PMID- 27229525
OWN - NLM
STAT- MEDLINE
DCOM- 20161230
LR  - 20181202
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 36
IP  - 8
DP  - 2016 Aug
TI  - The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An 
      Open-Label, 52-Week Study.
PG  - 673-82
LID - 10.1007/s40261-016-0412-0 [doi]
AB  - BACKGROUND AND OBJECTIVES: 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.
FAU - Yataba, Ikuko
AU  - Yataba I
AD  - Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, 
      Toshima-ku, Tokyo, 170-8633, Japan.
FAU - Otsuka, Noboru
AU  - Otsuka N
AD  - Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, 
      Toshima-ku, Tokyo, 170-8633, Japan. n-otsuka@so.taisho.co.jp.
FAU - Matsushita, Isao
AU  - Matsushita I
AD  - Development Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, 
      Toshima-ku, Tokyo, 170-8633, Japan.
FAU - Matsumoto, Hideo
AU  - Matsumoto H
AD  - Institute for Integrated Sports Medicine, School of Medicine, Keio University, 
      Tokyo, Japan.
FAU - Hoshino, Yuichi
AU  - Hoshino Y
AD  - Orthopedic Surgery, School of Medicine, Jichi Medical University, Tochigi, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 5GRO578KLP (Flurbiprofen)
SB  - IM
MH  - Administration, Topical
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Dermatitis, Contact/epidemiology
MH  - Female
MH  - Flurbiprofen/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/*drug therapy
MH  - Pain/drug therapy/etiology
MH  - Peptic Ulcer Hemorrhage/epidemiology
MH  - Prospective Studies
MH  - Transdermal Patch
MH  - Treatment Outcome
PMC - PMC4951513
EDAT- 2016/05/28 06:00
MHDA- 2016/12/31 06:00
PMCR- 2016/05/26
CRDT- 2016/05/28 06:00
PHST- 2016/05/28 06:00 [entrez]
PHST- 2016/05/28 06:00 [pubmed]
PHST- 2016/12/31 06:00 [medline]
PHST- 2016/05/26 00:00 [pmc-release]
AID - 10.1007/s40261-016-0412-0 [pii]
AID - 412 [pii]
AID - 10.1007/s40261-016-0412-0 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2016 Aug;36(8):673-82. doi: 10.1007/s40261-016-0412-0.