Improved tolerability with aceclofenac-hpβcd inclusion complex compared to aceclofenac in patients with knee osteoarthritis

Background: Aceclofenac is a NSAID which possesses anti-inflammatory and analgesic properties. However, it has low aqueous solubility, leading to poor dissolution, insufficient oral bioavailability and more gastrointestinal (GI) adverse effects. The aim of the study was to evaluate the efficacy, safety and tolerability of Aceclofenac-HPβCD complex tablets compared with Aceclofenac tablets in patients with knee osteoarthritis (OA).
Materials and Methods: This was a prospective, randomized, multi-centric study. A total of 240 subjects with OA were randomized into two groups: Group A (n=120) were administered Aceclofenac-HPβCD tablets, twice daily and Group B (n=120) were administered Aceclofenac tablets twice daily day for 6 weeks. The primary outcome was to assess and compare GI tolerability and safety between two treatments groups.  A visual analogue scale (VAS), WOMAC index, pain relief score and patients and investigators overall assessment of response to study were also noted. 
Results:  The results of the study showed a trend towards significantly lower incidence of GI adverse effects with group A compared to group B. The change in VAS score and WOMAC score showed significant improvement in group A compared to group B. The patients and investigators overall assessment of response to study drugs was better in Aceclofenac-HPβCD complex tablets group as compared to Aceclofenac tablets. The consumption of gastro-protective agents was also significantly lower in group A compared to group B. 
Conclusion: Aceclofenac-HPβCD tablets was found to safe and effective in improving pain, stiffness, and physical performance in knee OA patients. Aceclofenac-HPβCD tablets were associated with significantly better GI tolerability compared to Aceclofenac tablets.