David Brill
Aspirin is of no benefit for the primary prevention of cardiovascular events in diabetics, new randomized trial data suggest.
The Prevention of Progression of Arterial Disease and Diabetes (POPADAD) study found that neither aspirin nor antioxidants reduced the incidence of cardiovascular events among 1,276 diabetic adults with asymptomatic peripheral arterial disease.The findings of the study, which conflict with international guidelines, demonstrate that the medical community has extended its practices beyond the existing evidence base, the study’s lead researcher said.
"We do know that aspirin and antiplatelet agents are useful for secondary prevention in diabetes," said Professor Jill Belch of the Institute of Cardiovascular Research at the University of Dundee, UK.
"The trouble is, we have been guilty of therapeutic greed and we’ve extrapolated these findings back into primary prevention without any evidence.
"Although aspirin is a relatively safe drug we shouldn’t lose sight of the fact that it does have potential side effects … if something doesn’t benefit you, and has the potential to do harm, then the net effect is negative and perhaps we should wait until the evidence is available before writing our guidelines."
Belch said that the use of aspirin for primary cardiovascular prevention in diabetes is "endemic worldwide," yet the data from the POPADAD trial and other studies do not offer convincing support for the practice.
Doctors should instead focus strongly on getting patients’ lipid levels and blood pressure on target using statins and antihypertensive agents, she said, noting that aspirin can cause gastrointestinal bleeding and is one of the most common causes of drug-related hospitalizations.
She stressed, however, that aspirin remains a vital drug for secondary prevention, and urged doctors to reassure patients with established cardiovascular disease about the need to continue taking the drug.
Patients in the POPADAD trial were followed up for a median of 6.7 years. Of the 638 primary events that occurred during the study, 116 were among patients taking aspirin and 117 among those taking placebo or antioxidants alone. [BMJ 2008 Oct 16;337:a1840]
Patients in the study were aged over 40 with either type 1 or type 2 diabetes but no symptoms of cardiovascular disease, and had an ankle brachial pressure index of 0.99 or lower. Aspirin was given at a dosage of 100 mg once daily.
Further research is needed to confirm whether primary prevention could be achieved using a different aspirin dosing schedule or an alternative antiplatelet agent, Belch added.
The American Heart Association and American Diabetes Association jointly recommend that aspirin (75 – 162 mg/day) be used for primary prevention in diabetics at increased cardiovascular risk, including those aged over 40. [Circulation 2007 Jan 2;115(1):114-26]
There are similar recommendations in Asia. For example, guidelines from the Ministry of Health, Singapore, advocate aspirin (75 – 100 mg/day) for all type 2 diabetics over the age of 45, or those with dyslipidemia, hypertension or preexisting cardiovascular disease.
The POPADAD study is now the seventh well-controlled trial to show that aspirin is ineffective for this purpose, according to Professor William Hiatt from the University of Colorado Denver School of Medicine, US.
"Although aspirin is cheap and universally available, practitioners and authors of guidelines need to heed the evidence that aspirin should be prescribed only in patients with established symptomatic cardiovascular disease," he wrote in an accompanying editorial. [BMJ 2008;337:a1806]
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