Clinical profile of idiopathic pulmonary fibrosis patients treated with nintedanib in routine clinical practice in Spain: the BROAD Study / Perfil clínico de pacientes con fibrosis pulmonar idiopática tratados con nintedanib en la práctica clínica habitual en españa: estudio broad

Background. Few data are available on the clinical profile of patients diagnosed with idiopathic pulmonary fibrosis (IPF) treated with nintedanib. The primary objective of the study was to describe, based on pulmonary function variables, disease severity in IPF patients who initiated treatment with nintedanib in routine clinical practice. The secondary objectives were to analyze their clinical characteristics and comorbidities. Methods. A multicenter, retrospective study including 173 patients from 32 Spanish hospitals. Patients were stratified by their forced vital capacity (FVC) % predicted and diffusing capacity for carbon monoxide (DLCO) % predicted. These measures were taken as a marker of IPF severity. Results. Mean age ± SD at treatment initiation was 70.1 ± 8.1, and 76.6% of patients were male. Based on FVC, 57% of patients had mild IPF (FVC ≥ 70%), 38.4% moderate IPF (FVC 50%-69%), and 4.7% severe IPF (FVC < 50%). Based on DLCO, 42.5% of patients had mild IPF (DLCO ≥ 50%), 35.5% moderate IPF (DLCO 35%-49%), and 22.2% severe IPF (DLCO < 35%). Eighty-nine percent of patients had at least one comorbid condition. The most prevalent comorbidities were high blood pressure (45.9%), dyslipidemia (42.4%), gastroesophageal reflux (25.6%), diabetes (19.8%), emphysema (15.7%), and cardiovascular diseases (15.7%). Most patients received concomitant treatment (79.7%). Conclusions. The study provides relevant information on the clinical characteristics of IPF patients who initiate nintedanib treatment. Classification of severity depends on the lung function parameter used. The proportion of patients classified as having severe IPF was up to 4 times greater when DLCO, instead of FVC, was used (AU)

Introducción. Se dispone de pocos datos sobre el perfil clínico de los pacientes diagnosticados de fibrosis pulmonar idiopática (FPI) tratados con nintedanib. El objetivo principal del estudio fue describir, basándose en variables de función pulmonar, la gravedad de la enfermedad en pacientes con FPI que iniciaron tratamiento con nintedanib en la práctica clínica habitual. Los objetivos secundarios fueron analizar sus características clínicas y comorbilidades. Métodos. Estudio retrospectivo y multicéntrico que incluyeron a 173 pacientes de 32 hospitales españoles. Los pacientes fueron estratificados por su capacidad vital forzada (CVF) % predicho y por la capacidad de difusión de monóxido de carbono (DLCO) % predicho. Estas variables se consideraron como marcadores de la gravedad de la FPI. Resultados. La edad media ± DE al inicio del tratamiento fue de 70,1 ± 8,1 y el 76,6% de los pacientes eran varones. Según la CVF, el 57% de los pacientes tenían FPI leve (CVF ≥ 70%), el 38,4% FPI moderada (CVF 50%-69%) y el 4,7% FPI grave (CVF < 50%). Según la DLCO, el 42,5% de los pacientes tenían FPI leve (DLCO ≥ 50%), el 35,5% FPI moderada (DLCO 35%-49%) y el 22,2% FPI grave (DLCO < 35%). El 89% de los pacientes tenían al menos una comorbilidad, siendo las más prevalentes la hipertensión arterial (45,9%), dislipidemia (42,4%), reflujo gastroesofágico (25,6%), diabetes (19,8%), enfisema (15,7%) y enfermedades cardiovasculares (15,7%). La mayoría de los pacientes recibieron tratamientos concomitantes (79,7%) (AU)

Recommendations on the use of everolimus in lung transplantation.

The antiproliferative effect of everolimus provides a therapeutic option in the immunosuppression therapy of lung transplantation, by reducing both the risk of acute rejection and the process of progressive fibrosis that determines chronic graft rejection. However, few data on the use of everolimus in lung transplantation have been published to date, and the specific indications of the drug, along with the most adequate time for its introduction or dosing, have not been defined yet. The aim of this article is to propose recommendations for the use of everolimus in lung transplant recipients, including indications, dosing schedules and the use of concomitant immunosuppression. This consensus document has been developed by experts of all the Spanish lung transplant groups from the review of the existing literature and the clinical experience.

Conversion from cyclosporine to tacrolimus stabilizes the course of lung function in lung transplant recipients with bronchiolitis obliterans syndrome.

Bronchiolitis obliterans syndrome (BOS) continues to be the main factor limiting the long-term survival of lung transplant recipients. The objective of this study was to prospectively assess the impact of conversion from cyclosporine (CsA) to tacrolimus on lung function in patients who developed BOS while receiving CsA-based immunosuppressive therapy. A total of 79 patients with BOS were included in the study. Sixty percent of patients had stage II or III BOS according to the International Society for Heart and Lung Transplantation criteria. Mean time from transplantation was 30.4 +/- 21.9 months and all patients were on CsA therapy at enrollment in the study, with mean trough levels of 232.75 +/- 98.26 ng/mL. After conversion, tacrolimus trough levels were 11.0 +/- 3.6 ng/mL at 3 months and 9.0 +/- 3.4 ng/mL at 12 months. Sixteen deaths occurred during the first year postconversion, 56% of which were due to respiratory failure. Comparison of forced expiratory volume in 1 second (FEV(1)) preconversion versus postconversion showed a change in the slope of the FEV(1)-time curve. The slope of the preconversion curve was -0.44 versus a zero slope, whereas the slope of the postconversion curve was 0.005, with a statistically significant difference between both slopes. This change in slopes, which was also seen in FEV(1%), suggests that lung function loss closed after conversion from CsA to tacrolimus supporting this therapeutic strategy in lung transplant recipients with BOS treated with CsA.

Utility of home oximetry as a screening test for patients with moderate to severe symptoms of obstructive sleep apnea.

OBJECTIVE: To determine the value of home oximetry as a screening test in patients with moderate to severe symptoms of obstructive sleep apnea (OSA). DESIGN: Retrospective, observational study. SETTING: The Sleep Unit of a tertiary referral, university hospital. PATIENTS: 116 patients referred for evaluation of moderate to severe symptoms of OSA in which both home oximetry and polysomnography (PSG) were performed. INTERVENTIONS: NA. RESULTS: Three numerical oximetry indices were evaluated: average of desaturations > or =4% and average of resaturations > or =3% per hour of analysis time (DI4% and RI3%, respectively); and cumulative percentages of time spent at saturations below 90% (CT90%). A qualitative assessment was also performed. Oximetry indices were compared with apnea/hypopnea index (AHI) by simple linear regression and Bland-Altman analyses. Optimal cut-off points, in terms of sensitivity and specificity, for the oximetry indices were searched using ROC analysis, at an AHI threshold of > or =10. The correlation between AHI and the desaturation indices was r = 0.50 for CT90%, r = 0.60 for DI4%, and r = 0.58 for RI3%. No bias was found between PSG and oximetry indices in Bland-Altman plots. Neither the numerical indices nor the qualitative analysis achieved an adequate (>0.8) area under the ROC curve. A CT90% <0.79 excluded OSA with 84% sensitivity. A DI4% > or =31.4 or a RI3% > or =40.5 diagnosed OSA with 97% specificity. Using these values, 38% of the patients would have been correctly classified by oximetry alone, 10% would have been incorrectly classified, and 50% could not have been classified with certainty. Eleven (15%) OSA patients would have been missed by oximetry. CONCLUSIONS: Correlation between home oximetry and PSG was not high. Oximetry was more useful to confirm than to exclude OSA in our study. Qualitative assessment was not better than numerical analysis. The greatest value of oximetry in this setting seems to be as a tool to rapidly recognize and treat more severe OSA patients in waiting list for PSG.