Prospective Real-World Study Comparing the Safety and Effectiveness of Nimesulide with Available Antipyretic and Analgesics for Treatment of Fever or Fever with Pain-ENDEVER.

Fever and pain are natural body responses to infections and inflammation. This study aims to collect real-world data and compare the safety and effectiveness of nimesulide (100 mg), ibuprofen (400 mg) + paracetamol (325 mg), and paracetamol (650 mg) in individuals with fever or fever-related pain. A prospective, multicenter, comparative, and observational study was conducted in four centers across India with male and female subjects aged 18-60 years with fever or fever with pain. Fever reduction was assessed using a thermometer, and pain intensity was measured with the visual analog scale (VAS) at multiple intervals, up to 10 days. The study enrolled 303 subjects, divided into three groups: (1) group I (nimesulide), (2) group II (ibuprofen + paracetamol), and (3) group III (paracetamol). Remarkable fever and pain reduction were exhibited in the nimesulide group. Its effect on fever reduction was observed within 15 minutes of administration, with a significant improvement in VAS scores. Patients on nimesulide showed greater fever reduction at 1, 2, 4, and 6 hours, continuing through day 8, and greater improvements in VAS, especially by day 1 (p < 0.0001). No serious adverse events or deaths were reported. Nimesulide (100 mg) was superior to ibuprofen (400 mg) + paracetamol (325 mg) and paracetamol (650 mg) in managing fever or fever with pain, with a comparable safety profile.