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ANORO DELIVERS SUPERIOR LUNG FUNCTION IMPROVEMENT VS SPIRIVA HANDIHALER1,2

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

Studied in patients with moderate or worse COPD (GOLD 2-4).

In a separate study (DB2113374), ANORO ELLIPTA (n=217) compared with SPIRIVA HANDIHALER (n=215) showed a 60-mL difference* (208 mL and 149 mL, respectively), but due to testing hierarchy, statistical significance cannot be inferred.1

*Reflects rounding.

Description of studies1,2,4

The efficacy and safety of a once-daily dose of ANORO ELLIPTA and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) were evaluated in 24-week, multicenter, randomized, blinded, active-controlled, double-dummy, parallel-group studies in patients (mean age range: 62 to 65 years) with COPD. At screening, patients had a mean postbronchodilator FEV1 range of 46.4% to 47.7% predicted.

Primary endpoint

Trough (predose) FEV1 at Day 169 (defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 168).

ANORO reduced rescue medication use vs SPIRIVA HANDIHALER1,2

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

Studied in patients with moderate or worse COPD (GOLD 2-4).
*LS mean number of rescue albuterol puffs per day over Weeks 1 to 24: ANORO ELLIPTA=2.5, SPIRIVA HANDIHALER=3.2. Difference=0.7.

In ZEP117115, LS mean number of rescue albuterol puffs per day was 1.8 for ANORO ELLIPTA (n=454) and 2.3 for SPIRIVA HANDIHALER (n=451), which corresponds to a 0.5 difference or a 22% reduction. Other endpoint not adjusted for multiplicity.2,4

In DB2113374, as part of a predefined hierarchy, one comparison for the primary endpoint did not achieve statistical significance, and therefore subsequent comparisons are descriptive only. In this study, the LS mean number of rescue albuterol puffs per day for ANORO ELLIPTA (n=217) and SPIRIVA HANDIHALER (n=215) was 2.9 vs 3.5, respectively.1,4

Description of studies

See description of studies above.

Other efficacy endpoint

Rescue albuterol use (puffs/day), Weeks 1 to 24.

ADVERSE EVENTS OCCURRING IN ≥3% OF SUBJECTS IN ANY OF THE 3 STUDIES1,2,4

Range of adverse events across these studies (%)

Adverse event

ANORO ELLIPTA

(n=883)

SPIRIVA HANDIHALER

(n=874)

Headache 9-10 4-7
Nasopharyngitis 6-10 7-8
Back pain
2-5
2-5
Lower respiratory
tract infection
0-4 <1-1
Upper respiratory
tract infection
<1-4 <1-7
COPD <1-3 <1-2
Cough 2-3 2-3
Gastritis 0-3 <1
Pain in extremity <1-3 <1-2
Hypertension
<1-2 <1-3
Urinary tract infection 0-<1 <1-3

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

COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease; LABA=long-acting beta2-adrenergic agonist; LS=least squares.

References: 1. Decramer M, Anzueto A, Kerwin E, et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014;2(6):472-486. 2. Maleki-Yazdi MR, Kaelin T, Richard N, et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir Med. 2014;108(12):1752-1760. 3. SPIRIVA HANDIHALER [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2018. 4. Data on file, GSK.