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[Coxibs, which real therapeutic advance?: Recent pharmacoepidemiological data]
Jean-Louis Montastruc1, Maryse Lapeyre-Mestre, Mireille Gony
1Service de Pharmacologie Clinique du Centre Hospitalier Universitaire de Toulouse, France. montastruc@cict.fr
Therapie
|September 16, 2004
Summary
Currently marketed coxibs (celecoxib, rofecoxib) do not offer therapeutic advances over traditional nonsteroidal anti-inflammatory drugs. Real-world data show similar safety profiles and increased costs due to off-label use.
Area of Science:
- Pharmacology
- Drug Safety
- Health Economics
Context:
- Evaluation of coxibs (celecoxib, rofecoxib) based on therapeutic advance criteria: effectiveness, safety, and convenience.
- Analysis incorporates data from clinical trials and pharmacoepidemiological studies.
- Comparison with classical nonsteroidal anti-inflammatory drugs (NSAIDs).
Purpose:
- To assess whether currently marketed coxibs represent a therapeutic advance.
- To analyze the risk of adverse drug reactions (ADRs) in clinical trials versus real-world practice.
- To examine the cost-effectiveness and appropriate use of coxibs.
Summary:
- Clinical trial data on coxib ADRs differ from real-world observations.
- Rofecoxib and celecoxib share similar ADR profiles with traditional NSAIDs.
- Off-label prescribing of coxibs increases societal costs without clear therapeutic benefit.
Impact:
- Current coxibs may not meet established criteria for therapeutic advancement.
- Findings suggest limited clinical value beyond traditional NSAIDs.
- Highlights the economic burden of inappropriate coxib utilization.