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

• Published in: Journal of the Association of Physicians of India Vol. 73; no. 7; p. e1
• Main Authors: Ashraf, Syed Mustafa, Shejole, Vivek Samadhan, Kadam, Neelam Ramakant, Chandrappa, Ambrish M, Kondiba Toke, Sahebrao, Yadagiri, Sunil Kumar Yadav, Banerjee, Ritwik, Bhagat, Seema, Sanghavi, Arti Pradip, Pebbili, Kranthi Kiran, Katare, Sagar Shivanand, Kotak, Bhavesh Prabhudas
• Format: Journal Article
• Language: English
• Published: 01.07.2025
• Subjects: Acetaminophen - administration & dosage; Acetaminophen - adverse effects; Acetaminophen - therapeutic use; Adolescent; Adult; Analgesics - therapeutic use; Analgesics, Non-Narcotic - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Antipyretics - adverse effects; Antipyretics - therapeutic use; Drug Therapy, Combination; Female; Fever - drug therapy; Humans; Ibuprofen - administration & dosage; Ibuprofen - adverse effects; Ibuprofen - therapeutic use; India; Male; Middle Aged; Pain - drug therapy; Pain - etiology; Pain Measurement; Prospective Studies; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Treatment Outcome; Young Adult; India
• ISSN: 0004-5772
• DOI: 10.59556/japi.73.1053

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 ( < 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.