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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.
AuthorsOmid Zamani, Elke Böttcher, Jörg D Rieger, Johann Mitterhuber, Reinhold Hawel, Sylvia Stallinger, Norbert Eller
JournalWiener klinische Wochenschrift (Wien Klin Wochenschr) Vol. 126 Issue 11-12 Pg. 368-75 (Jun 2014) ISSN: 1613-7671 [Electronic] Austria
PMID24740137 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • dexibuprofen
  • Ibuprofen
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
  • Arthralgia (drug therapy, epidemiology)
  • Austria (epidemiology)
  • Causality
  • Comorbidity
  • Drug Tolerance
  • Female
  • Gastrointestinal Diseases (epidemiology, prevention & control)
  • Humans
  • Ibuprofen (administration & dosage, analogs & derivatives)
  • Male
  • Middle Aged
  • Osteoarthritis, Hip (drug therapy, epidemiology)
  • Osteoarthritis, Knee (drug therapy)
  • Prevalence
  • Risk Factors
  • Single-Blind Method
  • Treatment Outcome
  • Young Adult

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