A common pain killer has serious heart risks, study finds

A new, commonly used painkiller could be too risky for people to continue taking, suggests a new study published this week in the BMJ. It revealed that people who use diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), are more likely to suffer from cardiovascular disease than people who take other NSAIDs or have them. acetaminophen.

Diclofenac is sold under different brands, including Voltaren, Cambia and Solaraze, over-the-counter and prescription. While the drug may not be as well-known as other NSAIDs in the US, such as ibuprofen, it's actually one of the most popular and recommended drugs in the world, in both developing and developed countries. Diclofenac is classified as an essential drug in more than 70 countries, according to a 2013 study.

For years, doctors have worried about potential heart risks of diclofenac. Some research has suggested that the drug may increase the risk of cardiovascular complications, such as rofecoxib, a nonsteroidal anti-inflammatory drug (NSAID), now called Vioxx, which was withdrawn from the market in 2004, five years after its approval. Since it would probably be unethical (and costly) to carry out this type of large-scale randomized trial that could definitely confirm these suspicions, the Danish researchers behind the new paper opted for a type of unique study.

With the help of national population registers and prescription drugs, they were able to consult the medical records of more than 6 million Danish adults from 1996 to 2016. They then used this data to simulate hundreds of clinical trials. For example, they looked at people who reported taking diclofenac in 1996, then followed their health status for the next 12 months, comparing them to people who were taking other NSAIDs. acetaminophen or nothing at all.

When we averaged all of these simulated trials, people who took diclofenac were 50% more likely to have cardiovascular problems in the first 30 days following use than people did. Having nothing taken. They were also twice as likely to develop problems as those taking other NSAIDs or acetaminophen. The relatively increased risk was observed in all areas, including those who took a lower dose and those who had no history of cardiovascular disease. The use of diclofenac as a whole was also associated with a higher risk of gastrointestinal bleeding than most other NSAIDs and acetaminophen, but its risk was similar to that of naproxen NSAIDs (commonly sold under the name of Aleve).

"It's time to recognize the potential health risk of diclofenac and reduce its use," the authors wrote.

Although the figure of 50% is alarming, it should be kept in mind that the absolute risk remains relatively low. According to the study, out of 1,000 people who take diclofenac and have a low risk of cardiovascular disease, four more people would develop a major health problem in one year, one of which would be fatal (compared to people taking no medication ). For people at high risk of cardiovascular disease, this number would reach 40, with half of the deaths.

The study is also based on observational data, so it can not directly prove that diclofenac is a problem. However, in view of other research showing a similar increased risk, the authors clearly indicate that diclofenac should be handled with greater care, if it is not completely eliminated.

"The treatment of pain and inflammation with NSAIDs may be helpful for some patients to improve the quality of life despite potential side effects," they wrote. "However, given its cardiovascular and gastrointestinal risks, there is little justification to initiate treatment with diclofenac before other traditional NSAIDs."

They suggested banning diclofenac as an over-the-counter drug and only prescribing it with a warning label. Scientists should also avoid using diclofenac as a point of reference for comparing other NSAIDs and painkillers against safety testing, given its unique risks, they said.