Long-term nimesulide use in osteoarthritis: Assessment of requirement, efficacy and safety. Data from the openlabel 3-month observational study NORMA (Nimesulide in Osteoarthritis: vaRious Medical Aspects)

Long-term therapy with non-steroidal anti-inflammatory drugs (NSAIDs) may be appropriate in patients with osteoarthritis (OA) who have chronic pain. The aim – to evaluate the efficacy and safety of nimesulide in the 3-month treatment of osteoarthritis. Material and methods . The study group consisted of 282 patients, 79.4% women (age 54.5±8.9 years), with knee OA (50.0%), hip OA (12.4%) and multi-joint OA (37.6%). All patients had comorbidity, including 94.3% arterial hypertension (AH) and 22.7% type 2 diabetes mellitus. All patients had moderate to severe pain (≥4 on a numerical rating scale (NRS 0–10)) for at least 3 months. All patients were prescribed nimesulide 100 mg twice daily. If pain decreased, a reduction in the dose of nimesulide to 100 mg daily or a switch to an on-demand regimen was suggested. Results . After 1 and 3 months of therapy, 82.3% and 49.3% of patients continued to take nimesulide regularly, and 17.4% and 39.7% continued to take it ‘on demand’. 11,0% of patients stopped taking the drug by 3 months, mainly because of pain control or significant pain reduction. In 1 and 3 months all patients showed significant improvement in the severity of the main symptoms of OA. Thus, pain on movement (NRS) decreased from 6.7 to 4.3 and 2.0; WOMAC pain from 11.3 to 7.3 and 3.9; impaired function (NRS) from 5.4 to 3.4 and 1.6; WOMAC function from 38.9 to 25.4 and 14.7 (for all parameters p<0.001). For all parameters, more than 75% of patients showed improvement ≥50% from baseline. 83% of patients reported an acceptable symptom state (PASS). After 3 months, no serious adverse events (AEs) were noted. Dyspepsia was noted in 3.9%, stool disturbance and gastroesophageal reflux disease in 3.2% each, AH in 4.6%, and hyperglycaemia in 1.1%. No withdrawal of nimesulide due to HP was noted. Conclusion . Nimesulide is effective and relatively safe in the long-term treatment of patients with OA and chronic pain.