ABSTRACT
Objective: Nimesulide has been evaluated in numerous clinical studies in the management of a variety of acute painful conditions. However, there is limited Indian data available on the nimesulide/paracetamol fixed drug combination (FDC). Hence, an open-label prospective multicentric study was conducted to evaluate the safety and efficacy of this FDC in the management of acute painful conditions in real-world settings. Materials and methods: A prospective, open-label, and multicenter study conducted at 24 centers across Indian patients with acute painful conditions due to trauma, tendinitis, myalgia, low backache, sprains, pulled muscle, soft tissue injury, dental pain, and dental procedure/surgery. Nimesulide/paracetamol FDC was prescribed by clinicians as a part of routine practice. The effectiveness was evaluated on the numerical rating scale (NRS), that is, pain intensity at rest and movement, and the physician/patient global assessment scale (GAS) among the subgroups of acute painful conditions like myalgia, dental pain, low backache, etc. Hepatic safety was also evaluated among the subgroups at the end of treatment. Result: A total of 464 patients were included in the study. The reduction in NRS score at rest and movement during treatment duration across different types of pain was statistically significant (p < 0.001). Pain reduction was evident as per patient and physician GAS at the end of treatment in all indications. No clinically significant difference was found in liver parameters at the end of the study. Nimesulide/paracetamol (FDC) was well tolerated across all the subgroups. Conclusion: Nimesulide/paracetamol FDC was found to be well-tolerated and effective in pain management across all acute painful conditions in a real-world setting without any hepatic safety concerns.
ABSTRACT
Background: Nimesulide shows preferential inhibition for the cyclooxygenase-2 (COX-2) enzyme, which blocks the formation of prostaglandins critical in pain and inflammatory pathways. Few studies in the past have reported rare and unpredictable hepatic effects with nimesulide. The present study aimed to evaluate the efficacy and safety of nimesulide/paracetamol (100 mg + 325 mg) fixed-dose combination twice a day for 2 weeks in the management of acute pain in Indian population. Materials and methods: This was a multicenter study, performed on 500 patients, by 24 experienced physicians across India. The primary outcome assessed clinical safety at 2 weeks for mild/serious adverse effects (AEs), change in liver function tests (LFTs), serum bilirubin and alkaline phosphatase levels. The secondary outcomes assessed the clinical effectiveness in reduction of pain at rest and at movement. Results: Analysis of LFT at 2 weeks showed a slight increase (mean change) in the aspartate transaminase {-0.73 [95% confidence interval (CI) -1.54, 0.09; p = 0.081]}, alanine transaminase [-1.73 (95% CI -2.82, -0.64; p = 0.002)], serum bilirubin [-0.02 (95% CI -0.04, -0.001; p = 0.018)] and alkaline phosphatase levels [-1.92 (95% CI -5.84, 2; p = 0.336), not exceeding the normal range. Only one in 500 patients reported AEs. The numerical rating scale (NRS) scores for intensity of pain at rest and at movement at 2 weeks, ?7 days and >7 days were 68.38%, 68.44% and 68.39%; and 65.43%, 64.60% and 66.02%, respectively. An improvement of 96.6% was observed in patient global assessment scale (GAS) and 97.2% in physician GAS. Conclusion: Nimesulide/paracetamol combination was safe, effective and well-tolerated in acute pain conditions and did not lead to clinically significant changes in liver parameters indicating hepatic safety.
ABSTRACT
Introduction: This study aimed to develop a model utilizing the data from the top 10 countries (as of August 22, 2020) with the maximum number of infected cases. These countries are the United States of America, Brazil, India, Russia, South Africa, Peru, Mexico, Colombia, Chile, and Spain. The model is developed using the newly infected cases, new deaths, cumulative infected cases, and cumulative deaths due to COVID-19 starting from the day on which the first infected cases of COVID-19 in each of these countries is diagnosed to the date August 19, 2020. Materials and Methods: This study includes data such as the newly infected cases, new deaths, cumulative infected cases, and cumulative deaths due to COVID-19 starting from the day on which the first infected case of COVID-19 in each of these countries is diagnosed to the date August 19, 2020, in the top 10 most affected countries. The data were obtained from World Health Organization (WHO) website. To fit the data into a regression model, IBM SPSS Statistics 21.0 was used. The linear, logarithmic, quadratic, and cubic curves were fitted to the newly infected COVID-19 cases and daily deaths due to COVID-19. In choosing the best-fitted model, the coefficient of determination (R-square) was used. Results: Cubic regression model is the best fit model for new infected COVID-19 cases as well as COVID-19 deaths. It has the highest R-square value as compared to the linear, logarithmic and quadratic. Conclusion: To control the spread of infection, there is a need for aggressive control strategies from the administrative departments of all countries.