|
......................m.........................
Specific guide to this web site for:
1. Medical
School
Educators
in
Statistics
2. Medical Students
3. Science media writers
4. High School & College
Statistic Teachers
Misadventures:
1. Harvard led MI study
2. JACC
study
(J. of Amer. Coll.
Cardio.)
3. NEJM
cath study
4. Amer. J. of Cardio.
review of literature
5. ALLHAT
controversy
6. Oat bran study
7. Pregnancy & Alcohol
8. Are Geminis
really
different?
9. Columbia 'Miracle' Study
Additional
Topics:
Celebrex
Limitations of Meta-Analyses
Large Randomized Clinical
Trials
Tale of Two Large
Trials
Advocate
meta-analyses
Network
meta-analyses
| |
back
The initial JAMA article consisted of an analysis of the
data and implications of two prior randomized trials.
The JAMA article did not study any new patients, but was an article
evaluating and trying to synthesize data from the two previously published
trials.
The
VIGOR trial1
was a randomized trial comparing Vioxx (rofecoxib)
to naproxen (a generic version of Naprosyn) in 8000 patients with rheumatoid
arthritis to assess for the occurrence of gastrointestinal toxicity. The trial
unexpectedly showed a higher event rate of adverse cardiovascular events such as
heart attacks in the group treated with Vioxx.
Patients requiring aspirin for cardiac events were excluded.
Aspirin use was avoided in either treatment arm of the trial as per trial
protocol.
The
CLASS trial2 was a randomized trial comparing Celebrex (celecoxib)
to ibuprofen (a generic form of Motrin) or diclofenac (a generic form of
Cataflam) in a different 8000 patients. The
CLASS trial publication in 2001 showed no significant difference in cardiovascular event rates
between Celebrex and ibuprofen and diclofenac. Aspirin use was permitted as long
as limited to a regular strength aspirin (325mg) or less.
1.
Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal
toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl
J Med. 2000; 343:1520-1528
2.
Silverstein F, Faich G Goldstein J, et al. Gastrointestinal Toxicity with
celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and
rheumatoid arthritis, the CLASS Study: a randomized controlled trial. JAMA. 2000; 284:1247-1255.
back
|
