market, with nearly unanimous support for celecoxib but far narrower votes for rofecoxib
and valdecoxib, reflecting the strength of the data on the cardiovascular risks seen with those two drugs.
In contrast, rofecoxib
did not inhibit the growth of the prostate-tumor cells.
Using the selective serotonin reuptake inhibitors (SSRIs) and rofecoxib
as recent examples of drugs with serious adverse events that emerged after marketing, Dr.
Mean headache frequency declined from 5.6 during the 10-day baseline period to 2.6 with both doses of rofecoxib
, a significant difference, Dr.
(10) The safety profile of rofecoxib
and celecoxib in the long-term treatment of pain is not fully understood at this time.
Geba scrutinized the incidence of hypertension in 1,960 osteoarthritis patients treated with rofecoxib
, celecoxib, or acetaminophen in two randomized double-blind Merck-sponsored U.S.
In the current trial, patients were given either 25 mg/day of rofecoxib
, 200 mg of naproxen twice daily, or placebo.
Topol and his colleagues calculated that in the studies, heart attacks occurred at an annualized rate of 0.8 percent in people taking celecoxib and 0.74 percent of people taking rofecoxib
. The researchers contrast these rates with the 0.52 percent annualized heart attack rate among healthy people receiving placebos in trials testing aspirin's heart benefits, Topol says.
- The US Food and Drug Administration has granted an orphan drug designation, on a first cycle review, for TRM-201 (rofecoxib
), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), for the treatment of degenerative joint disease in patients with hemophilia, also known as hemophilic arthropathy, US-based pharmaceutical company Tremeau Pharmaceuticals, Inc said.
Overall, the risk was between 24 and 58 per cent higher if taking celecoxib, ibuprofen, diclofenac, naproxen or rofecoxib
, compared with not using the drugs.
The highest risk was found to be in the first month of taking the pills and to those on a high daily dose - such as more than 1,200mg of ibuprofen, 750mg of naproxen and 25mg rofecoxib
The Vioxx Gastrointestinal Outcomes Research (VIGOR) trial, published in 2000, was the first to raise concerns that NSAIDs (specifically, the COX-2 selective inhibitor rofecoxib
) might be associated with a higher risk for cardiovascular (CV) events.