Consistent and clinically relevant effects with fentanyl buccal tablet in the
treatment of patients receiving maintenance opioid therapy and experiencing
cancer-related breakthrough pain.
Author(s): Zeppetella G, Messina J, Xie F, Slatkin NE.
Affiliation(s): St Clare Hospice, Hastingwood, Essex, UK. john.zeppetella@stclarehospice.org.uk
Publication date & source: 2010, Pain Pract. , 10(4):287-93
Fentanyl buccal tablet (FBT) has shown efficacy and tolerability in patients with
cancer-related persistent pain treated with maintenance opioids. We conducted a
combined analysis of two similarly designed, randomized, placebo-controlled
studies to further evaluate the consistency and clinical relevance of analgesia
outcomes. Of the 252 patients enrolled, 150 fulfilled the criteria for efficacy
analysis and experienced 1,417 breakthrough pain episodes. A consistently greater
effect was noted with FBT vs. placebo on the following measures: improvements
from baseline of >or=33% and >or=50% in pain intensity (PI), a >or=2-point
reduction in PI, and a score of >or=2 for pain relief. Improvements in these
clinically meaningful efficacy measures were seen with FBT at 15 minutes
(earliest common evaluation) and remained evident at 60 minutes (final common
evaluation). They were also reflected in a more favorable global medication
performance assessment for FBT over placebo. FBT was generally well tolerated;
most adverse events were typical of potent opioid use in a cancer population.
Application-site (buccal) abnormalities were infrequent and led to withdrawal of
three patients. There were no serious adverse events or deaths attributable to
FBT. This analysis suggests that FBT provides an analgesic effect that is
consistent across multiple clinically relevant efficacy measures.
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