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   As of 4:56 p.m. EST Tuesday, December 21, 2004      
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Comparing the Studies


December 21, 2004 4:56 p.m.

Patients trying to make sense of the flood of news about painkillers must juggle and weigh the results of a half-dozen recent trials and studies. Below are the biggest and most-publicized reports, with details on how each was conducted and the findings.

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.

*Studies reviewed records of patients who had taken or were already taking the medications.

Sources: National Institutes of Health, National Cancer Institute, Pfizer, Merck, WSJ

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