OSTEOARTHRITIS;

EFFICACY AND SAFETY OF ACECLOFENAC IN THE TREATMENT: A RANDOMIZED DOUBLE-BLIND COMPARATIVE CLINICAL TRIAL VERSUS DICLOFENAC”

Abstract

Objective: To assess the efficacy and safety of aceclofenac in the treatment of
osteoarthritis. Study design: Randomized double blind Phase IV trial. Place and Duration of
study: This study was conducted in the department of Orthopaedics & Spine Surgery, Ghurki
Trust Teaching Hospital, Lahore. The duration was eight weeks. Methodology: A total of 90
subjects, fulfilling the inclusion criteria and willing to give free informed consent were enrolled in
this trial. All these subjects were randomized into two treatment groups (A & B). Subjects either
received Aceclofenac 100 mg twice daily or Diclofenac 75 mg twice daily for 08 weeks. During the
screening visit, information on their demographic characteristics, medical history and previous
and current medications were collected. A thorough physical examination and necessary
laboratory investigations were carried out before drug administration and after the completion of
treatment (end of week 8). Clinical examination was done at baseline visit, randomization and 2, 4
and 8 weeks. Gastrointestinal (GI) safety was assessed using adverse drug reaction (ADR)
reports. WOMAC questionnaire was used to see improvement in activities of daily living and pain
was assessed using visual analogue scale (VAS). All data was collected in the case report form
(CRF). Statistical evaluation was performed at the end of the trial and results were analyzed using
SPSS. Results: 70 subjects completed the study while 20 were lost in follow-up. There were 28
males and 34 females in the study with mean age of 56 years. There was a significant decrease in
WOMAC and VAS scores in both groups. In group A (Diclofenac group) VAS decreased from
7.107 to 2.538 (p= 0.000) and WOMAC decreased from 32.75 to 7.38 (p=0.000). In group B
(Aceclofenac group), VAS decreased from 7.912 to 6.0 (p=0.001) while WOMAC decreased from
37.29 to 21.50 (p=0.000) showing the efficacy of both drugs. There was also significant decrease
in the disease severity in both groups at the end of treatment. But the safety profile of (Diclofenac)
group A was not significant (p=0.767) as compared to (Aceclofenac) group B (p=0.022).
Conclusions: Aceclofenac is efficacious and safe drug for the treatment of osteoarthritis in adults
as compared to Diclofenac.