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; 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; Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh

doi:10.1136/bmj.a1840

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 (Lead / Corresponding author), 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 McKnightIain O'Brien, Colin Semple, John Petrie, Derek Gordon, Stuart Pringle, Ron MacWalter, Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh

Research output: Contribution to journal › Article › peer-review

653 Citations (Scopus)

Abstract

Objective To 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.

Design Multicentre, randomised, double blind, 2 x 2 factorial, placebo controlled trial.

Setting 16 hospital centres in Scotland, supported by 188 primary care groups.

Participants 1276 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. Interventions Daily, 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 measures Two 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.

Results Noevidence 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).

Conclusion This 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 registration Current Controlled Trials ISRCTN53295293.

Original language	English
Article number	a1840
Pages (from-to)	1-10
Number of pages	10
Journal	BMJ
Volume	337
Issue number	7677
DOIs	https://doi.org/10.1136/bmj.a1840
Publication status	Published - 1 Nov 2008

Keywords

CORONARY-HEART-DISEASE
CARDIOVASCULAR EVENTS
ANTIPLATELET THERAPY
SECONDARY PREVENTION
GENERAL-POPULATION
METAANALYSIS
RISK
ASSOCIATION
MELLITUS
STROKE

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Belch, J., MacCuish, A., Campbell, I., Cobbe, S., Taylor, R., Prescott, R., Lee, R., Bancroft, J., MacEwan, S., Shepherd, J., Macfarlane, P., Morris, A., Jung, R., Kelly, C., Connacher, A., Peden, N., Jamieson, A., Matthews, D., Leese, G., ... Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh (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. BMJ, 337(7677), 1-10. Article a1840. https://doi.org/10.1136/bmj.a1840

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title = "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",

abstract = "Objective To 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.Design Multicentre, randomised, double blind, 2 x 2 factorial, placebo controlled trial.Setting 16 hospital centres in Scotland, supported by 188 primary care groups.Participants 1276 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. Interventions Daily, 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 measures Two 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.Results Noevidence 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).Conclusion This 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 registration Current Controlled Trials ISRCTN53295293.",

keywords = "CORONARY-HEART-DISEASE, CARDIOVASCULAR EVENTS, ANTIPLATELET THERAPY, SECONDARY PREVENTION, GENERAL-POPULATION, METAANALYSIS, RISK, ASSOCIATION, MELLITUS, STROKE",

author = "Jill Belch and Angus MacCuish and Iain Campbell and Stuart Cobbe and Roy Taylor and Robin Prescott and Robert Lee and Jean Bancroft and Shirley MacEwan and James Shepherd and Peter Macfarlane and Andrew Morris and Roland Jung and Christopher Kelly and Alan Connacher and Norman Peden and Andrew Jamieson and David Matthews and Graeme Leese and John McKnight and Iain O'Brien and Colin Semple and John Petrie and Derek Gordon and Stuart Pringle and Ron MacWalter and {Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh}",

year = "2008",

month = nov,

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doi = "10.1136/bmj.a1840",

language = "English",

volume = "337",

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Belch, J, MacCuish, A, Campbell, I, Cobbe, S, Taylor, R, Prescott, R, Lee, R, Bancroft, J, MacEwan, S, Shepherd, J, Macfarlane, P, Morris, A, Jung, R, Kelly, C, Connacher, A, Peden, N, Jamieson, A, Matthews, D, Leese, G, McKnight, J, O'Brien, I, Semple, C, Petrie, J, Gordon, D, Pringle, S, MacWalter, R & Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh 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', BMJ, vol. 337, no. 7677, a1840, pp. 1-10. https://doi.org/10.1136/bmj.a1840

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. / Belch, Jill (Lead / Corresponding author); MacCuish, Angus; Campbell, Iain et al.
In: BMJ, Vol. 337, No. 7677, a1840, 01.11.2008, p. 1-10.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The prevention of progression of arterial disease and diabetes (POPADAD) trial

T2 - factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease

AU - Belch, Jill

AU - MacCuish, Angus

AU - Campbell, Iain

AU - Cobbe, Stuart

AU - Taylor, Roy

AU - Prescott, Robin

AU - Lee, Robert

AU - Bancroft, Jean

AU - MacEwan, Shirley

AU - Shepherd, James

AU - Macfarlane, Peter

AU - Morris, Andrew

AU - Jung, Roland

AU - Kelly, Christopher

AU - Connacher, Alan

AU - Peden, Norman

AU - Jamieson, Andrew

AU - Matthews, David

AU - Leese, Graeme

AU - McKnight, John

AU - O'Brien, Iain

AU - Semple, Colin

AU - Petrie, John

AU - Gordon, Derek

AU - Pringle, Stuart

AU - MacWalter, Ron

AU - Diabet Registry Grp, Prevent Progression Arterial Dis &, Royal Coll Phys Edinburgh

PY - 2008/11/1

Y1 - 2008/11/1

N2 - Objective To 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.Design Multicentre, randomised, double blind, 2 x 2 factorial, placebo controlled trial.Setting 16 hospital centres in Scotland, supported by 188 primary care groups.Participants 1276 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. Interventions Daily, 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 measures Two 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.Results Noevidence 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).Conclusion This 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 registration Current Controlled Trials ISRCTN53295293.

AB - Objective To 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.Design Multicentre, randomised, double blind, 2 x 2 factorial, placebo controlled trial.Setting 16 hospital centres in Scotland, supported by 188 primary care groups.Participants 1276 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. Interventions Daily, 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 measures Two 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.Results Noevidence 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).Conclusion This 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 registration Current Controlled Trials ISRCTN53295293.

KW - CORONARY-HEART-DISEASE

KW - CARDIOVASCULAR EVENTS

KW - ANTIPLATELET THERAPY

KW - SECONDARY PREVENTION

KW - GENERAL-POPULATION

KW - METAANALYSIS

KW - RISK

KW - ASSOCIATION

KW - MELLITUS

KW - STROKE

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U2 - 10.1136/bmj.a1840

DO - 10.1136/bmj.a1840

M3 - Article

SN - 0959-8146

VL - 337

SP - 1

EP - 10

JO - BMJ

JF - BMJ

IS - 7677

M1 - a1840

ER -

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

Abstract

Keywords

UN SDGs

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