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Efficacy and gastrointestinal safety of loxoprofen vs. diclofenac in gonarthrosis

Gonarthrosis Gonarthrosis
Gonarthrosis Gonarthrosis

Loxoprofen sodium, a phenylpropionic acid–derived nonsteroidal anti-inflammatory drug (NSAID) prodrug, is reported to have a favorable gastrointestinal (GI) and renal safety profile owing to its prodrug nature and intermediate cyclooxygenase-2 (COX-2) selectivity.

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Key take away

Loxoprofen (60 mg 3 times daily) provides comparable pain relief to diclofenac (50 mg 3 times daily) in gonarthrosis while significantly reducing gastrointestinal adverse events.

Background

Loxoprofen sodium, a phenylpropionic acid–derived nonsteroidal anti-inflammatory drug (NSAID) prodrug, is reported to have a favorable gastrointestinal (GI) and renal safety profile owing to its prodrug nature and intermediate cyclooxygenase-2 (COX-2) selectivity. This randomized controlled trial explored the efficacy and safety of loxoprofen sodium with diclofenac in gonarthrosis.

Method

Ambulatory patients aged 30–60 years with Kellgren–Lawrence grade 2 or 3 gonarthrosis and a body mass index (BMI) <30 kg/m² were enrolled. They were randomly assigned, under double-blind conditions, to receive either loxoprofen 60 mg 3 times daily or diclofenac 50 mg 3 times daily for 4 weeks.

Clinical assessments were conducted at baseline and at 2-week intervals, evaluating symptom severity, pain intensity (at rest, on movement, on pressure, and nocturnal pain) using a visual analog scale (VAS), knee swelling, functional impairment, global improvement, and treatment-related adverse events. Laboratory investigations were executed pre and post treatment.

Result

Overall, 60 patients were included, with 30 patients in each treatment group; 87% were older than 51 years. Baseline characteristics, including disease duration and prior NSAID use, were comparable between groups. Both loxoprofen and diclofenac elicited statistically significant improvements from baseline across all clinical parameters, with no vital differences in efficacy between treatments. However, GI adverse events were markedly less frequent in the loxoprofen group (10%) compared with the diclofenac group (40%).

Epigastric pain was the most commonly reported GI symptom. One serious GI event (enterorrhagia) occurred in the diclofenac group, leading to treatment discontinuation. Overall, tolerability was rated as good or very good in 90% of patients receiving loxoprofen and 79% receiving diclofenac. Treatment discontinuation occurred less frequently with loxoprofen than with diclofenac.

Conclusion

Loxoprofen sodium illustrated comparable clinical efficacy to diclofenac in gonarthrosis, with superior GI tolerability, and excellent tolerability and safety.

Source:

Annals of the Rheumatic Diseases

Article:

SAT0054 Clinical efficacy and safety of loxoprofen sodium in the treatment of gonarthrosis

Authors:

R Lederman et al.

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