Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD
| Autor: | Rabe, K. F., Martinez, F. J., Ferguson, G. T., Wang, C., Singh, D., Wedzicha, J. A., Trivedi, R., t. Rose E., S, Ballal, S., Mclaren, J., Darken, P., Aurivillius, M., Reisner, C., Dorinsky, P., Spanevello, A. |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Kaplan-Meier Estimate 030204 cardiovascular system & hematology Gastroenterology law.invention 0302 clinical medicine Randomized controlled trial law Forced Expiratory Volume Formoterol Fumarate 80 and over Medicine 030212 general & internal medicine Budesonide 11 Medical and Health Sciences Inhalation biology General Medicine Lama Middle Aged Intention to Treat Analysis Drug Combinations Administration Female hormones hormone substitutes and hormone antagonists Glucocorticoid medicine.drug Adult medicine.medical_specialty Chronic Obstructive Muscarinic Antagonists Severe copd Pulmonary Disease 03 medical and health sciences Double-Blind Method Internal medicine General & Internal Medicine Humans Adrenergic beta-2 Receptor Agonists Glucocorticoids Aged Intention-to-treat analysis business.industry Administration Inhalation Aged 80 and over Glycopyrrolate Pulmonary Disease Chronic Obstructive Muscarinic antagonist biology.organism_classification Multicenter study ETHOS Investigators business |
| Zdroj: | Rabe, K F, Martinez, F J, Ferguson, G T, Wang, C, Singh, D, Wedzicha, J A, Trivedi, R, St. Rose, E, Ballal, S, Mclaren, J, Darken, P, Aurivillius, M, Reisner, C & Dorinsky, P 2020, ' Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD ', New England Journal Of Medicine, vol. 383, no. 1, pp. 35-48 . https://doi.org/10.1056/NEJMoa1916046 |
| Popis: | BACKGROUND Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking. METHODS In a 52-week, phase 3, randomized trial to evaluate the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very-severe COPD and at least one exacerbation in the past year, we assigned patients in a 1:1:1:1 ratio to receive twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide], a LAMA [18 μg of glycopyrrolate], and a LABA [9.6 μg of formoterol]) or one of two dual therapies (18 μg of glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol). The primary end point was the annual rate (the estimated mean number per patient per year) of moderate or severe COPD exacerbations, as analyzed in the modified intention-to-treat population with the use of on-treatment data only. RESULTS The modified intention-to-treat population comprised 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg–budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg–budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate–formoterol group (2120 patients), and 1.24 in the budesonide–formoterol group (2131 patients). The rate was significantly lower with 320-μg–budesonide triple therapy than with glycopyrrolate–formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P |
| Databáze: | OpenAIRE |
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