title: Use of Fentanyl Patch for Treatment of Moderate-to-severe Chronic Noncancer Pain: Postmarketing Surveillance of Medical Practice in Japan Using a Risk Minimization Action Plan.
abstract: The purpose of this study was to discuss the safety, treatment profile, and clinical effectiveness of 12-month treatment with fentanyl patch (FP), a strong opioid, in medical practice in Japan under the risk minimization action plan (RMAP).
  
  
  
  Patients with moderate-to-severe chronic noncancer pain who had switched to FP from another opioid were registered to take this survey to assess adverse drug reactions (ADRs), therapeutic effect, and pain intensity for up to 12 months.
  
  
  
  A total of 517 patients were enrolled, and 499 patients (male, 50.9%; mean [SD] age, 63.0 [15.4] years) were included in the safety population. During the 12-month observation period, an ADR occurred in 262 patients (52.5%); most frequent ADRs included nausea (24.2%), somnolence (22.4%), constipation (18.2%), vomiting (9%), and dizziness (4.6%). The prespecified priority survey items, including respiratory depression, drug dependence, and drug withdrawal syndrome, occurred in 2 (both nonserious), 3 (all serious), and 9 (all serious) patients, respectively. In 418 patients from the efficacy population, the response rate was 77.3%, the rate of achievement of the therapeutic goal was 64.5%, and the visual analog scale (VAS) scores for pain severity decreased by 22.3 (26.9) mm.
  
  
  
  Our results identified a reasonable risk-benefit profile for the management of moderate-to-severe chronic noncancer pain in patients previously treated with opioids under long-term treatment with FP under the RMAP. Respiratory depression, drug dependency, and drug withdrawal were rarely observed even under the RMAP in Japan.
authors.affiliation: Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.|Ishinomaki Branch, Sendai Pain Clinic Center, Medical Corporation Kanteikai, Sendai, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Kawai
authors.affiliation: Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
authors.forename: Kazutake
authors.initials: K
authors.lastname: Yoshizawa
authors.affiliation: Japan Safety & Surveillance Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
authors.forename: Motoko
authors.initials: M
authors.lastname: Fujie
authors.affiliation: Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
authors.forename: Hisanori
authors.initials: H
authors.lastname: Kobayashi
authors.affiliation: Japan Safety & Surveillance Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Ogawa
authors.affiliation: Biostatistics Department, Quantitative Science Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yajima
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000453:epidemiology; D010147:Pain Measurement; D010818:Practice Patterns, Physicians'; D011358:Product Surveillance, Postmarketing; D040242:Risk Reduction Behavior; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: Japan; adverse reaction; chronic pain; fentanyl patch; long-term treatment; noncancer pain; opioids; risk mitigation