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

Vergleich der Arzneimittelsicherheit und – wirksamkeit von Dexibuprofen und Ibuprofen zur Behandlung der Osteoarthritis von Knie oder Hüfte

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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.

Zusammenfassung

In dieser „observer-blinded“, multizentrischen, „non-inferiority“ klinischen Studie wurden 489 Patienten mit schmerzhafter Osteoarthrose der Hüfte oder des Knies eingeschlossen. Studienziel war der Vergleich von Verträglichkeit und Wirksamkeit von Dexibuprofen und Ibuprofen Pulver zur Herstellung einer Suspension. Eingeschlossen wurden Patienten mit täglichen Gelenksschmerzen in den letzten drei Monaten und einer Schmerzintensität des betroffenen Hüft-/Kniegelenks von „mittelgradig“ bis „schwer“ in den letzten 48 h. Die Behandlungsdauer betrug 14 Tage. Eine Kontrolluntersuchung fand nach 3 Tagen statt. Die Testpräparate Dexibuprofen 400 mg und Ibuprofen 400 mg wurden mit einer Tagesdosis von 800 mg bzw. 1600 mg verabreicht. Gastrointestinale Nebenwirkungen wurden in 8 Patienten (3,3 %) in der Dexibuprofen Gruppe und bei 19 Patienten (7,8 %) in der Ibuprofen Gruppe detektiert. Der Gruppenvergleich mittels Chi Quadrat Test zeigte statistisch signifikant einen geringeren Anteil an gastrointestinalen Nebenwirkungen in der Dexibuprofen Gruppe. Alle Analysen der sekundären Verträglichkeitsparameter unterstützen die Aussage des besseren Verträglichkeitsprofiles von Dexibuprofen im Vergleich zu Ibuprofen. Die Analyse der „Summe der Schmerzintensitäten“, „Schmerzlinderung“ und die globale Beurteilung der Wirksamkeit durch Patient und Arzt zu Studienende der untersuchten Schmerzskalen zeigte keinen signifikanten Unterschied zwischen den Behandlungsgruppen. Diese Studie belegte „non-inferiority“ in Bezug auf Wirksamkeit und einen statistisch signifikanten Unterschied in Bezug auf Verträglichkeit zugunsten von Dexibuprofen.

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Acknowledgements

The authors thank Örjan Klappert, Martina Uranyi and Romana Höttinger for data management as well as Erich Kvas for statistical evaluation.

Conflict of interest

The clinical study was supported financially by Gebro Pharma GmbH, Fieberbrunn, Austria. Sylvia Stallinger and Norbert Eller are employed by Gebro Pharma. Omid Zamani, Elke Böttcher, Jörg D. Rieger, Johann Mitterhuber and Reinhold Hawel declare that they have no conflict of interest.

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Authors and Affiliations

  1. Rheuma Zentrum Favoriten, Vienna, Austria

    Omid Zamani, Elke Böttcher & Jörg D. Rieger

  2. Rehabilitationszentrum für Erkrankungen des rheumatischen Formenkreises, Bad Hofgastein, Austria

    Johann Mitterhuber & Reinhold Hawel

  3. Department Clinical Research, Gebro Pharma GmbH, 6391, Fieberbrunn, Austria

    Sylvia Stallinger &  Norbert Eller

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  1. Omid Zamani
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  2. Elke Böttcher
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Correspondence to Norbert Eller.

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Zamani, O., Böttcher, E., Rieger, J. et al. Comparison of safety, efficacy and tolerability of Dexibuprofen and Ibuprofen in the treatment of osteoarthritis of the hip or knee. Wien Klin Wochenschr 126, 368–375 (2014). https://doi.org/10.1007/s00508-014-0544-2

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  • DOI: https://doi.org/10.1007/s00508-014-0544-2

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