Evidence map›Paper›PMID 29655237›Full record

ArticlePharmacoepidemiology and drug safety2018

Cardiovascular safety signals with dipeptidyl peptidase-4 inhibitors: A disproportionality analysis among high-risk patients.

Sheriza N Baksh, Mara McAdams-DeMarco, Jodi B Segal, G Caleb Alexander

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PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 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

4 authors at 1 institution in 1 country.

Sheriza N BakshDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.ORCID 0000-0002-8341-860X
Mara McAdams-DeMarcoDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Jodi B SegalDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
G Caleb AlexanderDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Johns Hopkins University · US

Funding

NHLBI Training Program in PharmacoepidemiologyT32HL139426 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI G. Caleb Alexander, JODI B. SEGAL · 2018 to 2026
$2.5M
ENHANCING REGULATORY SCIENCE THROUGH A UNIQUE FDA-ACADEMIC PARTNERSHIPU01FD004977 · FDA · JOHNS HOPKINS UNIVERSITY · PI ALEXANDER, G. CALEB · 2014 to 2015
$1.2M
FDA HHS U01 FD004977FDA HHS U01 FD005942NHLBI NIH HHS T32 HL139426
6 · The paper itself

Abstract

purposeIn 2008, the US Food and Drug Administration (FDA) issued Draft Guidance on investigating cardiovascular risk with oral diabetic drugs, including dipeptidyl peptidase-4 inhibitors (DPP-4i). In 2014, underpowered, post hoc analyses of clinical trials suggested an increased risk of heart failure with the use of these products. As such, we assessed disproportionate reporting of major adverse cardiac events (MACE) among reports for DPP-4i submitted to the FDA Adverse Event Reporting System (FAERS) from 2006 to 2015.

methodsWe assessed the empirical Bayes geometric mean (EBGM) and its lower bound (EB05) of the relative reporting ratio for MACE among DPP-4i reports in the full FAERS database and in a subset of reports limited to cardiovascular and diabetic drugs. We then compared the EB05 in these 2 analyses and calculated the percent positive agreement for signals of disproportional reporting (SDRs) involving MACE.

resultsOf 180.3 million adverse event reports, 13.4 million were for diabetic and cardiovascular drugs. In the cardiovascular subset, there was an SDR for heart failure with linagliptin (EB05 = 2782.47) and saxagliptin (EB05 = 2.40), myocardial infarction with alogliptin (EB05 = 290.11), and cerebral infarction with sitagliptin (EB05 = 2.80). Of the 14 MACE, 8 had a percent positive agreement ≥50% for an SDR in both analyses. Overall, the cardiovascular subset elicited 11 more SDRs for DPP-4i than the full dataset.

conclusionsPostmarketing surveillance of DPP-4i through FAERS suggest increased reporting of MACE, supporting the current FDA warning of heart failure risk. This suggests the need for additional longitudinal, observational research into the association of DPP-4i and other MACE.

Indexed as

AdamantaneAdministration, OralAdverse Drug Reaction Reporting SystemsAgedBayes TheoremDatabases, FactualDiabetes Mellitus, Type 2DipeptidesDipeptidyl-Peptidase IV InhibitorsFemaleHeart FailureHumansLinagliptinMaleMiddle AgedPiperidinesAdamantanealogliptinDipeptidesDipeptidyl-Peptidase IV InhibitorsLinagliptinPiperidinessaxagliptinSitagliptin PhosphateUracildipeptidyl peptidase-IV inhibitorsdrug-related side effects and adverse reactionsheart failurepharmacoepidemiologypharmacovigilance

Identifiers

PMID29655237
PMCPMC6727842
OpenAlexW2796503087

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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.