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Obstructive Lung Diseases |

Efficacy and Tolerability of Once-Daily Indacaterol 75 μg in COPD Patient Subgroups Defined by Age, Gender, Severity of Airflow Limitation, and Smoking Status

Thomas Siler*, MD; Mark Gotfried, MD; Farid Kianifard, PhD; Danny McBryan, MD; James Williams, MD
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Midwest Chest Consultants, St Charles, MO


Chest. 2012;142(4_MeetingAbstracts):693A. doi:10.1378/chest.1386909
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Abstract

SESSION TYPE: COPD: Safety and Effectiveness of Newer Therapies

PRESENTED ON: Tuesday, October 23, 2012 at 02:45 PM - 04:15 PM

PURPOSE: We evaluated the efficacy and tolerability of indacaterol 75 µg once daily (qd), an inhaled long-acting β2-agonist bronchodilator, in COPD patient subgroups defined by age, gender, severity of airflow limitation, and smoking status.

METHODS: Data were pooled from two identically designed studies in patients with moderate-to-severe COPD randomized to double-blind treatment with indacaterol 75 µg qd or placebo for 12 weeks. Efficacy variables were 24-hour post-dose (‘trough’) FEV1 and health status (SGRQ total score), after 12 weeks (primary analysis time point).

RESULTS: 640 patients (post-albuterol FEV1 54% predicted, mean age 63 years) were randomized (indacaterol n=322, placebo n=318); 41% were receiving inhaled corticosteroids. Patients were categorized by age <65 or ≥65 years; male or female; airflow limitation moderate or severe, and ex- or current smokers. Efficacy results are least squares means differences with indacaterol versus placebo (all p<0.01). Indacaterol improved trough FEV1 by 150 and 110 mL, respectively, in males and females; by 110 and 150 mL in patients <65 and ≥65 years; by 150 and 110 mL in patients with moderate or severe airflow limitation, and by 140 and 130 mL in ex-smokers and current smokers. Indacaterol improved SGRQ score similarly in males and females (by 3.8 and 3.7 units, respectively). In other subgroups improvements were numerically larger in patients ≥65 years (4.5, vs 3.3 units in <65s), patients with severe airflow limitation (4.6, vs 3.3 in moderate subgroup), and in ex-smokers (4.1, vs 3.5 in current smokers). Adverse events were reported for 44%/50% of <65s/≥65s receiving indacaterol (placebo: 43%/45%); 38%/57% of males/females receiving indacaterol (placebo: 40%/48%); 48%/44% of moderate/severe patients (placebo: 46%/42%), and 52%/42% of ex-/current smokers (placebo: 45%/43%).

CONCLUSIONS: Indacaterol provided statistically significant improvements in bronchodilation and health status regardless of age, severity of airflow limitation, smoking status and sex. Indacaterol was well tolerated.

CLINICAL IMPLICATIONS: Indacaterol may be used to treat a range of COPD patients in the reasonable expectation of substantial and worthwhile improvements in bronchodilation and health status.

DISCLOSURE: Thomas Siler: Grant monies (from industry related sources): GSK, Grant monies (from industry related sources): Novartis, Grant monies (from industry related sources): Boehringer-Ingelheim, Grant monies (from industry related sources): Forest Research Institute, Grant monies (from industry related sources): Daiichi Sankyo, Grant monies (from industry related sources): Sunovion, Grant monies (from industry related sources): Merck, Grant monies (from industry related sources): Genentech, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Forest Research Institute

Mark Gotfried: Consultant fee, speaker bureau, advisory committee, etc.: Novartis Training Consultancy, Other: Novartis Research Support

Farid Kianifard: Employee: Novartis Pharmaceuticals

Danny McBryan: Employee: Novartis Pharmaceuticals

James Williams: Employee: Novartis Pharmaceuticals

No Product/Research Disclosure Information

Midwest Chest Consultants, St Charles, MO

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