Chest
-
Randomized Controlled Trial Multicenter Study Comparative Study
Cardiovascular Safety in Patients Receiving Roflumilast for the Treatment of COPD.
Evaluation of cardiovascular safety for new therapies for COPD is important because of a high prevalence of cardiac comorbidities in the COPD population. Hence, we evaluated the effects of roflumilast, a novel oral phosphodiesterase 4 inhibitor developed for the treatment and prevention of COPD exacerbations, on major adverse cardiovascular events (MACEs). ⋯ A lower rate of cardiovascular events was observed with roflumilast than with placebo in patients with COPD, indicating the lack of a cardiovascular safety signal when treating patients with COPD. Potential cardiovascular benefits of roflumilast should be evaluated in future controlled clinical trials.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Oral Treprostinil for the Treatment of Pulmonary Arterial Hypertension in Patients Receiving Background Endothelin Receptor Antagonist and Phosphodiesterase Type 5 Inhibitor Therapy (The FREEDOM-C2 Study): A Randomized Controlled Trial.
Treprostinil is a stable prostacyclin analog approved for the treatment of pulmonary arterial hypertension (PAH) as parenteral or inhaled therapy. Treprostinil diolamine, a sustained-release oral formulation of treprostinil, was studied to determine whether it could provide a more convenient prostacyclin treatment option for patients with less severe PAH. The objective of this study was to evaluate the efficacy and safety of oral treprostinil in patients with PAH receiving stable background endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE-5I) therapy, or both. ⋯ The addition of oral treprostinil to background ERA and PDE-5I therapy did not result in a statistically significant improvement in exercise capacity. Side effects were common but tolerated by most subjects.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Heparin-induced thrombocytopenia in medical surgical critical illness.
In a recent multicenter randomized trial comparing unfractionated heparin (UFH) with low-molecular-weight heparin (dalteparin) for thromboprophylaxis in 3,746 critically ill patients, 17 patients (0.5%) developed heparin-induced thrombocytopenia (HIT) based on serotonin-release assay-positive (SRA+) status. A trend to a lower frequency of HIT with dalteparin vs UFH was observed in the intention-to-treat analysis (five vs 12 patients, P = .14), which was statistically significant (three vs 12 patients, P = .046) in a prespecified per-protocol analysis that excluded patients with DVT at study entry. We sought to characterize HIT outcomes and to determine how dalteparin thromboprophylaxis may reduce HIT frequency in patients in the ICU. ⋯ The lower risk of HIT in patients in the ICU receiving dalteparin appears related to both decreased antibody formation and decreased clinical breakthrough of HIT among patients forming antibodies.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Longitudinal trends in health-related quality of life in adults with cystic fibrosis.
Health-related quality-of-life (HRQOL) measures have been used as patient-reported outcomes in clinical trials in cystic fibrosis (CF), but there are limited data on HRQOL changes over time in adults with CF. ⋯ In a longitudinal multicenter population of adults with CF, clinical variables such as FEV1, exacerbation frequency, and weight were correlated with related CFQ-R subscales. For the population as a whole, the physical domains of CFQ-R, such as respiratory symptoms, were stable. In contrast, population changes in several psychosocial domains of CFQ-R suggest that differentiating between the physical and the psychosocial trajectories in health among adults with CF is critical in evaluating patient-reported outcomes.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Incidence and Risk Factors of Legionella pneumophila Pneumonia During Anti-Tumor Necrosis Factor Therapy: A Prospective French Study.
Our objective was to describe the incidence and risk factors of legionellosis associated with tumor necrosis factor (TNF)-α antagonist use. ⋯ The incidence rate of legionellosis for patients receiving TNF-α antagonists is high, and the risk is higher for patients receiving anti-TNF-α monoclonal antibodies than soluble TNF-receptor therapy. In case of pneumonia occurring during TNF-α antagonist therapy, specific urine antigen detection should be performed and antibiotic therapy should cover legionellosis.