For appropriate patients with COPD,

START WITH ANORO INSTEAD OF SPIRIVA HANDIHALER

Explore the head-to-head data for ANORO vs SPIRIVA

Hear from HCPs and Patients About ANORO

The 2 bronchodilators in ANORO provide nearly 2x the lung function improvement vs SPIRIVA HANDIHALER, a single bronchodilator2-

 

ANORO versus SPIRIVA study information
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Studied in patients with moderate or worse COPD (GOLD 2-4).3,4

 

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.3

 

*Reflects rounding.

 

  • DESCRIPTION OF STUDIES

     

    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) FEV 1 at Day 169 (defined as the mean of the FEV 1 values obtained 23 and 24 hours after dosing on Day 168). 

ANORO reduced rescue medication use vs SPIRIVA3,4

Patients taking ANORO had fewer rescue albuterol puffs per day over 24 weeks compared with patients taking SPIRIVA3-5 

 

ANORO vs. SPIRIVA rescue albuterol puffs per day comparison
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Studied in patients with moderate or worse COPD (GOLD 2-4).3,4

 

*In DB2113360, LS mean number of rescue albuterol puffs per day over Weeks 1 to 24: ANORO ELLIPTA=2.5, SPIRIVA HANDIHALER=3.2. Difference=0.73,5

 

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.4,5

 

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.3,5

  • DESCRIPTION OF STUDIES

     

    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) FEV 1 at Day 169 (defined as the mean of the FEV 1 values obtained 23 and 24 hours after dosing on Day 168). 
     
    Other efficacy endpoint

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

     

Adverse events occurring in ≥3% of subjects in any of the 3 clinical studies3-5

RANGE OF ADVERSE EVENTS ACROSS THESE STUDIES (%)

 

ADVERSE EVENTS 

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

*Signs, symptoms, or progression of COPD are more severe than expected for the subject's condition.

 

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

Patients who switched to ANORO from SPIRIVA showed significant lung function improvement6

 

Patients who switched to ANORO ELLIPTA from SPIRIVA HANDIHALER showed significant improvement in trough FEV1 at Day 85 vs patients who stayed on SPIRIVA

 

Lung function improvement after switch data
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  • DESCRIPTION OF STUDIES

     

    The efficacy and safety of a once-daily dose of ANORO ELLIPTA and SPIRIVA HANDIHALER were evaluated in a 12-week, multicenter, randomized, blinded, double-dummy, parallel-group study in patients (mean age: 64 years) with COPD who were symptomatic based on mMRC of at least 1 while on SPIRIVA HANDIHALER. At screening, patients had a mean postbronchodilator FEV1 of 59.6% predicted. Patients included in the study had been prescribed SPIRIVA for at least 3 months prior to screening and then completed a 4-week run-in on open-label SPIRIVA HANDIHALER prior to randomization. Patients had an mMRC of at least 1 at screening and at randomization. 

     

    mMRC=modified Medical Research Council, rating scale of dyspnea (0-4); 1=troubled by shortness of breath when hurrying on level ground or walking up a slight hill.

     

    Primary endpoint
    Trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained 23 and 24 hours after dosing on Day 84). 
     
    Adverse events

    In ≥3% of subjects in either treatment group for ANORO ELLIPTA and SPIRIVA HANDIHALER, respectively: nasopharyngitis (7%, 7%) and headache (6%, 7%). Safety data are descriptive only. The study was not powered to compare the safety profiles of the products.6