PMID- 25589840
OWN - NLM
STAT- MEDLINE
DCOM- 20151022
LR  - 20181113
IS  - 2005-6648 (Electronic)
IS  - 1226-3303 (Print)
IS  - 1226-3303 (Linking)
VI  - 30
IP  - 1
DP  - 2015 Jan
TI  - The efficacy of low-dose transdermal fentanyl in opioid-naive cancer patients 
      with moderate-to-severe pain.
PG  - 88-95
LID - 10.3904/kjim.2015.30.1.88 [doi]
AB  - BACKGROUND/AIMS: Little is known about the efficacy of low-dose transdermal 
      fentanyl (TDF) patches in opioid-naive patients with moderate-to-severe cancer 
      pain. METHODS: This study had an open-label, prospective design, and was 
      conducted between April 2007 and February 2009 in seven tertiary cancer 
      hospitals; 98 patients were enrolled. TDF was started using a low-dose 
      formulation (12.5 microg/hr), and the dose was adjusted according to the clinical 
      situation of individual patients. Pain intensity, the TDF doses used, and adverse 
      events (AEs) were monitored over 4 weeks. Data were analyzed using the 
      intent-to-treat and per-protocol principles. RESULTS: Of the 98 patients 
      enrolled, 64 (65%) completed the study. The median pain intensity decreased from 
      6.0 to 3.0 (p < 0.001) at the follow-up visit. The efficacy of low-dose TDF on 
      pain relief was consistent across groups separated according to gender (p < 
      0.001), age (p < 0.001), metastasis (p < 0.001), previous treatment (p < 0.001), 
      and baseline pain intensity (p < 0.001). The decrease in pain intensity was 
      significantly greater in the severe group compared with the moderate group (mean 
      +/- SD, 5.10 +/- 2.48 vs. 2.48 +/- 1.56; p < 0.001). TDF dose (27.8 microg/hr vs. 24.8 
      microg/hr, p = 0.423) and the mean treatment time (7.5 days vs. 7.9 days, p = 0.740) 
      required for pain control were not different between the two pain-intensity 
      groups. Patients had AEs of only mild or moderate intensity; among these, nausea 
      (38%) was the most common, followed by vomiting (22%) and somnolence (22%). 
      CONCLUSIONS: Low-dose TDF was an effective treatment for patients with cancer 
      pain of moderate-to-severe intensity. Further randomized trials assessing the 
      efficacy of TDF for severe pain and/or optimal starting doses are warranted.
FAU - Kang, Jung Hun
AU  - Kang JH
AD  - Department of Internal Medicine, Gyeongsang National University School of 
      Medicine, Jinju, Korea.
FAU - Oh, Sung Yong
AU  - Oh SY
AD  - Department of Internal Medicine, Dong-A University College of Medicine, Busan, 
      Korea.
FAU - Song, Seo-Young
AU  - Song SY
AD  - Department of Internal Medicine, Kangwon National University School of Medicine, 
      Chuncheon, Korea.
FAU - Lee, Hui-Young
AU  - Lee HY
AD  - Department of Internal Medicine, Kangwon National University School of Medicine, 
      Chuncheon, Korea.
FAU - Kim, Jung Han
AU  - Kim JH
AD  - Department of Internal Medicine, Hallym University College of Medicine, Seoul, 
      Korea.
FAU - Lee, Kyoung Eun
AU  - Lee KE
AD  - Department of Internal Medicine, Ewha Womans University School of Medicine, 
      Seoul, Korea.
FAU - Lee, Hye Ran
AU  - Lee HR
AD  - Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, 
      Korea.
FAU - Hwang, In Gyu
AU  - Hwang IG
AD  - Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, 
      Korea.
FAU - Park, Se Hoon
AU  - Park SH
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Kim, Won Seok
AU  - Kim WS
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Park, Young Suk
AU  - Park YS
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Park, Keunchil
AU  - Park K
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141230
PL  - Korea (South)
TA  - Korean J Intern Med
JT  - The Korean journal of internal medicine
JID - 8712418
RN  - 0 (Analgesics, Opioid)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*administration & dosage/adverse effects
MH  - Female
MH  - Fentanyl/*administration & dosage/adverse effects
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*complications
MH  - Pain/diagnosis/*drug therapy/etiology
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Republic of Korea
MH  - Severity of Illness Index
MH  - Tertiary Care Centers
MH  - Time Factors
MH  - Transdermal Patch
MH  - Treatment Outcome
PMC - PMC4293569
OTO - NOTNLM
OT  - Fentanyl
OT  - Neoplasms
OT  - Opioids
OT  - Pain
OT  - Transdermal patch
COIS- This study was sponsored by Janssen Korea.
EDAT- 2015/01/16 06:00
MHDA- 2015/10/23 06:00
PMCR- 2015/01/01
CRDT- 2015/01/16 06:00
PHST- 2013/10/29 00:00 [received]
PHST- 2014/01/15 00:00 [revised]
PHST- 2014/04/07 00:00 [accepted]
PHST- 2015/01/16 06:00 [entrez]
PHST- 2015/01/16 06:00 [pubmed]
PHST- 2015/10/23 06:00 [medline]
PHST- 2015/01/01 00:00 [pmc-release]
AID - 10.3904/kjim.2015.30.1.88 [doi]
PST - ppublish
SO  - Korean J Intern Med. 2015 Jan;30(1):88-95. doi: 10.3904/kjim.2015.30.1.88. Epub 
      2014 Dec 30.