Evidence map›Paper›PMID 35568573›Full record

ArticleTherapie

Comparative study of the adverse event profile of hydroxychloroquine before and during the Sars-CoV2 pandemic.

Pauline Lory, Jeffrey Lombardi, Clémence Lacroix, Paola Sanchez-Pena, Serena Romani, Aurélie Grandvuillemin, Réseau Français des Centres Régionaux de Pharmacovigilance

Abstract read
In one paragraph

Article in Therapie. 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
–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

1 citing paper in PubMed.

  1. Observational
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.

Pauline LoryRegional Pharmacovigilance Center, Dijon University Hospital, 21000 Dijon, France. Electronic address: pauline.lory@chu-dijon.fr.
Jeffrey LombardiRegional Pharmacovigilance Center, Dijon University Hospital, 21000 Dijon, France.
Clémence LacroixRegional Pharmacovigilance Center, Department of Clinical Pharmacology and Pharmacovigilance, AP-HM, 13000 Marseille, France.
Paola Sanchez-PenaRegional Pharmacovigilance Center, Department of Clinical Pharmacology, Bordeaux University Hospital, 33000 Bordeaux, France.
Serena RomaniRegional Pharmacovigilance Center, Department of Clinical Pharmacology, Pasteur Hospital, 06000 Nice, France.
Aurélie GrandvuilleminRegional Pharmacovigilance Center, Dijon University Hospital, 21000 Dijon, France.
Réseau Français des Centres Régionaux de Pharmacovigilance

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAt the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, there were no clinically-tested medications for the effective treatment of coronavirus disease. In this context, on 5 March 2020, the French Public Health Council issued several recommendations for the therapeutic management of this new disease, including the use of hydroxychloroquine (HCQ). An unexpected cardiovascular safety signal was quickly identified as being more frequent than expected thanks to the reports of adverse drug reactions (ADRs) submitted to French regional pharmacovigilance centres (RPVC). The objective of this study was to compare all ADRs reported with HCQ used in its usual indication, collected before the pandemic period (1985 to 31 December, 2019) with those reported with the coronavirus disease 2019 (COVID-19) indication (1 January to 21 July, 2020).

methodsFor this purpose, reports were extracted from the French pharmacovigilance database and analysed for these two periods.

resultsOur study showed a different safety profile in COVID-19 patients with more cardiac disorders (57% of ADRs versus 5% before the pandemic period), especially QT interval prolongation, resulting from an interaction with azithromycin in more than 20% of cases. Hepatobiliary disorders were also significantly more frequent.

conclusionsThese observations could be associated with the effect of the virus itself on the various organs, the profile of the patients treated, and concomitant drug treatments.

Indexed as

COVID-19 Drug TreatmentLong QT SyndromeHumansHydroxychloroquinePandemicsRNA, ViralSARS-CoV-2HydroxychloroquineRNA, ViralAdverse drug reactionsHydroxychloroquinePharmacovigilance

Identifiers

PMID35568573
PMCPMC8712669

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.