Research presented at this week's meeting of the American Heart Association concerning the post-MI use of COX-2s adds little new information to the ongoing controversy about the cardiovascular safety of NSAIDs, Dr Gail Cawkwell, Senior Medical Director, Arthritis, Pain and Musculoskeletal, Pfizer, told PharmaTimes Newsonline.
“The Danish researchers did not find an increased risk of a second heart attack with any of the COX-2 inhibitors or other NSAIDs studied. What they did find was that all NSAIDs increased risk of death when prescribed after an acute MI.”
However, Dr Cawkwell said it was unclear what patients in the study had died from, what the putative relationship with treatment might be, and whether confounders such as disease severity might play a role. She also commented that the cut points used to classify 'high' and 'low' NSAID doses in the Danish study did not reflect doses widely used in clinical practice.
Dr Cawkwell was speaking at the American College of Rheumatology meeting, held in San Diego, California. Data presented there today from a meta-analysis of 41 randomized clinical studies of Pfizer's Celebrex (celecoxib) versus both placebo and non-selective NSAIDs in more than 44,300 patients show that patients taking celecoxib had no more risk for heart attack, stroke, or cardiovascular death combined, than those given placebo or non-selective NSAIDs.
There were no significant differences in the number of strokes among patients given celecoxib or placebo, however, there were significantly more strokes among patients taking ns-NSAIDs than those treated with celecoxib. When evaluated against people taking placebo, people taking celecoxib had no significant difference in the number of heart attacks.
“This meta analysis suggests that all NSAIDs - selective and nonselective - carry similar levels of cardiovascular risk - we feel there is a level playing field,” said Dr Cawkwell.
Data from the US NIH-sponsored GAIT Study comparing glucosamine hydrochloride with celecoxib, also presented at the ACR, showed that only Celebrex met the primary efficacy endpoint and that the safety of the COX-2 inhibitor was indistinguishable from that of the dietary supplements, she added.
Source: Ian Mason at the ACR, San Diego, USA.