Diclofenac Tied to Major Cardiovascular Risk

A recent study has found more evidence of cardiovascular health risks associated with the use of the nonsteroidal anti-inflammatory drug (NSAID) diclofenac.

Following the discovery of the thromboembolic properties of rofecoxib, the cardiovascular risks of non-aspirin NSAIDs has been a major health concern, according to the study authors.

To examine the risks associated with the use of diclofenac compared with other NSAIDs, the researchers conducted a series of 252 nationwide cohort studies of emulated trial design. They included 1,370,832 diclofenac initiators, 3,878,454 ibuprofen initiators, 291,490 naproxen initiators, 764,781 healthcare seeking paracetamol initiators matched by propensity score, and 1,303,209 healthcare seeking non-initiators also matched by propensity score.

Overall, they found that the adverse event rate among users of diclofenac increased by 50% compared with non-initiators, 20% compared with paracetamol or ibuprofen initiators, and 30% compared with naproxen initiators. While the relative risk of major cardiovascular events was highest among those with low or moderate baseline risk, the absolute risk was highest in those with high baseline risk.

Gastrointestinal bleeding risk at 30 days was also increased in diclofenac users by approximately 4.5-fold compared with non-users and 2.5-fold compared with those using ibuprofen or paracetamol.

“It is time to acknowledge the potential health risk of diclofenac and to reduce its use. Diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks,” the researchers concluded.

—Michael Potts

Reference:

Schmidt M, Sorensen HT, Pedersen L, et al. Diclofenac use and cardiovascular risks: series of nationwide cohort studies [published online September 4, 2018]. BMJ. https://doi.org/10.1136/bmj.k3426