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More side effects with rofecoxib than with celecoxib?
Rofecoxib (Vioxx) might be more likely to cause oedema and changes in
blood pressure than celecoxib (Celebrex), according to researchers from
America. However, questions have been raised over the equivalence of the
doses used in the study.
Dr Andrew Whelton (Johns Hopkins University School of Medicine, Baltimore)
and colleagues conducted a six-week study to compare the effects of celecoxib
and rofecoxib on the heart and kidneys of patients aged over 65 years
who had hypertension and osteoarthritis.
They say that, although both drugs caused significant oedema and changes
to blood pressure, these side effects were more likely to occur in patients
treated with rofecoxib. The finding that celecoxib was associated
with a lower incidence of cardiorenal events compared with rofecoxib,
especially with regard to hypertension, should be considered when selecting
a cyclo-oxygenase 2-specific inhibitor for the treatment of osteoarthritis,
they say.
The trial involved 811 subjects, 412 of whom received celecoxib 200mg
daily and 399 rofecoxib 25mg daily. The British National Formulary states
that the recommended doses for osteoarthritis for celecoxib is 200mg (maximum
400mg) daily and for rofecoxib is 12.5mg (maximum 25mg) daily.
Significant oedema occurred in 9.5 per cent of patients who received rofecoxib
compared with 4.9 per cent of those taking celecoxib. In addition, 16.5
per cent of patients treated with rofecoxib experienced an increase in
systolic blood pressure of more than 20mmHg compared with 10.9 per cent
of those taking celecoxib. However, more patients in the celecoxib group
were also receiving angiotensin converting enzyme inhibitors than in the
rofecoxib group, although the authors say this did not affect blood pressure
changes.
The overall number of patients who experienced side effects was similar
in both groups and the number of withdrawals from the study because of
adverse events was the same (9 per cent). The paper is published in the
American Journal of Therapeutics 2001; 8:85).
A spokeswoman for Merck, Sharp & Dohme, manufacturers of rofecoxib,
told The Journal on April 11 that the study compared rofecoxib's
highest dose for osteoarthritis with celecoxib's lowest dose. In addition,
the oedema endpoint was assessed using a non-validated technique, with
no baseline measurements. The potential for changes in renal function,
including sodium retention, oedema and increased blood pressure was reflected
in the prescribing information for rofecoxib, celecoxib and other non-steroidal
anti-inflammatory drugs, she said.
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