7. Article
  8. Article
  9. Article
  10. Use of fixed-dose combination antihypertensives in Germany between 2016 and 2020: an example of guideline inertia.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  11. Article
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  13. Review
  14. Article
  15. Article
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  17. Article
  18. Impact of national valsartan recalls on Veterans' outcomes.Therapeutic advances in drug safety · 2021
    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

7 authors.

Ulrike Maria RudolphDepartment of Cardiology, University Hospital Leipzig, Leipzig, Germany. Ulrike.Rudolph@medizin.uni-leipzig.de.ORCID 0000-0002-8055-8519
Salka EnnersGerman Institute for Drug Use Evaluation, Berlin, Germany.ORCID 0000-0001-6706-295X
Marita KiebleGerman Institute for Drug Use Evaluation, Berlin, Germany.
Felix MahfoudDepartment of Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.ORCID 0000-0002-4425-549X
Michael BöhmDepartment of Internal Medicine III-Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.
Ulrich LaufsDepartment of Cardiology, University Hospital Leipzig, Leipzig, Germany.
Martin SchulzGerman Institute for Drug Use Evaluation, Berlin, Germany.ORCID 0000-0002-5876-7322

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In Germany, ~8 million patients take angiotensin receptor blockers (ARBs) and 2.25 million of them valsartan. In 2018, contamination of generic ARBs with probable carcinogenic nitrosamines resulted in more than 30 recalls. The impact of such a huge recall has never been explored in Europe. We analyzed the utilization of valsartan, all ARBs, and other alternative antihypertensive drugs in Germany. We used our database of anonymized dispensing data from >80% of community pharmacies at the expense of the statutory health insurance (SHI) funds from January 2017 to December 2019. We analyzed 290.8 million prescriptions, including all oral mono- and fixed-dose combinations of ARBs and plausible alternatives, i.e. ACE inhibitors (ACEi), beta-blockers (BB), and calcium channel blockers (CCB). Utilization was calculated by defined daily doses per 1000 SHI-insured persons per day (DID). Valsartan use decreased substantially after the recalls in July 2018 from 39.0 to 14.2 DID (-64%) in the second quarter of 2019 and to 16.9 DID (-57%) in the fourth quarter of 2019. Simultaneously, the use of alternative ARBs increased from 77.7 DID in the second quarter of 2018 to 121.9 DID (+57%) in the fourth quarter of 2019, mainly due to an increase of candesartan dispensing to 99.8 DID (+73%). There were no changes in the utilization of ACEi, BB, or CCB. The majority of recalled generic valsartan products were replaced by other ARBs, predominantly candesartan, despite documented drug shortages. In contrast to previous safety warnings/recalls, our data do not suggest an under-prescription of antihypertensives during this period.

Indexed as

Antihypertensive AgentsHypertensionAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsHumansProduct Recalls and WithdrawalsAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAntihypertensive Agents

Identifiers

PMID33057175
PMCPMC8502678

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Registered trials

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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.