Clinical Scorecard: Evaluation of Safety and Efficacy of a Fixed-Dose Combination of Prolonged Release Pregabalin and Etoricoxib in Patients with Chronic Low Back Pain Featuring Neuropathic Symptoms: A Phase IV Multicenter Study

At a Glance

Key Highlights

• Fixed-dose combination of pregabalin prolonged release 75 mg and etoricoxib 60 mg was well tolerated with no serious adverse events.
• Patients experienced meaningful pain relief and improved daily functioning over 8 weeks.
• Use of rescue medication decreased over time, indicating sustained pain control.

Guideline-Based Recommendations

Diagnosis

• Identify neuropathic and nociceptive components of chronic low back pain for targeted treatment.
• Use pain scores (≥4 on 11-point numeric rating scale) and clinical signs (e.g., sharp shooting pain below knee, sensory loss in L5/S1) for patient selection.

Management

• Employ fixed-dose combination therapy targeting both neuropathic and nociceptive pain components.
• Use pregabalin at low doses (50–75 mg/day) to balance efficacy and safety for neuropathic pain.
• Use etoricoxib, a selective COX-2 inhibitor, for nociceptive pain with a favorable safety profile.

Monitoring & Follow-up

• Monitor for mild to moderate adverse effects; serious adverse events are rare.
• Assess pain relief and functional improvement using standard pain and disability scales over treatment duration.
• Track use of rescue medication to evaluate adequacy of pain control.

Risks

• Mild or moderate adverse effects occurred in approximately 7.18% of patients.
• No serious side effects reported in the study population.

Patient & Prescribing Data

Patients with chronic low back pain featuring neuropathic symptoms, aged 18–65 years, in Indian outpatient settings.

Fixed-dose combination of pregabalin PR 75 mg and etoricoxib 60 mg provides effective pain relief and functional improvement with good tolerability and reduced need for rescue medication.

Clinical Best Practices

• Use fixed-dose combinations to reduce pill burden and improve patient compliance.
• Target both neuropathic and nociceptive pain mechanisms simultaneously for better outcomes in chronic low back pain.
• Prescribe pregabalin at low doses to minimize toxicity while maintaining efficacy.
• Prefer etoricoxib for its long half-life and superior safety profile among NSAIDs.

References

• Global and Indian prevalence of low back pain
• International Association for the Study of Pain guidelines on neuropathic pain
• Indian Council of Medical Research guidelines for chronic low back pain
• Phase III study of pregabalin PR and etoricoxib FDC in chronic low back pain
• Clinical Trial Registry of India CTRI/2022/05/042521