Should GPs stop aspirin in diabetes patients without CVD?
Dr Colin Kenny says the harms far outweigh the risks while Professor Steve Bain says GPs should be wary of this sudden change
We know we need to urgently manage patients with diabetes who die prematurely from cardiovascular disease, with many authorities recommending the routine use of aspirin. NICE guidance CG87 advised the use of aspirin 75mg daily in patients with type 2 diabetes aged 50 years and older whose blood pressure is less than 145/90mmHg and patients under 50 if significant other cardiovascular risk factors are present. This means many practices will have people with diabetes being routinely prescribed aspirin.
In the past I would have recommended this, in line with this NICE guidance. However, important studies changed my view, and they also changed NICE’s view so their newer guidance from December 2015¹ recommends that GPs do not offer antiplatelet therapy (aspirin or clopidogrel) for adults with type 2 diabetes without cardiovascular disease. A similar recommendation was made in the SIGN type 2 diabetes guidance from 2010.² Therefore, I would argue that previous orthodoxy is now outdated and GPs should stop aspirin in people with diabetes where its use can no longer be justified.
But let’s look at the evidence. Two of the most important studies contributing to these recommendations were randomised control trials of aspirin in diabetes which only showed a small non-significant reduction in CV risk with aspirin and recommendations were therefore not to use aspirin routinely.
New studies have also highlighted the harm aspirin can cause. In a recent study of patients with diabetes, the use of low-dose aspirin showed an increased risk of hospitalisation for ischaemic stroke.³ These results suggest that low-dose aspirin for the primary prevention of ischaemic stroke should be reconsidered in patients with diabetes. In another Swedish study daily low-dose aspirin treatment did not prevent cardiovascular events or death in people with type 2 diabetes and no previous cardiovascular disease, and suggested an increase in the risk of coronary heart disease in female patients.4
This is all quite apart from the benefit of reducing the medication burden in a group of patients often taking multiple pills.
Therefore, I have gone from being proactive about the use of aspirin to stopping it at medication reviews. I urge other GPs to take a similar approach.
Dr Colin Kenny is a GP in Dromore, County Down with a special interest in diabetes
With increasing workload in general practice do you really want to go to the effort of taking patients off aspirin who are doing perfectly well?
The evidence NICE used for its new recommendation advising against the use of aspirin in type 2 diabetes without cardiovascular disease was not strong. One study was an unpublished post-hoc analysis of cardiovascular outcomes on the Early Treatment Diabetic Retinopathy Study5 (not peer reviewed) and the second was performed in a Japanese population6 with notoriously low levels of cardiovascular events. The doses of aspirin used ranged from 61-650mg (higher than previously recommended), and the median follow-up was 3.7 to five years. The quality of the evidence was rated by NICE as ‘moderate’ to ‘very low’.
Other guidelines do not concur with NICE. The American Diabetes Association Standards of Care 2016 continues to recommend ‘aspirin therapy (75–162mg/day) as a primary prevention strategy in those with type 1 or type 2 diabetes who are at increased cardiovascular risk (10-year risk >10%). This includes most men or women with diabetes aged 50 years who have at least one additional major risk factor.’ This is very similar to the old NICE guidance.
And new evidence is just around the corner. NICE acknowledged the UK-based ASCEND trial and ACCEPT-D in Italy. These studies aim to assess the effects of low-dose aspirin on major vascular events in people with diabetes and no clinical evidence of vascular disease. It might be worth waiting for the results before changing patients’ medication.
In addition, NICE decided against going as far as recommending that you stop aspirin in those already on it to ‘avoid confusion’. There is also evidence in the literature (albeit weak) of an increased risk of ischaemic stroke four weeks after discontinuation.7 And evidence that duration of aspirin use is not a risk factor for bleeding, so patients who are established on aspirin are at low risk of its major downside.8 This balance of risks should make practitioners wary of change. It would take a lot of work to take patients off aspirin with no clear benefit. With workload in general practice increasing more than ever, why go looking for more to do?
Professor Steve Bain is a consultant diabetologist at Singleton Hospital, Swansea, and professor of medicine at Swansea University
1 NICE. Type 2 diabetes in adults. Clinical Guideline Update (NG28). 2015.
2 SIGN. Management of diabetes. 2010.
3 Kim, Y-J, Choi N-K, K M-S et al. Evaluation of low-dose aspirin for primary prevention of ischemic stroke among patients with diabetes: a retrospective cohort study. Diabetol Metab Syndr 2015;7:8
4 Ekström, N, Cederholm J, Zethelius B et al. Aspirin treatment and risk of first incident cardiovascular diseases in patients with type 2 diabetes: an observational study from the Swedish National Diabetes Register. BMJ Open 2013;3:e002688.
5 ETDRS unpublished data 2013
6 Ogawa H, Nakayama M, Morimoto T et al. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA 2008;300:2134-41
7 Maulaz AB et al. Effect of discontinuing aspirin therapy on the risk of brain ischemic stroke. Arch Neurol 2005;62:1217-20
8 Huang ES et al. Long Term Use of Aspirin and the Risk of Gastrointestinal Bleeding. Am J Med 2011;124:426–339