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More Evidence on Cardiovascular Risks of COX-2 Inhibitors, Other NSAIDs
This article recounts the findings of four studies on COX-2 inhibitors and other NSAIDS (along with an accompanying editorial) in the January 24 issue of the Archives of Internal Medicine.
The first study found that “patients taking warfarin [a blood thinner] concomitantly with selective Cox-2 inhibitors have an increased risk of hospitalization for upper GI hemorrhage,” although the “risk appears similar to that of patients simultaneously taking warfarin and non-selective NSAIDs.”
The second study found that after COX-2 inhibitors were introduced on the market there was a “rapid nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history [of safety]…by millions of people with little or nothing to gain from long-term use.” The study found that for doctor’s visits after which a COX-2 inhibitor or NSAID was prescribed, “the frequency of COX-2 inhibitor use increased from 35%” in 1999 to 61% in 2002.
The third study, an observational cohort “looking at the cardiovascular risk of COX-2 inhibitors compared with nonspecific NSAIDs” found that, overall, COX-2 use showed no significant effect on cardiovascular thrombotic events after treatment. “The investigators concluded that COX-2 inhibitors did not increase cardiovascular risk over nonnaproxen NSAIDS in this population.” (The population was “high risk”: 70% female, 50% African American, and 30% older than 50 years.)
The fourth study found that in patients with type 2 diabetes, hypertension, and osteoarthritis, “patients mean systolic blood pressure was increased significantly by rofecoxib…but not by celecoxib…or naproxen. Furthermore, the proportion of patients with controlled hypertension at baseline who developed ambulatory hypertension was significantly greater with rofecoxib (30%) than with celecoxib (16%), but not significantly greater with naproxen (19%).”
The editorial accompanying the studies concluded that “the current [FDA] postmarketing surveillance system does not work…The [FDA] will need to be more effective in requiring specially designed premarketing clinical safety trials when phase II or small phase III trials suggest reasons for specific concerns. Such a system should be rapidly responsive and objective, and safeguards to protect this agenda against industry influence must be put in place.”
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