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

N. Yakhno; A. Guekht; A. Skoromets; N. Spirin; E. Strachunskaya; A. Ternavsky; K.J. Olsen; P.L. Moller


Clin Drug Invest. 2006;26(5):267-277. 

In This Article

Abstract and Introduction


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.


Low back pain remains one of the most common causes of disability in industrialised countries and is a challenging diagnosis in everyday clinical practice. Lifetime prevalence exceeds 70%, with peak point prevalence between the ages of 35 and 55 years.[1] Low back pain frequently leads to absence from work and associated loss of productivity, representing a major socioeconomic burden.[1,2,3] Most adults will at some time develop low back pain and many will have recurrent episodes of acute pain at various intervals throughout their life.[4,5] Timely management and treatment of low back pain are essential to relieve pain and the underlying inflammation, restore physical functioning and decrease the burden of the disease on the patient as well as on society.[6,7] NSAIDs are widely used for patients presenting with low back pain. Numerous guidelines have been published, all recommending the prescription of NSAIDs in primary care for symptomatic relief in the early management of low back pain.[8,9,10,11] According to a recent systematic review involving 50 randomised controlled trials (4863 patients), the available evidence supported the effectiveness of NSAIDs in acute and chronic low back pain.[7] The rationale for treatment of low back pain with NSAIDs is based on their analgesic potential and their anti-inflammatory action through inhibition of prostaglandin biosynthesis.[12]

Lornoxicam is a potent NSAID from the chemical class of oxicams, and is marketed in a number of European countries for the treatment of various painful conditions associated with inflammation.[13,14] In contrast to the other oxicams, lornoxicam has a very short half-life (approximately 4 hours as compared with >24 hours for the others) and is therefore especially suitable for short-term treatment.[15] The short half-life of the drug probably explains the improved gastrointestinal safety profile observed with lornoxicam.[14] A quick-release formulation of lornoxicam has been developed, and this has been found to offer a faster onset of pain relief (PAR) compared with the standard tablet in a dental surgery model.[16]

Diclofenac potassium is a phenylacetic acid NSAID with a faster onset of PAR than the standard formulation, diclofenac sodium.[17] It is used in many countries for treatment of acute pain, providing fast onset of PAR.

Standard formulations of lornoxicam and diclofenac sodium have been compared using the low back pain model, and performed equally well.[6] The aim of the present study was to compare time to onset of pain relief and other standard analgesic efficacy outcomes with lornoxicam and diclofenac potassium administered as quick-release formulations for acute low back pain.


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