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START WITH ANORO FOR SUPERIOR IMPROVEMENT IN LUNG FUNCTION VS AN ESTABLISHED ICS/LABA1

The indication for ANORO differs from the indication for ADVAIR in that ANORO is not indicated for reducing COPD exacerbations.

Studied in patients with moderate to severe COPD (GOLD 2 or 3).1

Description of studies1,2

The efficacy and safety of a once-daily dose of ANORO ELLIPTA and a twice-daily dose of ADVAIR DISKUS 250 mcg/50 mcg were evaluated in 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group studies in patients (mean age range: 63 to 64 years) with COPD with no exacerbations (COPD symptoms requiring oral corticosteroids, antibiotics, and/or hospitalization) in the previous year. At screening, patients had a mean postbronchodilator FEV1 range of 49.4% to 49.5% predicted. The studies were not powered to compare the safety profiles of the products.

Primary endpoint

Weighted mean FEV1 (0-24 hours postdose) on Day 84.

ANORO provided more patients with a ≥100 mL lung function improvement vs an established ICS/LABA1

The indication for ANORO differs from the indication for ADVAIR in that ANORO is not indicated for reducing COPD exacerbations.

Studied in moderate to severe COPD (GOLD 2 or 3).1

Description of studies

See description of studies above.

Other efficacy endpoint

Proportion of patients achieving an increase of ≥100 mL above baseline in trough FEV1 at Day 85.

ANORO: Rescue medication use vs an established ICS/LABA1

The indication for ANORO differs from the indication for ADVAIR in that ANORO is not indicated for reducing COPD exacerbations.

Studied in patients with moderate to severe COPD (GOLD 2 or 3).1

Description of studies1,2

See description of studies above.
These studies were not designed to demonstrate noninferiority between treatment groups.

Other efficacy endpoint

Rescue albuterol use (puffs/day), Weeks 1 to 12.

Adverse events occurring in ≥3% of subjects in the 2 studies1

Adverse event ANORO ELLIPTA
ADVAIR DISKUS
STUDY DB2114930 (n=353) (n=353)
Headache 7% 5%
Nasopharyngitis
5%
2%
STUDY DB2114951 (n=349) (n=348)
Headache 7% 7%
Nasopharyngitis
4% 2%

Safety data are descriptive only. The studies were not powered to compare the safety profiles of the products. See the description of studies above.

Rescue Albuterol Use vs Placebo2-4

Study DB21133732,3

A 24-week, double-blind, placebo-controlled study evaluated the efficacy and safety of ANORO ELLIPTA (n=413), placebo (n=280), and other treatment arms in patients with COPD. The primary endpoint was trough FEV1 at Day 169. For the other endpoint of rescue albuterol use (puffs/day), Weeks 1 to 24, the LS mean number of rescue albuterol puffs per day was 3.3 for ANORO and 4.1 for placebo, which corresponds to a 0.8 difference. This endpoint was not adjusted for multiplicity.

Study 2012112,4

A 12-week, double-blind, placebo-controlled study evaluated the efficacy and safety of ANORO ELLIPTA (n=248) compared with placebo (n=248) in patients with COPD. The primary endpoint was the SGRQ total score at Week 12. For the secondary endpoint of rescue albuterol use (puffs/day), Weeks 1 to 12, the LS mean number of rescue albuterol puffs per day was 2.2 for ANORO and 2.9 for placebo, which corresponds to a 0.7 difference (P<0.001).

CI=confidence interval; COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease; ICS=inhaled corticosteroid; LABA=long-acting beta2-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; OR=odds ratio.

References: 1. Donohue JF, Worsley S, Zhu C-Q, et al. Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med. 2015;109(7):870-881, Appendix B. 2. Data on file, GSK. 3. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107(10):1538-1546. 4. Siler TM, Donald AC, O’Dell D, et al. A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 µg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:971-979.