PMID- 29572732
OWN - NLM
STAT- MEDLINE
DCOM- 20181008
LR  - 20181114
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 18
IP  - 2
DP  - 2018 Jun
TI  - Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain 
      Management According to Cancer Stage and Background Opioid Medication.
PG  - 119-128
LID - 10.1007/s40268-018-0231-2 [doi]
AB  - OBJECTIVE: Our objective was to assess the effect of sublingual fentanyl tablets 
      (SFTs) on pain relief, quality of life, and adverse effects in patients with 
      cancer pain, according to cancer stage and background opioid regimen. METHODS: 
      Subgroup analyses from a recently completed study were performed according to 
      cancer stage (locally advanced cancer [LAC] vs. metastatic cancer) and most 
      frequent background opioid medication (fentanyl vs. oxycodone/naloxone). The 
      efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset 
      of pain relief, and adverse events (AEs). Health status was assessed with the 
      Short Form 12, version 2 (SF-12v2) questionnaire and the Hospital Anxiety and 
      Depression Scale (anxiety subscale [HADS-A] and depression subscale [HADS-D]). 
      RESULTS: In total, 54 (67.5%) patients had LAC and 26 (32.5%) had metastatic 
      cancer. The oxycodone/naloxone group included 39 patients (48.1%) and the 
      fentanyl group 29 (35.8%). In all subgroups, pain relief was achieved within 
      5 min in an increasing number of individuals over time; at the end of the study, 
      PI values decreased (PI-end: 44.4% for LAC vs. 57.9% for metastatic cancer; 44.4% 
      for fentanyl vs. 38.6% for oxycodone/naloxone). HADS and mental component summary 
      (MCS) SF-12v2 scores significantly improved in the LAC group (HADS-A 9.44-8.04; 
      HADS-D 10.46-8.15; MCS 44.69-45.94) and in the fentanyl group (HADS-A 10.05-8.33; 
      HADS-D 11.95-8.76; MCS 44.38-47.19). AEs were reported in few patients and were 
      mostly mild. CONCLUSIONS: Exploratory subgroup analyses show the efficacy and 
      safety of SFTs for the treatment of breakthrough pain in patients with cancer, 
      regardless of their cancer stage and background opioid medication.
FAU - Guitart, Jordi
AU  - Guitart J
AD  - Department of Anesthesiology, Hospital Plato, C/Plato 21, 08006, Barcelona, 
      Spain. jordi.guitart@hospitalplato.com.
FAU - Vargas, Maria Isabel
AU  - Vargas MI
AD  - Department of Anesthesiology, Parc Sanitari Sant Joan de Deu, Barcelona, Spain.
FAU - De Sanctis, Vicente
AU  - De Sanctis V
AD  - Pain Unit, Department of Anesthesiology, Hospital Universitari Sagrat Cor, 
      Barcelona, Spain.
FAU - Folch, Jordi
AU  - Folch J
AD  - Department of Anesthesiology, Hospital Plato, C/Plato 21, 08006, Barcelona, 
      Spain.
FAU - Salazar, Rafael
AU  - Salazar R
AD  - Department of Anesthesiology, Hospital Comarcal d'Inca, Palma de Mallorca, Spain.
FAU - Fuentes, Jose
AU  - Fuentes J
AD  - Department of Anesthesiology, Pius Hospital de Valls, Tarragona, Spain.
FAU - Coma, Joan
AU  - Coma J
AD  - Department of Anesthesiology, Hospital General de l'Hospitalet, Barcelona, Spain.
FAU - Ferreras, Julia
AU  - Ferreras J
AD  - Pain Unit, Department of Anesthesiology, Hospital Residencia Sant Camil, 
      Barcelona, Spain.
FAU - Moya, Jordi
AU  - Moya J
AD  - Pain Unit, Department of Anesthesiology, Hospital Mateu Orfila, Menorca, Spain.
FAU - Tomas, Albert
AU  - Tomas A
AD  - Pain Unit, Department of Anesthesiology, Fundacio Hospital Sant Bernabe, 
      Barcelona, Spain.
FAU - Estivill, Pere
AU  - Estivill P
AD  - Department of Anesthesiology, Parc Sanitari Sant Joan de Deu, Barcelona, Spain.
FAU - Rodelas, Francisco
AU  - Rodelas F
AD  - Department of Anesthesiology, Hospital Comarcal d'Inca, Palma de Mallorca, Spain.
FAU - Jimenez, Antonio Javier
AU  - Jimenez AJ
AD  - Kyowa Kirin Farmaceutica SLU, Madrid, Spain.
FAU - Sanz, Almudena
AU  - Sanz A
AD  - Kyowa Kirin Farmaceutica SLU, Madrid, Spain.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Drug Combinations)
RN  - 0 (oxycodone naloxone combination)
RN  - 36B82AMQ7N (Naloxone)
RN  - CD35PMG570 (Oxycodone)
RN  - UF599785JZ (Fentanyl)
SB  - IM
EIN - Drugs R D. 2018 Sep;18(3):247-248. PMID: 29987670
MH  - Administration, Sublingual
MH  - Aged
MH  - Analgesics, Opioid/therapeutic use
MH  - Breakthrough Pain/*complications/*drug therapy
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fentanyl/administration & dosage/*adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Naloxone/therapeutic use
MH  - Neoplasm Staging
MH  - Neoplasms/*complications/*pathology
MH  - Oxycodone/therapeutic use
MH  - Pain Management/*methods
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC5995789
COIS- FUNDING: This work was supported by Kyowa Kirin Farmaceutica SLU. The authors 
      received research funding from Kyowa Kirin Farmaceutica SLU for this study. 
      CONFLICTS OF INTEREST: Antonio Javier Jimenez and Almudena Sanz are employees of 
      Kyowa Kirin Farmaceutica SLU. The authors have no further competing interests.
EDAT- 2018/03/25 06:00
MHDA- 2018/10/09 06:00
PMCR- 2018/03/23
CRDT- 2018/03/25 06:00
PHST- 2018/03/25 06:00 [pubmed]
PHST- 2018/10/09 06:00 [medline]
PHST- 2018/03/25 06:00 [entrez]
PHST- 2018/03/23 00:00 [pmc-release]
AID - 10.1007/s40268-018-0231-2 [pii]
AID - 231 [pii]
AID - 10.1007/s40268-018-0231-2 [doi]
PST - ppublish
SO  - Drugs R D. 2018 Jun;18(2):119-128. doi: 10.1007/s40268-018-0231-2.