Safety and Efficacy of Pregabalin PR 75 mg + Etoricoxib 60 mg in Chronic LBP with Neuropathy

Overview

This phase IV multicenter study demonstrated that the fixed-dose combination of pregabalin prolonged release 75 mg and etoricoxib 60 mg was well tolerated and effective in patients with chronic low back pain featuring neuropathic symptoms. Patients experienced meaningful pain relief and improved daily functioning over 8 weeks, with a low incidence of mild to moderate adverse effects.

Background

Chronic low back pain (CLBP) is a prevalent condition globally and in India, often involving both nociceptive and neuropathic pain mechanisms. Standard treatments frequently fail to adequately address the neuropathic component, leading to persistent pain and disability. Pregabalin is a first-line agent for neuropathic pain, while etoricoxib, a selective COX-2 inhibitor, targets nociceptive pain with a favorable safety profile. Combining these agents in a fixed-dose formulation aims to improve pain control and patient compliance.

Data Highlights

Key Findings

• The fixed-dose combination was well tolerated with no serious adverse events reported.
• Only 7.18% of patients experienced mild or moderate adverse effects.
• Patients reported significant pain relief and improved daily functioning over 8 weeks.
• Use of additional rescue medication decreased progressively, indicating sustained pain control.
• The combination targets both neuropathic and nociceptive pain components effectively.
• The study was conducted in a real-world clinical setting across multiple centers in India.

Clinical Implications

This fixed-dose combination offers a practical and effective treatment option for patients with chronic low back pain featuring neuropathic symptoms by addressing mixed pain mechanisms simultaneously. Its favorable safety profile and reduction in rescue medication use may improve patient adherence and outcomes in routine clinical practice.

Conclusion

The pregabalin prolonged release and etoricoxib fixed-dose combination is a safe and efficacious therapy for chronic low back pain with neuropathic features, providing meaningful pain relief and functional improvement in a real-world setting.

References

1. Study Authors/Phase IV Multicenter Study -- Evaluation of Safety and Efficacy of a Fixed-Dose Combination of Pregabalin PR and Etoricoxib in CLBP