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Clinical Question: In patient with Osteoarthritis and
Rheumatoid Arthritis, does lumiracoxib increase the risk of cardiovascular
events compare to Celecoxib (Celebrex),and rofecoxib (Vioxx)?
Bottom Line: Meta-analysis of 34,668 patients receiving
>/=1 week and up to 1 year of treatment found no evidence that lumiracoxib
was associated with a significant increase in CV risk compared with
naproxen, placebo, or all comparators (placebo, diclofenac, ibuprofen,
celecoxib, rofecoxib, and naproxen)
Reference: Clin Ther. 2005
Aug;27(8):1196-214.Cardiovascular safety of lumiracoxib: A meta-analysis of
all randomized controlled trials >/=1 week and up to 1 year in duration of
patients with osteoarthritis and rheumatoid arthritis.Matchaba P, Gitton X,
Krammer G, Ehrsam E, Sloan VS, Olson M, Mellein B, Hoexter G, Orloff J,
Garaud JJ.
Study Design: Meta-Analysis
Synopsis: The cardiovascular (CV) safety of non-steroidal
anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitors
has been the subject of considerable debate. This study was to determine the
risk of CV events with lumiracoxib by meta-analysis of all completed,
randomized controlled trials (RCTs) of >/=1 week and up to 1 year in
duration of patients with osteoarthritis and rheumatoid arthritis. The
Novartis Lumiracoxib Clinical Trial Database, which includes all clinical
studies conducted to date with lumiracoxib, was reviewed. Data were
extracted from RCTs of >/=1 week and up to 1 year in duration, the maximum
study duration; 34,668 patients were included in standard and cumulative
meta-analyses. Twenty-two RCTs of lumiracoxib 100 to 1200 mg daily were
identified; 22,781 patients were included in 1-year trials. Mean age of the
patients was 61.5 years and 74% were female. More than 50% of the patients
in these studies had hypertension at baseline and 6% had diabetes.
Parameters analyzed were the Antiplatelet Trialists' Collaboration (APTC)
composite CV end point of myocardial infarction (MI), stroke (ischemic and
hemorrhagic), and CV death; MI alone; and stroke alone. Twenty-one of the 22
RCTs have been published. For all 3 parameters, relative risk (RR) was
calculated versus non-naproxen NSAIDs, naproxen, and placebo. The results
were as follows: for the APTC end point versus non-naproxen NSAIDs: RR 0.83,
95% CI, 0.46-1.51; versus naproxen: RR 1.49, 95% CI, 0.94-2.36; versus
placebo: RR 1.08, 95% CI, 0.41-2.86; for MI alone versus non-naproxen NSAIDs:
RR 0.80, 95% CI, 0.28-2.25; versus naproxen: RR 1.69, 95% CI, 0.82-3.48;
versus placebo: RR 1.27, 95% CI, 0.25-6.56; and for stroke alone versus
non-naproxen NSAIDs: RR 0.91, 95% CI, 0.35-2.35; versus naproxen: RR 1.42,
95% CI, 0.70-2.91; versus placebo: RR 0.59, 95% CI, 0.13-2.74. Cumulative
meta-analyses of lumiracoxib versus all comparators (placebo, diclofenac,
ibuprofen, celecoxib, rofecoxib, and naproxen) did not find any significant
differences in APTC, MI alone, or stroke alone.
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lumiracoxib, Vioxx,
Celebrex,
Celecoxib,
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rheumatoid-arthritis,
osteoarthritis,
diclofenac,
ibuprofen,
naproxen
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