What to Know About Merck's Vioxx Clinical Trial VIGOR
VIGOR [Vioxx GI Clinical outcomes Research] was a study initiated by Merck & Co. Inc. in January 1999 to evaluate the incidences of GI events that included, but were not limited to, obstructions or bleeding (PUB) in the upper gastrointestinal tract. The study included 8076 patients, of which 4047 were on 50mg twice daily of Vioxx, and 4029 patients received naproxen 500mg twice daily. Compared to naproxen, Vioxx reduced 54% of serious gastrointestinal events and 57% of complicated gastrointestinal events.
Even though it significantly reduced gastrointestinal events in comparison to naproxen, Vioxx also showed a significantly higher incidence of serious cardiovascular thrombotic events. The incidences occurred as soon as 4 months of chronic use of which there were 17 cardiovascular thrombotic adverse events. At the end of 8 and 10½ months there was an additional 12 and 16 cardiovascular thrombotic events respectively.
When the preliminary results for the VIGOR test were received by the FDA in 2000, new prescribing information was updated in April of 2002 of which included results from the VIGOR study and to add Rheumatoid Arthritis to the prescribing indication.
If you or a loved one has suffered due to a side effect of Vioxx, you can fill out this simple form for a free case review within 24 hours.
Weitz & Luxenberg is no longer accepting Vioxx cases.
see also:
APPROVe
What happens when Merck tests its own drug Vioxx? APPROVe happensRead about Vioxx's Clinical Trial APPROVe & see what Merck discovered
Alzheimer's Disease
Affected by Alzheimer’s Disease? Vioxx has been tested to helpWhat you should know about Alzheimer's Disease and Vioxx testing
Vioxx Clinical Trials
Want some history? See the Vioxx Clinical Trials & FDA Studies chartWhat you need to know about Vioxx - Clinical Trials & FDA Studies
