Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most frequent and effective prescribed medication to treat patients with low back pain (LBP) but are associated with a high incidence of GI adverse events. Loxoprofen sodium, a NSAID prodrug from phenylpropionic group, claimed to have lesser GI and renal toxicity, has a large clinical experience in Japan, but its use in occidental people is scarce. Thus, it was conducted a clinical trial with Loxoprofen in the treatment of acute LBP in comparison with diclofenac K, using a validated assessment questionnaire for monitoring the outcome.
Objectives Objective of this double blind, randomised, controlled, multicentre study was compare efficacy and safety of Loxoprofen with that of diclofenac in the treatment of acute LBP.
Methods Patients of both gender, aged >18 years, with non-specific lumbar pain complying with exclusion criteria were admitted to the study. After the informed consent, patients were randomly allocated into the treatment groups – Loxoprofen 60 mg t.i.d. (LOX) or diclofenac 50 mg t.i.d. (DIC). Duration of treatment was 2 weeks. Patients were evaluated at pre-treatment and weekly during therapy for the following parameters: overall severity of symptoms; pain at rest, on pressure, and on movement using a visual analogue scale (VAS); physical examination (Schober and lateral flexion indexes, finger-floor distance); physician and patient global impression; side-effects; and Roland-Morris Questionnaire for LBP duly validated to Brazilian patients.
Results A total of 96 patients were treated in 5 centres ? 47 with LOX (19 M and 28 F), and 49 with DIC (16 M and 33 F). There was no significant difference between groups. 83% of cases were classified as acute in LOX; in DIC, 57% of cases were acute, 29% were sub acute and 14% recurrent. Severity of symptoms, pain (at rest, on movement, and on pressure), and objectives indexes showed statistically significant improvements compared with baseline (p < 0.001 ? chi square) with both treatments; there were no statistically significance differences between groups. Roland-Morris Questionnaire showed a good correlation with evolution of symptoms. 14 patients in LOX reported adverse events, being 12 GI effects (25.5%), and 23 patients in DIC, with 18 GI effects (36.7%) (p < 0.001). Epigastralgia was the most prevalent GI event reported. Four patients in LOX and 7 in DIC discontinued therapy due to GI adverse events. Tolerability assessments were classified as both very good and good in 97% in LOX and in 90% in DIC (p < 0.05). Physician and patient overall assessment were >95% as either very good or good in both groups (n.s.).
Conclusion Loxoprofen 60 mg, t.i.d., showed efficacy and excellent tolerability and safety in acute low back pain, superior to that of an established NSAID, diclofenac 50 mg, t.i.d. Rolland-Morris Questionnaire was a useful tool to assess the disease outcome.
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