Non-steroidal anti-inflammatory drugs (NSAIDs) are a class of drugs widely prescribed to arthritis sufferers. Among this class of drugs are those that were designed to specifically inhibit the cyclooxygenase (cox-2) enzyme which is involved in inflammation. Cox-2 inhibitors include Vioxx, Bextra and Celebrex.
Vioxx was approved by the FDA in 1999 for use in treating osteoarthritis. In 2001 Merck, the maker of Vioxx, began a 3 year study involving 2,587 people to show that Vioxx, which caused fewer gastrointestinal problems that older NSAIDs, could prevent the recurrence of colon cancer. However, Merck terminated the study 2 months early when the analysis of the data showed a doubled risk of heart attack and other cardiovascular issues, including death, in the study group receiving Vioxx over the placebo group.
Merck pull Vioxx from the market several months later on September 30th, 2004.
A follow up study was conducted to determine the lingering effects of long term use of Vioxx. This study was funded by Merck, which also provided the data, but was conducted independently. This analysis found that during the year following the halt of the 2004 study the risk of heart attack was 94% higher for those that took Vioxx (34) over those that took the placebo (18). They also found that the risk of stroke was more that double for the Vioxx group (19) over the placebo group (9).
In all, 76 Vioxx users suffered a stroke, heart attack, blood clot or died compared to 46 in the placebo group during that follow-up year.
Results of this study were published October 14th in the British medical journal The Lancet.
Merck issued the following statement in response to the Lancet study: “Merck believes that this post-hoc analysis using limited data from a prematurely terminated study needs to be interpreted very cautiously and in the context of the rest of the data from the extensive clinical development program for Vioxx.”
To be fair, it must be restated that older NSAIDs, such as naproxen and , also carry cardiovascular risks, along with risks of stomach bleeding and other complications.
Of the three cox-2 inhibitors, only Celebrex, manufactured by Pfizer, is still available in the U.S.
Originally posted 2008-10-20 15:12:28. Republished by Blog Post Promoter
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Vioxx was approved by the FDA in 1999 for use in treating osteoarthritis. In 2001 Merck, the maker of Vioxx, began a 3 year study involving 2,587 people to show that Vioxx, which caused fewer gastrointestinal problems that older NSAIDs, could prevent the recurrence of colon cancer. However, Merck terminated the study 2 months early when the analysis of the data showed a doubled risk of heart attack and other cardiovascular issues, including death, in the study group receiving Vioxx over the placebo group.
Merck pull Vioxx from the market several months later on September 30th, 2004.
A follow up study was conducted to determine the lingering effects of long term use of Vioxx. This study was funded by Merck, which also provided the data, but was conducted independently. This analysis found that during the year following the halt of the 2004 study the risk of heart attack was 94% higher for those that took Vioxx (34) over those that took the placebo (18). They also found that the risk of stroke was more that double for the Vioxx group (19) over the placebo group (9).
In all, 76 Vioxx users suffered a stroke, heart attack, blood clot or died compared to 46 in the placebo group during that follow-up year.
Results of this study were published October 14th in the British medical journal The Lancet.
Merck issued the following statement in response to the Lancet study: “Merck believes that this post-hoc analysis using limited data from a prematurely terminated study needs to be interpreted very cautiously and in the context of the rest of the data from the extensive clinical development program for Vioxx.”
To be fair, it must be restated that older NSAIDs, such as naproxen and , also carry cardiovascular risks, along with risks of stomach bleeding and other complications.
Of the three cox-2 inhibitors, only Celebrex, manufactured by Pfizer, is still available in the U.S.
Originally posted 2008-10-20 15:12:28. Republished by Blog Post Promoter