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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.
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.
Osteoarthritis Cartilage. 2017 Sep 9
A new lipid formulation of low dose ibuprofen shows non-inferiority to high dose standard ibuprofen: the FLARE study (flaring arthralgia relief evaluation in episodic flaring knee pain) – a randomised double-blind study
S.M.A. Bierma-Zeinstra et al.
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