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Related Experiment Videos

Two comparative endoscopic evaluations of Naprelan

C Hawkey1, C O'Morain, F Murray

  • 1Department of Medicine, University Hospital, Queens Medical Centre, Nottingham, United Kingdom.

American Journal of Orthopedics (Belle Mead, N.J.)
|September 1, 1996
PubMed
Summary

Naprelan, a controlled-release naproxen sodium, showed a favorable trend in reducing gastroduodenal damage compared to Naprosyn. Naprelan demonstrated superior duodenal protection against erosions versus Naprosyn and aspirin.

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Area of Science:

  • Gastroenterology
  • Pharmacology
  • Clinical Research

Background:

  • Naprelan is a controlled-release formulation of naproxen sodium.
  • Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) commonly used for pain and inflammation.
  • NSAIDs can cause gastrointestinal adverse events, necessitating research into safer formulations.

Purpose of the Study:

  • To evaluate the gastrointestinal safety and tolerability of Naprelan compared to Naprosyn and aspirin using endoscopic assessments.
  • To compare the incidence of gastroduodenal mucosal damage, including erosions and ulcers, between different formulations and dosages of naproxen and aspirin.

Main Methods:

  • Two endoscopic studies were conducted in healthy male subjects.
  • Study 1: Compared Naprelan 500 mg once daily versus Naprosyn 500 mg twice daily.

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  • Study 2: Compared Naprelan 1,000 mg once daily, Naprosyn 500 mg twice daily, and aspirin 650 mg four times daily.

    • Main Results:

    • In the stomach, Naprelan and Naprosyn showed significantly less damage than aspirin (P < 0.0001).
    • In the duodenum, Naprelan demonstrated significantly fewer erosions than both Naprosyn (P = 0.0236) and aspirin (P = 0.0086).
    • Naprelan was associated with fewer reported adverse events compared to Naprosyn and aspirin.

    Conclusions:

    • Naprelan, a controlled-release naproxen sodium formulation, appears to offer improved gastrointestinal safety, particularly in the duodenum, compared to immediate-release naproxen and aspirin.
    • The controlled-release formulation may reduce the risk of NSAID-induced gastroduodenal mucosal injury.
    • Further clinical trials are warranted to confirm these findings in patient populations.