PMID- 28899844 OWN - NLM STAT- MEDLINE DCOM- 20180718 LR - 20180718 IS - 1522-9653 (Electronic) IS - 1063-4584 (Linking) VI - 25 IP - 12 DP - 2017 Dec TI - 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. PG - 1942-1951 LID - S1063-4584(17)31197-4 [pii] LID - 10.1016/j.joca.2017.09.002 [doi] AB - OBJECTIVE: To investigate short-term efficacy and safety of a novel lipid ibuprofen formulation 1200 mg/day compared with standard ibuprofen 1200 mg/day and 2400 mg/day in episodic knee arthralgia/flaring pain. DESIGN: Multicentre, randomised, double-blind, 3-arm, non-inferiority trial conducted at 27 primary care centres. Adults with >/=1 knee flare episode within 12 months were recruited within 24 h of new flare with pain severity >/=5 on a 0-10 numerical rating scale (NRS). Primary outcome was change from baseline in WOMAC pain subscale over 5 days. Main secondary outcome was Gastrointestinal Symptom Rating Scale (GSRS) change from baseline. Other endpoints included assessment of WOMAC total subscale scores and self-reported NRS for pain, subject nominated activity, stiffness and swelling. RESULTS: 462 patients were enrolled (58.9% males; mean age 52.2 years). Treatment allocation comprised 148 lipid 1200 mg, 155 soft-gel 1200 mg, 159 soft-gel 2400 mg. WOMAC pain subscale scores decreased in all groups, with lipid 1200 mg being non-inferior to soft-gel 1200 mg (adjusted mean difference -0.26 [95% confidence interval [CI] -0.69, 0.17]) and to soft-gel 2400 mg (difference 0.19 [95% CI -0.24, 0.62]). No differences were seen in mean GSRS total scores. NRS secondary endpoints suggested greater improvements in the lipid 1200 mg group compared to soft-gel 1200 mg, with similar results to soft-gel 2400 mg. The most frequent drug-related adverse events (AEs) were gastrointestinal (GI) disorders, with statistically fewer events for lipid 1200 mg vs soft-gel 2400 mg (P = 0.01, post-hoc analysis). CONCLUSIONS: Ibuprofen 1200 mg/day lipid formulation was non-inferior to standard ibuprofen soft-gel capsules 1200 mg and 2400 mg/day in relieving flaring knee pain. NRS endpoints showed lipid 1200 mg was numerically similar to soft-gel 2400 mg. TRIAL REGISTRATION NUMBER: EudraCT number: 2014-004254-33. CI - Copyright (c) 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved. FAU - Bierma-Zeinstra, S M A AU - Bierma-Zeinstra SMA AD - Department of General Practice, Erasmus MC - University Medical Centre, Rotterdam, The Netherlands; Department of Orthopedics, Erasmus MC - University Medical Centre, Rotterdam, The Netherlands. Electronic address: s.bierma-zeinstra@erasmusmc.nl. FAU - Brew, J AU - Brew J AD - Infirst Healthcare Ltd, 45 Beech Street, London, UK. Electronic address: John.Brew@seekacure.com. FAU - Stoner, K AU - Stoner K AD - Infirst Healthcare Ltd, 45 Beech Street, London, UK. Electronic address: Karen.Stoner@infirst.co.uk. FAU - Wilson, R AU - Wilson R AD - Spica Consultants Ltd, Marlborough, UK. Electronic address: rosamund@spicaconsultants.com. FAU - Kilbourn, A AU - Kilbourn A AD - Infirst Healthcare Ltd, 45 Beech Street, London, UK. Electronic address: Tony.Kilbourn@infirst.co.uk. FAU - Conaghan, P G AU - Conaghan PG AD - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds, UK. Electronic address: p.conaghan@leeds.ac.uk. LA - eng SI - EudraCT/2014-004254-33 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170909 PL - England TA - Osteoarthritis Cartilage JT - Osteoarthritis and cartilage JID - 9305697 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Capsules) RN - 0 (Lipids) RN - WK2XYI10QM (Ibuprofen) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage MH - Arthralgia/*drug therapy MH - Capsules MH - Double-Blind Method MH - Equivalence Trials as Topic MH - Female MH - Gastrointestinal Diseases/*chemically induced MH - Headache/chemically induced MH - Humans MH - Hypertension/chemically induced MH - Ibuprofen/*administration & dosage MH - *Knee Joint MH - *Lipids MH - Male MH - Middle Aged MH - Pain Measurement MH - Symptom Flare Up MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Arthralgia OT - Ibuprofen OT - Joint pain OT - Knee OT - Osteoarthritis OT - Symptom flare-up EDAT- 2017/09/14 06:00 MHDA- 2018/07/19 06:00 CRDT- 2017/09/14 06:00 PHST- 2017/04/04 00:00 [received] PHST- 2017/08/22 00:00 [revised] PHST- 2017/09/01 00:00 [accepted] PHST- 2017/09/14 06:00 [pubmed] PHST- 2018/07/19 06:00 [medline] PHST- 2017/09/14 06:00 [entrez] AID - S1063-4584(17)31197-4 [pii] AID - 10.1016/j.joca.2017.09.002 [doi] PST - ppublish SO - Osteoarthritis Cartilage. 2017 Dec;25(12):1942-1951. doi: 10.1016/j.joca.2017.09.002. Epub 2017 Sep 9.