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.
Chronic low back pain (CLBP) is highly prevalent in industrialized countries, where it is one of the main causes of disability. Patients with CLBP in treatment with opioids often experience episodes of breakthrough pain (BTP), but data on prevalence and treatment preferences are scarce. The objectives of this study were, first, the evaluation of the prevalence of BTP in patients with CLBP in the South of Spain (N = 1,868) and, second, the characterization of BTP in these patients (N = 295). Data was collected on presence of BTP, type and location of pain, treatment, compliance, and patient satisfaction. We found a prevalence of BTP in patients with CLBP of 37.5% (95% CI: 35.3%–39.7%), similar in men and women. 75% of the patients were older than 50 years. The preferred drug of patients who control BTP with opioids is fentanyl (78.3%) and its most common form of administration is nasal (53.2%). Therapeutic compliance was high and 46.3% of patients considered the control of their BTP very satisfactory. Our study showed that BTP is common in patients with CLBP and that current treatments seem adequate.
ObjectiveOur 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.MethodsSubgroup 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]).ResultsIn 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.ConclusionsExploratory 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.
IntroductionBreakthrough 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.MethodsWe 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).ResultsTwenty-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%).ConclusionAge 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.
IntroductionSublingual 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.MethodsWe 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.ResultsLevels 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.ConclusionsThe 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.
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