title: Post hoc analysis of a randomized, double-blind, placebo-controlled efficacy and tolerability study of tramadol extended release for the treatment of osteoarthritis pain in geriatric patients.
abstract: BACKGROUND
  Once-daily tramadol extended release (ER) was evaluated for 12 weeks in a randomized, double-blind, placebo-controlled, parallel-group study in 1020 patients with osteoarthritis of the knee or hip. As previously reported, compared with placebo, the results of the study showed that patients treated with tramadol ER had significant improvement in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and in pain-related sleep parameters.
  
  
  OBJECTIVE
  Because chronic/persistent arthritis pain is common in geriatric patients, this post hoc analysis evaluated the efficacy and tolerability of tramadol ER in geriatric patients 65 years or older (n=317) from this study.
  
  
  METHODS
  In the original study, the co-primary efficacy variables to evaluate the efficacy and tolerability of 100-, 200-, 300-, and 400-mg doses of tramadol ER were the WOMAC Osteoarthritis Index subscale scores for pain (0-500) and physical function (0-1700), and patient global assessment of disease (0-100). Secondary efficacy variables included arthritis pain intensity, 36-Item Short-Form Health Survey, daily pain diaries, sleep parameters, and tolerability assessments. Patients rated their arthritis pain utilizing a 100-mm visual analog scale (VAS) (0=no pain, 100=extreme pain). Sleep parameters were evaluated based on a 100-mm VAS (0=never, 100=always).
  
  
  RESULTS
  A total of 317 patients 65 years or older were included in the analysis (186 women, 131 men). Compared with placebo, this analysis found a significant improvement from baseline to the final visit in the co-primary efficacy variables of pain (least-squares [LS] mean [SE], 108.7 [16.9]; P<or=0.05) and physical function (LS mean [SE], 366.4 [57.7]; P<or=0.05) subscale scores of the WOMAC Osteoarthritis Index; the patient global assessment of disease activity (LS mean [SE], 27.9 [3.9]; P<or=0.01) for the tramadol ER 300-mg group; and for the pain-related sleep effects for less awakenings by pain in the morning (100-, 200-, and 300-mg groups; P<or=0.05), less awakenings by pain during the night (200- and 300-mg groups; P<or=0.035), significantly better overall sleep quality (200-mg group only; P=0.037), and less trouble falling asleep due to pain (200-mg group only; P=0.025). Commonly reported adverse events in patients 65 years or older treated with tramadol ER included constipation (27.5%), nausea (23.4%), dizziness (22.7%), and headache (15.6%).
  
  
  CONCLUSIONS
  This post hoc analysis suggests that the tramadol ER 300-mg dose was associated with statistically significant improvement in pain intensity and physical function, and for most of the pain-related sleep effects among these geriatric patients with moderate chronic/persistent pain.
authors.affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey 08869, USA. GVorsang@OMJUS.jnj.com
authors.forename: Gary
authors.initials: G
authors.lastname: Vorsanger
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.forename: Donna
authors.initials: D
authors.lastname: Jordan
authors.forename: Jean
authors.initials: J
authors.lastname: Farrell
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D012890:Sleep / Q000502:physiology; D014147:Tramadol / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D014147:Tramadol