Knee pain affects approximately 25% of adults >55 years. NSAIDs are the commonest OA therapy, with ibuprofen being the most commonly prescribed. Unlike the lower doses (1200 mg/day), high daily doses of ibuprofen (2400 mg/day) are associated with increased risk of cardiovascular events. In this research, it has been reported for the first time that a lipid formulation of ibuprofen 1200 mg/day has been shown to be as effective as ibuprofen 2400 mg/day in relieving flaring joint pain.

To examine short-term safety and effectiveness of a 1200 mg/day novel lipid Ibuprofen than standard 1200 mg/day and 2400 mg/day  Ibuprofen during episodic knee flaring/arthralgia pain.

Participants with ≥1 knee flare episode in one year were selected in 24 h of new flare with pain severity ≥5. The change from baseline in WOMAC pain subscale over five days was considered as the primary outcome, and the change in the Gastrointestinal Symptom Rating Scale (GSRS) from baseline is regarded as the main secondary outcome. Additional endpoints involved swelling, stiffness, subject nominated activity, assessment of WOMAC total subscale scores and self-reported NRS for pain.

A total of 462 participants were selected. Treatment allocation included 159 soft-gel 2400 mg, 155 soft-gel 1200 mg, 148 lipid 1200 mg. WOMAC pain subscale scores declined in all classes, with lipid 1200 mg being non-inferior to soft-gel 2400 mg and soft-gel 1200 mg. No variations were observed in mean GSRS total scores. NRS secondary endpoints recommended excellent improvements in the lipid 1200 mg group than soft-gel 1200 mg, with comparable outcomes to soft-gel 2400 mg. Gastrointestinal (GI) disorders were the most common drug-associated adverse events (AEs).  

Ibuprofen 1200 mg/day lipid formulation was non-inferior to standard 2400 mg and 1200 mg/day Ibuprofen soft-gel capsules in reducing flaring knee pain.