Long-term high-dose use of painkillers such as ibuprofen or
diclofenac is "equally hazardous" in terms of heart attack risk as
use of the drug Vioxx, which was withdrawn due to its potential dangers,
researchers said on Thursday.
Presenting the results of a large international study into a
class of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the
researchers said high doses of them increase the risk of a major vascular event
- a heart attack, stroke or dying from cardiovascular disease - by around a
This means that for every 1 000 people with an average risk
of heart disease who take high-dose diclofenac or ibuprofen for a year, about
three extra would have an avoidable heart attack, of which one would be fatal,
the researchers said.
Links to heart risks
This puts the heart risks of generic NSAIDs on a par with a
newer class of NSAIDs known as COX-2 inhibitors or coxibs, which includes Vioxx
- a painkiller that US drug manufacturer Merck pulled from sale in 2004 because of
links to heart risks. Other drugs in the coxib class include cerecoxib, sold by
Pfizer under the brand name Celebrex, and etoricoxib, sold by Merck under the
brand name Arcoxia.
"What we are saying is that they (coxibs, ibuprofen and
diclofenac) have similar risks, but they also have similar benefits," said
Colin Baigent of the clinical trial service unit at Britain's Oxford
University, who led the study published in The Lancet medical journal on
He stressed that the risks are mainly relevant to people who
suffer chronic pain, such as patients with arthritis who need to take high
doses of painkillers - such as 150mg of diclofenac or 2400mg of ibuprofen a day
- for long periods."A short course of lower dose tablets purchased without
a prescription, for example, for a muscle sprain, is not likely to be
hazardous," he said.
Balancing risks and
The study team gathered data, including on admissions to
hospital for cardiovascular or gastrointestinal disease, from all randomized
trials that have previously tested NSAIDs. This allowed them to pool results of
639 randomized trials involving more than 300,000 people and re-analyze the
data to establish the risks of NSAIDs in certain types of patients. In contrast
to the findings on ibuprofen and diclofenac, the study found that high doses of
naproxen, another NSAID, did not appear to increase the risk of heart attacks.
The researchers said this may be because naproxen also has
protective effects that balance out any extra heart risks. Baigent said it was
important patients should not make hasty decisions or change their treatment
without consulting a doctor."For many arthritis patients, NSAIDs reduce
joint pain and swelling effectively and help them to enjoy a reasonable quality
of life," he said.
"We really must be careful about the way we present the
risks of these drugs."They do have risks, but they also have benefits, and
patients should be presented with all those bits of information and allowed to
make choices for themselves."Donald Singer, a professor of clinical
pharmacology and therapeutics at Britain's Warwick University, who was not
involved in the study, said its findings "underscore a key point for
patients and prescribers: powerful drugs may have serious harmful
effects. It is therefore important for prescribers to take into
account these risks and ensure patients are fully informed about the medicines
they are taking," he said in an emailed comment.