A safety profile of controlled release naproxen tablets

Area of Science:

• Pharmacology
• Clinical Trials
• Geriatric Medicine

Background:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen are widely used for pain and inflammation.
• Concerns exist regarding adverse effects and patient adherence with NSAID therapy, particularly in elderly populations.
• Controlled-release formulations aim to improve therapeutic profiles and patient compliance.

Purpose of the Study:

• To compare the adverse reactions and adherence rates between standard naproxen and a controlled-release formulation (Naprosyn CR).
• To evaluate the acceptability and tolerability of controlled-release naproxen in a diverse patient population, including the elderly.

Main Methods:

• A randomized, single-blind, controlled study involving 520 patients.
• Patients received either standard naproxen 750 mg daily or controlled-release naproxen (Naprosyn CR) 750 mg daily for 10 weeks.
• Adverse events, patient withdrawals, and study completion rates were monitored.

Main Results:

• No significant differences in major adverse reactions were observed between standard naproxen and Naprosyn CR.
• A higher rate of reported clinical events occurred with Naprosyn CR, but medication withdrawal rates were similar.
• Patients on Naprosyn CR demonstrated higher study completion rates (57%) compared to standard naproxen (46%).
• Patients over 60 years, particularly females, showed a tendency to complete the study with Naprosyn CR, indicating good tolerability.

Conclusions:

• Controlled-release naproxen (Naprosyn CR) is comparable to standard naproxen regarding adverse reactions.
• The controlled-release formulation enhances patient adherence and study completion, especially in older individuals.
• Naprosyn CR represents an acceptable and potentially beneficial treatment option for the elderly, a group often at higher risk for NSAID-related adverse effects.