"In our study, we found that diclofenac initiators were at increased risk of major adverse cardiovascular events - both compared with no NSAID initiation, initiation of paracetamol as an analgesic alternative to NSAIDs, as well as initiation of other traditional NSAIDs", the authors wrote in the British Medical Journal.
It's always important to discuss medication and the potential risks it will have on your health with a GP or health professional.
The researchers concluded that diclofenac should not be available over the counter, but should have to be prescribed by a doctor, with warning labels on the packaging to ensure patients are aware of the risk before they begin to take the drug. Risks that were overlooked or unapparent during safety studies that occurred years to decades ago. The risks were evident whether the participants took high, or low doses of the drug.
All subjects who were not taking diclofenac were matched by propensity score to diclofenac users, meaning that the groups were created to mitigate influences from factors like age and pre-existing diseases.
They suggested diclofenac be prescribed with a warning label attached and banned as an over-the-counter drug in countries like the United States where it's available as such.
Diclofenac, a widely used worldwide drug with anti-inflammatory and analgesic properties, is associated with an increased risk of heart attack, stroke and other serious cardiovascular problems, so its use should be done with moderation rather than for a long time.
To conduct this study, the researchers utilized the national registry data containing details on the 6.3 million adults residing in Denmark. But given other research showing a similar heightened risk, the authors say it's clear that diclofenac needs to be more carefully handled, if not phased out of use completely.
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The risk of gastrointestinal bleeding at 30 days increased 4.5-fold in patients who started diclofenac compared to those who didn't.
Starting diclofenac was also associated with an increased rate of cardiac death compared with those taking no NSAIDs.
They said in the paper: 'Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite potential side effects.
However, researchers point out that, while the relative risk increased significantly, the overall risk was still pretty small.
By the way, the worst result was recorded for those people who took the drug at a lower dose than this required. Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs.
And compared to those using ibuprofen, the risk of using diclofenac increased by 20%.