title: Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain.
abstract: BACKGROUND
  Tapentadol is a novel, centrally acting analgesic with 2 mechanisms of action: µ-opioid receptor agonism and norepinephrine reuptake inhibition. This randomized, open-label phase 3 study (ClinicalTrials.gov Identifier: NCT00361504) assessed the long-term safety and tolerability of tapentadol extended release (ER) in patients with chronic knee or hip osteoarthritis pain or low back pain.
  
  
  METHODS
  Patients were randomized 4:1 to receive controlled, adjustable, oral, twice-daily doses of tapentadol ER (100 to 250 mg) or oxycodone HCl controlled release (CR; 20 to 50 mg) for up to 1 year. Efficacy evaluations included assessments at each study visit of average pain intensity (11-point numerical rating scale) over the preceding 24 hours. Treatment-emergent adverse events (TEAEs) and discontinuations were monitored throughout the study.
  
  
  RESULTS
  A total of 1,117 patients received at least 1 dose of study drug. Mean (standard error) pain intensity scores in the tapentadol ER and oxycodone CR groups, respectively, were 7.6 (0.05) and 7.6 (0.11) at baseline and decreased to 4.4 (0.09) and 4.5 (0.17) at endpoint. The overall incidence of TEAEs was 85.7% in the tapentadol ER group and 90.6% in the oxycodone CR group. In the tapentadol ER and oxycodone CR groups, respectively, TEAEs led to discontinuation in 22.1% and 36.8% of patients; gastrointestinal TEAEs led to discontinuation in 8.6% and 21.5% of patients.
  
  
  CONCLUSIONS
  Tapentadol ER (100 to 250 mg bid) was associated with better gastrointestinal tolerability than oxycodone HCl CR (20 to 50 mg bid) and provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis or low back pain for up to 1 year.
authors.affiliation: Upstate Clinical Research Associates, Williamsville, New York, USA.
authors.forename: James E
authors.initials: JE
authors.lastname: Wild
authors.forename: Stefan
authors.initials: S
authors.lastname: Grond
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kuperwasser
authors.forename: Jane
authors.initials: J
authors.lastname: Gilbert
authors.forename: Bettyanne
authors.initials: B
authors.lastname: McCann
authors.forename: Bernd
authors.initials: B
authors.lastname: Lange
authors.forename: Achim
authors.initials: A
authors.lastname: Steup
authors.forename: Thomas
authors.initials: T
authors.lastname: Häufel
authors.forename: Mila S
authors.initials: MS
authors.lastname: Etropolski
authors.forename: Christine
authors.initials: C
authors.lastname: Rauschkolb
authors.forename: Robert
authors.initials: R
authors.lastname: Lange
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D010349:Patient Compliance; D010636:Phenols / Q000008:administration & dosage*; D000077432:Tapentadol
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010636:Phenols; D000077432:Tapentadol