Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Clinical study well performed.
Data source
Reference
- Reference Type:
- publication
- Title:
- Cyclooxygenase-1 and Cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs.
- Author:
- Cryer B, Feldman M
- Year:
- 1 998
- Bibliographic source:
- Am. J. Med., 104, 413-421.
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Details on test material:
- salicylic acid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: Study approved by the Human Studies Subcommittee of the Dallas Department of Veterans Affairs Medical Center.
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Acetyl salicylic acid has poor COX-1 and COX-2 inhibitory potencies, and salicylic acid a very low activities. Inhibitory effects of NSAIDs on gastric
prostaglandin E2 synthesis correlated with COX-1 inhibitory potency in blood (P<0.001) and with COX-1 selectivity (P<0.01), but not with COX-2 inhibitory potency. Even COX-2 "selective" NSAIDs still had sufficient COX-1 activity to cause potent inhibitory effects on gastric prostaglandin E2 synthesis at concentrations achieved in vivo. No currently marketed NSAID, even those that are COX-2 selective, spare gastric COX activity at therapeutic
concentrations. Thus, all NSAIDs should be used cautiously until safer agents are developed.
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