PMID- 20594801
OWN - NLM
STAT- MEDLINE
DCOM- 20110225
LR  - 20151119
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 40
IP  - 5
DP  - 2010 Nov
TI  - Long-term safety and tolerability of fentanyl buccal tablet for the treatment of 
      breakthrough pain in opioid-tolerant patients with chronic pain: an 18-month 
      study.
PG  - 747-60
LID - 10.1016/j.jpainsymman.2010.02.009 [doi]
AB  - CONTEXT: Breakthrough pain (BTP) is highly prevalent in patients with chronic 
      cancer and noncancer pain, commonly requiring treatment with short-acting or 
      rapid-onset opioids. This is the first report of an analysis of long-term safety 
      from combined clinical trials of a rapid-onset transmucosal formulation of 
      fentanyl, the fentanyl buccal tablet (FBT). OBJECTIVES: This long-term 
      (18-month), open-label study assessed the safety and tolerability of FBT for the 
      treatment of BTP in a large cohort (n=646) of opioid-tolerant patients receiving 
      around-the-clock (ATC) opioids for persistant noncancer pain. METHODS: This was a 
      long-term, multicenter, open-label safety study that accepted patients naive to 
      FBT (new patients) as well as rollover patients from one of two previous 
      short-term, randomized, placebo-controlled studies involving opioid-tolerant 
      adults with chronic noncancer pain. All patients gave written informed consent, 
      and the study was conducted according to Good Clinical Practice and with 
      Independent Ethics Committee or Institutional Review Board approval. RESULTS: 
      During maintenance treatment, 70 of 646 patients (11%) discontinued because of 
      adverse events (AEs), 69 of 646 (11%) because of withdrawn consent, and 57 of 646 
      (9%) because of noncompliance. A total of 571 of 646 patients (88%) had one or 
      more AEs; most were mild to moderate in intensity and typical of AEs associated 
      with opioid use in a noncancer chronic pain population. Serious AEs were seen in 
      118 of 646 patients (18%); most were considered by the investigators to be 
      unrelated or unlikely to be related to FBT. There were six deaths (three 
      myocardial infarction, two cardiac arrest, and one pneumonia) that were 
      considered by investigators to be unrelated or unlikely to be related to FBT. 
      There were two reports of accidental overdose contained within nine reports of 
      nonfatal overdose (FBT and/or ATC and/or other medications). Four patients had 
      AEs of abuse or drug dependence, two in association with FBT. Drug withdrawal 
      syndrome occurred in 23 patients after discontinuation of FBT alone or in 
      combination with other opioids. Secondary assessments showed that average pain 
      ratings, as assessed by the Brief Pain Inventory, remained relatively stable 
      throughout the study and that consistent improvements were noted in functional 
      measures. CONCLUSION: FBT was generally safe and well tolerated, with 
      self-reported functional improvement observed in most of the opioid-tolerant 
      patients with BTP in association with chronic noncancer pain.
CI  - Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 
      All rights reserved.
FAU - Fine, Perry G
AU  - Fine PG
AD  - Department of Anesthesiology, Pain Management Center, Suite 200, 615 Arapeen 
      Drive, University of Utah, Salt Lake City, UT 84109, USA. perry.fine@hsc.utah.edu
FAU - Messina, John
AU  - Messina J
FAU - Xie, Fang
AU  - Xie F
FAU - Rathmell, James
AU  - Rathmell J
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100701
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Administration, Buccal
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/administration & dosage/adverse effects
MH  - Chronic Disease/drug therapy
MH  - Female
MH  - Fentanyl/administration & dosage/*adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/*drug therapy
MH  - Pain Measurement
MH  - *Patient Satisfaction
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2010/07/03 06:00
MHDA- 2011/02/26 06:00
CRDT- 2010/07/03 06:00
PHST- 2009/12/21 00:00 [received]
PHST- 2010/02/16 00:00 [revised]
PHST- 2010/02/17 00:00 [accepted]
PHST- 2010/07/03 06:00 [entrez]
PHST- 2010/07/03 06:00 [pubmed]
PHST- 2011/02/26 06:00 [medline]
AID - S0885-3924(10)00390-8 [pii]
AID - 10.1016/j.jpainsymman.2010.02.009 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2010 Nov;40(5):747-60. doi: 
      10.1016/j.jpainsymman.2010.02.009. Epub 2010 Jul 1.