Why the Prevention of COPD Exacerbations Demands a Proactive Therapeutic Approach

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Why the Prevention of COPD Exacerbations Demands a Proactive Therapeutic Approach

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Did you know that just one moderate exacerbation increased the risk of a future hospitalization for a severe
COPD exacerbation?1* 

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  • Overview

    We know the burden that chronic obstructive pulmonary disease (COPD) has on our patients, but have you considered that just one moderate exacerbation increased the risk of a future hospitalization for a severe COPD exacerbation.This elevates the importance of why we need to be proactive in our treatment choices. Here to walk us through that data and treatment options for patients with COPD is Dr Antonio Anzueto.

    *Data from a UK population-based study of ~100,000 patients with COPD (up to 10 years of follow-up). Severe exacerbations were defined as those requiring hospitalization and moderate exacerbations were defined as those managed outside the hospital. 


    1. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471.

  • Important Safety Information


        • BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients
        • BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD 
        • BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition
        • BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist
        • BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
        • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation
        • Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap
        • Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients 
        • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI 
        • Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy
        • Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur
        • If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy
        • Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy
        • Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles
        • Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content
        • Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur 
        • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur
        • Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines
        • Be alert to hypokalemia or hyperglycemia
        • Most common adverse reactions in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%)
        • BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system
        • BREZTRI should be administered with caution to patients being treated with:
            o Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects)
            o Adrenergic drugs (may potentiate effects of formoterol fumarate)
            o Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes)
            o Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm)
            o Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI 
        • Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored
  • Indication

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

  • Limitations of Use

    Not indicated for the relief of acute bronchospasm or for the treatment of asthma.

    Please see full Prescribing Information, including Patient Information.

    BREZTRI AEROSPHERE is a trademark of the AstraZeneca group of companies.

    ©2020 AstraZeneca. All rights reserved. US-40138 Last Updated 10/20 

Programs 9/21/21