Issue 2010/056 Title Cyclooxygenase-2 Selective Non-Steroidal Anti-Inflammatory Drugs (Etodolac, Meloxicam, Celecoxib, Rofecoxib, Etoricoxib, Valdecoxib and Lumiracoxib) for Osteoarthritis and Rheumatoid Arthritis: A Systematic Review and Economic Evaluation Agency NETSCC, HTA, NIHR Evaluation and Trials Coordinating Centre Alpha House, University of Southampton Science Park, Southampton, SO16 7NS, United Kingdom; Reference Volume 12.11. ISSN 1366-5278. www.hta.ac.uk/project/1383.asp Recommendations
To review the clinical and cost effectiveness of cyclo -
This report summarizes the best available evidence and
oxygenase-2 (COX-2) selective nonsteroidal antiinflam-
discusses its implications, but does not make recom-
matory drugs (NSAIDs) for osteoarthritis (OA) and
mendations about policy or clinical care. Conclusions and results
Systematic reviews of randomized controlled trials and
The COX-2 selective NSAIDs examined in this report
a model-based economic evaluation were undertaken.
(ie, etodolac, meloxicam, celecoxib, rofecoxib, valde-
Electronic databases were searched up to November
coxib, etoricoxib, and lumiracoxib) were found to be
2003. Industry submissions to the National Institute
similar to nonselective NSAIDs for the symptomatic
for Health and Clinical Excellence in 2003 were also re-
relief of RA and OA and to provide superior gastrointes-
viewed. Meta-analyses were undertaken for each COX-2
tinal (GI) tolerability (most evidence is in patients with
selective NSAID compared with placebo and nonselec-
OA). Although COX-2 selective NSAIDs offer protec-
tion against serious GI events compared to nonselective
NSAIDs, the amount of evidence for this protective ef-
Further research/reviews required
fect varied considerably across individual drugs. The
With reduced costs of PPIs, future primary research
volume of trial evidence with regard to cardiovascular
needs to compare the effectiveness and cost effective-
safety also varied substantially between COX-2 selec-
ness of COX-2 selective NSAIDs relative to nonselective
tive NSAIDs. Increased risk of myocardial infarction
NSAIDs with a PPI. Direct comparisons of different
(MI) compared to nonselective NSAIDs was observed
COX-2 selective NSAIDs, using equivalent doses that
among those drugs with greater volume of evidence in
compare GI and MI risk are needed. Pragmatic studies
terms of exposure in patient-years. Subgroup analyses of
that include a wider range of people, including the older
clinical and complicated upper GI events and MI events
age groups with a greater burden of arthritis, are also
related to aspirin use, steroid use, prior GI history, and
Helicobacter pylori status were based on relatively small
numbers and were inconclusive. Economic modeling
shows a wide range of possible costs per quality-adjusted
life year (QALY) gained in patients with OA and RA.
Costs per QALY varied if individual drugs were used in standard- or high-risk patients, the choice of nonselective
NSAID comparator, and whether NSAID was com-
bined with a proton pump inhibitor (PPI). When the
model was run using ibuprofen or diclofenac combined
with a PPI as the comparator, the results changed sub-
stantially, with the COX-2 selective NSAIDs looking
generally unattractive from a cost-effectiveness stand-
point. See Executive Summary link at www.hta.ac.uk/
Written by Dr Yen-Fu Chen, University of Birmingham, NETSCC, United Kingdom
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