A Randomized, Placebo-controlled Study of Fentanyl Buccal Tablet for Breakthrough Pain in Opioid-treated Patients With Cancer

Portenoy, Russell K.; Taylor, Donald R.; Messina, John; Tremmel, Lothar

doi:10.1097/01.ajp.0000210932.27945.4a

Cited by 198 publications

(192 citation statements)

References 24 publications

Supporting

Mentioning

167

Contrasting

Unclassified

Order By: Relevance

“…The pattern of AEs and the number of patient deaths during the study are reflective of the underlying disease states of the patients. The AEs judged to be related to INFS included vomiting, dizziness, fatigue and euphoric mood, all of which are commonly observed with the use of rapid onset opioid analgesics in this indication [16,42,43], as well as rhinalgia and sneezing attributable to the intranasal mode of drug delivery. The lower frequency of AEs observed in the current study, compared with those reported in controlled studies [16][17][18], may in part reflect the shorter duration of this study, as well as differences in reporting procedures and study design.…”

Section: Discussionmentioning

confidence: 99%

Efficiency of Intranasal Fentanyl in Patients with Breakthrough Cancer Pain in Daily Practice - Results of the German Non-Interventional Study with Instanyl® (GENISIS)

Ueberall¹

2014

Glob J Anesth

View full text Add to dashboard Cite

Objective: Breakthrough cancer pain (BTcP) affects 19-95% of cancer patients (dependent on the definition and methods used and the populations studied) and is associated with detrimental physical, psychological and social complications in affected individuals as well as with significant economic burden on society and the healthcare system. This study evaluated the analgesic efficacy and safety of intranasal fentanyl spray (INFS) for the treatment of BTcP in a clinical setting with a special focus on its impact on health care resource utilization. Research design and methods:This was a prospective, open-label, noninterventional, multi-center study. Opioid-tolerant adult patients with BTcP received INFS in the course of routine clinical practice, and completed standardized questionnaires as well as BTcP diaries over a 28-day observation period. Clinical trial registration: ClinicalTrials.gov Identifier: NCT00994760Main outcome measures: Efficacy was assessed using measures of BTcP intensities, the times to first and to the maximum effect of INFS, as well as changes in BTcP-related restrictions in quality-of-life (QoL), activities of daily life (ADL) and overall wellbeing. Further analyses based on INFS-related changes in health care resource utilization. Treatment emergent adverse events (TEAEs) were recorded throughout.Results: Overall, 58 centers participated and enrolled 131 patients, of whom 116 (88.5%) completed the observation period and documented a total of 556BTcP episodes. The 100µg dose was judged as the most effective INFS dose in 64.0a% of patients, followed by 50 µg (28.0a%) and 200 µg (8.0 a%). The study recorded a substantial INFSrelated improvement in maximum BTcP intensity, compared with baseline as well as prior use. Patients reported experiencing the first effects of the study drug within 5 minutes of administration in 81.9% of episodes, and a time to maximum effect within 10 minutes in 81.4% of episodes. QoL and BTcP-related restrictions in ADL showed considerable improvements during the observation period. INFS was well tolerated, with sixpatients (4.6%) experiencing ≥1 study drug-related adverse event. Study limitations include a modest size and duration, and the single-arm design. Conclusion:Under the conditions of this non-interventional open-label study, INFS proved to be a rapid onset, highly effective and well tolerated alternative for the treatment of BTcP in opioid-tolerant cancer patients. INFS treatment was not only associated with substantial improvements in BTcP intensity as well as related restrictions in QoL and ADL, but also with a respectable decrease of health care resource demands -especially in the field of ambulatory palliative care nursing services.relatively stable and adequately controlled background pain [2]. Due to epidemiological studies, BTcP is a common cancer complication with reported prevalence rates ranging between 19-95% (dependent on the definition and methods used, and the populations studied) [3][4][5][6][7], which is accompanied by detrimental rest...

show abstract

Section: Discussionmentioning

confidence: 99%

Efficiency of Intranasal Fentanyl in Patients with Breakthrough Cancer Pain in Daily Practice - Results of the German Non-Interventional Study with Instanyl® (GENISIS)

Ueberall¹

2014

Glob J Anesth

View full text Add to dashboard Cite

show abstract

“…Pain relief has been observed to begin as early as 10 minutes after administration and to last throughout the 120-minute observation period 64 . In two randomized controlled trials that compared fentanyl buccal tablets with placebo, btcp relief attained significantly favoured fentanyl buccal tablets 64,65 .…”

Section: Contemporary Approaches To the Management Of Btcp With Rapidmentioning

confidence: 98%

“…In a randomized placebo-controlled study of fentanyl sublingual tablets in 131 adult patients with btcp, use of the tablets resulted in significant improvements in pain intensity and relief compared with placebo 66 . In phase iii studies evaluating the long-term effectiveness of transmucosal immediate-release fentanyl, patients reported high levels of satisfaction with the formulation 65,67 .…”

Section: Contemporary Approaches To the Management Of Btcp With Rapidmentioning

confidence: 99%

See 1 more Smart Citation

Canadian Recommendations for the Management of Breakthrough Cancer Pain

et al. 2016

View full text Add to dashboard Cite

Breakthrough cancer pain (btcp) represents an important element in the spectrum of cancer pain management. Because most btcp episodes peak in intensity within a few minutes, speed of medication onset is crucial for proper control. In Canada, several current provincial guidelines for the management of cancer pain include a brief discussion about the treatment of btcp; however, there are no uniform national recommendations for the management of btcp. That lack, accompanied by unequal access to pain medication across the country, contributes to both regional and provincial variability in the management of btcp.Currently, immediate-release oral opioids are the treatment of choice for btcp. This approach might not always offer optimal speed for onset of action and duration to match the rapid nature of an episode of btcp. Novel transmucosal fentanyl formulations might be more appropriate for some types of btcp, but limited access to such drugs hinders their use. In addition, the recognition of btcp and its proper assessment, which are crucial steps toward appropriate treatment selection, remain challenging for many health care professionals.To facilitate appropriate management of btcp, a group of prominent Canadian specialists in palliative care, oncology, and anesthesiology convened to develop a set of recommendations and suggestions to assist Canadian health care providers in the treatment of btcp and the alleviation of the suffering and discomfort experienced by adult cancer patients.

show abstract

“…Availability of FBT was 48%, in comparison with 22% of OTFC. Controlled studies have shown that FBT is effective in treating breakthrough cancer pain [32].…”

Section: New Delivery Systemsmentioning

confidence: 99%