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Obstructive Lung Diseases |

Addition of Arformoterol Tartrate (ARF), a Long-Acting β2 Agonist (LABA), to Tiotropium Bromide (TIO) Improves Outcomes of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With TIO Alone or Placebo (PBO) FREE TO VIEW

James Donohue, MD; Nicola Hanania, MD; Barry Make, MD; Robert Tosiello, MS; Alistair Wheeler, MD
Author and Funding Information

Univ. of NC, Chapel Hill NC, Chapel Hill, NC


Chest. 2015;148(4_MeetingAbstracts):742A. doi:10.1378/chest.2274201
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Abstract

SESSION TITLE: Emerging Therapies in COPD

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Tuesday, October 27, 2015 at 02:45 PM - 04:15 PM

PURPOSE: Inhaled LABAs and long-acting anticholinergics (eg, TIO) are effective treatments for patients with COPD; yet, the effect on outcomes of combining the LABA ARF 15 μg twice daily with TIO has not been extensively studied.

METHODS: We analyzed, post-hoc, data from a double-blind, randomized, PBO-controlled study (NCT00909779) of patients (≥40 years, baseline forced expiratory volume in 1 second [FEV1] ≤50% of predicted, ≥15 pack-year smoking history) receiving ARF or PBO for 1 year. Patients could continue TIO on stable doses at study entry. We evaluated the primary assessment (respiratory death or COPD exacerbation-related hospitalization), lung function, and adverse events (AEs) for ARF vs PBO stratified by concomitant TIO use (stable dose ≥14 days pre-baseline through study end) in patients with COPD.

RESULTS: 420 patients received ARF (235 ARF, 185 ARF+TIO) and 421 received PBO (259 PBO, 162 PBO+TIO). Hazard ratios for the primary outcome were 0.59 (confidence interval [CI], 0.42-0.85) for ARF vs no ARF after stratifying by TIO use and 1.52 (CI, 1.06-2.18) for TIO vs no TIO. Primary event rates were 0.07 (ARF), 0.13 (PBO), 0.15 (ARF+TIO), and 0.24 (PBO+TIO). At study end, least-squares mean change from baseline (LSM ΔBL) in FEV1 was 137mL (ARF), 53mL (PBO), 12mL (ARF+TIO), and 0mL (PBO+TIO). LSM ΔBL in inspiratory capacity was 114mL (ARF), 41mL (PBO), -5mL (ARF+TIO), and -22mL (PBO+TIO). In all, 68.5% (ARF), 63.7% (PBO), 78.4% (ARF+TIO), and 75.3% (PBO+TIO) of patients reported treatment-emergent AEs; 18.7% (ARF), 23.9% (PBO), 29.2% (ARF+TIO), and 34.6% (PBO+TIO) of patients reported COPD AEs; and 5.0%-6.8% of patients across all treatment groups reported cardiac disorders. Reports of at least 1 Major Adverse Cardiovascular Event (MACE) were identical (3 each) in the ARF, ARF+TIO, and PBO groups; 1 patient in the PBO+TIO group reported at least 1 MACE. In all, 16.2% (ARF), 18.5% (PBO), 25.9% (ARF+TIO), and 29.0% (PBO+TIO) of patients reported serious AEs (SAEs).

CONCLUSIONS: Patients receiving ARF had a lower risk of respiratory death or COPD exacerbation-related hospitalization, improved lung function, and lower AEs over 1 year than those receiving PBO, regardless of concomitant TIO use. Higher AE and SAE rates in patients receiving TIO±ARF/PBO vs ARF or PBO alone are likely a result of worse physical condition before study entry.

CLINICAL IMPLICATIONS: ARF treatment may improve outcomes regardless of concomitant TIO in patients with COPD.

DISCLOSURE: James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim , Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Novartis Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim , Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline , Consultant fee, speaker bureau, advisory committee, etc.: Mylan , Consultant fee, speaker bureau, advisory committee, etc.: Novartis , Consultant fee, speaker bureau, advisory committee, etc.: Pearl Therapeutics , Consultant fee, speaker bureau, advisory committee, etc.: Pfizer , Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals , Grant monies (from industry related sources): Sunovion Pharmaceuticals Barry Make: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals , Grant monies (from industry related sources): Sunovion Pharmaceuticals , Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca , Grant monies (from industry related sources): AstraZeneca , Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim GmbH , Grant monies (from industry related sources): Boehringer Ingelheim GmbH , Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline , Grant monies (from industry related sources): GlaxoSmithKline , Consultant fee, speaker bureau, advisory committee, etc.: Forest Laboratories Inc , Grant monies (from industry related sources): Forest Laboratories Inc , Grant monies (from industry related sources): Pfizer , Consultant fee, speaker bureau, advisory committee, etc.: Pfizer , Consultant fee, speaker bureau, advisory committee, etc.: Coviden , Consultant fee, speaker bureau, advisory committee, etc.: Theravance Robert Tosiello: Employee: Sunovion Pharmaceuticals Alistair Wheeler: Employee: Sunovion Pharmaceuticals

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