A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF DICLOFENAC AND ACECLOFENAC IN THE TREATMENT OF OSTEOARTHRITIS PATIENTS

Abstract

Objectives: Osteoarthritis is a slowly evolving, active disease of degeneration of the articular cartilage associated with symptoms of joint pain, stiffness and limitation of movement. Typically, these symptoms tend to worse with weight bearing and activity. Non-steroidal anti-inflammatory drugs play an important role in the management of osteoarthritis. This study was conducted to compare efficacy and safety of Aceclofenac and Diclofenac in the treatment of osteoarthritis patient.

Design: Randomized, single blinded, parallel group clinical study

Intervention: The study was conducted in 140 patients of OA. After initial clinical assessment and baseline investigations, Aceclofenac was prescribed to 70 patients and Diclofenac to another 70 patients for 8 weeks. At follow-up, the patients were re-evaluated and compared statistically.

Main outcome measures: were Western Ontario MacMaster (WOMAC) scores, time taken to walk 100 feet, visual analogue scores for pain, investigators assessment for disease status and response to therapy, patient response to drug and joint tenderness. Safety assessment was based on adverse events.

Results: Aceclofenac significantly improved patient’s clinical condition from baseline to day 56. Aceclofenac was found to be superior to Diclofenac in efficacy parameters of WOMAC osteoarthritis index scores (p<0.0001), joint tenderness (p<0.0001), investigator assessment for disease status (p=0.01) and response to therapy (p=0.038), patient response to drug (p=0.024). Aceclofenac and Diclofenac were equally effective in other efficacy parameters. Aceclofenac was found well tolerated than Diclofenac in terms of epigastric discomfort, dyspepsia and abdominal pain.

Conclusion: Aceclofenac is a better choice in osteoarthritis in comparison to Diclofenac due to its better efficacy and safety.