0000000000374274
AUTHOR
Peter M.a. Calverley
Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials.
Abstract Background An extensive clinical trial program supports the efficacy and safety of tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of tiotropium/olodaterol compared with tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patient…
The effect of tiotropium/olodaterol versus tiotropium on COPD exacerbation rates in patients with/without frequent exacerbation history
Background: Patients with COPD with a history of frequent exacerbations are at increased risk of future exacerbations. There are limited data as to whether combining LAMA/LABA reduces exacerbation risk in all patients. We investigated whether tiotropium/olodaterol (T/O) reduced exacerbation rate versus tiotropium (tio) in patients with a range of exacerbation histories. Methods: TONADO 1+2 (NCT01431274/NCT01431287) and DYNAGITO (NCT02296138) were 52-week, parallel-group, randomised, double-blind, Phase III trials in COPD patients with FEV1 Results: There was a lower rate of moderate/severe exacerbations with T/O (0.68 per patient-year) than tio (0.77 per patient-year) (rate ratio [RR] vs ti…
Palliative Treatment of Dyspnea With Epidural Methadone in Advanced Emphysema
This study investigated whether epidural methadone perfusion at the thoracic level can mitigate dyspnea in patients with advanced emphysema.Open-label clinical trial without a control group.University hospital.The inclusion criteria were a diagnosis of emphysema, basal dyspnea index (Mahler scale)or = 3, FEV(1)or = 35%, and no indication for pneumoreduction or lung transplantation surgery.An epidural catheter was inserted at the thoracic level connected to a perfusion pump for administering methadone (6 mg/24 h). Assessments were made at baseline, 1 week, and 1 month after catheter insertion.Pulmonary function tests were performed, and determinations were made of arterial blood gas levels, …