PMID- 28744772 OWN - NLM STAT- MEDLINE DCOM- 20180628 LR - 20240327 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 17 IP - 3 DP - 2017 Sep TI - Breakthrough Pain Management with Sublingual Fentanyl Tablets in Patients with Cancer: Age Subgroup Analysis of a Multicenter Prospective Study. PG - 419-425 LID - 10.1007/s40268-017-0198-4 [doi] AB - INTRODUCTION: Breakthrough pain (BTP) management in patients with cancer is challenging, especially in the elderly. However, no studies examining the influence of age on BTP medication have been conducted. The aim of this work was to investigate the effect of sublingual fentanyl tablets (SFTs) in terms of efficacy, safety, and quality of life in two age categories. METHODS: We performed age subgroup analyses (<65 and >/=65 years) from a recently completed study conducted in Spain. Pain intensity (PI), onset of pain relief, frequency and duration of BTP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health-status instruments used were the Short Form 12, version 2 (SF-12v2) questionnaire, and the Hospital Anxiety and Depression Scale (HADS-A and HADS-D). RESULTS: Twenty-six patients were aged <65 years and 54 were aged >/=65 years. SF-12v2 scores did not enhance significantly from baseline. HADS scores and PI decreased significantly at the end of the study, particularly in younger patients (HADS-A: 19.05 vs. 14.41%; HADS-D: 21.35 vs. 18.57%; PI: 67.23 vs. 56.30%). Onset of analgesia began in 2-5 min in 63.3% of subjects aged <65 years and in 36.4% of subjects aged >65 years. Most patients experienced one to five daily episodes after 30 days, and <5% needed a treatment change. AEs were less frequently reported in older individuals (20.5 vs. 36.4%). CONCLUSION: Age subgroup analyses suggest that SFTs are an effective and safe treatment for the management of BTP in cancer patients of all ages. SFTs may offer a well-tolerated and efficient option to control cancer BTP in the elderly. 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 PL - New Zealand TA - Drugs R D JT - Drugs in R&D JID - 100883647 RN - 0 (Analgesics, Opioid) RN - 0 (Tablets) RN - UF599785JZ (Fentanyl) SB - IM MH - Administration, Sublingual MH - Age Factors MH - Aged MH - Analgesics, Opioid/*administration & dosage/adverse effects MH - Anxiety/epidemiology MH - Breakthrough Pain/*drug therapy/etiology MH - Cancer Pain/*drug therapy MH - Depression/epidemiology MH - Fentanyl/*administration & dosage/adverse effects MH - Humans MH - Middle Aged MH - Neoplasms/complications MH - Prospective Studies MH - Psychiatric Status Rating Scales MH - Quality of Life MH - Spain MH - Tablets PMC - PMC5629138 COIS- CONFLICTS OF INTEREST: Jordi Guitart, MD declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Maria Isabel Vargas declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Vicente De Sanctis, MD declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Jordi Folch declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Rafael Salazar declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Jose Fuentes declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Joan Coma declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Julia Ferreras declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Jordi Moya declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Albert Tomas declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Pere Estivill declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Francisco Rodelas declares he has no financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. Antonio Javier Jimenez works at Medical Department of Kyowa Kirin Farmaceutica, S.L.U. Almudena Sanz works at Medical Department of Kyowa Kirin Farmaceutica, S.L.U. FUNDING: This study was funded by Kyowa Kirin Farmaceutica, S.L.U. EDAT- 2017/07/27 06:00 MHDA- 2018/06/29 06:00 PMCR- 2017/07/25 CRDT- 2017/07/27 06:00 PHST- 2017/07/27 06:00 [pubmed] PHST- 2018/06/29 06:00 [medline] PHST- 2017/07/27 06:00 [entrez] PHST- 2017/07/25 00:00 [pmc-release] AID - 10.1007/s40268-017-0198-4 [pii] AID - 198 [pii] AID - 10.1007/s40268-017-0198-4 [doi] PST - ppublish SO - Drugs R D. 2017 Sep;17(3):419-425. doi: 10.1007/s40268-017-0198-4.