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Loxoprofen (60 mg three times daily) demonstrates comparable efficacy to diclofenac (50 mg three times daily) for acute low back pain while showing fewer gastrointestinal adverse events and better overall tolerability.
A clinical trial has highlighted loxoprofen (LOX) as a potentially well-tolerated nonsteroidal anti-inflammatory drug (NSAID) option for acute low back pain (LBP) , with pain relief comparable to diclofenac (DIC) and fewer reported gastrointestinal (GI) adverse events.
This double-blind, randomized, controlled, multicentre study included 96 adults with nonspecific LBP treated across five centres. Participants received either LOX 60 mg three times daily or DIC 50 mg three times daily for 2 weeks. Patients were assessed at baseline and weekly for symptom severity, pain at rest, during movement and on pressure, physical function, global treatment response, adverse events, and LBP-related disability using the Roland-Morris Questionnaire.
Both treatments were associated with remarkable improvements in pain, symptom severity, and objective measures of physical function from baseline (p < 0.001). However, the analysis found no pivotal difference in efficacy between LOX and DIC, suggesting that the two NSAIDs provided comparable relief of acute LBP.
The safety findings showed a difference in the frequency of GI adverse events. GI effects were reported in 25.5% of patients receiving LOX compared with 36.7% of those receiving DIC. Epigastralgia was the most frequently reported GI complaint. Treatment was discontinued because of GI adverse events in 4 patients receiving LOX and 7 receiving DIC. Tolerability also favored LOX, as depicted in Table 1:
More than 95% of patients in both groups received good or very good overall assessments from physicians and patients. The Roland-Morris Questionnaire also tracked well with changes in clinical symptoms, supporting its usefulness for evaluating functional recovery in LBP. To sum up, LOX offered pain relief comparable to DIC while being associated with fewer GI adverse events and favorable overall tolerability during the 2-week treatment period. The relatively small sample size and short follow-up, however, meant that the findings required confirmation in larger and longer-duration studies.
Annals of the Rheumatic Diseases
FRI0238 Efficacy and safety of loxoprofen in acute low back pain
J Natour et al.
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