PMID- 26507617
OWN - NLM
STAT- MEDLINE
DCOM- 20160701
LR  - 20181202
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 35
IP  - 12
DP  - 2015 Dec
TI  - Sublingual Fentanyl Tablets for Relief of Breakthrough Pain in Cancer Patients 
      and Association with Quality-of-Life Outcomes.
PG  - 815-22
LID - 10.1007/s40261-015-0344-0 [doi]
AB  - BACKGROUND AND OBJECTIVE: Breakthrough pain (BTP) is highly prevalent in patients 
      with cancer and is strongly associated with adverse outcomes related to health 
      status, mood, anxiety and depression. However, studies on the effect of BTP 
      medication on quality of life (QOL) are lacking. The purpose of this study was to 
      provide a qualitative evaluation of the effect of sublingual fentanyl tablets 
      (SFT), a therapy specifically developed for BTP, on the QOL of cancer pain 
      patients. METHODS: We conducted a multicentre, prospective observation 
      post-authorisation, open-label study between March and December 2013. The study 
      consisted of a screening visit and four assessment points at 3, 7, 15 and 
      30 days. Pain intensity (PI), frequency of BTP, onset of pain relief and adverse 
      events (AEs) were assessed at each visit. Anxiety and depression were evaluated 
      using the validated Hospital Anxiety and Depression Scale (HADS) and health 
      status using the Short Form 12, version 2 (SF-12v2) Health Survey. RESULTS: Of 
      the 102 patients considered eligible, 81 (79.4 %) were enrolled; of these, 69 
      (85.1 %) completed the study. Significant pain reduction was achieved for average 
      PI (p < 0.001) compared with baseline. At the end of the observational period, 
      HADS scores showed significant improvement in the depression subscale (p = 0.005) 
      and the anxiety subscale (p < 0.001). Similarly, SF-12 scores showed significant 
      improvement, both in the mental component score (p < 0.001) and the physical 
      component score (p = 0.002). SFT was well-tolerated and only one patient withdrew 
      from the study due to drug-related AEs. CONCLUSION: SFT represents an effective, 
      well-tolerated treatment for cancer BTP. Results provide consistent evidence for 
      the positive impact of SFT on health-related QOL and physical functioning as well 
      as other co-morbidities of cancer BTP such as anxiety and depression.
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, Jordi
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, Minorca, 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  - Laboratorios ProStrakan SLU, Madrid, Spain.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Tablets)
RN  - UF599785JZ (Fentanyl)
SB  - IM
EIN - Clin Drug Investig. 2016 Aug;36(8):695. PMID: 27256618
MH  - Administration, Sublingual
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*administration & dosage
MH  - Breakthrough Pain/diagnosis/*drug therapy/epidemiology
MH  - Female
MH  - Fentanyl/*administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/diagnosis/*drug therapy/epidemiology
MH  - Pain Management/*methods
MH  - Pain Measurement/drug effects/methods
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Tablets
MH  - Treatment Outcome
EDAT- 2015/10/29 06:00
MHDA- 2016/07/02 06:00
CRDT- 2015/10/29 06:00
PHST- 2015/10/29 06:00 [entrez]
PHST- 2015/10/29 06:00 [pubmed]
PHST- 2016/07/02 06:00 [medline]
AID - 10.1007/s40261-015-0344-0 [pii]
AID - 10.1007/s40261-015-0344-0 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2015 Dec;35(12):815-22. doi: 10.1007/s40261-015-0344-0.