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Analgesic Efficacy and Safety of Lornoxicam Quick-Release Formulation Compared with Diclofenac Potassium

Randomised, Double-Blind Trial in Acute Low Back Pain

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Abstract

Background: NSAIDs are widely used for patients presenting with low back pain. A quick-release formulation of lornoxicam, a potent NSAID from the chemical class of oxicams, offers a faster onset of pain relief compared with the standard tablet formulation.

Methods: Time to onset of pain relief with lornoxicam was compared with the quick-release formulation of diclofenac potassium in acute low back pain in a randomised, double-blind, multicentre study. 220 patients received either lornoxicam 24mg or diclofenac potassium 150mg on day 1 followed by lornoxicam 8mg twice daily or diclofenac potassium 50mg twice daily for 5 days. Efficacy outcomes included time to onset of pain relief, as measured by the stopwatch method (primary outcome), pain intensity, pain relief, rescue medication, ability to perform daily activities and global evaluation of the study medication.

Results: The time to onset of pain relief ratios between diclofenac potassium/ lornoxicam was 1.03 (95% CI 0.91, 1.26) and 1.05 (95% CI 0.93, 1.29) in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively, demonstrating the non-inferiority of lornoxicam (defined by lower limits of the 95% CIs >0.80). Time to onset of pain relief was shorter with lornoxicam (30 minutes) compared with diclofenac potassium (36 minutes). The difference was not statistically significant (ITT analysis). A higher magnitude of analgesic effect associated with better global evaluation of the study medication for lornoxicam was also demonstrated. The drugs were equally well tolerated.

Conclusion: Lornoxicam administered as a quick-release formulation was shown to be non-inferior to the equivalent formulation of diclofenac potassium in terms of onset of pain relief and more effective on most of the major standard efficacy outcomes.

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Acknowledgements

This study was supported by an unrestricted grant from Nycomed. The authors have no conflicts of interest directly relevant to the content of this study.

The authors thank all the co-investigators for their valuable contributions to the performance of this study. The co-investigators were: E.V. Podchufarova, A.I. Isaykin, D.V. Galanov, K.S. Glushkov, T.V. Mikhailova, T.A. Skoromets, A.P. Rachin, O.M. Ustennaya, Y.V. Yurieva, V.A. Bulanova, S.B. Ossipova, A.G. Raybov, E.V. Zakhovskaya.

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Authors and Affiliations

  1. Municipal Clinical Hospital #61, Moscow, Russia

    N. Yakhno

  2. Russian State Medical University, Municipal Clinical Hospital #1, Moscow, Russia

    A. Guekht

  3. St Petersburg State Medical University, Liva Tolstogo, St Petersburg, Russia

    A. Skoromets

  4. Municipal Clinical Hospital #8, Yaroslavl, Russia

    N. Spirin

  5. Smolensk Regional Hospital, Smolensk, Russia

    E. Strachunskaya

  6. Clinical Trial Department, Municipal Clinical Hospital #13, Moscow, Russia

    A. Ternavsky

  7. International Medical Affairs, Nycomed, Langebjerg 1, Roskilde, 4000, Denmark

    K. J. Olsen &  P. L. Moller

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  1. N. Yakhno
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  2. A. Guekht
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  7. K. J. Olsen
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  8. P. L. Moller
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Correspondence to P. L. Moller.

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Yakhno, N., Guekht, A., Skoromets, A. et al. Analgesic Efficacy and Safety of Lornoxicam Quick-Release Formulation Compared with Diclofenac Potassium. Clin. Drug Investig. 26, 267–277 (2006). https://doi.org/10.2165/00044011-200626050-00004

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  • DOI: https://doi.org/10.2165/00044011-200626050-00004

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