Evidence mapPaperPMID 31294090Full record

ArticleEndocrinology, diabetes & metabolism2019

Association between vildagliptin and risk of angioedema, foot ulcers, skin lesions, hepatic toxicity, and serious infections in patients with type 2 diabetes mellitus: A European multidatabase, noninterventional, postauthorization safety study.

Rachael Williams, Wolfgang Kothny, Carmen Serban, Sandra Lopez-Leon, Frank de Vries, Raymond Schlienger

Open access · goldAbstract read
In one paragraph

Article in Endocrinology, diabetes & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 28% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Angioedema associated with dipeptidyl peptidase-IV inhibitors.Clinical and molecular allergy : CMA · 2021
    Review
  2. 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 4 institutions in 4 countries.

Rachael WilliamsClinical Practice Research Datalink London UK.
Wolfgang KothnyNovartis Pharma AG Basel Switzerland.
Carmen SerbanNovartis Pharma AG Basel Switzerland.
Sandra Lopez-LeonNovartis Pharmaceuticals Corporation East Hanover New Jersey USA.
Frank de VriesUtrecht Institute for Pharmaceutical Sciences Utrecht University Utrecht The Netherlands.
Raymond SchliengerNovartis Pharma AG Basel Switzerland.ORCID https://orcid.org/0000-0001-5160-0872
Novartis (Switzerland) · CHClinical Practice Research Datalink · GBNovartis (United States) · USUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis noninterventional, multidatabase, analytical cohort study explored whether vildagliptin is associated with an increased risk of specific safety events of interest, namely angioedema, foot ulcers, or skin lesions, adverse hepatic events, or serious infections compared with other noninsulin antidiabetic drugs (NIADs) using real-world data from five European electronic healthcare databases.

designPatients with type 2 diabetes mellitus aged ≥18 years on NIAD treatment were included between January 2005 and June 2014. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest were estimated using negative binomial regression. PATIENTS: Approximately 2.8% of the included patients (n = 738 054) used vildagliptin at any time during the study, with an average follow-up time of 1.4 years.

resultsThe adjusted IRRs (vildagliptin vs. other NIADs) were in the range of 0.87-3.71 (angioedema), 0.73-1.19 (foot ulcers), 0.37-1.18 (skin lesions), 0.24-1.14 (composite of foot ulcer or skin lesions), 0.29-0.55 (serious hepatic events), and 0.59-1.04 (serious infections), with no lower bound of the 95% CIs > 1.

conclusionsOverall, there was no increased risk of the events of interest in association with vildagliptin use compared with other NIADs.

Indexed as

angioedemadipeptidyl peptidase‐4 inhibitorsfoot ulcershepatic toxicityserious infectionsskin lesionstype 2 diabetes mellitusvildagliptin

Identifiers

PMID31294090
PMCPMC6613220
OpenAlexW2949918910

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.