TY - JOUR
T1 - Predictors of response to tiotropium versus salmeterol in asthmatic adults
AU - Peters, Stephen P.
AU - Bleecker, Eugene R.
AU - Kunselman, Susan J.
AU - Icitovic, Nikolina
AU - Moore, Wendy C.
AU - Pascual, Rodolfo
AU - Ameredes, Bill T.
AU - Boushey, Homer A.
AU - Calhoun, William J.
AU - Castro, Mario
AU - Cherniack, Reuben M.
AU - Craig, Timothy
AU - Denlinger, Loren C.
AU - Engle, Linda L.
AU - Dimango, Emily A.
AU - Israel, Elliot
AU - Kraft, Monica
AU - Lazarus, Stephen C.
AU - Lemanske, Robert F.
AU - Lugogo, Njira
AU - Martin, Richard J.
AU - Meyers, Deborah A.
AU - Ramsdell, Joe
AU - Sorkness, Christine A.
AU - Sutherland, E. Rand
AU - Wasserman, Stephen I.
AU - Walter, Michael J.
AU - Wechsler, Michael E.
AU - Chinchilli, Vernon M.
AU - Szefler, Stanley J.
PY - 2013/11
Y1 - 2013/11
N2 - Background Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described. Objective We sought to describe individual and differential responses of asthmatic patients to salmeterol and tiotropium when added to an inhaled corticosteroid, as well as predictors of a positive clinical response. Methods Data from the double-blind, 3-way, crossover National Heart, Lung, and Blood Institute's Asthma Clinical Research Network's Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number, NCT00565266) trial were analyzed for individual and differential treatment responses to salmeterol and tiotropium and predictors of a positive response to the end points FEV1, morning peak expiratory flow (PEF), and asthma control days (ACDs). Results Although approximately equal numbers of patients showed a differential response to salmeterol and tiotropium in terms of morning PEF (n = 90 and 78, respectively) and ACDs (n = 49 and 53, respectively), more showed a differential response to tiotropium for FEV1 (n = 104) than salmeterol (n = 62). An acute response to a short-acting bronchodilator, especially albuterol, predicted a positive clinical response to tiotropium for FEV1 (odds ratio, 4.08; 95% CI, 2.00-8.31; P <.001) and morning PEF (odds ratio, 2.12; 95% CI, 1.12-4.01; P = 0.021), as did a decreased FEV1/forced vital capacity ratio (FEV1 response increased 0.39% of baseline for every 1% decrease in FEV1/forced vital capacity ratio). Higher cholinergic tone was also a predictor, whereas ethnicity, sex, atopy, IgE level, sputum eosinophil count, fraction of exhaled nitric oxide, asthma duration, and body mass index were not. Conclusion Although these results require confirmation, predictors of a positive clinical response to tiotropium include a positive response to albuterol and airway obstruction, factors that could help identify appropriate patients for this therapy.
AB - Background Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described. Objective We sought to describe individual and differential responses of asthmatic patients to salmeterol and tiotropium when added to an inhaled corticosteroid, as well as predictors of a positive clinical response. Methods Data from the double-blind, 3-way, crossover National Heart, Lung, and Blood Institute's Asthma Clinical Research Network's Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number, NCT00565266) trial were analyzed for individual and differential treatment responses to salmeterol and tiotropium and predictors of a positive response to the end points FEV1, morning peak expiratory flow (PEF), and asthma control days (ACDs). Results Although approximately equal numbers of patients showed a differential response to salmeterol and tiotropium in terms of morning PEF (n = 90 and 78, respectively) and ACDs (n = 49 and 53, respectively), more showed a differential response to tiotropium for FEV1 (n = 104) than salmeterol (n = 62). An acute response to a short-acting bronchodilator, especially albuterol, predicted a positive clinical response to tiotropium for FEV1 (odds ratio, 4.08; 95% CI, 2.00-8.31; P <.001) and morning PEF (odds ratio, 2.12; 95% CI, 1.12-4.01; P = 0.021), as did a decreased FEV1/forced vital capacity ratio (FEV1 response increased 0.39% of baseline for every 1% decrease in FEV1/forced vital capacity ratio). Higher cholinergic tone was also a predictor, whereas ethnicity, sex, atopy, IgE level, sputum eosinophil count, fraction of exhaled nitric oxide, asthma duration, and body mass index were not. Conclusion Although these results require confirmation, predictors of a positive clinical response to tiotropium include a positive response to albuterol and airway obstruction, factors that could help identify appropriate patients for this therapy.
KW - Asthma
KW - predictor of response
KW - responder analysis
KW - salmeterol
KW - tiotropium
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U2 - 10.1016/j.jaci.2013.08.003
DO - 10.1016/j.jaci.2013.08.003
M3 - Article
C2 - 24084072
AN - SCOPUS:84887024692
SN - 0091-6749
VL - 132
SP - 1068-1074.e1
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 5
ER -