PMID- 24128821
OWN - NLM
STAT- MEDLINE
DCOM- 20150406
LR  - 20181202
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 47
IP  - 6
DP  - 2014 Jun
TI  - A report on the long-term use of fentanyl pectin nasal spray in patients with 
      recurrent breakthrough pain.
PG  - 1001-7
LID - S0885-3924(13)00480-6 [pii]
LID - 10.1016/j.jpainsymman.2013.07.012 [doi]
AB  - CONTEXT: As patients with cancer are living longer, there is a need to ensure 
      that treatments used for palliative care are well tolerated and effective during 
      long-term use. OBJECTIVES: To investigate the long-term use of fentanyl pectin 
      nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in 
      patients receiving regular opioid therapy. METHODS: Adult patients (N = 401) 
      taking at least 60 mg/day oral morphine or equivalent, experiencing one to four 
      episodes of BTPc a day, entered an open-label long-term study (NCT00458510). 
      Patients had either completed an FPNS randomized controlled trial or were newly 
      identified. Of these, 171 patients continued into an extension study. Up to four 
      episodes of BTPc a day were treated with FPNS at 100-800 mug titrated doses. 
      During the extension study, patients visited the clinic every four weeks for 
      assessment and reporting of adverse events (AEs). RESULTS: There were 163 
      patients with documented FPNS use. The mean duration of use was 325 days; 46 
      patients used FPNS for >/=360 days; the maximum duration was 44 months. Seventy 
      percent of patients did not change their FPNS dose; 2% of patients withdrew from 
      the study because of the lack of efficacy. The most common AEs, aside from 
      disease progression, were insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and 
      peripheral edema, 9.4%. The overall incidence of FPNS-related AEs was 11.1%, the 
      most common being constipation (4.1%), with no apparent dose relationship. 
      Ten patients (5.8%) experienced nasal AEs, most of which were mild or moderate. 
      CONCLUSION: FPNS appeared to provide sustained benefit and was well tolerated 
      during long-term treatment of BTPc.
CI  - Copyright (c) 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 
      All rights reserved.
FAU - Taylor, Donald
AU  - Taylor D
AD  - Georgia Center for Cancer Pain Management & Palliative Medicine, Marietta, 
      Georgia, USA. Electronic address: dtaylor@cpcnopain.com.
FAU - Radbruch, Lukas
AU  - Radbruch L
AD  - Klinik fur Palliativmedizin, Universitatsklinikum Bonn, Bonn, Germany.
FAU - Revnic, Julia
AU  - Revnic J
AD  - Hopital Jean Jaures, Paris, France.
FAU - Torres, Luis M
AU  - Torres LM
AD  - Hospital Universitario Puerta del Mar, Cadiz, Spain.
FAU - Ellershaw, John E
AU  - Ellershaw JE
AD  - Marie Curie Palliative Care Institute, Liverpool, United Kingdom.
FAU - Perelman, Michael
AU  - Perelman M
AD  - Archimedes Development Ltd., Nottingham, United Kingdom.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20131012
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Drug Combinations)
RN  - 0 (Nasal Sprays)
RN  - 76I7G6D29C (Morphine)
RN  - 89NA02M4RX (Pectins)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Intranasal/adverse effects
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*administration & dosage
MH  - Breakthrough Pain/*drug therapy/physiopathology
MH  - Drug Combinations
MH  - Female
MH  - Fentanyl/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphine/therapeutic use
MH  - Nasal Sprays
MH  - Neoplasms/physiopathology
MH  - Palliative Care
MH  - Pectins/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Young Adult
OTO - NOTNLM
OT  - Breakthrough
OT  - FPNS
OT  - cancer
OT  - fentanyl
OT  - long-term
OT  - pain
OT  - palliative care
EDAT- 2013/10/17 06:00
MHDA- 2015/04/07 06:00
CRDT- 2013/10/17 06:00
PHST- 2013/05/30 00:00 [received]
PHST- 2013/07/24 00:00 [revised]
PHST- 2013/07/31 00:00 [accepted]
PHST- 2013/10/17 06:00 [entrez]
PHST- 2013/10/17 06:00 [pubmed]
PHST- 2015/04/07 06:00 [medline]
AID - S0885-3924(13)00480-6 [pii]
AID - 10.1016/j.jpainsymman.2013.07.012 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2014 Jun;47(6):1001-7. doi: 
      10.1016/j.jpainsymman.2013.07.012. Epub 2013 Oct 12.