Analgesic Efficacy of Valdecoxib in the Management of Post-arthroscopic Menisectomy Pain: a Placebo Controlled and Active Comparators Clinical Trial

Objective: this randomized, double blinded, placebo-controlled and active comparators study aimed at evaluating the analgesic activity and tolerability of valdecoxib, a new cyclo-oxygenase (COX)-2 specific inhibitor, as compared with either etoricoxib or codeine/paracetamol combination. Methods: A total of 81 patients with moderate to severe pain following arthroscopic menisectomy of the knee were randomly allocated to receive single oral doses of valdecoxib 40 mg (n=21), etoricoxib 120 mg (n=19), codeine/paracetamol 60/300 mg (n=21) or placebo (n=20). Efficacy was assessed by onset of analgesia, pain intensity difference (PID), pain relief (PR), time weighted sum of total pain relief (TOTPAR), sum of pain intensity difference (SPID), duration of analgesia (by time to rescue medication), percentage of patients requiring rescue analgesia and patients’ global evaluation. Patients were assessed for 24 hours and reported PID and PR scores at 14 pre-determined time points. Results: All active treatments were significantly superior to placebo for all efficacy measures (P<0.001 for all). Patients treated with valdecoxib or codeine/paracetamol experienced faster onset and longer duration of analgesia compared with those treated with etoricoxib (P<0.01). Patients receiving valdecoxib experienced significantly higher PI, PR, TOTPAR and SPID scores and greater satisfaction with their study medication compared with etoricoxib (P<0.01). Lower percentage of patients in valdecoxib group required rescue analgesia compared with etoricoxib group (P<0.01). Onset of analgesia with codeine/paracetamol group was comparable to that with valdecoxib group. Valdecoxib and codeine/paracetamol treatments provided a similar magnitude of analgesia up to 6 hours post-dose. Analgesia provided by valdecoxib was significantly superior to that of codeine/paracetamol from 8-24 hours post-dose (P<0.01). Codeine/paracetamol treatment resulted in more frequent overall adverse events (AEs) and drug related AEs compared with valdecoxib and etoricoxib treatments. Conclusion: Analgesia provided by 40 mg valdecoxib to patients with post-arthroscopic menisectomy pain is : rapid and sustained over 24 hours period, superior to that achieved by etoricoxib 120 mg, and comparable but longer lasting than that with codeine/paracetamol 60/300 mg. Valdecoxib and etoricoxib have a tolerability profile superior to that of codeine/paracetamol combination.