Researcher/ Study name
|
Drugs Tested (all vs. placebo)
|
Studying
|
Subjects
|
Length of Study
|
Released
|
Findings
|
Outcome
|
FDA and Kaiser Permanente/no name*
|
Celebrex, Vioxx and other NSAIDs
|
Occurrence of heart problems in patients taking painkillers (NSAIDs)
|
1.4 million Kaiser patients who had taken one of the NSAIDs vs. patients who hadn't
|
n.a.
|
August 2004
|
Patients who had taken doses of Vioxx higher than 25 mg a day were 3.15 times as likely to have a heart problem.
|
Kaiser begins reconsidering covering Vioxx costs for its member patients.
|
Merck/Adenomatous Polyp Prevention on Vioxx (Approve)
|
25 milligrams of Vioxx once daily
|
Whether Vioxx could prevent recurrence of colorectal polyps
|
2,600 patients
|
Started in 2000. Patients to participate for three years from enrollment.
|
Sept. 30, 2004
|
Increased risk for confirmed cardiovascular events, such as heart
attack and stroke, started after 18 months of treatment in the patients
taking Vioxx compared to those taking placebo. |
Merck pulls Vioxx from market.
|
Pfizer/no name*
|
Bextra
|
Bextra's results in heart-surgery patients
|
1,500 patients after coronary bypass surgery
|
n.a.
|
Dec. 9, 2004
|
Increased risk of heart problems (including heart attacks, strokes,
blood clots in the legs and lungs) and potentially fatal skin
reactions. |
FDA orders new "boxed" warning on Bextra labels
|
Pfizer/Prevention of Spontaneous Adenomatopus Polyps (PreSAP)
|
400 milligrams of Celebrex once a day
|
Whether Celebrex could prevent polyps from progressing to colon cancer
|
1,500 patients
|
Started in 2001
|
Dec. 17, 2004
|
1.8% of placebo patients either died from cardiovascular disease or
suffered a heart attack or stroke compared with 1.7% of those taking
400 mg of Celebrex once a day. |
Pfizer advises patients to seek doctors' advice.
|
National Cancer Institute/Adenoma Prevention with Celecoxib (APC)
|
Celebrex (200 milligrams twice a day) vs. Celebrex (400 mg twice a day)
|
Whether Celebrex could prevent colon cancer
|
More than 2,000 patients
|
Started in 1999. Each patient to participate for three years from enrollment.
|
Dec. 17, 2004
|
0.9% of placebo patients had suffered a serious event, compared with
2.2% of those on 200 mg of Celebrex twice a day, and 3% of those on 400
mg twice a day. |
Pfizer advises patients to seek doctors' advice.
|
National Institutes of Health/Alzheimer's Disease Anti-Inflammatory Prevention Trial (Adapt)
|
Naproxen (Aleve) (220 milligrams twice a day) vs Celebrex (200 mg twice a day)
|
Whether certain drugs could help prevent Alzheimer's
|
About 2,400 patients
|
Started in 2001. Each patient to participate up to three years from enrollment.
|
Dec. 20, 2004
|
Patients taking naproxen had a 50% higher rate of cardiovascular events
compared to those on placebo. Those on Celebrex had about the same
number as the placebo patients. |
FDA advises limited use and close adherence to label.
|