Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain

Shimoyama, Naohito; Gomyo, Ikuo; Teramoto, Osamu; Kojima, Kensuke; Higuchi, Hitomi; Yukitoshi, Nobuyuki; Ohta, Eri; Shimoyama, Megumi

doi:10.1093/jjco/hyu182

Cited by 16 publications

(5 citation statements)

References 13 publications

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“…The total number of participants in different studies was 1,004 patients. [15][16][17][18][19][20][21][22][23][24][25][26] ( Figure 1) 1 of the studies was conducted in the USA, 1 in the UK, 1 in Japan, 1 in the Netherlands, 1 in India, 1 in Europe and Indian, 1 in Spain and 5 were conducted in Italy. The study period varied between 1997 to 2017.…”

Section: Results Study Selection and Characteristicsmentioning

confidence: 99%

Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis

Manirakiza¹,

Irakoze

Manirakiza

et al. 2020

EAHRJ

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Background: Cancer pain is experienced by numerous patients; thus, the main pain-relieving opioid analgesics, fentanyl and morphine, are of great importance. However, their analgesic efficacy and safety are different among individuals and are still controversial. The aim of this study was to compare the safety and efficacy of fentanyl and morphine among patients with cancer. Methods: We performed a meta-analysis by searching PubMed and the Cochrane Library up to 01 April 2019. The search terms were fentanyl, morphine, opioids and cancer pain. All randomised controlled trials comparing fentanyl and morphine were included in the analysis. Results: Overall, the initial search identified 2970 published studies; among them, 9 studies were included in the efficacy analysis and 8 studies were included in the safety analysis. The oral morphine versus oral transmucosal fentanyl subgroup analysis showed a mean difference(MD)=0.47[Confidence interval(CI):0.35-0.58] with an overall effect, Z=8.10, P<.00001. The outcome of the oral morphine versus nasal/transdermal fentanyl subgroup indicated a MD=0.20[CI:0.3-0.37] with an overall effect, Z=2.24 and P=.02. For the oral morphine versus buccal/sublingual fentanyl subgroup, the analysis revealed a MD=1.80[CI:1.35-2.25] with an overall effect, Z=7.87 and P<.00001. The oral morphine versus other forms of fentanyl subgroup showed a MD=0.70[95%CI:0.34-1.06] with the test for the overall effect, Z=3.81 and P=.0001. Constipation, drowsiness, confusion and dry mouth were more common in the morphine group than in the fentanyl group, with a risk ratio=0.60[

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Section: Results Study Selection and Characteristicsmentioning

confidence: 99%

Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis

Manirakiza¹,

Irakoze

Manirakiza

et al. 2020

EAHRJ

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“…However, there has been a study suggesting doses of a transmucosal immediate-release buccal fentanyl formulation proportional to a patient's ATC opioid regimen was more efficacious than oral morphine during the first 30 min posttreatment [32]. Another approach calculated the dose of a transmucosal immediate-release sublingual fentanyl formulation for BTCP from a precalculated morphine dose for BTCP and found that a conversion ratio of 1/50 provided efficacious analgesia [33]. In the current study, initiating treatment with a low dose of a fentanyl sublingual spray and titrating upward to identify an effective dose, was found to be an efficacious strategy for patients receiving ATC transdermal fentanyl patch.…”

Section: Discussionmentioning

confidence: 99%

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Alberts

Rauck

Parikh³

et al. 2014

JCO

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aim: To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP). Methods: Adults tolerating ATC opioids received open-label FSS for 26 days, followed by a 26-day double-blind phase for patients achieving an effective dose (100-1600 μg). Results: Out of 50 patients on ATC TFP at baseline, 32 (64%) achieved an effective dose. FSS effective dose moderately correlated with mean TFP dose (r = 0.4; p = 0.03). Patient satisfaction increased during the study. Common adverse events included nausea (9%) and peripheral edema (9%). conclusion: FSS can be safely titrated to an effective dose for BTCP in patients receiving ATC TFP as chronic cancer pain medication. clinicaltrials.gov identifier: NCT00538850 Keywords• breakthrough cancer pain • fentanyl sublingual spray • transmucosal immediate-release fentanyl David S Alberts, MD, and co-authorsPersistent underlying pain in patients with cancer is effectively managed by around-the-clock (ATC) opioid analgesics; however, transient exacerbations of pain that occur spontaneously over the underlying pain, commonly described as breakthrough cancer pain (BTCP), can occur [1,2]. BTCP is reported by 15-100% of patients with cancer depending on the clinical setting and patient population studied [3][4][5][6][7][8][9]. In a systematic review of 19 observational Practice points• Patients with cancer-related pain may require around-the clock (ATC) opioid analgesics.• Despite ATC opioids, breakthrough cancer pain (BTCP) may necessitate the use of additional analgesics.• Fentanyl products such as the transdermal fentanyl patch and fentanyl sublingual spray may be prescribed to manage BTCP.• Treatment of cancer-related pain is complex and requires thorough understanding of the relationship between doses of concomitant medications and their analgesic and adverse effects.• The current study indicates a weak-to-moderate correlation between the effective dose of fentanyl sublingual spray used to treat BTCP and the effective dose of ATC transdermal fentanyl patch.• Initiating treatment with a low dose of a fentanyl sublingual spray and titrating upward to identify an effective dose may be an efficacious strategy for patients receiving ATC transdermal fentanyl patch and fentanyl sublingual fentanyl spray.• Fentanyl sublingual spray is generally well tolerated in patients receiving ATC transdermal fentanyl patch for BTCP.Pain Manag. (Epub ahead of print)

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“… a Shimoyama 2015 173,185 ; Farrar 1998 174 ; Portenoy 2006 and 2010 175,180 ; Slatkin 2007 176 ; Kress 2009 177 ; Rauck 2009, 2010, and 2012 178,181,182 ; Lennernäs 2010 179 ; Kosugi 2014 183 ; Novotna 2014 184 ; and Thronæs 2015 186 …”

Section: Methodsunclassified

“…Most randomized, placebo-controlled trials in the cancer pain field have evaluated fentanyl for breakthrough pain (acute episodes of pain superimposed on chronic/background cancer pain). A 2022 guideline identified 14 placebo-controlled trials (n = 1347) [173][174][175][176][177][178][179][180][181][182][183][184][185][186] of fentanyl administered via the sublingual (n = 5), intranasal (n = 3), buccal (n = 4), or oral transmucosal (spray) route (n = 2; Table 2; see Table S12).…”

Section: Placebo-controlled Trials For Breakthrough Cancer Painmentioning

confidence: 99%

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Opioid analgesics for nociceptive cancer pain: A comprehensive review

Abdel Shaheed,

Hayes,

Maher

et al. 2023

CA A Cancer J Clinicians

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Pain is one of the most burdensome symptoms in people with cancer, and opioid analgesics are considered the mainstay of cancer pain management. For this review, the authors evaluated the efficacy and toxicities of opioid analgesics compared with placebo, other opioids, nonopioid analgesics, and nonpharmacologic treatments for background cancer pain (continuous and relatively constant pain present at rest), and breakthrough cancer pain (transient exacerbation of pain despite stable and adequately controlled background pain). They found a paucity of placebo‐controlled trials for background cancer pain, although tapentadol or codeine may be more efficacious than placebo (moderate‐certainty to low‐certainty evidence). Nonsteroidal anti‐inflammatory drugs including aspirin, piroxicam, diclofenac, ketorolac, and the antidepressant medicine imipramine, may be at least as efficacious as opioids for moderate‐to‐severe background cancer pain. For breakthrough cancer pain, oral transmucosal, buccal, sublingual, or intranasal fentanyl preparations were identified as more efficacious than placebo but were more commonly associated with toxicities, including constipation and nausea. Despite being recommended worldwide for the treatment of cancer pain, morphine was generally not superior to other opioids, nor did it have a more favorable toxicity profile. The interpretation of study results, however, was complicated by the heterogeneity in the study populations evaluated. Given the limited quality and quantity of research, there is a need to reappraise the clinical utility of opioids in people with cancer pain, particularly those who are not at the end of life, and to further explore the effects of opioids on immune system function and quality of life in these individuals.

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Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain

Cited by 16 publications

References 13 publications

Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis

Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis

Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.

Opioid analgesics for nociceptive cancer pain: A comprehensive review

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