A safety profile of controlled release naproxen tablets.
This randomised single blind controlled study examines adverse reactions to standard Naprosyn (naproxen) 750 mg daily with controlled release naproxen, Naprosyn CR, 750 mg daily, in a total of 520 patients. Overall there were no major differences between the two preparations. The reporting rate of any adverse clinical event was greater in the group taking the controlled release preparation but withdrawals from medication were similar in the two groups, for whatever reason. The main finding of the study was that patients in each decile age group, mainly between 40 and 80 years, were more likely to continue on this preparation for the full 10 weeks of the trial: 57% of patients on controlled release and 46% on plain Naprosyn completed the study. Patients over 60 years, particularly females, tended to complete the study, indicating that the simpler treatment regimen without any increase in major adverse effects is useful in the elderly who are thought to be at special risk of adverse reactions from NSAIDs. In addition, a review of spontaneous reports of adverse reactions to naproxen reported nationally to the Medicines Adverse Reactions Committee shows that the pattern has not changed over the last two years during which the controlled release formulation has been available. This experience supports the acceptability of controlled release naproxen.
Allen
B
B
National Toxicology Group, Dunedin.
Edwards
I R
IR
D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects*; D010349:Patient Compliance; D011897:Random Allocation; D013607:Tablets; D013997:Time Factors
D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen