Sept 99
The Food and Drug Administration recently approved
two new drugs in the new class of anti-inflammatory agents called COX-2
inhibitors. The drugs, Celebrex (celecoxib) and Vioxx (rofecoxib) are
anti-inflammatory drugs that work like many of the existing drugs, called
NSAIDs, which stands for non-steroidal anti-inflammatory drugs. However, there
is one very significant difference with Celebrex and Vioxx: the incidence of
gastrointestinal ulcerations is not far from that of placebo, about 2-3%, as
opposed to other NSAIDs in which ulceration occurs at about a 16% rate. This is
tremendous news for those at risk for gastrointestinal ulceration/bleeding from
the use of NSAIDs yet need relief from pain and inflammation associated with
osteo- or rheumatoid arthritis where using more traditional NSAIDs was
contraindicated.
Although the FDA has placed a warning that Celebrex and Vioxx are still
associated with ulcers, the clinical data thus far show a rate that is far
lower than other NSAIDs. For example, in one study, in comparison to placebo
and Naprosyn 500mg twice daily, the following percent incidence of ulcerations
occurred: Placebo- 2.3 and 2%; Celebrex- 3.4 and 3.1%; and Naprosyn- 16.2 and
17.6%. As you can see, there is a very low incidence of ulcerations in both the
placebo group and the Celebrex group. There is other data available with
similar findings.
Celebrex can be used in osteoarthritis for pain relief at doses of 100mg twice
daily or 200mg once daily with no further benefit of doses over 200mg daily.
Celebrex can be taken without regard to meals. Common side effects are stomach
upset, nausea, diarrhea, flatulence. Celebrex is effective in managing pain and
inflammation in those with rheumatoid arthritis. The effective daily dose may
need to be higher than in those with osteoarthritis, up to 400mg daily as
divided doses. E.g. 200mg twice daily.
For the treatment of osteoarthritis, 12.5-25 mg of Vioxx taken once daily is
recommended. Side effects may include: dizziness, heartburn, tinnitus, among
others. No anaphylactic reactions have been reported.
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