title: The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.
abstract: OBJECTIVE
  The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients.
  
  
  METHODS
  This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms.
  
  
  RESULTS
  Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment.
  
  
  CONCLUSIONS
  No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.
authors.affiliation: Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
authors.forename: Ikuko
authors.initials: I
authors.lastname: Yataba
authors.affiliation: Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan. n-otsuka@so.taisho.co.jp.
authors.forename: Noboru
authors.initials: N
authors.lastname: Otsuka
authors.affiliation: Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Matsushita
authors.affiliation: Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Matsumoto
authors.affiliation: Orthopedic Surgery, School of Medicine, Jichi Medical University, Tochigi, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Hoshino
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003877:Dermatitis, Contact / Q000453:epidemiology; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010438:Peptic Ulcer Hemorrhage / Q000453:epidemiology; D011446:Prospective Studies; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005480:Flurbiprofen