A new analysis shows that some popular nonsteroidal pain killers are just as likely to increase the risk of heart attacks as the Cox-2 inhibitors, two of which were removed from the market.
Researchers described the risk as “modest” for people who do not already have heart or vascular disease.
Prior to the fall of 2004, three Cox-2 inhibitors — Vioxx, Celebrex, and Bextra — were sold by prescription in the U.S. The Cox-2 inhibitors are a newer type of nonsteroidal painkiller. They were considered safer than traditional nonsteroidal anti-inflammatory (NSAID) pain relievers because of a lower risk for stomach bleeding and ulcers.
But concerns about heart attack and stroke risk led to the removal of Vioxx and Bextra from the market. Only Celebrex remains.
There is still widespread confusion about just how risky these drugs really are, compared with traditional NSAIDS.
Absolute Risk ‘Small’
Researchers from the United Kingdom and Italy combined data from 138 clinical trials involving 140,000 patients in an effort to give a more comprehensive picture of risk than has been previously available.
Their findings are published in the June 3 issue of the BMJ (British Medical Journal).
As expected, Cox-2 inhibitors were associated with an increased risk of vascular events, mostly due to a twofold increase in heart attack risk among users.
But researcher Colin Baigent, MD, of the University of Oxford in England, tells WebMD that the absolute risk for people without pre-existing cardiovascular disease is relatively small. Risk among people with heart and vascular disease could not be assessed because they are generally excluded from clinical trials.
Cox-2 inhibitor use was associated with roughly three additional heart attacks or other vascular events each year for every 1,000 users.
The degree of risk is similar to that seen with regular aspirin or nonsteroidal pain reliever use and bleeding stomach ulcers, Baigent says.
“These risks must be kept in perspective,” he adds. “In an absolute sense they can be considered modest and comparable to the sorts of risks that we deal with every day with other commonly used drugs.”
Better Cox-2 Studies Needed
Some of the studies included in the analysis compared Cox-2 inhibitors with placebo and others compared them with traditional nonsteroidal anti-inflammatory drugs (NSAIDS).
Two of these drugs — ibuprofen (sold as Advil, Motrin, and Nuprin) and diclofenac (sold as Cataflam, Voltaren, and VoltarenXR) — were found to have a similar cardiovascular risk profile when used in high doses as that seen with the Cox-2s.
A smaller cardiovascular risk was seen in people taking the NSAID naproxen (Aleve, Naprosyn).
Baigent says it is clear from the analysis that more rigorously designed clinical trials are needed to better understand the cardiovascular risks associated with long-term Cox-2 and traditional NSAID use.
People with arthritis and other chronic pain sufferers should discuss their pain relief options with their doctors, he says.
In an editorial accompanying the report, Tufts University professor of public health Allen Shaughnessy, PharmD, called on doctors to explore a wide array of traditional and nontraditional approaches to pain relief with their patients — especially with older patients who often live with chronic pain.
Shaughnessy suggests that acupuncture and other alternative approaches be tried in treating pain in older people.
“Patients may not have to live with pain if they can live with the solutions that we explore with them,” he wrote.
SOURCES: Kearney, P.M. BMJ, June 3, 2006; vol 332: pp 1302-1305. Colin Baigent, MD, reader in clinical epidemiology, Clinical Trial Service Unit, University of Oxford, Oxford, U.K. American Heart Association statement on pain medications, March 22, 2005. Allen F. Shaughnessy, PharmD, adjunct professor of public health and family medicine, Tufts University, Malden, Mass.