Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials
| Autor: | Leonardo M. Fabbri, Vijay Alagappan, Antonio Anzueto, Peter M.A. Calverley, Jonas Román, Andrew McIvor, Shahid Siddiqui, Sofia Zetterstrand, Emilio Pizzichini, Debasree Purkayastha, Klaus F. Rabe, Nitin Bagul, Sanjay Sethi, Colin Reisner, Fernando J. Martinez, Stephen I. Rennard |
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| Rok vydání: | 2018 |
| Předmět: |
Pulmonary and Respiratory Medicine
Cyclopropanes Male Chronic bronchitis medicine.medical_specialty Aminopyridines macromolecular substances Critical Care and Intensive Care Medicine Severe chronic obstructive pulmonary disease Severity of Illness Index law.invention 03 medical and health sciences Pulmonary Disease Chronic Obstructive 0302 clinical medicine Cigarette smoking Randomized controlled trial Double-Blind Method law Adrenal Cortex Hormones Internal medicine Administration Inhalation medicine Humans In patient 030212 general & internal medicine Roflumilast business.industry Middle Aged Pooled analysis Treatment Outcome 030228 respiratory system Benzamides Sputum Drug Therapy Combination Female medicine.symptom business medicine.drug |
| Zdroj: | American journal of respiratory and critical care medicine. 198(10) |
| ISSN: | 1535-4970 |
| Popis: | Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of exacerbations. Further characterization of patients most likely to benefit is warranted.Define characteristics that most robustly identify patients who derive greatest exacerbation risk reduction with roflumilast.Predefined, pooled analyses of REACT (Roflumilast in the Prevention of COPD Exacerbations While Taking Appropriate Combination Treatment; NCT01329029) and REIn the overall intention-to-treat population (n = 4,287), roflumilast reduced moderate or severe exacerbations by 12.3% (rate ratio, 0.88, 95% confidence interval, 0.80-0.97; P = 0.0086) and severe exacerbations by 16.1% (0.84; 0.71-0.99; P = 0.0409) versus placebo. The reduction in moderate or severe exacerbations with roflumilast was most pronounced in patients who had been hospitalized for an exacerbation in the prior year (0.74; 0.63-0.88; P = 0.0005); had more than two exacerbations in the prior year (0.79; 0.65-0.96; P = 0.0160); or had baseline eosinophils ≥150 cells/μl (0.81; 0.71-0.93; P = 0.0020), ≥150 to300 cells/μl (0.84; 0.71-0.98; P = 0.0282), or ≥300 cells/μl (0.77; 0.61-0.97; P = 0.0264). Similar subgroup results were noted for severe exacerbations. In patients with prior hospitalization and higher baseline blood eosinophil concentrations, roflumilast reduced moderate or severe exacerbations by 34.5% at ≥150 cells/μl (0.65; 0.52-0.82; P = 0.0003) and 42.7% at ≥300 cells/μl (0.57; 0.37-0.88; P = 0.0111) versus placebo.This prespecified, pooled analysis confirms the benefit of roflumilast in decreasing exacerbations in patients with prior hospitalization for exacerbation, greater exacerbation frequency, and higher (≥150 cells/μl, ≥150 to300 cells/μl, or ≥300 cells/μl) baseline blood eosinophil count. |
| Databáze: | OpenAIRE |
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