A comparative clinical trial evaluating efficacy and safety of fixed dose combination of nimesulide (100 mg) and racemethionine (50 mg) (namsafe) versus reference drug (nimesulide) and other NSAIDs in the treatment of osteo-arthritis.

摘要

Sixty consecutive patients of either sex, above the age of 18 years with symptoms of osteo-arthritis participated in this open, randomised, comparative clinical trial carried out over 3 months. Patients were randomised into 5 groups: Group A (paracetamol 500 mg), group B (ibuprofen 400 mg), group C (nimesulide 100 mg), group D (diclofenac 50 mg), and group E [fixed dose combination of nimesulide (100 mg) and racemethionine (50 mg) (namsafe)]. The efficacy parameters were pain intensity, pain on movement, tenderness and swelling. The liver function tests were carried out to estimate the effect of the drugs on the hepatic profile. The Wilcoxon signed rank test and the Kruskal Wallis (one way ANOVA) test were utilised to evaluate the significance of the change from baseline to the final visit. The treatment with combination of nimesulide and racemethionine gave the best relief from tenderness. With respect to pain intensity and pain movement, combination of nimesulide and racemethionine with nimesulide efficacy was comparable. Theliver function test data at the end of 6 months show that combination of nimesulide and racemethionine treated group showed the least rise in the serum asparatate aminotransferase and alanine aminotransferase levels, whereas in the other treatment groups it was very pronounced. Thereby, combination of nimesulide and racemethionine is found to be better for the long-term treatment of osteo-arthritis in patients. The combination of the two agents, namely nimesulide and racemethionine is expected to augment the safety profile of nimesulide, without influencing the effectiveness of the analgesic agent, i.e., nimesulide.