Evidence map›Paper›PMID 22164237›Full record

ArticlePloS one2011

Risk of death and cardiovascular outcomes with thiazolidinediones: a study with the general practice research database and secondary care data.

Arlene M Gallagher, Liam Smeeth, Suzie Seabroke, Hubert G M Leufkens, Tjeerd P van Staa

Erratum issuedOpen access · goldFull text read
In one paragraph

Article in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.1field-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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
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  8. Observational
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Arlene M GallagherGeneral Practice Research Database, Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
Liam Smeeth
Suzie Seabroke
Hubert G M Leufkens
Tjeerd P van Staa
Utrecht University · NLLondon School of Hygiene & Tropical Medicine · GB

Funding

Department of HealthMedical Research CouncilWellcome Trust
6 · The paper itself

Abstract

objectiveTo describe the likely extent of confounding in evaluating the risks of cardiovascular (CV) events and mortality in patients using diabetes medication.

methodsThe General Practice Research Database was used to identify inception cohorts of insulin and different oral antidiabetics. An analysis of bias and incidence of mortality, acute coronary syndrome, stroke and heart failure were analysed in GPRD, Hospital Episode Statistics and death certificates.

results206,940 patients were identified. The bias analysis showed that past thiazolidinedione users had a lower mortality risk compared to past metformin users. There were no differences between past users of rosiglitazone and pioglitazone (adjusted RR of 1.04; 95% CI 0.93-1.18). Current rosiglitazone users had an increased risk of death (adjusted RR 1.20; 95% CI 1.08-1.34) and of hospitalisation for heart failure (adjusted RR of 1.73; 95% CI 1.19-2.51) compared to current pioglitazone users. Risk of mortality was increased two-fold shortly after starting rosiglitazone. Excess risk of death over 3 years with rosiglitazone was 0.3 per 100 in those aged 50-64 years, 2.0 aged 65-74, 3.0 aged 75-84, and 7.0 aged 85+. The cause of death with rosiglitazone was more likely to be due to a disease of the circulatory system.

conclusionsHigher risks for death (overall and due to cardiovascular disease) and heart failure were found for rosiglitazone compared to pioglitazone. These excess risks were largest in patients aged 65 years or older. The European regulatory decision to suspend rosiglitazone is supported by this study.

Indexed as

Acute Coronary SyndromeAgedAged, 80 and overCardiovascular DiseasesCohort StudiesDatabases, FactualDiabetes ComplicationsDiabetes MellitusFemaleHeart FailureHospitalizationHumansInsulinMaleMetforminMiddle AgedInsulinMetforminPioglitazoneRosiglitazoneThiazolidinediones

Identifiers

PMID22164237
PMCPMC3229530
OpenAlexW2160567487

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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.