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Obstructive Lung Diseases |

Treatment With Formoterol Fumarate Inhalation Solution (FFIS) Among COPD Patients With High Use of Nebulized Short Acting Beta 2-Agonists (SABAs)

Amir Sharafkhaneh*, MD; Nicola Hanania, MD; Gene Colice, MD; James Donohue, MD; Aylin Riedel, PhD; Jonathan Kurlander, MS; Paul Mastoridis, PharmD; Pablo Altman, MD
Author and Funding Information

Baylor College of Medicine, Houston, TX


Chest. 2012;142(4_MeetingAbstracts):657A. doi:10.1378/chest.1389889
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Abstract

SESSION TYPE: COPD Posters II

PRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PM

PURPOSE: We recently showed that use of 3 or more SABA nebulizations every two days on average (Rule of 3-2) was associated with higher rates of COPD exacerbations and costs. We compared outcomes (mortality, exacerbations) among patients above the mentioned threshold who were using FFIS, a nebulized long-acting beta 2-agonist (LABA), with those of patients with similar characteristics and disease severity, but on other treatments.

METHODS: Retrospective analysis of two US databases with medical and pharmacy data. Enrollees presented at least 2 claims for COPD during 1/1/2008-3/31/2010 and had SABA use of 1.5 vials (2.5mg albuterol or equivalent) per day or more (≥3 nebulizations in 2 days). Propensity matching (using demographics, COPD medications, and claims-based COPD severity) was used to identify FFIS users and matched controls with no nebulized LABA use. Outcomes (assessed until death, disenrollment, or up to 42 months) included mortality and any severe outcome (death or COPD-related inpatient or emergency department visit).

RESULTS: The study included 384 COPD patients, 96 with FFIS matched to 288 controls. 10.42% of FFIS users and 17.36% of controls died, with 46.88% and 52.08% experiencing a serious outcome (including death). 58 of the FFIS patients had 1 or more refills, with mortality of 5.17% (FFIS) vs 16.67% (matched controls, n=174) and severe outcomes 44.83% vs. 50.00%. 26 FFIS patients had at least one refill and a medication possession ratio of 70% or greater, with a mortality of 3.85% (FFIS) vs. 10.26% (matched controls, n=78); severe outcomes were 38.5% vs. 47.44%. These analyses had insufficient statistical power most likely due to sample size.

CONCLUSIONS: Rates of severe outcomes were numerically lower among FFIS users with a history of 3 or more SABA nebulizations every two days on average. Due to sample size constraints, this should be explored in follow up studies.

CLINICAL IMPLICATIONS: FFIS showed numerically lower rates of severe outcomes than comparator in COPD patients with high use of nebulized SABA, though differences were not statistically significant.

DISCLOSURE: Amir Sharafkhaneh: Consultant fee, speaker bureau, advisory committee, etc.: Mylan Specialty LP, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline

Nicola Hanania: Grant monies (from industry related sources): Mylan Specialty L.P., Consultant fee, speaker bureau, advisory committee, etc.: Mylan Specialty L.P.

Gene Colice: Consultant fee, speaker bureau, advisory committee, etc.: Consultant/speaker/advisory board member for Mylan Specialty L.P., Teva, MedImmune, Boehringer Ingelheim, Merck, and Pearl Therapeutics

James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Mylan Specialty L.P., Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Laboratories Almirall, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Forest Laboratories, Consultant fee, speaker bureau, advisory committee, etc.: Pfizer, Consultant fee, speaker bureau, advisory committee, etc.: Sunovion, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Gilead, Consultant fee, speaker bureau, advisory committee, etc.: Grifols, Grant monies (from industry related sources): Aerocrine

Paul Mastoridis: Employee: Mylan Specialty L.P.

Pablo Altman: Employee: Mylan Specialty L.P.

The following authors have nothing to disclose: Aylin Riedel, Jonathan Kurlander

No Product/Research Disclosure Information

Baylor College of Medicine, Houston, TX

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