A Multicenter, Retrospective, Real-World Evidence Study to Evaluate the Effectiveness and Safety of Nimesulide-Paracetamol Combination Therapy for the Management of Acute Painful Conditions

Abstract

Introduction: Nimesulide-Paracetamol fixed-dose combination is widely used for managing acute painful conditions, yet real-world evidence remains limited. This study aimed to evaluate its effectiveness and safety in patients presenting with various acute painful conditions in clinical practice. Methods: This multicenter, retrospective study analyzed records of 1873 adult patients across 528 centers in India who received nimesulide-paracetamol. Pain severity was documented at baseline and follow-up (7 ± 2 days). Statistical analysis included descriptive summaries of patient characteristics and treatment outcomes. Results: Among 1873 patients (69.6% male; mean age 45.54 ± 21.22 years), common diagnoses included low back pain (33.6%), soft tissue injury (14.5%), myalgia (14.0%), and dental pain (13.2%). At baseline, 8.7% had mild pain, 34.6% moderate, and 56.7% severe pain. Following treatment, 66.8% achieved complete pain relief. Of patients with severe baseline pain (n=1062), 71.7% became pain-free, 20.2% improved to mild, 4.4% to moderate, and 3.7% remained with severe pain. Among those with moderate pain (n=648), 57.4% reported no pain after treatment. No adverse events were reported during the treatment period. Conclusion: Nimesulide-paracetamol combination therapy demonstrated substantial effectiveness and good tolerability in real-world management of acute painful conditions, achieving significant pain relief with no reported safety concerns.