1. One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPD
- Author
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Donald A. Mahler, Alistair Wheeler, James F. Donohue, Robert Tosiello, Donald P. Tashkin, Barry J. Make, Matthew C. Miles, Lisa Curry, and Nicola A. Hanania
- Subjects
Pulmonary and Respiratory Medicine ,Adult ,Male ,medicine.medical_specialty ,Randomization ,Time Factors ,Drug-Related Side Effects and Adverse Reactions ,Critical Care and Intensive Care Medicine ,Lower risk ,Placebo ,Risk Assessment ,Severity of Illness Index ,Drug Administration Schedule ,FEV1/FVC ratio ,Pulmonary Disease, Chronic Obstructive ,Double-Blind Method ,Reference Values ,Internal medicine ,Formoterol Fumarate ,Administration, Inhalation ,Medicine ,Humans ,COPD ,Adverse effect ,Aged ,Proportional Hazards Models ,Original Research ,Dose-Response Relationship, Drug ,business.industry ,Arformoterol ,Middle Aged ,medicine.disease ,Arformoterol Tartrate ,Survival Analysis ,Surgery ,Bronchodilator Agents ,Respiratory Function Tests ,Treatment Outcome ,Ethanolamines ,Delayed-Action Preparations ,Female ,Patient Safety ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug ,Follow-Up Studies - Abstract
BACKGROUND: Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β 2 -agonist approved for maintenance treatment of COPD. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV 1 ≤ 65% predicted, FEV 1 > 0.50 L, FEV 1 /FVC ≤ 70%, and ≥ 15 pack-year smoking history) received arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization. RESULTS: Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with arformoterol than placebo ( P = .003). Numerically more patients on arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV 1 and FVC were greater with arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with arformoterol vs placebo ( P CONCLUSIONS: Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00909779; URL:www.clinicaltrials.gov
- Published
- 2014