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Medizin 2000
27.05.2023
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von Dr. med. Jochen Kubitschek
Aspirin (ASS) eignet sich nur dann für die Vorbeugung von Herz-Kreislauferkrankungen, wenn der individuelle Patient bereits herzkrank ist. Diese Rolle bei dieser sog. "sekundären Prophylaxe" konnte in verschiedenen Studien gut belegt werden. Auf der anderen Seite haben zahlreiche Untersuchungen auch gezeigt, dass Aspirin nicht geeignet ist, Herz-Kreislauferkrankungen bei gesunden Menschen zu verhindern. Aufgrund dieser Datenlage verweigerte die US-amerikanische Arzneimittelbehörde FDA auch eine Ausweitung der Indikation für den Einsatz von Aspirin für die sog. "Primäre Prophylaxe" - beispielsweise die Verhütung von Herzinfarkten. Doch obgleich die wissenschaftlichen Daten in dieser Hinsicht eindeutig sind, nehmen zahlreiche Menschen Aspirin oder ein anderes Mittel aus der "Aspirin-Familie" ein, um ihr Herzinfarktrisiko zu vermindern. Dies ist allerdings nicht sinnvoll, da Aspirin mit einem relativ hohen Nebenwirkungsrisiko behaftet ist. Es ist unbestritten, dass weltweit pro Jahr weltweit viele tausend Menschen an den Folgen einer durch Aspirin ausgelösten Magen-Darmblutung sterben. Umstritten
war bisher allerdings, ob sich der Einsatz von Aspirin im Zuge
der primären Herzinfarkt-Prophylaxe zumindest bei jenen Patienten
lohnt die bereits - wie beispielsweise Diabetiker oder Patienten
mit peripherer Arterienverkalkung - ein hohes Herz-Kreislaufrisiko
haben.
Englischsprachige Informationen zu dieser Studie finden Sie hier kostenlose Vollversion Editorial hier
Published
16 October 2008, doi:10.1136/bmj.a1840 ResearchThe 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 diseaseJill Belch, professor of vascular medicine1, Angus MacCuish, consultant diabetologist2, Iain Campbell, professor of diabetic medicine3, Stuart Cobbe, Walton professor of cardiology4, Roy Taylor, professor of medicine and metabolism5, Robin Prescott, professor of health technology assessment8, Robert Lee, research associate8, Jean Bancroft, senior research nurse1, Shirley MacEwan, honorary senior research fellow1, James Shepherd, professor of pathological biochemistry6, Peter Macfarlane, professor of electrocardiology7, Andrew Morris, professor of diabetic medicine9, Roland Jung, consultant physician (endocrine and diabetes) and honorary professor of medicine10, Christopher Kelly, consultant diabetologist11, Alan Connacher, consultant diabetologist and endocrinologist12, Norman Peden, consultant diabetologist13, Andrew Jamieson, consultant physician14, David Matthews, consultant physician15, Graeme Leese, consultant endocrinologist, John McKnight, consultant physician and honorary senior lecturer16, Iain O’Brien, consultant diabetologist17, Colin Semple, consultant physician18, John Petrie, reader in diabetes9, Derek Gordon, consultant physician19, Stuart Pringle, professor of cardiology20, Ron MacWalter, consultant stroke physician1, Prevention of Progression of Arterial Disease and Diabetes Study Group, Diabetes Registry Group, and Royal College of Physicians Edinburgh 1 Institute of Cardiovascular Research, University of Dundee, Ninewells Hospital, Dundee DD1 9SY, 2 Diabetes Centre, Glasgow Royal Infirmary, 3 Department of Medicine, Royal Victoria Hospital, Kirkcaldy, 4 British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, 5 Royal Victoria Infirmary, Newcastle upon Tyne, 6 Department of Biochemistry, Glasgow Royal Infirmary, 7 Department of Medical Cardiology, Glasgow Royal Infirmary, 8 Medical Statistics Unit, University of Edinburgh, 9 Diabetes Research Centre, Ninewells Hospital, 10 Diabetes and Endocrinology, Ninewells Hospital, 11 Diabetes Centre, Stirling Royal Infirmary, 12 Diabetes Centre, Perth Royal Infirmary, 13 Diabetes Centre, Falkirk and District Royal Infirmary, Falkirk, 14 Diabetes Centre, Queen Margaret Hospital, Dunfermline, 15 Diabetes Centre, Monklands Hospital, Airdrie, 16 Metabolic Unit, Western General Hospital, Edinburgh, 17 Wishaw General Hospital, Wishaw, 18 Southern General Hospital NHS Trust, Glasgow, 19 Medical Unit B, Stobhill NHS Trust, Glasgow, 20 Cardiology Department, Ninewells Hospital Correspondence to: J Belch J.J.F.Belch@dundee.ac.uk 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, 2x2 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 No 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). 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 [controlled-trials.com] .
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