Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study

Background In randomised studies, the capsaicin 8% patch has demonstrated effective pain relief in patients with peripheral neuropathic pain (PNP) arising from different aetiologies. Methods ASCEND was an open-label, non-interventional study of patients with non-diabetes-related PNP who received capsaicin 8% patch treatment, according to usual clinical practice, and were followed for ≤52 weeks. Co-primary endpoints were percentage change in the mean numeric pain rating scale (NPRS) ‘average daily pain’ score from baseline to the average of Weeks 2 and 8 following first treatment; and median time from first to second treatment. The primary analysis was intended to assess analgesic equivalence between post-herpetic neuralgia (PHN) and other PNP aetiologies. Health-related quality of life (HRQoL, using EQ-5D), Patient Global Impression of Change (PGIC) and tolerability were also assessed. Results Following first application, patients experienced a 26.6% (95% CI: 23.6, 29.62; n = 412) reduction in mean NPRS score from baseline to Weeks 2 and 8. Equivalence was demonstrated between PHN and the neuropathic back pain, post-operative and post-traumatic neuropathic pain and ‘other’ PNP aetiology subgroups. The median time from first to second treatment was 191 days (95% CI: 147, 235; n = 181). Forty-four percent of all patients were responders (≥30% reduction in NPRS score from baseline to Weeks 2 and 8) following first treatment, and 86.9% (n = 159/183) remained so at Week 12. A sustained pain response was observed until Week 52, with a 37.0% (95% CI: 31.3, 42.7; n = 176) reduction in mean NPRS score from baseline. Patients with the shortest duration of pain (0–0.72 years) experienced the highest pain response from baseline to Weeks 2 and 8. Mean EQ-5D index score improved by 0.199 utils (responders: 0.292 utils) from baseline to Week 2 and was maintained until Week 52. Most patients reported improvements in PGIC at Week 2 and at all follow-up assessments regardless of number of treatments received. Adverse events were primarily mild or moderate reversible application site reactions. Conclusion In European clinical practice, the capsaicin 8% patch provided effective and sustained pain relief, substantially improved HRQoL, improved overall health status and was generally well tolerated in a heterogeneous PNP population

Hemodialysis Removes Uremic Toxins That Alter the Biological Actions of Endothelial Cells

Chronic kidney disease is linked to systemic inflammation and to an increased risk of ischemic heart disease and atherosclerosis. Endothelial dysfunction associates with hypertension and vascular disease in the presence of chronic kidney disease but the mechanisms that regulate the activation of the endothelium at the early stages of the disease, before systemic inflammation is established remain obscure. In the present study we investigated the effect of serum derived from patients with chronic kidney disease either before or after hemodialysis on the activation of human endothelial cells in vitro, as an attempt to define the overall effect of uremic toxins at the early stages of endothelial dysfunction. Our results argue that uremic toxins alter the biological actions of endothelial cells and the remodelling of the extracellular matrix before signs of systemic inflammatory responses are observed. This study further elucidates the early events of endothelial dysfunction during toxic uremia conditions allowing more complete understanding of the molecular events as well as their sequence during progressive renal failure

Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications

BACKGROUND Limited information exists about the epidemiology and outcome of surgical patients at increased risk of postoperative pulmonary complications (PPCs), and how intraoperative ventilation was managed in these patients. OBJECTIVES To determine the incidence of surgical patients at increased risk of PPCs, and to compare the intraoperative ventilation management and postoperative outcomes with patients at low risk of PPCs. DESIGN This was a prospective international 1-week observational study using the ‘Assess Respiratory Risk in Surgical Patients in Catalonia risk score’ (ARISCAT score) for PPC for risk stratification. PATIENTS AND SETTING Adult patients requiring intraoperative ventilation during general anaesthesia for surgery in 146 hospitals across 29 countries. MAIN OUTCOME MEASURES The primary outcome was the incidence of patients at increased risk of PPCs based on the ARISCAT score. Secondary outcomes included intraoperative ventilatory management and clinical outcomes. RESULTS A total of 9864 patients fulfilled the inclusion criteria. The incidence of patients at increased risk was 28.4%. The most frequently chosen tidal volume (VT) size was 500 ml, or 7 to 9 ml kg1 predicted body weight, slightly lower in patients at increased risk of PPCs. Levels of positive end-expiratory pressure (PEEP) were slightly higher in patients at increased risk of PPCs, with 14.3% receiving more than 5 cmH2O PEEP compared with 7.6% in patients at low risk of PPCs (P < 0.001). Patients with a predicted preoperative increased risk of PPCs developed PPCs more frequently: 19 versus 7%, relative risk (RR) 3.16 (95% confidence interval 2.76 to 3.61), P < 0.001) and had longer hospital stays. The only ventilatory factor associated with the occurrence of PPCs was the peak pressure. CONCLUSION The incidence of patients with a predicted increased risk of PPCs is high. A large proportion of patients receive high VT and low PEEP levels. PPCs occur frequently in patients at increased risk, with worse clinical outcome

Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - An observational study in 29 countries

BACKGROUND Limited information exists about the epidemiology and outcome of surgical patients at increased risk of postoperative pulmonary complications (PPCs), and how intraoperative ventilation was managed in these patients. OBJECTIVES To determine the incidence of surgical patients at increased risk of PPCs, and to compare the intraoperative ventilation management and postoperative outcomes with patients at low risk of PPCs. DESIGN This was a prospective international 1-week observational study using the ‘Assess Respiratory Risk in Surgical Patients in Catalonia risk score’ (ARISCAT score) for PPC for risk stratification. PATIENTS AND SETTING Adult patients requiring intraoperative ventilation during general anaesthesia for surgery in 146 hospitals across 29 countries. MAIN OUTCOME MEASURES The primary outcome was the incidence of patients at increased risk of PPCs based on the ARISCAT score. Secondary outcomes included intraoperative ventilatory management and clinical outcomes. RESULTS A total of 9864 patients fulfilled the inclusion criteria. The incidence of patients at increased risk was 28.4%. The most frequently chosen tidal volume (V T) size was 500 ml, or 7 to 9 ml kg−1 predicted body weight, slightly lower in patients at increased risk of PPCs. Levels of positive end-expiratory pressure (PEEP) were slightly higher in patients at increased risk of PPCs, with 14.3% receiving more than 5 cmH2O PEEP compared with 7.6% in patients at low risk of PPCs (P ˂ 0.001). Patients with a predicted preoperative increased risk of PPCs developed PPCs more frequently: 19 versus 7%, relative risk (RR) 3.16 (95% confidence interval 2.76 to 3.61), P ˂ 0.001) and had longer hospital stays. The only ventilatory factor associated with the occurrence of PPCs was the peak pressure. CONCLUSION The incidence of patients with a predicted increased risk of PPCs is high. A large proportion of patients receive high V T and low PEEP levels. PPCs occur frequently in patients at increased risk, with worse clinical outcome.</p

Validation of a Greek version of PSS-14; A global measure of perceived stress

Aim: To evaluate validity of the Greek version of a global measure of perceived stress PSS-14 (Perceived Stress Scale - 14 item). Materials and Methods: The original PSS.14 (theoretical range 0.56) was translated into Greek and then back-translated. One hundred men and women (39±10 years old, 40 men) participated in the validation process. Firstly, participants completed the Greek PSS-14 and, then they were interviewed by a psychologist specializing in stress management. Cronbach&apos;s alpha (a) evaluated internal consistency of the measurement, whereas Kendall&apos;s tau-b and Bland &amp; Altman methods assessed consistency with the clinical evaluation. Exploratory and Confirmatory Factor analyses were conducted to reveal hidden factors within the data and to confirm the two-dimensional character of the scale. Results: Mean (SD) PSS-14 score was 25(7.9). Strong internal consistency (Cronbach&apos;s a = 0.847) as well as moderate-to-good concordance between clinical assessment and PSS-14 (Kendall&apos;s tau-b = 0.43, p&lt;0.01) were observed. Two factors were extracted. Factor one explained 34.7% of variability and was heavily laden by positive items, and factor two that explained 10.6% of the variability by negative items. Confirmatory factor analysis revealed that the model with 2 factors had chi-square equal to 241.23 (p&lt;0.001), absolute fix indexes were good (i.e. GFI=0.733, AGFI=0.529), and incremental fix indexes were also adequate (i.e. NFI=0.89 and CFI=0.92). Conclusion: The developed Greek version of PSS-14 seems to be a valid instrument for the assessment of perceived stress in the Greek adult population living in urban areas; a finding that supports its local use in research settings as an evaluation tool measuring perceived stress, mainly as a risk factor but without diagnostic properties

Validation of a Greek version of PSS-14; A global measure of perceived stress

Aim: To evaluate validity of the Greek version of a global measure of perceived stress PSS-14 (Perceived Stress Scale - 14 item). Materials and Methods: The original PSS.14 (theoretical range 0.56) was translated into Greek and then back-translated. One hundred men and women (39±10 years old, 40 men) participated in the validation process. Firstly, participants completed the Greek PSS-14 and, then they were interviewed by a psychologist specializing in stress management. Cronbach's alpha (a) evaluated internal consistency of the measurement, whereas Kendall's tau-b and Bland & Altman methods assessed consistency with the clinical evaluation. Exploratory and Confirmatory Factor analyses were conducted to reveal hidden factors within the data and to confirm the two-dimensional character of the scale. Results: Mean (SD) PSS-14 score was 25(7.9). Strong internal consistency (Cronbach's a = 0.847) as well as moderate-to-good concordance between clinical assessment and PSS-14 (Kendall's tau-b = 0.43, p<0.01) were observed. Two factors were extracted. Factor one explained 34.7% of variability and was heavily laden by positive items, and factor two that explained 10.6% of the variability by negative items. Confirmatory factor analysis revealed that the model with 2 factors had chi-square equal to 241.23 (p<0.001), absolute fix indexes were good (i.e. GFI=0.733, AGFI=0.529), and incremental fix indexes were also adequate (i.e. NFI=0.89 and CFI=0.92). Conclusion: The developed Greek version of PSS-14 seems to be a valid instrument for the assessment of perceived stress in the Greek adult population living in urban areas; a finding that supports its local use in research settings as an evaluation tool measuring perceived stress, mainly as a risk factor but without diagnostic properties

Increased abdominal fat levels measured by bioelectrical impedance are associated with histological lesions of nonalcoholic steatohepatitis

Background/aim Abdominal fat is considered to play an important role in nonalcoholic fatty liver disease (NAFLD), although it is not adequately studied because abdominal fat levels cannot be estimated easily. In this study, associations between abdominal obesity, as assessed by abdominal bioelectrical impedance analysis (BIA), and the characteristics of patients with NAFLD were explored. Patients and methods Seventy-four consecutive NAFLD patients who underwent measurement of abdominal fat levels by BIA were included. Levels of abdominal fat 12.5 or less and more than 12.5 were considered to be average and increased, respectively. Results The mean±SD BMI was 30±4 kg/m 2 and the mean abdominal fat levels were 16±5, whereas 26% of patients had average abdominal fat levels. Patients with average compared with those with increased abdominal fat levels were more frequently women (50 vs. 12%, P=0.001), had lower BMI (27±3 vs. 31±4 kg/m 2, P&lt;0.001), lower Homeostasis Model Assessment index (2.6±1.4 vs. 3.9±2.7, P=0.045), and lower median liver stiffness on transient elastography (5.3 vs. 6.8 kPa, P=0.025). In patients with available liver biopsy, steatohepatitis was present more frequently in patients with increased compared with average abdominal fat levels (78 vs. 38%, P=0.030) and in patients with BMI 30 or more compared with less than 30 kg/m 2 (87 vs. 48%, P=0.033), but similar in patients with increased or normal waist circumference (67 vs. 56%, P=0.693). Conclusion Average levels of abdominal fat, as assessed by abdominal BIA, are mainly present in female patients with NAFLD and are associated with a lower degree of insulin resistance. Increased abdominal fat as assessed by BIA and obesity seem to represent strong risk factors for histological steatohepatitis. © 2015 Wolters Kluwer Health, Inc. All rights reserved