Sept. 5 (UPI) -- Diclofenac, a commonly used painkiller, was associated with an increased risk of major cardiovascular problems, including heart attacks and strokes, compared with no medication or other medication, according to a study in Denmark.
This is the first time the drug's cardiovascular risks were compared with those of other traditional non-steroidal anti-inflammatory drugs, or NSAIDs, including ibuprofen and naproxen, in large randomized controlled trials.
Diclofenac is a NSAID used for treatment of pain and inflammation with the brand names Voltaren, Cataflam and Zipsor. It is similar to ibuprofen or Motrin. The drug requires a prescription in the United States, though in other countries it is available over the counter.
The findings were published Tuesday in The BMJ.
"Treatment of pain and inflammation with NSAIDs may be worthwhile for some patients to improve quality of life despite potential side effects," the authors in Denmark wrote. "Considering its cardiovascular and gastrointestinal risks, however, there is little justification to initiate diclofenac treatment before other traditional NSAIDs."
The adverse event rate among diclofenac initiators increased 50 percent compared with non-medication users, 20 percent compared with paracetamol or ibuprofen initiators and 30 percent compared with naproxen initiators.
The study included more than 6.3 million adults with an average age of 46-49 in Denmark with at least one year of continuous prescription records from 1996 to 2016. The study included more than 1.37 million diclofenac users, 3.87 million taking ibuprofen, 291,490 using naproxen, 764,781 paracetamol users and 1.3 million using no pain relievers.
They found an increased rate of major adverse cardiovascular events within 30 days compared with starting other traditional NSAID or starting paracetamol. The incidents included irregular heart beat or flutter, ischaemic stroke, heart failure and heart attack.
Both men and women were at higher risk for heart problems, as were those taking low doses of the drug. The researchers add that while the relative risk for heart issues was seen to increase, the absolute risk for patients stayed low.