Ibuprofen may affect heart in high-risk patients
Last Updated: 2007-04-05 15:05:01 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Compared to treatment with the COX-2 inhibitor lumiracoxib (Prexige), ibuprofen appears to increase the risk of congestive heart failure and blood clots in high-risk patients with osteoarthritis who take aspirin for cardiovascular protection, new research shows.
By contrast, in patients who don't use aspirin, naproxen seems to carry a lower risk of cardiovascular events than lumiracoxib does, according to the study published in the Annals of the Rheumatic Diseases.
A number of reports have linked use of COX-2 inhibitors and non-steroidal antiinflammatory drugs (NSAIDs) with an increased risk of cardiovascular events, lead author Dr. M. E. Farkouh, from the Mount Sinai School of Medicine in New York, and colleagues note.
However, few studies have compared the adverse cardiovascular effects of these drugs in patients who use aspirin because of a high risk of having a cardiovascular episode.
In the study, called the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), a total of 18,325 osteoarthritis patients were divided into two subgroups in which lumiracoxib was compared with ibuprofen or naproxen.
At the beginning of the trial, the patients were also stratified by the extent of their cardiovascular risk and aspirin use. The patients were followed for one year and the number of non-fatal heart attacks, strokes or deaths from cardiovascular disease were noted.
In high-risk patients who used aspirin, 2.4 percent of the ibuprofen-treated patients had one of these events compared with 0.25 percent of the lumiracoxib-treated patients. Treatment with naproxen or lumiracoxib in this group was associated with similar rates of one or more of these three cardiovascular events.
In high-risk patients not using aspirin, none of the patients on naproxen therapy had one of these cardiovascular events compared with 1.57 percent among those on lumiracoxib. In this group, the cardiovascular risk for ibuprofen and lumiracoxib was similar.
Ibuprofen resulted in a higher rate of congestive heart failure compared with lumiracoxib, but the rate associated with naproxen was similar to that seen with ibuprofen.
Because of the ongoing debate about the cardiovascular safety of NSAIDs and COX-2 inhibitors, further research concentrating on patients at high cardiovascular risk and on the interaction between aspirin and NSAIDs is warranted, the authors conclude.
The study was funded by Novartis AG, which has been marketing lumiracoxib as Prexige in the UK and elsewhere. The drug has yet to be approved for use in the U.S.
SOURCE: Annals of the Rheumatic Diseases, April 2007
