Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain

Introduction This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100–250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg twice daily). Methods Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100–250 mg), or oxycodone HCl CR (20–50 mg) for a 12-week maintenance period, preceded by a 3-week titration period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the maintenance period and for the overall maintenance period using last observation carried forward for imputation of values missing after treatment discontinuation. Results A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall maintenance period (all P