Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
BACKGROUND
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<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P<or=0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]).


CONCLUSIONS
Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20-50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
Lange
Bernd
B
Global Development, Grünenthal GmbH, D-52078 Aachen, Germany. bernd.lange@grunenthal.com
Kuperwasser
Brigitte
B
Okamoto
Akiko
A
Steup
Achim
A
Häufel
Thomas
T
Ashworth
Judy
J
Etropolski
Mila
M
D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000704:Analysis of Variance; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016018:Least-Squares Analysis; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010098:Oxycodone / Q000627:therapeutic use; D010147:Pain Measurement; D010636:Phenols / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D012720:Severity of Illness Index; D000077432:Tapentadol; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010636:Phenols; D010098:Oxycodone; D000077432:Tapentadol