High doses of these common painkillers double the risk of heart failure, finds a new study.
By Lorie A. Parch
As every pain patient knows, non-steroidal anti-inflammatory drugs–better known as NSAIDs–are the backbone of pain relief. So any risks associated with these very common drugs–which include ibuprofen, naproxen, diclofenac, and COX-2 inhibitors (coxibs))–is definitely something to pay attention to. That’s why a new study from the medical journal The Lancet brings some disturbing news for regular NSAID users, especially those who take higher doses of this type of drug. NSAIDs work by inhibiting an enzyme that causes inflammation and pain.
The study was an analysis of over 600 clinical trials involving hundreds of thousands of patients that looked at NSAID use to see if there was a connection between taking the drugs and having a heart attack, a stroke, GI problems, or dying of a stroke or heart attack.
The findings were striking: For people who took COX-2 inhibitors or diclofenac, the risk of having a non-fatal heart attack or stroke, or vascular death rose by about one-third. Ibuprofen also significantly raised the chances of having a “major coronary event,” meaning a non-fatal heart attack or coronary death.
“The risk of [congestive] heart failure was roughly doubled by all NSAIDs,” wrote the study authors, and all the drugs raised the risk of upper GI complications, such as a bleeding ulcer.
Previous studies have shown that COX-2 pain relievers increase the risk of heart problems and stroke, which led to the removal of Vioxx (rofecoxib) from the market in 2004. In 2005, the Food and Drug Administration asked drugmakers to change product labels to include a boxed warning noting the drugs’ increased risk for heart problems and GI bleeding.
The new analysis also looked at dosage and found that taking more of these pain relievers was linked to increased risk of these serious side effects: “This new study now shows that higher dose regimens of older NSAIDs, such as diclofenac (150 mg) and ibuprofen (2400mg) daily, are associated with similar risks of heart disease,” said the press release that accompanied the study’s release. Those who are at increased risk for heart disease–such as having had a heart attack, or having high blood pressure or cholesterol–are at particularly high risk. Among all the drugs reviewed, only higher doses of naproxen did not increase the risk for nonfatal heart attack, stroke, or vascular death (though as noted above, it did, along with all other NSAIDs, double the risk of congestive heart failure).
If there’s any reassuring news to be gleaned from the new research it may be that the analysis may make it easier to predict which patients are most at risk, allowing physicians to choose the best and safest regimen for their patients, says lead study author Professor Colin Baigent of the Clinical Trial Service Unit and Epidemiological Studies Unit, at the University of Oxford, UK.
Marie Griffin from Vanderbilt University Medical Center, in Nashville, noted in a comment accompanying the study that physicians and patients need a better understanding of the risks of lower doses of NSAIDs and of the risks to people who take the drugs long-term. Identification of safe and effective strategies for chronic pain is sorely needed,” she writes. “In the meantime, long-term use of high dose NSAIDs should be reserved for those who receive considerable symptomatic benefit from the treatment and understand the risks.