# Evaluation of Polmacoxib 2 mg for the Management of Hip and Knee Osteoarthritis: A Prospective, Single-Arm, Multicenter, Open-Label Study

## TL;DR

Polmacoxib 2 mg provides effective and rapid pain relief for hip and knee osteoarthritis with minimal side effects in Indian patients.

## Contribution

This study provides new clinical evidence on the efficacy and safety of polmacoxib in managing osteoarthritis in an Indian population.

## Key findings

- Polmacoxib significantly reduced pain, stiffness, and physical function scores in patients with hip or knee osteoarthritis.
- The drug showed a rapid onset of action, with over 40% of patients experiencing symptom relief within 30 minutes.
- Polmacoxib was well tolerated, with only 2% of patients reporting mild adverse events.

## Abstract

Purpose: Polmacoxib is a novel cyclooxygenase-2 (COX-2) selective inhibitor with effective analgesic and anti-inflammatory properties and a favorable safety profile. This study evaluated polmacoxib's effectiveness, onset of action, and tolerability in Indian patients with knee or hip osteoarthritis.

Method: This was a prospective, multicenter, single-arm, open-label, observational study among Indian patients with knee/hip osteoarthritis. All patients with knee/hip osteoarthritis received polmacoxib capsule 2 mg orally once daily for six weeks. Patients were followed up for eight weeks (six weeks of treatment + two-week follow-up). Outcomes evaluated were pain, stiffness, and physical function using Western Ontario and McMaster Universities Arthritis Index (WOMAC) (CRD Pune version), severity of pain by Visual Analog Scale (VAS), and time of onset of action (in minutes), post-taking the first dose of polmacoxib 2 mg capsule on Day 1. Safety and compliance were monitored throughout the study period.

Results: In the study, 150 (male: female, 89:61) patients with a mean (standard deviation, or SD) age of 46.6 (9.9) years were enrolled. Statistically and clinically significant improvements were observed in all parameters. The mean (SD) pain score on the WOMAC Index declined significantly by -2.6 (2.1) and -5.9 (3.1) at Weeks 3 and 6, respectively, compared to the baseline score of 11.4 (4.6). Compared to the baseline mean (SD) score of 4.9 (2.1), the stiffness score on the WOMAC Index declined significantly by -1.0 (1.0) at Week 3, and by -2.4 (1.3) at Week 6. Mean (SD) difficulty (in physical function) score on the WOMAC Index declined significantly by -7.8 (5.9) and by -19.8 (10.2) at Weeks 3 and 6 respectively, compared to the baseline score of 41.6 (15.7), leading to a significant decline in total WOMAC Index by -11.4 (7.9) and by -28.1 (13.8) at Weeks 3 and 6 respectively, compared to the baseline score of 57.9 (21.9). The mean (SD) intensity of pain score (VAS) also declined significantly by -1.3 (1.3) and -2.9 (1.9) at Weeks 3 and 6, respectively, compared to the baseline score of 7.5 (0.9). Six (4.0%), 69 (46.0%), 62 (41.3%), and 13 (8.7%) of patients reported the onset of action of the study drug within 15, 30, 45, and 60 minutes of the first dose, respectively. The drug was well tolerated, with only 2% of patients experiencing mild, unrelated adverse events. Tolerability was rated “Excellent to Very Good” in 96.0% of cases by investigators and 89.3% of patients.

Conclusion: Polmacoxib 2 mg demonstrated early onset of symptom relief, significant improvements in clinical symptoms, and an acceptable safety and tolerability profile over a six-week treatment period, suggesting that polmacoxib is a well-tolerated treatment option for osteoarthritis patients necessitating effective and rapid symptom control with minimal systemic side effects.