Re: Gout from Lipitor damage? NAPROXEN increases heart attack risk. BEWARE

From: Frankie (birm47_at_gmail.com)
Date: 12/25/04 

Date: 25 Dec 2004 13:53:36 -0800

Source: http://www.nih.gov/news/pr/dec2004/od-20.htm

The trial that started the chain of events:
Alzheimer's Disease Anti-Inflammatory Prevention Trial [ADAPT]
ADAPT was launched Jan 31, 2001, sponsored by NIA.

QUOTE: Data from the ADAPT trial indicated an apparent increase
in cardiovascular and cerebrovascular events among the participants
taking naproxen when compared with those on placebo. END QUOTE
*******************************************************************
Source: http://www.alz.org/news/04q4/122104.asp

QUOTE: The suspension came after data from the Alzheimer's
Disease Anti-Inflammatory Prevention Trial (ADAPT) linked
naproxen to an increased risk of "heart attack" and "stroke".

FDA officials called the situation with regard to NSAID safety
"confusing." The agency is in the process of reviewing all
available
data about the drugs and will hold a meeting in February to discuss
future regulatory implications. END QUOTE
*******************************************************************
"hold a meeting in Februrary" ????
What's wrong with now???
*******************************************************************
Source: http://www.nia.nih.gov/
I was shocked not to see any info at all as to the latest status of
the ADAPT Trials, as NIA sponsors this trial.
*******************************************************************
Naproxin Info
Source: http://www.drugs.com/naproxen.html
Who should not take naproxen?
· Before taking this medication, tell your doctor if you
· have an allergy to aspirin or any other NSAIDs
· have an ulcer or bleeding in your stomach
· drink more than three alcoholic beverages a day
· have liver disease
· have kidney disease
· have a coagulation (bleeding) disorder
· have congestive heart failure
· have fluid retention
· have heart disease
· have high blood pressure
*******************************************************************
ADAPT
Source: http://clinicaltrials.gov/show/NCT00007189

ADAPT Trial Exclusion Criteria:

History of peptic ulcer disease with bleeding or obstruction.
Clinically significant liver or kidney disease.
History of hypersensitivity to aspirin, ibuprofen, celecoxib,
naproxen, or other NSAIDs.
Use of anti-coagulant medication.
Cognitive impairment or dementia.
Current alcohol abuse or dependence
*******************************************************************
My analysis of the info above....

Individuals that should not even take naproxin:
CHF, heart disease and high BP

YET, these individuals were not even considered in those
that should be excluded from the ADAPT trial. The only
exclusion pertained to "anti-coagulant medication".
Seems this trial was doomed from the onset.

Frankie

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