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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






 

 

 

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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.

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