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Naproxen-associated gastroduodenal toxicity: enteric coated granules versus plain tablets
L Aabakken1, M Ugstad, O N Gamst
1Ullevål Hospital, Department of gastroenterology, Oslo, Norway.
European Journal of Rheumatology and Inflammation
|January 1, 1992
Summary
This study compared plain naproxen tablets to enteric-coated granules, finding no endoscopic differences in healthy volunteers. However, formulation type matters, as enteric-coated naproxen should be evaluated individually for gastrointestinal effects.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Research
Background:
- Naproxen is a common nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation.
- Different naproxen formulations exist, potentially affecting gastrointestinal tolerability.
- Enteric coating is designed to protect the stomach lining from NSAID-induced damage.
Purpose of the Study:
- To compare the gastroduodenal endoscopic findings of two different naproxen formulations.
- To assess the gastrointestinal safety profile of plain naproxen tablets versus enteric-coated naproxen granules.
Main Methods:
- A randomized, cross-over, double-blind, double-dummy study was conducted.
- Sixteen healthy male volunteers received 500 mg of naproxen twice daily for one week.
- Participants were assigned to either plain tablets or enteric-coated granules in a gelatine capsule.
Main Results:
- Endoscopic evaluation showed no significant difference in gastroduodenal findings between the two naproxen formulations.
- Both plain tablets and enteric-coated granules resulted in similar endoscopic outcomes.
Conclusions:
- The study suggests that not all enteric-coated naproxen formulations are equivalent in their gastrointestinal effects.
- Individual evaluation of different enteric-coated formulations is necessary to understand their specific side effect profiles.
- Further research is warranted to elucidate the differences in gastrointestinal tolerability among various enteric-coated naproxen products.