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Erschienen in: Wiener klinische Wochenschrift 11-12/2014

01.06.2014 | original article

Comparison of safety, efficacy and tolerability of Dexibuprofen and Ibuprofen in the treatment of osteoarthritis of the hip or knee

verfasst von: Omid Zamani, Elke Böttcher, Jörg D. Rieger, Johann Mitterhuber, Reinhold Hawel, Sylvia Stallinger, Dr. Norbert Eller

Erschienen in: Wiener klinische Wochenschrift | Ausgabe 11-12/2014

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Summary

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.
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Metadaten
Titel
Comparison of safety, efficacy and tolerability of Dexibuprofen and Ibuprofen in the treatment of osteoarthritis of the hip or knee
verfasst von
Omid Zamani
Elke Böttcher
Jörg D. Rieger
Johann Mitterhuber
Reinhold Hawel
Sylvia Stallinger
Dr. Norbert Eller
Publikationsdatum
01.06.2014
Verlag
Springer Vienna
Erschienen in
Wiener klinische Wochenschrift / Ausgabe 11-12/2014
Print ISSN: 0043-5325
Elektronische ISSN: 1613-7671
DOI
https://doi.org/10.1007/s00508-014-0544-2