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.
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.
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DOI：
10.1136/bmj.a1840
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发表时间：
2008-10-16
期刊：
影响因子：
--
通讯作者：
Royal College of Physicians Edinburgh
中科院分区：
文献类型：
--
作者：
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;Prevention of Progression of Arterial Disease and Diabetes Study Group;Diabetes Registry Group;Royal College of Physicians Edinburgh
目的探讨阿司匹林与抗氧化治疗联合或单用在减少糖尿病合并无症状外周动脉疾病患者心血管事件发生方面是否比安慰剂更有效。设计多中心、随机、双盲、2×2因子、安慰剂对照试验。在苏格兰设立了16个医院中心，得到188个初级保健团体的支持。参与者1276名年龄在40岁或以上的1型或2型糖尿病患者，踝肱压力指数为0.99或更低，但没有症状性心血管疾病。干预措施：每日100mg阿司匹林片加抗氧化胶囊（n=320），阿司匹林片加安慰剂胶囊（n=318），安慰剂片加抗氧化胶囊（n=320），或安慰剂片加安慰剂胶囊（n=318）。两个分层复合主要终点：冠心病或卒中死亡、非致死性心肌梗死或卒中死亡、因严重肢体缺血而踝关节以上截肢死亡；以及死于冠心病或中风。结果未发现阿司匹林与抗氧化剂相互作用的证据。总体而言，638例主要事件中有116例发生在阿司匹林组，而未服用阿司匹林组的638例中有117例发生（18.2% vs 18.3%）：风险比0.98（95%可信区间0.76 ~ 1.26）。服用阿司匹林组有43人死于冠心病或中风，未服用阿司匹林组有35人（6.7% vs 5.5%）： 1.23 （0.79 vs 1.93）。在抗氧化剂组中，640例中有117例（18.3%）发生原发性事件，而在无抗氧化剂组中，636例中有116例（18.2%）发生原发性事件（1.03,0.79至1.33）。抗氧化剂组有42例（6.6%）死于冠心病或中风，而无抗氧化剂组有36例（5.7%）（1.21,0.78至1.89）。结论：本试验未提供证据支持阿司匹林或抗氧化剂在糖尿病患者心血管事件和死亡率一级预防中的应用。当前对照试验ISRCTN53295293。
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, 2×2 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 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.
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影响因子：
7.4
作者：
BELCH, JJF;CHOPRA, M;SMITH, WE
通讯作者：
SMITH, WE
影响因子：
158.5
作者：
CRIQUI, MH;LANGER, RD;BROWNER, D
通讯作者：
BROWNER, D
影响因子：
16.2
作者：
Howard, BV;Best, LG;Devereux, RB
通讯作者：
Devereux, RB
影响因子：
16.2
作者：
Buse, John B.;Ginsberg, Henry N.;Stone, Neil J.
通讯作者：
Stone, Neil J.
影响因子：
105.7
作者：
FAULKNER, G;PRICHARD, P;LANGMAN, MJS
通讯作者：
LANGMAN, MJS