Now a groundbreaking study of more than six million people, the biggest of its kind, has linked them to "major cardiovascular events". The researchers' paper is titled, "Diclofenac use and cardiovascular risks: series of nationwide cohort studies". Diclofenac is a traditional NSAID that has similar selectivity for cyclo-oxygenase-2 (COX 2) as COX 2 inhibitors, but the cardiovascular risks of diclofenac in comparison with other traditional NSAIDs have not been investigated through a randomized controlled trial.
Diclofenac is a component frequently found in painkillers used to treat back pain, sciatica and arthritis.
The team examined 10 years of national registry data for 6.3 million adults with at least one year of prescription records before the decade under scrutiny began.
After taking account of potentially influential factors, starting diclofenac during the study period (1996 to 2016) was associated with an increased rate of major adverse cardiovascular events within 30 days compared with starting other traditional NSAIDs (ibuprofen or naproxen) or starting paracetamol.
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A study carried out by researchers in Denmark looked at nearly 1,400,000 patients who were started on diclofenac between 1996 and 2016, as well as patients who were initiated on other types of NSAIDs and patients who weren't initiated on any NSAIDs.
"Diclofenac poses a cardiovascular health risk compared with non-use, paracetamol use, and use of other traditional nonsteroidal anti-inflammatory drugs", explain the authors.
Diclofenac was also associated with an increased rate of cardiac death and upper gastrointestinal bleeding.
The researchers said that despite the potential side effects, treatment with NSAIDs may be worthwhile for improving the quality of life of patients suffering from pain and inflammation.
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Specifically, the risk of such adverse cardiovascular events was 50 percent higher among those who started taking diclofenac, compared with those who did not take it. Researchers also said that the drug should come with an appropriate front package warning to inform users of its potential health risks.
However, researchers point out that, while the relative risk increased significantly, the overall risk was still pretty small.
However, the study's sample size is larger than most previous analyses of observational and randomised studies taken together and provides strong evidence to guide clinical decision making.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said in June 2013 that the drug should not be used by people with serious underlying heart conditions-people who had suffered heart failure, heart disease or a stroke were advised to stop using it completely.
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