Mexico. Agencies. – Diclofenac analgesic is associated with an increased risk of cardiovascular events, such as heart attack and stroke, compared to paracetamol and the use of other traditional analgesics, according to a study published by The BMJ (originally called British Medical Journal).
According to the study, the findings induce researchers to say that diclofenac should not be available without a prescription and, when prescribed, must be accompanied by an appropriate front label warning of its potential risks.
Diclofenac is a traditional nonsteroidal anti-inflammatory drug (NSAID) for treating pain and inflammation and is widely used worldwide. But its cardiovascular risks compared to other traditional NSAIDs have never been examined in large randomized controlled trials, and current concerns about these risks make these trials unethical.
A research team, led by Morten Schmidt, at Aarhus University Hospital in Denmark, examined the cardiovascular risks of starting treatment with diclofenac compared to non-NSAIDs, other traditional NSAIDs and paracetamol.
The results are based on national registry data for more than 6.3 million adults in Denmark with at least one year of continuous prescription records prior to study entry in January 1996. Participants were divided into low, moderate, and high initial cardiovascular risk. The average age was 46-49 years among participants who started NSAIDs and 56 years among those who started paracetamol.
After considering potentially influential factors, the initiation of diclofenac during the study period (1996-2016) was associated with a higher rate of major adverse cardiovascular events in 30 days compared to other traditional NSAIDs (ibuprofen or naproxen) or paracetamol. Events included irregular heartbeat or agitation, ischaemic stroke, heart failure and heart attack. The increased risks apply to men and women of all ages and also to low doses of diclofenac.
Betting first on other traditional NSAIDs
Starting with diclofenac was also associated with an increased rate of cardiac death compared to NSAIDs, and an increased risk of upper gastrointestinal bleeding compared to NSAIDs, ibuprofen or paracetamol, but not naproxen. The authors note that although the relative risk increased, the absolute risk remained low for the individual patient.
When the results were analyzed for initial cardiovascular risk, the absolute number of events per 1,000 diclofenac initiators per year also increased. For example, among patients with low initial risk, diclofenac initiators had one additional event versus ibuprofen, one additional event versus naproxen, three additional events versus acetaminophen, and four additional events versus NSAIDs.
Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite possible side effects,” they write. Considering their cardiovascular and gastrointestinal risks, however, there is little justification for starting diclofenac treatment earlier than other traditional NSAIDs.
The specialists commented that with reference to the results presented, it should not be sold over-the-counter in any country, nor consumed in an abusive manner without first consulting a physician who determines if it is necessary to use it.
The Yucatan Times