Low-dose diclofenac, naproxen, and ibuprofen cohort study

Area of Science:

• Pharmacovigilance
• Drug Safety
• Epidemiology

Background:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for pain and inflammation.
• Concerns exist regarding the safety profile of low-dose NSAIDs, particularly for serious adverse events.
• Diclofenac, naproxen, and ibuprofen are common NSAIDs with varying dosing regimens.

Purpose of the Study:

• To assess the risk of serious adverse events within 30 days of initiating low-dose diclofenac, naproxen, or ibuprofen.
• To compare the incidence of upper gastrointestinal bleeding and hepatic injury among users of these three NSAIDs.
• To identify the primary serious adverse event associated with short-term, low-dose NSAID use.

Main Methods:

• A cohort study was conducted in the United Kingdom.
• Identified users of low-dose diclofenac (<= 75 mg), naproxen (<= 750 mg), and ibuprofen (<= 1200 mg).
• Reviewed medical records to confirm cases of upper gastrointestinal bleeding, liver failure, renal failure, agranulocytosis, aplastic anemia, severe skin disorders, and anaphylaxis.

Main Results:

• Incidence of upper gastrointestinal bleeding per 10,000 people: diclofenac 1.8, naproxen 2.3, ibuprofen 0.4.
• Three cases of hepatic injury were observed: one with naproxen and two with ibuprofen.
• Gastrointestinal toxicity was identified as the most significant serious adverse event for all studied NSAIDs, despite low incidence rates.

Conclusions:

• Low-dose NSAIDs (diclofenac, naproxen, ibuprofen) are associated with a risk of serious adverse events, primarily gastrointestinal toxicity.
• The incidence of upper gastrointestinal bleeding varies among these NSAIDs, with ibuprofen showing the lowest rate in this study.
• While rare, healthcare providers should remain vigilant for serious adverse events when prescribing these commonly used medications.