ANORO ELLIPTA vs. SPIRIVA For COPD

For appropriate patients with COPD,

START WITH ANORO INSTEAD OF SPIRIVA HANDIHALER

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

A LAMA/LABA vs A LAMA?

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TROUGH FEV₁
RESCUE MED USE
ADVERSE EVENTS
SWITCH DATA

The 2 bronchodilators in ANORO provide nearly 2x the lung function improvement vs SPIRIVA HANDIHALER, a single bronchodilator²^-⁴

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 ₁at 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 SPIRIVA^3,4

Patients taking ANORO had fewer rescue albuterol puffs per day over 24 weeks compared with patients taking SPIRIVA^3-5

ANORO vs. SPIRIVA rescue albuterol puffs per day comparison

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=0.7^3,⁵

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 85 (defined as the mean of the FEV ₁ values obtained 23 and 24 hours after dosing on Day 84).

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 studies^3-5

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 SPIRIVA⁶

Lung function improvement after switch data

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

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INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION & IMPORTANT SAFETY INFO

INDICATION

ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ANORO is NOT for the relief of acute bronchospasm or for asthma.

ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

ANORO is NOT for the relief of acute bronchospasm or for asthma.

ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

ANORO is NOT for the relief of acute bronchospasm or for asthma.

ANORO is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium, vilanterol, or any of the excipients.

CONTRAINDICATIONS

ANORO is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
Use of a long-acting beta2-adrenergic agonist (LABA) without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ANORO is contraindicated in patients with severe hypersensitivity to milk proteins or with hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
Use of a long-acting beta2-adrenergic agonist (LABA) without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

WARNINGS AND PRECAUTIONS

The safety and efficacy of ANORO in patients with asthma have not been established. ANORO is not indicated for the treatment of asthma. Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. Available data do not suggest an increased risk of death with use of LABA in patients with COPD.
ANORO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
ANORO is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
ANORO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur.
If paradoxical bronchospasm occurs, discontinue ANORO and institute alternative therapy.
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO. Discontinue ANORO if such reactions occur.
Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, ANORO may need to be discontinued. ANORO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions (≥1% and more common than placebo) reported in four 6‑month clinical trials with ANORO (and placebo) were: pharyngitis, 2% (<1%); sinusitis, 1% (<1%); lower respiratory tract infection, 1% (<1%); constipation, 1% (<1%); diarrhea, 2% (1%); pain in extremity, 2% (1%); muscle spasms, 1% (<1%); neck pain, 1% (<1%); and chest pain, 1% (<1%).
In addition to the 6-month efficacy trials with ANORO, a 12-month trial evaluated the safety of umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse reactions (incidence ≥1% and more common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.

DRUG INTERACTIONS

Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors as increased systemic exposure to vilanterol and cardiovascular adverse effects may occur. See prior Warning and Precaution regarding CYP3A4 inhibitors.
ANORO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
Use beta‐blockers with caution as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
Avoid coadministration of ANORO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

Please see full Prescribing Information, including Patient Information, for ANORO.

REFERENCES

Mapel DW, Dalal AA, Blanchette CM, Petersen H, Ferguson GT. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J Chron Obstruct Pulmon Dis. 2011;6:573-581.
Cazzola M, Molimard M. The scientific rationale for combining long-acting β2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther. 2010;23(4):257-267.
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.
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.
Data on file, GSK.
Kerwin EM, Kalberg CJ, Galkin DV, et al. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. Int J Chron Obstruct Pulmon Dis. 2017;12:745-755.
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.
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.
Siler TM, Donald AC, O’Dell D, et al. A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 mcg on health-related quality of life in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:971-979.
Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

DEFINITIONS

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; QOL =quality of life; UMEC=umeclidinium; VI=vilanterol.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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UCVWCNT200037 October 2020
Produced in USA.

A LAMA/LABA vs A LAMA?

Primary endpoint

Primary endpoint

Other efficacy endpoint

RANGE OF ADVERSE EVENTS ACROSS THESE STUDIES (%)

Primary endpoint

Adverse events

REFERENCES

DEFINITIONS