Evidence map›Paper›PMID 35909259›Full record

ArticlePharmacoepidemiology and drug safety2022

A cohort study to assess risk of cutaneous small vessel vasculitis among users of different oral anticoagulants.

Adebola Ajao, Austin Cosgrove, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Oren Shapira, Joy Kolonoski, John G Connolly

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Innovations in pharmacovigilance studies of medicines in older people.British journal of clinical pharmacology · 2025
    Review
  3. 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

8 authors at 2 institutions in 1 country.

Adebola AjaoDivision of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-4913-1234
Austin CosgroveHarvard Medical School Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA.
Efe EworukeDivision of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-8971-9748
Mohamed MohamoudDivision of Pharmacovigilance, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Rongmei ZhangDivision of Biometrics VII, Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Oren ShapiraHarvard Medical School Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA.
Joy KolonoskiHarvard Medical School Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA.
John G ConnollyHarvard Medical School Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA.
Center for Drug Evaluation and Research · USHarvard University · US

Funding

FDA HHS HHSF223201400030IIntramural FDA HHS FD999999
6 · The paper itself

Abstract

purposeCutaneous small vessel vasculitis (CSVV) was identified as a safety signal among patients treated with direct oral anticoagulants (DOAC). This study aimed to determine if CSVV risk differed among patients with atrial fibrillation (Afib) who newly initiated warfarin or a DOAC.

methodsWe identified enrollees aged ≥21 years diagnosed with Afib who newly initiated rivaroxaban, dabigatran, apixaban, and warfarin in the Sentinel Distributed Database from October 19, 2010 to February 29, 2020. We selected and followed patients who did not have evidence of the following in the 183 days prior to initiating treatment: CSVV diagnosis, dispensing of other study drugs, select autoimmune diseases or autoimmune medications, cancer diagnoses or chemotherapeutic treatment, kidney dialysis or transplant, alternative anticoagulation indications, or an institutional (nursing home, hospice, hospital) stay on the treatment initiation date (index date) until CSVV outcome or pre-specified censoring. We conducted 1:1 propensity score matching in six comparisons.

resultsCSVV incidence rates for DOACs and warfarin ranged from 3.3 to 5.6 per 10 000-person years in our matched Afib population. The adjusted CSVV hazard ratio (HR) and 95% confidence interval (CI) was 0.94 (0.64, 1.39) for rivaroxaban versus warfarin; 1.17 (0.67, 2.06) for dabigatran vs. warfarin; 0.85 (0.62, 1.16) for apixaban vs. warfarin; 0.86 (0.49, 1.50) for rivaroxaban vs. dabigatran; 0.99 (0.68, 1.45) for rivaroxaban versus apixaban; and 1.70 (0.90, 3.21) for dabigatran versus apixaban.

conclusionWe did not find significant evidence of differential CSVV risk in pair-wise comparisons of DOACs and warfarin.

Indexed as

Atrial FibrillationStrokeVasculitisAnticoagulantsCohort StudiesDabigatranHumansPyridonesRetrospective StudiesRivaroxabanWarfarinAnticoagulantsDabigatranPyridonesRivaroxabanWarfarinatrial fibrillationcutaneous small vesseldirect oral anticoagulantsvasculitisvasculitisanticoagulants

Identifiers

PMID35909259
PMCPMC9872093
OpenAlexW4289133603

What OpenQuestion holds

Textmetadata
LicenceTDM
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.