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Letters to the Editor
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COX-2s
What is the POEM evidence for celecoxib?
From Mr P. D. Burrill, MRPharmS
I wish to respond to the letter from Chris
Walker, of Pfizer Ltd
(PJ, 24/31December 2005, p773). His letter is similar to one published
in the BMJ of 17 December (p1473) from Joe Feczko, chief medical officer
at Pfizer, New York. Both these letters claim that celecoxib has a
lower risk of gastrointestinal complications than competitors. Unfortunately,
they rely on observational studies to support their claim and appear
to be ignoring the randomised controlled trial data.
Observational studies occupy a lower place on the hierarchy of evidence
than a large, prospective RCT measuring patient-oriented outcomes.
Our colleague from the National Prescribing Centre, Jonathan Underhill,
responded to the letter from Dr Feczko (ibid, p1474) and, for the benefit
of readers who may not have seen it, the following abstract should prove
informative: “The only POEM evidence for celecoxib is the CLASS
study. CLASS showed no significant difference between celecoxib and the
comparators (diclofenac and ibuprofen) in terms of the primary outcome
of the study — gastrointestinal ulcer complications. Only when
a post-hoc sub-group analysis of these data was performed in those not
taking aspirin was a significant benefit seen (with a P value of 0.04).
This was one of over 34 post hoc analyses performed on this study (so,
by chance, we would expect at least one of these to show a difference
with a P value slightly less than 0.05). Others have recently highlighted
the folly of post hoc subgroup analyses where the primary end point does
not show a significant difference.
“The regulators in the USA and in Europe have concluded that the
data from the CLASS study do not show a meaningful benefit for celecoxib
.
… That the prescribing of this drug continues to increase despite
the lack of good quality evidence for its usefulness in providing a benefit
to patients is disappointing.
“Perhaps we should stop arguing about the wording of the conclusions
of hypothesis generating data (like those of Hippisley-Cox et al). Although
such data are interesting, they do not inform our practice in the same
way that a negative prospective randomised controlled trial does.”
Peter Burrill
Assistant Director of Public Health
North Derbyshire Public Health Network
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The
Pharmaceutical Journal