Drug development (an overview with real drugs, Vioxx)
7 important questions on Drug development (an overview with real drugs, Vioxx)
What three kind of reactions do NSAIDS have?
- analgesic effect
- antipyretic effect
What is the difference between COX-1 and COX-2 inhibition?
COX-1 is also more involved in house-keeping and it is constitutive in contrary to COX-2. COX-2 is inducible and it is involved with cancer and inflammation
How is the mechanism of action of aspirin?
- acetylation of COX-1 creates a steric block that prevents the binding of arachidonic acid at the cyclooxygenase active site.
- acetylation of COX-2 retains the cyclooxygenase activity although the reaction produces a novel product 15-R-HETE.
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What is the history of Vioxx?
After Vioxx was released on the drug market a research group was set up named VIOGOR (VIOXX gastrointestinal Outcomes research). This study group reported about the risks but the company did not mention those data in the sales.
What is the story of COX-2 inhibitors?
In 1998 the Vioxx NDA was large.
There were no cardiovascular signals in the clinical trials, but there were prothrombotic effects signalized.
Vioxx was approved in 1999 in 47 countries.
Then in 2000 the VIOGOR trial and several other trials started. The found lots of evidence that Vioxx induced cardiovascular events. These effects were evident after 18 months of treatment.
Why do the cardiovascular events of Vioxx occur?
In conclusion, COX-2 selectivity alone is not a good predictor of adverse side effects.
What are the 3 parts of a safety assessment?
- Risk
- Hazard
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