The approval was based on a 12-week randomized, double-blind study of 310 children and adolescents to assess the efficacy and safety of low- and high-dose
rofecoxib regimens compared with a naproxen regimen.
Los nuevos medicamentos para controlar el dolor cronico buscan reducir los efectos secundarios a nivel gastrointestinal como gastritis y ulceras, tal es el caso del
rofecoxib, que aun en dosis altas protege el sistema digestivo.
The good news is that a new study published in the Archives of Internal Medicine compared the efficacy and tolerability of the old with the new--ibuprofen (COX-1 and -2) and
rofecoxib (COX-2 only).
The non-selective NSAID diclofenac was associated with early onset risk similar to the selective COX-2 inhibitor
rofecoxib.
Data were available for naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib,
rofecoxib, and lumiracoxib.
The safety of
rofecoxib versus naproxen was assessed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) (2) trial in patients with RA who were not taking aspirin.
1) This randomised controlled trial reported a 50% reduction in serious gastrointestinal side-effects, but a 5-fold increase in thromboembolic cardiovascular events (primarily acute MI) in patients taking
rofecoxib 50 mg daily compared with naproxen 1 000 mg daily at 9 months.
Ever since reports of sudden heart attack and stroke prompted
rofecoxib (Vioxx) and valdecoxib (Bextra) to be taken off the market, other nonsteroidal anti-inflammatory drugs (NSAIDs) have been living under a shadow.
Although celecoxib is an effective NSAID,
rofecoxib and lumericoxib are the only COX-2 selective inhibitors that definitively reduce gastrointestinal (GI) ulcerations/complications compared with nonselective NSAID therapy.
All the media attention has focused on the COX-2-selective inhibitors as the drugs that cause heart attacks, but when you look at the coxibs compared to noncoxibs--and this is very important--it turns out the coxibs do not cause heart attacks any more than the non-COX-2 drugs, except for
rofecoxib (Vioxx), which has a higher rate than all the other noncoxibs.
Leading up to the results of the adenoma prevention trial, the preponderance of evidence supported the notion that celecoxib (Celebrex) does not increase the risk of MI, but that
rofecoxib (Vioxx), now removed from the market, does.
Vioxx, which has the scientific name
rofecoxib, was prescribed to 400,000 patients in the UK and belongs to a family of drugs known as Cox-2 inhibitors.
