Evidence map›Paper›PMID 30298362›Full record

ArticleEuropean journal of clinical pharmacology2019

Incidence of Stevens-Johnson syndrome/toxic epidermal necrolysis among new users of different individual drugs in a European population: a case-population study.

Sara Rodríguez-Martín, Elisa Martín-Merino, Victoria Lerma, Antonio Rodríguez-Miguel, Olga González, Carlos González-Herrada, Elena Ramírez, Teresa Bellón, Francisco J de Abajo

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Article in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.9field-weighted citation impact, top 9% 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

10 citing papers in PubMed, 29 citations in OpenAlex.

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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

9 authors at 5 institutions in 1 country.

Sara Rodríguez-MartínClinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain.
Elisa Martín-MerinoDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices, Madrid, Spain.
Victoria LermaClinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain.
Antonio Rodríguez-MiguelClinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain.
Olga GonzálezDermatology Department, University Hospital of Getafe, Getafe, Madrid, Spain.
Carlos González-HerradaDermatology Department, University Hospital of Getafe, Getafe, Madrid, Spain.
Elena RamírezClinical Pharmacology Department, La Paz University Hospital, Madrid, Spain.
Teresa BellónDrug Hypersensitivity Laboratory, Institute for Health Research IdiPAZ, La Paz University Hospital, Madrid, Spain.
Francisco J de AbajoClinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain. francisco.abajo@uah.es.
Instituto Ramón y Cajal de Investigación Sanitaria · ESHospital Universitario de Getafe · ESHospital La Paz Institute for Health Research · ESHospital Universitario La Paz · ESUniversidad de Alcalá · ES

Funding

Instituto de Salud Carlos III #PI12/02267
6 · The paper itself

Abstract

purposeTo estimate the specific incidences of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) among new users of drugs frequently reported to be associated with this serious event.

methodsWe performed a case-population approach, which combined data from a registry of SJS/TEN cases from the Madrid region (numerator) during the study period 2005-2015 and a primary healthcare database from the same catchment population. The proportion of new users of drugs estimated in the primary healthcare database was stratified by calendar year, sex and age (5-year bands), and then applied to the same strata of Madrid's population census to compute the number of new users (denominator). Incidences were re-estimated using only cases in which the concerned drug had a probable or very probable causal relationship.

resultsA total of 44 SJS/TEN cases aged > 14 years were registered during the study period. The highest SJS/TEN incidence was found for phenytoin with 68.9 per 100,000 new users (95% CI 27.7-141.9), followed by dexamethasone (5.48; 1.49-14.03), allopurinol (3.29; 1.07-7.67) and cotrimoxazole (3.19; 0.87-8.16). Considering only probable and very probable cases, the incidences hardly changed, except for dexamethasone, which was left without cases. Pantoprazole, levofloxacin and lorazepam showed incidences between 1 per 100,000 and 1 per 1,000,000 new users. Ibuprofen, amoxicillin-clavulanic acid, metamizole, amoxicillin, paracetamol and omeprazole showed incidences around 1 per one million new users.

conclusionsPhenytoin was the drug with the highest incidence of SJS/TEN, followed by allopurinol and cotrimoxazole. For the rest of the drugs, the estimated incidences were below 1 in 100,000 new users.

Indexed as

AdolescentAdultDatabases, FactualDrug-Related Side Effects and Adverse ReactionsEuropeFemaleHumansIncidenceMaleMiddle AgedPharmaceutical PreparationsRegistriesStevens-Johnson SyndromeYoung AdultPharmaceutical PreparationsCase-population studyHypersensitivitySCARStevens-Johnson syndromeToxic epidermal necrolysis

Identifiers

PMID30298362
OpenAlexW2896374103

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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.