title: Comparison of safety, efficacy and tolerability of dexibuprofen and ibuprofen in the treatment of osteoarthritis of the hip or knee.
abstract: In this observer-blinded, multicenter, non-inferiority study, 489 patients suffering from painful osteoarthritis of the hip or knee were included to investigate safety and tolerability of Dexibuprofen vs. Ibuprofen powder for oral suspension. Only patients who had everyday joint pain for the past 3 months and "moderate" to "severe" global pain intensity in the involved hip/knee of within the last 48 h were enrolled. The treatment period was up to 14 days with a control visit after 3 days. The test product was Dexibuprofen 400 mg powder for oral suspension (daily dose 800 mg) compared to Ibuprofen 400 mg powder for oral suspension (daily dose 1,600 mg). Gastrointestinal adverse drug reactions were reported in 8 patients (3.3 %) in the Dexibuprofen group and in 19 patients (7.8 %) in the Ibuprofen group. Statistically significant non-inferiority was shown for Dexibuprofen. Comparing both groups by a Chi square test showed a statistical significant lower proportion of related gastrointestinal events in the Dexibuprofen group. All analyses of secondary tolerability parameters showed the same result of a significantly better safety profile in this therapy setting for Dexibuprofen compared to Ibuprofen. The sum of pain intensity, pain relief and global assessments showed no significant difference between treatment groups. In summary, analyses revealed at least non-inferiority in terms of efficacy and a statistically significant better safety profile for the Dexibuprofen treatment.
authors.affiliation: Rheuma Zentrum Favoriten, Vienna, Austria.
authors.forename: Omid
authors.initials: O
authors.lastname: Zamani
authors.forename: Elke
authors.initials: E
authors.lastname: Böttcher
authors.forename: Jörg D
authors.initials: JD
authors.lastname: Rieger
authors.forename: Johann
authors.initials: J
authors.lastname: Mitterhuber
authors.forename: Reinhold
authors.initials: R
authors.lastname: Hawel
authors.forename: Sylvia
authors.initials: S
authors.lastname: Stallinger
authors.forename: Norbert
authors.initials: N
authors.lastname: Eller
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D018771:Arthralgia / Q000188:drug therapy* / Q000453:epidemiology*; D001317:Austria / Q000453:epidemiology; D015984:Causality; D015897:Comorbidity; D004361:Drug Tolerance; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology* / Q000517:prevention & control; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000453:epidemiology; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D015995:Prevalence; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C539402:dexibuprofen; D007052:Ibuprofen
references.citation: Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000
references.pmid: 17719803
references.citation: Scand J Rheumatol. 2007 Jul-Aug;36(4):247-58
references.pmid: 17853003
references.citation: Drugs Aging. 2005;22(2):141-61
references.pmid: 15733021
references.citation: Int J Clin Pharmacol Ther. 2003 Apr;41(4):153-64
references.pmid: 12708604
references.citation: Inflammopharmacology. 2003;11(4):371-83
references.pmid: 15035791
references.citation: Gastroenterology. 2008 Apr;134(4):937-44
references.pmid: 18294634
references.citation: Orthopade. 2005 Aug;34(8):782-90
references.pmid: 15912329
references.citation: Arthritis Rheum. 2008 Apr 15;59(4):568-74
references.pmid: 18383398
references.citation: Int J Clin Pharmacol Ther. 2011 Mar;49(3):237-46
references.pmid: 21329626
references.citation: Osteoarthritis Cartilage. 2010 Apr;18(4):476-99
references.pmid: 20170770
references.citation: Drugs Aging. 2007;24(8):629-42
references.pmid: 17702533
references.citation: Drugs Aging. 2003;20(7):517-26
references.pmid: 12749749
references.citation: Scand J Gastroenterol. 2007 Aug;42(8):923-32
references.pmid: 17613921
references.citation: Drugs Aging. 2007;24(7):573-80
references.pmid: 17658908
references.citation: J Pharm Pharmacol. 2012 May;64(5):626-36
references.pmid: 22471358
references.citation: Wien Klin Wochenschr. 1997 Jan 31;109(2):53-9
references.pmid: 9123945
references.citation: Lancet. 2011 Jun 18;377(9783):2115-26
references.pmid: 21684382
references.citation: Wien Klin Wochenschr. 1994;106(7):208-11
references.pmid: 8197755
references.citation: Clin Rheumatol. 2001 Nov;20 Suppl 1:S15-21
references.pmid: 11771569
references.citation: J Rheumatol. 2010 Jan;37(1):6-8
references.pmid: 20040636
references.citation: J Indian Med Assoc. 2008 Sep;106(9):615-8, 622, 624
references.pmid: 19552094
references.citation: Int J Biochem Cell Biol. 2010 Oct;42(10):1594-601
references.pmid: 20603225
references.citation: Anesth Analg. 2003 Aug;97(2):402-408
references.pmid: 12873925
references.citation: Drugs Aging. 2010 Oct 1;27(10):775-89
references.pmid: 20883058