A RANDOMIZED, PLACEBO-CONTROLLED STUDY OF FENTANYL EFFERVESCENT BUCCAL TABLETS FOR BREAKTHROUGH PAIN IN OPIOID-TOLERANT PATIENTS WITH CANCER

2.50
Hdl Handle:
http://hdl.handle.net/10755/164690
Category:
Abstract
Type:
Presentation
Title:
A RANDOMIZED, PLACEBO-CONTROLLED STUDY OF FENTANYL EFFERVESCENT BUCCAL TABLETS FOR BREAKTHROUGH PAIN IN OPIOID-TOLERANT PATIENTS WITH CANCER
Author(s):
Manco, Lorraine; Messina, John; Portenoy, Russell
Author Details:
Lorraine Manco, RN, Senior Research Nurse, Beth Israel Medical Center, New York, New York, USA, email: lmanco@chpnet.org; John Messina and Russell Portenoy
Abstract:
Topic: Cancer-related breakthrough pain (BTP) can significantly affect quality of life and functional status and typically is managed with a short-acting oral opioid, taken as needed, to supplement an around-the-clock opioid regimen. Since episodes of BTP occur unpredictably and peak rapidly, there is benefit in providing faster pain relief. Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa. They may provide rapid-onset analgesia. Purpose: This study evaluated FEBT in opioid-tolerant patients with cancer-related BTP. Framework: Breakthrough pain may be unpredictable and of severe or excruciating intensity and requires an analgesic with a rapid onset of action. Methods: Patients receiving >/- 60 morphine equivalent mg/day as baseline medication for chronic cancer-related pain and experiencing 1- 4 episodes of BTP daily were enrolled in this double-blind, randomized, placebo-controlled study. After open-label titration, patients were randomized to predefined 10-tablet sequences (7 FEBT, 3 placebo) to assess FEBT efficacy versus placebo. Pain intensity (PI) and pain relief (PR) were recorded at 15, 30, 45, and 60 minutes; pain intensity differences (PID) and total pain relief (TOTPAR) were calculated; SPID at 30 minutes (SPID30) was the primary efficacy variable. Adverse events and supplemental medication use were recorded. Findings: Eighty of 123 enrolled patients (65%) identified an effective FEBT dose during titration (100 micrograms to 800 micrograms), 77 continued in the double-blind phase, and 72 were efficacy-evaluable. The SPID30 was 3.0 +/- 0.12 (mean +/- SE) for patients receiving FEBT versus 1.8 +/- 0.18 for those receiving placebo (P<.0001). The mean PID, PR, SPID, and TOTPAR scores at each time point were significantly better for patients receiving FEBT than for those receiving placebo (P<.003 at 15 minutes; P >/- .0001 for later time points). Patients were twice as likely to require supplemental medications for episodes of BTP for which placebo was used. The most commonly reported adverse events (nausea, 22%; dizziness, 22%; headache, 15%; fatigue, 12%; vomiting, 11%) were mild or moderate in severity. Two patients discontinued because of oral tolerability issues. This study provides evidence that FEBT are well tolerated and effective for the treatment of BTP associated with cancer.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2006
Conference Name:
31st Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Boston, Massachusetts, USA
Sponsors:
Funding Sources: Cephalon Inc., Frazer, PA.
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleA RANDOMIZED, PLACEBO-CONTROLLED STUDY OF FENTANYL EFFERVESCENT BUCCAL TABLETS FOR BREAKTHROUGH PAIN IN OPIOID-TOLERANT PATIENTS WITH CANCERen_GB
dc.contributor.authorManco, Lorraineen_US
dc.contributor.authorMessina, Johnen_US
dc.contributor.authorPortenoy, Russellen_US
dc.author.detailsLorraine Manco, RN, Senior Research Nurse, Beth Israel Medical Center, New York, New York, USA, email: lmanco@chpnet.org; John Messina and Russell Portenoyen_US
dc.identifier.urihttp://hdl.handle.net/10755/164690-
dc.description.abstractTopic: Cancer-related breakthrough pain (BTP) can significantly affect quality of life and functional status and typically is managed with a short-acting oral opioid, taken as needed, to supplement an around-the-clock opioid regimen. Since episodes of BTP occur unpredictably and peak rapidly, there is benefit in providing faster pain relief. Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa. They may provide rapid-onset analgesia. Purpose: This study evaluated FEBT in opioid-tolerant patients with cancer-related BTP. Framework: Breakthrough pain may be unpredictable and of severe or excruciating intensity and requires an analgesic with a rapid onset of action. Methods: Patients receiving &gt;/- 60 morphine equivalent mg/day as baseline medication for chronic cancer-related pain and experiencing 1- 4 episodes of BTP daily were enrolled in this double-blind, randomized, placebo-controlled study. After open-label titration, patients were randomized to predefined 10-tablet sequences (7 FEBT, 3 placebo) to assess FEBT efficacy versus placebo. Pain intensity (PI) and pain relief (PR) were recorded at 15, 30, 45, and 60 minutes; pain intensity differences (PID) and total pain relief (TOTPAR) were calculated; SPID at 30 minutes (SPID30) was the primary efficacy variable. Adverse events and supplemental medication use were recorded. Findings: Eighty of 123 enrolled patients (65%) identified an effective FEBT dose during titration (100 micrograms to 800 micrograms), 77 continued in the double-blind phase, and 72 were efficacy-evaluable. The SPID30 was 3.0 +/- 0.12 (mean +/- SE) for patients receiving FEBT versus 1.8 +/- 0.18 for those receiving placebo (P&lt;.0001). The mean PID, PR, SPID, and TOTPAR scores at each time point were significantly better for patients receiving FEBT than for those receiving placebo (P&lt;.003 at 15 minutes; P &gt;/- .0001 for later time points). Patients were twice as likely to require supplemental medications for episodes of BTP for which placebo was used. The most commonly reported adverse events (nausea, 22%; dizziness, 22%; headache, 15%; fatigue, 12%; vomiting, 11%) were mild or moderate in severity. Two patients discontinued because of oral tolerability issues. This study provides evidence that FEBT are well tolerated and effective for the treatment of BTP associated with cancer.en_GB
dc.date.available2011-10-27T12:05:13Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:05:13Z-
dc.conference.date2006en_US
dc.conference.name31st Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationBoston, Massachusetts, USAen_US
dc.description.sponsorshipFunding Sources: Cephalon Inc., Frazer, PA.-
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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