Entries for September 2016
Donald A. Mahler, MD1 Dorothy L. Keininger, MSc2 Karen Mezzi, MD2 Robert Fogel, MD3 Donald Banerji, MD3
Author Affiliations
- Professor Emeritus, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
- Novartis Pharma AG, Basel, Switzerland
- Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
Address correspondence to:
Donald A. Mahler, MD
Valley Regional Hospital
243 Elm Street
Claremont, NH 03743
Tel: (603) 277-0383
Fax: (603) 542-6731
Email: mahlerdonald@gmail.com
Abstract
Introduction: The Global initiative for chronic Obstructive Lung Disease (GOLD) recommends treating patients with chronic obstructive pulmonary disease (COPD) based on a combined assessment of symptom severity and airflow limitation and/or exacerbation risk. According to GOLD, patients with mild-to-moderate airflow limitation and distressing symptoms such as dyspnea should be treated with a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA). If symptoms persist on monotherapy, GOLD recommends a combination of bronchodilators (LABA/LAMA).
Methods: We performed a post-hoc analysis of data from two 26-week, prospective clinical trials to investigate the effect of treating patients with moderate-to-severe dyspnea with the once-daily LABA/LAMA combination indacaterol/glycopyrronium (IND/GLY) 110/50 µg compared with placebo, once-daily tiotropium 18 µg, and twice-daily salmeterol/fluticasone propionate (SFC) 50/500 µg. In this analysis, a Baseline Dyspnea Index (BDI) score ≤7 was used to identify dyspneic patients.
Results: In dyspneic patients, IND/GLY significantly improved Transition Dyspnea Index (TDI) total scores compared with tiotropium (0.59 units; p<0.05) and SFC (0.97 units; p<0.05), and significantly increased the likelihood of a patient achieving a 1-unit improvement in TDI compared with tiotropium (odds ratio [OR] 1.87; p<0.05). IND/GLY also significantly improved trough forced expiratory volume in 1 second (FEV1) compared with tiotropium and SFC (p<0.001 and p<0.0001, respectively), and significantly reduced rescue medication use compared with tiotropium (p<0.001).
Conclusions: Our analysis indicates that IND/GLY provides additional improvements in dyspnea and lung function compared with tiotropium and SFC in dyspneic patients.
Citation
Citation: Mahler DA, Keininger DL, Mezzi K, Fogel R, Banerji D. Efficacy of indacaterol/glycopyrronium in patients with COPD who have increased dyspnea with daily activities. J COPD F. 2016; 3(4): 758-768. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0138
Marie Topp, PhD1 Jørgen Vestbo, DMSc2 Erik Lykke Mortensen, MS3
Author Affiliations
- Department of Respiratory Medicine, Hvidovre Hospital, Denmark
- Respiratory and Allergy Research Group, Manchester Academic Health Science Centre, University Hospital South Manchester, NHS Foundation Trust, Manchester, United Kingdom
- Department of Public Health and Center for Healthy Aging, University of Copenhagen, Denmark
Address correspondence to:
Marie Topp, PhD
Kettegaard Alle 30
2650 Hvidovre, Denmark
E-mail: marie_topp@hotmail.com
Phone: +45 61463089
Abstract
Background: Understanding non-adherence in patients with chronic obstructive pulmonary disease (COPD) remains challenging. The necessity and the concerns scales of the Beliefs about Medicines Questionnaire (BMQ) are known to correlate with adherence behavior in several chronic diseases including asthma but less is known about COPD. In the present study a COPD-specific BMQ (BMQ-COPD) was translated and administered to Danish COPD outpatients. Our aim was to derive high-quality measures of the 2 dimensions included in the BMQ-COPD.
Methods: A total of 168 patients with COPD were included from a Danish respiratory outpatient clinic. The Rasch model was used to evaluate psychometric characteristics of the BMQ-COPD and to obtain necessity and concerns scales fulfilling criteria of unidimensionality and overall fit, and with all items showing individual item fit with no local dependencies, and no differential item functioning. Further, we explored the association with disease-related variables and subsequent adherence behavior.
Results: Shortened versions of the original necessity and concerns scales fitted the Rasch model and were at least as good as the original scales as predictors of adherence, although only the necessity scale was significantly associated with adherence.
Conclusion: In a Danish COPD setting high-quality measures of necessity and concerns could be derived from the BMQ-COPD. The excluded items appear to reflect other dimensions.
Citation
Citation: Topp M, Vestbo J, Mortensen EL. Psychometric properties of the COPD-specific Beliefs about Medicine Questionnaire in an outpatient population: A Rasch-analysis. J COPD F. 2016; 3(4): 748-757. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0134