Real-world evidence in COPD:
STIOLTO RESPIMAT vs ANORO®
ELLIPTA®1
Patients had fewer COPD-related ER visits with STIOLTO RESPIMAT in a retrospective analysis1
Successfully balanced propensity score matching was used to minimize bias between STIOLTO RESPIMAT and ANORO ELLIPTA* groups at baseline.1
*Umeclidinium and vilanterol inhalation powder.
Results from real-world studies are not intended for comparisons with clinical trials. Real-world studies were observational trials. Differences in study designs, patient populations, outcomes definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.
Boehringer lngelheim Pharmaceuticals, Inc. either owns or uses the SPIRIVA® RESPIMAT®and STIOLTO® RESPIMAT® trademarks under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer lngelheim Pharmaceuticals, Inc.
ER, emergency room.
Study Design & Limitations
Expand allA retrospective, non-interventional, observational study of 2 different subgroup analyses was completed comparing patients initiating STIOLTO RESPIMAT with patients on ANORO® ELLIPTA® (umeclidinium + vilanterol), as well as other LAMA+LABA fixed-dose combinations (FDCs) in a real-world setting.1
The first analysis of this study, STIOLTO RESPIMAT vs other LAMA+LABAs, used administrative claims data from January 2013 to October 2018 in the Optum Research Database to examine the differences in COPD-related and all-cause healthcare resource utilization (HRU) and costs associated with treatment initiation.
The second analysis of this study, STIOLTO RESPIMAT vs ANORO ELLIPTA, also examined the differences in HRU and costs associated with treatment initiation. After meeting all study criteria, propensity score matching (1:2 ratio) was used to match 4115 patients on STIOLTO RESPIMAT with 8230 patients on ANORO ELLIPTA to adjust for observed baseline differences.
Key inclusion criteria were: ≥1 diagnosis code indicating COPD in any position during the study period (January 2013 through October 2018); ≥1 fill for a LAMA+LABA FDC during the identification period provided (January 2014 through September 2018; 1st fill date=index date), pharmacy fill was for only one index medication on the index date; continuously enrolled with both medical and pharmacy coverage in the 12-month baseline period and ≥1 month post-index (follow-up period); and aged 40 years or older as of the index date year.
Patients were excluded if they were aged <40 years or had incomplete demographic information; ≥2 distinct medical claim dates involving a diagnosis of asthma, interstitial lung disease, cystic fibrosis, and/or lung cancer during the baseline or follow-up periods; evidence of free- or fixed-dose triple therapy on the index date; or a baseline prescription for free- or fixed-dose LAMA+LABA or triple therapy.
After meeting all study criteria, propensity score matching (1:2 ratio) was used in the first analysis to match 4175 patients on STIOLTO RESPIMAT with 8350 patients on other LAMA+LABA FDCs (91.3% UMEC+VI; 8.5% GLY+FORM; 0.2% GLY+IND) to adjust for observed baseline differences.
Post-match, cohorts were well balanced on baseline characteristics (standardized difference was <10%). Patients were followed while on treatment until there was an index regimen discontinuation (≥60-day gap), switch, coverage disenrollment, or end of study period, whichever came first.
The outcomes assessed were the annualized rates of both COPD-related and all-cause inpatient stays, ER visits, ambulatory visits, other medical visits, and pharmacy fills. COPD-related claims included medical claims with a diagnosis of COPD or pharmacy claims for COPD medications (maintenance, rescue, oral corticosteroids, and/or respiratory antibiotics).
LAMA, long-acting antimuscarinic agent; LABA, long-acting beta2-agonist; UMEC+VI, umeclidinium and vilanterol; GLY+FORM, glycopyrrolate and formoterol; GLY+IND, glycopyrronium and indacaterol; ER, emergency room.
The retrospective design makes it challenging to establish causality between the difference in treatments and difference in outcomes. Claims data may present certain inherent limitations given claims are typically collected for payment purposes, not research. The presence of a diagnosis code on a medical claim does not guarantee positive presence of a disease, as the diagnosis code may be incorrectly coded or included as a rule-out criterion. Presence of a claim for a filled prescription does not indicate that the medication was consumed as prescribed.
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitations of Use
STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.
Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.
STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.
In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.
WARNINGS AND PRECAUTIONS
LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.
Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.
If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.
If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.
STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.
Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.
Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician 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 consult a physician immediately should any of these signs or symptoms develop.
Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) should be monitored closely for anticholinergic side effects.
Be alert to hypokalemia and hyperglycemia.
ADVERSE REACTIONS
The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).
DRUG INTERACTIONS
Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.
Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.
The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
STIOLTO is for oral inhalation only.
The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.
Inform patients not to spray STIOLTO into the eyes as this may cause blurring of vision and pupil dilation.
CL-STO-100021 6.5.2019
Please see full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.
REFERENCE
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Palli SR, Xie B, Chastek B, Elliott CA, Bengtson LGS. Comparison of COPD health care utilization and associated costs across patients treated with LAMA+LABA fixed-dose therapies. J Manag Care Spec Pharm. 2021;27(7):810-824.