0000000000789691
AUTHOR
Jadwiga A. Wedzicha
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…
Monotherapy with indacaterol once daily reduces the rate of exacerbations in patients with moderate-to-severe COPD: Post-hoc pooled analysis of 6 months data from three large phase III trials
Summary Background In patients with COPD, exacerbations are associated with poor quality of life and may shorten survival. Prevention of exacerbations is, therefore, a key objective in COPD management. Indacaterol, a once-daily ultra-long-acting β 2 -agonist, has been shown to reduce exacerbations in various studies. This pooled analysis evaluated the effect of indacaterol on exacerbations versus placebo. Methods Six-month data were pooled from three randomized, double-blind, and placebo-controlled studies: indacaterol 300 μg versus placebo (1 year); indacaterol 150 μg and 300 μg versus placebo (6 months); and indacaterol 150 μg versus placebo (6 months). All treatments were administered on…
Pooled safety analysis of the fixed-dose combination of indacaterol and glycopyrronium (QVA149), its monocomponents, and tiotropium versus placebo in COPD patients
BACKGROUND: To further assess the safety profile of the fixed-dose combination of indacaterol and glycopyrronium (QVA149) and its monocomponents; we investigated the impact of individual patient-level factors and time by integrating the patient-level safety data from the QVA149 clinical programme with relevant information from the independent indacaterol and glycopyrronium safety databases.METHODS: Data from 11,404 patients with chronic obstructive pulmonary disease (COPD) were pooled from 14 clinical studies of QVA149, indacaterol and glycopyrronium of ≥3 month's duration with at least two of the treatment groups: QVA149 110/50 μg, glycopyrronium 50 μg, indacaterol 150 μg, placebo or tiotr…