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A randomized, double-blind, crossover comparative endoscopy study on the gastroduodenal tolerability of a highly specific cyclooxygenase-2 inhibitor, flosulide, and naproxen.

AbstractBACKGROUND:
Inhibition of constitutively expressed cyclooxygenase (Cox-1) is thought to play an important role in the gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs (NSAID), while their therapeutic action may be due to inhibition of the enzyme Cox-2, which is specifically expressed at sites of inflammation. NSAIDs with high affinity and specifity for Cox-2 hold the promise of maintaining efficacy without the gastrointestinal side effects of conventional NSAIDs.
METHODS:
We assessed the gastrointestinal tolerability of flosulide (20 mg twice a day), a highly selective Cox-2 inhibitor with that of naproxen (500 mg twice a day), which has equal affinity for Cox-1 and -2 in 19 patients with osteoarthrosis in a randomized, double blind, crossover endoscopy study. Subjects were treated for 2 weeks with a 2-week washout period. Gastroduodenal damage was primarily assessed as by Lanza (grades 0-4).
RESULTS:
No stomach damage was seen in 13 (68%) patients after flosulide and in 5 (37%) after naproxen (P < 0.001). Lanza scores were significantly lower after flosulide (0.58) than after naproxen (1.47) (P < 0.001; odds ratio, 84.4; 95% confidence interval, 1.45-4908). Flosulide was significantly better tolerated (P < 0.005) than naproxen.
CONCLUSION:
These results endorse the idea that highly selective Cox-2 inhibitors may be associated with lesser gastrointestinal side effects than conventional NSAIDs.
AuthorsI Bjarnason, A Macpherson, H Rotman, J Schupp, J Hayllar
JournalScandinavian journal of gastroenterology (Scand J Gastroenterol) Vol. 32 Issue 2 Pg. 126-30 (Feb 1997) ISSN: 0036-5521 [Print] England
PMID9051872 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors
  • Indans
  • Isoenzymes
  • Membrane Proteins
  • Naproxen
  • Cyclooxygenase 2
  • PTGS2 protein, human
  • Prostaglandin-Endoperoxide Synthases
  • flosulide
Topics
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
  • Cross-Over Studies
  • Cyclooxygenase 2
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors (adverse effects, therapeutic use)
  • Double-Blind Method
  • Duodenum (drug effects)
  • Endoscopy, Gastrointestinal
  • Female
  • Gastrointestinal Diseases (chemically induced, pathology)
  • Humans
  • Indans (adverse effects, therapeutic use)
  • Intestinal Mucosa (drug effects)
  • Isoenzymes
  • Male
  • Membrane Proteins
  • Middle Aged
  • Naproxen (adverse effects, therapeutic use)
  • Osteoarthritis (drug therapy)
  • Prostaglandin-Endoperoxide Synthases
  • Stomach (drug effects)

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