Diclofenac caution over higher GI bleed risk

Research

By Michael Woodhead

6 Sep 2018

The NSAID diclofenac should not be used first line because it has “considerably higher” GI bleeding risks and cardiovascular risk than some other NSAIDs, a Danish study has concluded.

With few prospective head to head trials of NSAID risks, researchers examined the cardiovascular risks of diclofenac initiation compared with initiation of other NSAIDs and paracetamol based on Danish population based health registries from 1996-2016.

Their study, published in the BMJ, included 1.4 million patients starting diclofenac, 3.9 million ibuprofen users, 292,000 naproxen users and 765,000 patients using paracetamol as well as 1.3 million people not using NSAIDs or paracetamol.

Diclofenac initiation increased the risk of upper gastrointestinal bleeding at 30 days by 2.5-fold compared with initiation of ibuprofen or paracetamol and to a similar extent as naproxen initiation. The risk of GI bleeding was increased approximately 4.5-fold compared with no drug initiation,

In terms of major adverse cardiovascular events within 30 days of starting a drug, patients taking diclofenac had a 30% higher incidence rate compared with naproxen users, a 20% higher rate than ibuprofen or paracetamol users and a 50% higher incidence rate than people not using any drug.

The increased risk with diclofenac was seen in both males and females, all ages and even at low doses of diclofenac.

The study authors said the higher toxicity of diclofenac may arise from its short half life of one-two hours, requiring it to be prescribed in high doses to maintain peak levels.

Given the drug’s cardiovascular and gastrointestinal risks, there was little justification to use it first line before other traditional NSAIDs, they concluded.

“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,” they recommended.

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