Evidence map›Paper›PMID 18927173›Full record

Trial reportBMJ (Clinical research ed.)2008

The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease.

Jill Belch, Angus MacCuish, Iain Campbell, Stuart Cobbe, Roy Taylor, Robin Prescott, Robert Lee, Jean Bancroft, Shirley MacEwan, James Shepherd and 19 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03869268 (The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin), which is not on this map. Cited by 295 papers, 34 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
295citing papers in PubMed, 34 pooled it
73.9field-weighted citation impact, top 1% 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.

NCT03869268 phase4completednot on this mapstarted 2019, after this paper: background citation

The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin

TypeinterventionalSponsorSheffield Teaching Hospitals NHS Foundation TrustRan2019 to 2023Enrolled72ConditionsAcute Coronary SyndromeArmsAspirin, Ticagrelor
3 · Its place in the literature

Who cites it

295 citing papers in PubMed, 34 syntheses or guidelines pooled it, 969 citations in OpenAlex.

  1. Guideline
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  10. Canadian Stroke Best Practice Recommendations, seventh edition: acetylsalicylic acid for prevention of vascular events.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2020
    Guideline
  11. Aspirin for primary prevention of stroke in individuals without cardiovascular disease-A meta-analysis.International journal of stroke : official journal of the International Stroke Society · 2020
    Pooled it
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  13. Guideline
  14. Aspirin Efficacy in Primary Prevention: A Meta-analysis of Randomized Controlled Trials.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2019
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235 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 14 institutions in 1 country.

Jill BelchInstitute of Cardiovascular Research, University of Dundee, Ninewells Hospital, Dundee DD1 9SY. J.J.F.Belch@dundee.ac.uk
Angus MacCuish
Iain Campbell
Stuart Cobbe
Roy Taylor
Robin Prescott
Robert Lee
Jean Bancroft
Shirley MacEwan
James Shepherd
Peter Macfarlane
Andrew Morris
Roland Jung
Christopher Kelly
Alan Connacher
Norman Peden
Andrew Jamieson
David Matthews
Graeme Leese
John McKnight
Iain O'Brien
Colin Semple
John Petrie
Derek Gordon
Stuart Pringle
Ron MacWalter
Prevention of Progression of Arterial Disease and Diabetes Study Group
Diabetes Registry Group
Royal College of Physicians Edinburgh
Ninewells Hospital · GBGlasgow Royal Infirmary · GBUniversity of Edinburgh · GBMonklands Hospital · GBPerth Royal Infirmary · GBQueen Margaret Hospital · GBRoyal Victoria Infirmary · GBSouthern General Hospital · GBStobhill Hospital · GBUniversity of Dundee · GBUniversity of Glasgow · GBVictoria Hospital · GBWestern General Hospital · GBWishaw General Hospital · GB

Funding

Medical Research Council G9534799
6 · The paper itself

Abstract

objectiveTo determine whether aspirin and antioxidant therapy, combined or alone, are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease.

designMulticentre, randomised, double blind, 2x2 factorial, placebo controlled trial.

setting16 hospital centres in Scotland, supported by 188 primary care groups.

participants1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease.

interventionsDaily, 100 mg aspirin tablet plus antioxidant capsule (n=320), aspirin tablet plus placebo capsule (n=318), placebo tablet plus antioxidant capsule (n=320), or placebo tablet plus placebo capsule (n=318).

main outcome measuresTwo hierarchical composite primary end points of death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or amputation above the ankle for critical limb ischaemia; and death from coronary heart disease or stroke.

resultsNo evidence was found of any interaction between aspirin and antioxidant. Overall, 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups (18.2% v 18.3%): hazard ratio 0.98 (95% confidence interval 0.76 to 1.26). Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups (6.7% v 5.5%): 1.23 (0.79 to 1.93). Among the antioxidant groups 117 of 640 (18.3%) primary events occurred compared with 116 of 636 (18.2%) in the no antioxidant groups (1.03, 0.79 to 1.33). Forty two (6.6%) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 (5.7%) in the no antioxidant groups (1.21, 0.78 to 1.89).

conclusionThis trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied.

trial registrationCurrent Controlled Trials ISRCTN53295293.

Indexed as

AdultAgedAntioxidantsAspirinDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic AngiopathiesDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleHumansKaplan-Meier EstimateMaleMiddle AgedPeripheral Vascular DiseasesAntioxidantsAspirinPlatelet Aggregation Inhibitors

Identifiers

PMID18927173
PMCPMC2658865
OpenAlexW2034942998

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.