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Real-world evidence on nimesulide/paracetamol FDC for acute pain management

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Created On: 29/10/2025

Nimesulide has been studied extensively for its role in managing various acute pain conditions.

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Key take away

The fixed-dose combination of nimesulide and paracetamol provides significant pain reduction and is well-tolerated across multiple acute pain conditions, with no hepatic concerns.The fixed-dose combination of nimesulide and paracetamol provides significant pain reduction and is well-tolerated across multiple acute pain conditions, with no hepatic concerns.

Background

Nimesulide has been studied extensively for its role in managing various acute pain conditions. However, data specific to the fixed-dose combination (FDC) of nimesulide and paracetamol in the Indian population remain limited. Hence, this open-label, prospective study sought to assess the real-world safety and efficiency of this FDC in patients experiencing acute pain.

Method

This study was carried out across 24 centers in India, involving patients presenting with acute pain due to conditions such as trauma, tendinitis, myalgia, low back pain, sprains, muscle strain, soft tissue injuries, dental pain, or dental procedures/surgeries. The nimesulide/paracetamol FDC was prescribed as part of standard clinical practice.

Efficacy was assessed via the Numerical Rating Scale (NRS) for pain at rest and during movement, along with physician and patient Global Assessment Scales (GAS) across different pain subgroups (like myalgia, dental pain, low back pain). Hepatic safety was monitored by monitoring liver function parameters at the end of intervention.

Result

Overall, 464 volunteers were recruited. There was a statistically significant reduction in NRS scores for both resting and movement-related pain across all pain categories. Improvements in pain were corroborated by both patient and physician GAS evaluations. Liver function tests showed no clinically relevant changes post-treatment, indicating no hepatic safety concerns. Overall, the FDC was well-tolerated across all patient subgroups.

Conclusion

In real-world clinical practice, the nimesulide/paracetamol FDC illustrated favorable safety and efficacy profiles for tackling various acute pain conditions, with no significant hepatic adverse effects observed.