Worldwide clinical safety experience with diclofenac

Area of Science:

• Pharmacology
• Clinical Trials
• Rheumatology

Background:

• Diclofenac is a widely used nonsteroidal anti-inflammatory drug (NSAID).
• Assessing the safety and tolerability of NSAIDs is crucial for patient care.
• Understanding comparative safety profiles aids in treatment selection for rheumatic conditions.

Purpose of the Study:

• To evaluate the safety and tolerability of diclofenac.
• To compare diclofenac's adverse event profile with placebo, aspirin, and other NSAIDs.
• To assess diclofenac's safety in long-term use and in elderly patients.

Main Methods:

• Analysis of data from over 100,000 patients in foreign and U.S. trials.
• Comparison of adverse experiences, drop-out rates, and hepatic issues.
• Inclusion of both short-term and long-term treatment data.

Main Results:

• Diclofenac demonstrated favorable safety and tolerability, with infrequent and mild adverse experiences.
• Side effect rates and drop-out rates for diclofenac were comparable or better than comparators.
• No significant differences in hepatic problems were noted between diclofenac and other treatments.
• Long-term use (≥1 year) and use in patients ≥65 years showed good safety.

Conclusions:

• Diclofenac is a safe and well-tolerated NSAID for treating rheumatic conditions.
• Its safety profile is supported by extensive clinical trial and post-marketing data.
• Diclofenac is considered one of the safest agents in its class.