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Obstructive Lung Diseases |

Cardio- and Cerebrovascular (CCV) Safety of Once-Daily Indacaterol 75 μg in the Treatment of Patients With COPD

James Donohue*, MD; Charles Fogarty, MD; Huilin Hu, PhD; Danny McBryan, MD; James Williams, MD
Author and Funding Information

University of North Carolina School of Medicine, Chapel Hill, NC


Chest. 2012;142(4_MeetingAbstracts):682A. doi:10.1378/chest.1386257
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Abstract

SESSION TYPE: New Insights into COPD

PRESENTED ON: Monday, October 22, 2012 at 04:00 PM - 05:30 PM

PURPOSE: Clinical efficacy of indacaterol 75 µg qd (IND75), the approved US dose, has been reported [Kerwin, Clin Ther 2011]. Investigations with higher doses report CCV safety over 6 months [Worth, Respir Med 2011] and overall safety up to 1 year [Donohue, Int J COPD 2011]. We report the CCV safety of IND75 in patients with moderate-to-severe COPD.

METHODS: Pooled data with IND75 (n=449) and placebo (n=2012 overall) given for up to 3 months were analyzed for CCV adverse events (AEs) and serious AEs (SAEs). CCV events were any preferred terms in standardized MedDRA query categories ‘cardiac failure’, ‘ischemic heart disease’, ‘cerebrovascular disorders’ and ‘cardiac arrhythmias’. AEs were also analyzed using Anti-Platelet Trialists’ Collaboration (APTC) criteria defining serious vascular events.

RESULTS: In the 3-month dataset, overall frequency of CCV AEs was similar with IND75 (n=9, 2.00%) and placebo (2.58% overall). No single CCV AE occurred in more than two patients receiving IND75 (>0.45%). CCV SAEs were reported for two patients (0.45%) on IND75 and 0.65% on placebo. One IND75 (0.22%) patient had an APTC event (cerebrovascular accident, not suspected related to study treatment) versus eight (0.40%) on placebo. For comparison, in the 6-month safety population the overall frequency of patients with CCV AEs ranged from 3.3 to 5.8%: indacaterol 75 µg (n=6, 4.7%), 150 µg (n=52, 5.6%), 300 μg (n=50, 4.8%) and 600 μg qd (n=18, 3.3%) versus placebo (n=56, 4.1%). There was no dose-response between IND75 and higher doses (up to 600 μg) for CCV AEs and SAEs overall or for any preferred term, in 3- or 6-month datasets (total n=4764 and 2648, respectively, receiving indacaterol). No deaths were reported in the 449 patients who received IND75.

CONCLUSIONS: IND75 had an acceptable CCV safety profile in patients with moderate-to-severe COPD.

CLINICAL IMPLICATIONS: Considered together with previous reports of acceptable safety with doses up to eight times higher for 1 year, these results suggest IND75 lacks any specific CCV safety signal.

DISCLOSURE: James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Novartis consultant, advisory, Consultant fee, speaker bureau, advisory committee, etc.: GSK consultant, advisory, Consultant fee, speaker bureau, advisory committee, etc.: BI consultant, advisory, Consultant fee, speaker bureau, advisory committee, etc.: Forest consultant advisor, Consultant fee, speaker bureau, advisory committee, etc.: Pfizer consultant

Charles Fogarty: Grant monies (from industry related sources): Novartis Pharmaceuticals, Grant monies (from industry related sources): Glaxo Smith Kline, Grant monies (from sources other than industry): Forest Research Institute, Grant monies (from industry related sources): Boerhringer Ingelheim, Grant monies (from sources other than industry): Pearl Therapeutics, Grant monies (from sources other than industry): MedImmune, Grant monies (from industry related sources): Elevation Pharmaceuticals, Grant monies (from sources other than industry): Roche, Grant monies (from industry related sources): Ardea Biosciences, Grant monies (from industry related sources): Otsuka, Grant monies (from sources other than industry): Shionogi Biosciences, Grant monies (from industry related sources): Pfizer

Huilin Hu: Employee: Novartis

Danny McBryan: Employee: Novartis

James Williams: Employee: Novartis

The presenter will be discussing safety data on the indacaterol licensed dose of 75 mcg and also for comparison will include some data at higher doses that are not licensed in the US.

University of North Carolina School of Medicine, Chapel Hill, NC

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