PMID- 31177479 OWN - NLM STAT- MEDLINE DCOM- 20200130 LR - 20200225 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 19 IP - 3 DP - 2019 Sep TI - Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets. PG - 247-254 LID - 10.1007/s40268-019-0276-x [doi] AB - INTRODUCTION: Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population. METHODS: We performed subgroup analyses of a recently completed trial in two subsets of individuals: patients aged 65-74 years (low age group) and patients >/= 75 years (high age group). Pain intensity (PI), onset of pain relief, frequency and duration of BTcP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health status instruments used were the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Short Form 12, version 2 (SF-12v2) questionnaire. RESULTS: Levels of PI at the end of the study improved significantly as compared with baseline in both the low and the high age groups (30.0% and 27.7% reduction, respectively). The onset of analgesia at the end of the study began in < 10 min in 85.0% of young-old subjects and in 62.5% of patients >/= 75 years, but no significant differences were found. BTcP episodes lasted < 15 min in 75.0% of patients in the low age group and 58.3% in the high age group (p = 0.24). Most of patients in both groups experienced one to five BTcP daily episodes, at all assessment points. HADS-D decreased from 10.78 (+/- 4.33) to 8.21 (+/- 3.57) in the low age group, and from 10.96 (+/- 4.26) to 9.36 (+/- 3.35) in the high age group (p = 0.02). Significant differences in HADS-A scores from baseline to the end of the study were also observed in both subgroups (p < 0.05). Patients in the low age group had less favorable mental component summary (MCS) and physical component summary (PCS) scores than patients in the high age group. At the end of the study, 10.0% of young-old patients and 29.2% of patients aged >/= 75 years reported AEs related to their treatment. The most commonly reported AEs included nausea, vomiting, constipation, somnolence, and skin disorders and they were generally mild to moderate in severity. CONCLUSIONS: The results of this study showed that SFTs provided safe and clinically meaningful pain relief in both elderly subgroups. Clinical implications of these findings await validation in large, confirmatory studies to identify age subgroup divergences among elderly cancer patients treated with SFTs. 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, 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 - Kyowa Kirin Farmaceutica SLU, Madrid, Spain. FAU - Sanz, Almudena AU - Sanz A AD - Kyowa Kirin Farmaceutica SLU, Madrid, Spain. LA - eng PT - Journal Article 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 - Aged MH - Analgesics, Opioid/*administration & dosage MH - Breakthrough Pain/*drug therapy MH - Cancer Pain/*drug therapy MH - Female MH - Fentanyl/*administration & dosage MH - Humans MH - Male MH - Neoplasms/*complications MH - Pain Management/methods MH - Tablets/*administration & dosage PMC - PMC6738361 COIS- Antonio Javier Jimenez and Almudena Sanz are employees of Kyowa Kirin Farmaceutica SLU. The authors declared they have no further competing interests. EDAT- 2019/06/10 06:00 MHDA- 2020/01/31 06:00 PMCR- 2019/06/08 CRDT- 2019/06/10 06:00 PHST- 2019/06/10 06:00 [pubmed] PHST- 2020/01/31 06:00 [medline] PHST- 2019/06/10 06:00 [entrez] PHST- 2019/06/08 00:00 [pmc-release] AID - 10.1007/s40268-019-0276-x [pii] AID - 276 [pii] AID - 10.1007/s40268-019-0276-x [doi] PST - ppublish SO - Drugs R D. 2019 Sep;19(3):247-254. doi: 10.1007/s40268-019-0276-x.