title: Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice.
abstract: OBJECTIVE
  To evaluate the overall safety profile and clinical effectiveness of tramadol hydrochloride/acetaminophen (TA) combination tablets in Japanese patients with chronic noncancer pain unrelieved by non-opioid drugs for up to 12 weeks in real-world practice.
  
  
  METHODS
  This survey was a multicenter, prospective, longitudinal registry on the use of TA as a newly initiated pain treatment for chronic noncancer pain incurable by non-opioid analgesics that was conducted under the Good Post Marketing Study Practice regulation controlled by the Japan Ministry of Health, Labor and Welfare. Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period.
  
  
  RESULTS
  A total of 1316 patients were registered. ADRs were reported in 259 patients (20.5%); most events were nonserious (99.4%), including nausea (n = 87 [6.9%]), constipation (n = 63 [5.0%]), dizziness and somnolence (n = 29 [2.3%] each), and vomiting (n = 21 [1.7%]). No event related to drug dependence or respiratory depression was reported. In addition, 82.8% of patients showed acceptable effectiveness based on PGI at Week 4. Numerical rating scale for intensity of pain and EQ-5D utility scores were improved by -2.7 (SD 2.3) and 0.16 (SD 0.20) at Week 4, respectively, and the improvement was maintained until Week 12.
  
  
  CONCLUSIONS
  This is a first report to evaluate the risk-benefit profile of TA in Japanese real-world practice using large size registry data. It is suggested that the favorable risk-benefit balance of TA was confirmed for patients with chronic noncancer pain unrelieved by non-opioid drugs in real-world practice. Limitations of this study were those inherent to open-label and non-interventional study designs.
  
  
  BACKGROUND
  This registry survey is registered at umin.ac.jp (identifier: UMIN000015901).
authors.affiliation: a a Medical Affairs Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: K
authors.initials: K
authors.lastname: Yoshizawa
authors.affiliation: a a Medical Affairs Division, Janssen Pharmaceutical KK , Tokyo , Japan.|b b Sendai Pain Clinic Center, Medical Corporation Kanteikai , Sendai , Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kawai
authors.affiliation: c c Research and Development Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: M
authors.initials: M
authors.lastname: Fujie
authors.affiliation: c c Research and Development Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: J
authors.initials: J
authors.lastname: Suzuki
authors.affiliation: c c Research and Development Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ogawa
authors.affiliation: c c Research and Development Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yajima
authors.affiliation: c c Research and Development Division, Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: J
authors.initials: J
authors.lastname: Yokomori
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059350:Chronic Pain / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D013607:Tablets; D014147:Tramadol / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D013607:Tablets; D000082:Acetaminophen; D014147:Tramadol
keywords: Acetaminophen; Adverse drug reactions; Effectiveness; Naturalistic practice; Pain, Chronic; Tramadol hydrochloride