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Researchers in the TARGET (Therapeutic Arthritis Research and Gastrointestinal Event Trial) study urge caution in giving cyclo-oxygenase (COX)-2 inhibitors and non-selective NSAIDs, especially ibuprofen, for osteoarthritis to patients at high cardiovascular (CVR) risk.
The trial suggests that these agents raise the risk, though a long term placebo controlled randomised trial is needed to assess their safety in high risk patients, especially as ibuprofen and naproxen are readily available over the counter.
In high risk patients, taking low dose aspirin and ibuprofen resulted in a significant increase in CVR events after one year compared with lumiracoxib (2.14% vs 0.25%). In high risk patients not taking aspirin naproxen was safer, resulting in no CVR events as against lumiracoxib (0% vs 1.57%), whereas the incidence of events with ibuprofen and lumiracoxib was similar. Furthermore, patients given ibuprofen, but not naproxen, developed congestive heart failure more often than those given lumiracoxib (1.28% vs 0.14%).
The international double blind study compared outcomes with high dose non-selective NSAIDs ibuprofen or naproxen versus high dose selective COX-2 inhibitor lumiracoxib in more than 18 000 patients aged 50 years and over with high CVR risk and primary osteoarthritis. The primary endpoint was CVR death, non-fatal myocardial infarction or stroke at one year and the secondary endpoint was congestive heart failure. Post hoc analysis was performed by baseline CVR risk, arthritis treatment and taking low dose aspirin.
CVR side effects of NSAIDs and COX-2 inhibitors are a major concern, but hard evidence from randomised trials in high risk patients is scarce.