SESSION TITLE: COPD Safety of Treatment Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: This study was performed to evaluate risk of life-threatening respiratory events (COPD exacerbation-related hospitalizations and respiratory death) during 1 year of treatment with ARF15µg twice daily (ARF) compared with placebo in subjects with moderate-to-severe COPD.
METHODS: This was a double blind, randomized, placebo controlled, parallel group study. Subjects meeting inclusion criteria (≥40 years old with COPD, baseline FEV1 ≤50% of predicted, ≥15 pack year smoking history) were randomized to ARF (BROVANA® [arformoterol tartrate] Inhalation Solution, N=420) or placebo (N=421) for 1 year. Subjects remained on other COPD medications except LABAs. Short acting bronchodilators were only withheld prior to visits and inhaled steroids and xanthines were permitted throughout at constant dosage. The primary assessment was time from randomization to a primary event (respiratory death or first COPD exacerbation related hospitalization, whichever occurred first). The hazard ratio and 90%CI comparing ARF to placebo for the primary assessment were estimated using a Cox proportional hazards regression model, with treatment group, baseline smoking status, age, and baseline FEV1 as covariates. Secondary analysis of treatment by covariate interaction for the primary assessment was conducted and is reported here.
RESULTS: 466 subjects completed 1 year of treatment. Subjects who prematurely discontinued the study treatment were followed for a primary event for the remainder of the treatment period. 142 primary events occurred in 103 subjects, with majority experiencing a single event. 63 (15.0%) placebo and 40 (9.5%) ARF subjects had at least one primary event. The primary event hazard ratios (HR) by baseline covariates of interest were: current smokers (n=432; HR:0.809), former smokers (n=409; HR:0.445); <65 years old (n=426; HR:0.707), 65 to 75 years old (n=301; HR:0.786) and >75 years old (n=114; HR:0.269); COPD disease severity (% Predicted FEV1): <30% (n=233; HR:0.565), 30-<50% (n=388; HR:0.648) and ≥50% (n=219; HR:0.618).
CONCLUSIONS: In this long-term safety study, arformoterol tartrate 15µg BID for 1 year significantly decreased the risk of respiratory death or COPD exacerbation-related hospitalizations compared with placebo irrespective of the smoking status, age, or disease severity.
CLINICAL IMPLICATIONS: The results of this study showed that arformoterol tartrate reduced risk of respiratory death and COPD-exacerbations related hospitalizations during 1 year of treatment with Arformoterol tartrate 15µg BID.
DISCLOSURE: James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals Inc Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals Inc, Grant monies (from industry related sources): Sunovion Pharmaceuticals Inc (past, completed) Barry Make: Grant monies (from sources other than industry): National HEart, Lung, and Blood Institute, Grant monies (from industry related sources): Boehringer-Ingelheim, Forest, NABI, Pfizer, Consultant fee, speaker bureau, advisory committee, etc.: Abbott, AstraZeneca, Boehringer-Ingelheim, Breathe, Coviden, Forest, GSK, Ikaria, Merck, MedImmune, NABI, Novartis, Pfizer
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