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1.
Drug Saf ; 43(10): 971-980, 2020 10.
Article in English | MEDLINE | ID: mdl-32734423

ABSTRACT

INTRODUCTION: Nintedanib, a tyrosine kinase receptor inhibitor, may be associated with increased bleeding risk. Thus, patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF). OBJECTIVE: Our objective was to examine real-world bleeding events in patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy. METHODS: The European MultiPartner IPF Registry (EMPIRE) enrolled 2794 patients with IPF: group A (1828: no anticoagulant or antiplatelet treatment), group B (227: anticoagulant treatment), group C (659: antiplatelet treatment), and group D (80: anticoagulant and antiplatelet treatment). Overall, 673 (24.1%) received nintedanib and 933 (33.4%) received pirfenidone. Bleeding events and their relationship to antifibrotic and anticoagulation treatment were characterized. RESULTS: Group A patients, versus those in groups B, C, and D, were typically younger and generally had the lowest comorbidity rates. A higher proportion of patients in groups A and C, versus group B, received nintedanib. Pirfenidone, most common in group D, was more evenly balanced across groups. In patients with reported bleeding events, seven of eight received nintedanib (groups A, C, and D). Bleeding incidence was 3.0, 0, 1.3, and 18.1 per 10,000 patient-years (groups A, B, C, and D, respectively). CONCLUSION: Real-world data from EMPIRE showed that patients on anticoagulant medications received nintedanib less frequently, perhaps based on its mechanism of action. Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).


Subject(s)
Anticoagulants/therapeutic use , Hemorrhage/epidemiology , Idiopathic Pulmonary Fibrosis/drug therapy , Indoles/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Europe/epidemiology , Female , Hemorrhage/etiology , Humans , Incidence , Indoles/adverse effects , Male , Middle Aged , Protein Kinase Inhibitors/adverse effects , Registries , Risk Factors
2.
Thorac Cancer ; 10(9): 1819-1826, 2019 09.
Article in English | MEDLINE | ID: mdl-31317672

ABSTRACT

BACKGROUND: Pulmonary malignancy is one of the most frequent and fatal cancers in older patients. As data on lower respiratory tract infection (LRTI) and the outcome of lung cancer are scarce, our objective was to determine the impact of LRTI on therapeutic possibilities and one-year mortality. METHODS: Patients undergoing bronchoscopy in 2017 who had bronchial microbial sampling at the time of the lung cancer diagnosis (n = 143) were included. Group 1 (LRTI+) included patients with confirmed infection (n = 74) while Group 2 (LRTI-) included patients without infection (n = 69). Clinical characteristics, pathogen profile and one-year survival were analyzed. RESULTS: Age, gender, TNM stage, histology type, comorbidities or underlying lung disease did not differ among groups. The most common LRTI pathogens included aerobic (n = 49), anaerobic (n = 14) and fungal (n = 26) infections. Chemo/immune/target therapy alone, or in combination with radiotherapy were significantly less frequently used, whilst palliative care was more common in Group 1 (LRTI+). Multiple pathogen LRTI patients were significantly older, less frequently diagnosed with adenocarcinoma and had worse performance status compared to solitary pathogen LRTI patients. One-year median survival was 274 days (235 vs. 305 days Group 1 vs. Group 2). Risk factors for increased one-year mortality included performance status ≥2 (OR 30.00, CI 95% 5.23-313.00), performance status 1 (OR 11.87, CI 95% 4.12-33.78), male gender (OR 4.04, CI 2.03-8.04), LRTI with multiple pathogens (OR 2.72, CI 1.01-6.81) and nonadenocarcinoma histology (OR 2.26, CI 1.15-4.56). CONCLUSION: LRTIs in lung cancer patients, especially multiple pathogen infections, are associated with less oncotherapeutic possibilities and significant risk for lower one-year median survival.


Subject(s)
Adenocarcinoma of Lung/mortality , Carcinoma, Squamous Cell/mortality , Lung Neoplasms/mortality , Respiratory Tract Infections/complications , Small Cell Lung Carcinoma/mortality , Adenocarcinoma of Lung/etiology , Adenocarcinoma of Lung/pathology , Adenocarcinoma of Lung/therapy , Aged , Carcinoma, Squamous Cell/etiology , Carcinoma, Squamous Cell/pathology , Carcinoma, Squamous Cell/therapy , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Lung Neoplasms/etiology , Lung Neoplasms/pathology , Lung Neoplasms/therapy , Male , Middle Aged , Prognosis , Risk Factors , Small Cell Lung Carcinoma/etiology , Small Cell Lung Carcinoma/pathology , Small Cell Lung Carcinoma/therapy , Survival Rate
3.
Lung ; 197(4): 465-472, 2019 08.
Article in English | MEDLINE | ID: mdl-31089858

ABSTRACT

INTRODUCTION: Marfan syndrome is a genetic disorder affecting the connective tissue. Changes in lung tissue might influence respiratory function; however, a detailed respiratory functional assessment according to the need for major thoracic surgery is missing. METHODS: Comprehensive pulmonary examinations were performed in 55 Marfan patients including respiratory symptoms, lung function (LF) testing using European Coal and Steel Community (ECSC) reference values, TLCO and quality of life measurements. Groups included patients who did not need surgery (Mf, n = 32) and those who underwent major thoracic surgery (Mfop, n = 23). RESULTS: Respiratory symptoms affected 20% of patients. Scoliosis was significantly more frequent in the Mfop group. LF demonstrated in all Marfan patients a tendency towards airway obstruction (FEV1/FVC = 0.77 ± 0.10), more prominent in Mfop patients (0.74 ± 0.08 vs. Mf: 0.80 ± 0.11; p = 0.03). Correction of LF values using a standing height modification by arm span (Hcorrected) revealed additional changes in FVC and FEV1. TLCO and quality of life did not differ between groups. CONCLUSIONS: Marfan syndrome is associated with airway obstruction, especially in patients who have undergone major thoracic surgery, indicative of more severe connective tissue malfunction. The use of arm span for height correction is suitable to evaluate LF changes in this special patient group including patients with significant scoliosis.


Subject(s)
Airway Obstruction/etiology , Lung/physiopathology , Marfan Syndrome/complications , Thoracic Surgical Procedures , Adult , Airway Obstruction/diagnosis , Airway Obstruction/physiopathology , Female , Forced Expiratory Volume , Humans , Male , Marfan Syndrome/diagnosis , Middle Aged , Plethysmography , Pulmonary Diffusing Capacity , Quality of Life , Scoliosis/complications , Scoliosis/physiopathology , Spirometry , Thoracic Surgical Procedures/adverse effects , Vital Capacity , Young Adult
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