These findings are subject to the usual limitations of an observational analysis of registry data. There is a potential for residual confounding despite adjustment of Cox proportional hazards for baseline differences; NSAID use was not stratified by type of NSAID (selective vs. non-selective) as this information was not available, and NSAID dose and frequency of use was also not recorded between the scheduled 1-year follow-up visits.
An increased risk of heart attack and stroke with some non-selective NSAIDs is well recognised, particularly with long-term use of high doses and in patients who are already at high risk. Warnings for healthcare professionals and patients have been included in the product information and in the BNF for some years. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has recently recommended updates to the treatment advice for diclofenac in light of the findings of a Europe-wide review of the cardiovascular safety of NSAIDs. The review found further evidence that the arterial thrombotic risk with diclofenac is similar to that for the selective COX-2 inhibitors. Thus in June 2013, diclofenac became contraindicated in patients with established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease and congestive heart failure (NYHA II–IV).Clinicians were advised that diclofenac should only be initiated after careful consideration for patients with significant risk factors for cardiovascular events.
With regards to other NSAID, the decision to prescribe should be based on an assessment of a patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness. Naproxen and low-dose ibuprofen are considered to have the most favourable thrombotic cardiovascular safety profiles of all non-selective NSAIDs. The lowest effective dose should be used for the shortest duration necessary to control symptoms. A patient’s need for symptomatic relief and response to treatment should be re-evaluated periodically.