Inhaled Corticosteroids and LABAs — Removal of the FDA’s Boxed Warning

Seymour, Sally; Lim, Robert; Xia, Changming; Andraca‐Carrera, Eugenio; Chowdhury, Badrul A.

doi:10.1056/nejmp1716858

Cited by 22 publications

(8 citation statements)

References 4 publications

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“…Large clinical safety studies of budesonide-formoterol and other approved ICS-LABA combinations given as maintenance therapy, initiated by the US FDA [26], have dispelled any lingering safety concerns (or misperceptions) relating to serious asthma-related AEs with LABA treatment when taken with an ICS from the same device [27][28][29][30]. The FDA subsequently removed the boxed warning from all approved ICS-LABA combinations [31]. As-needed LABA use along with ICS did not reveal any additional concerns.…”

Section: Discussionmentioning

confidence: 99%

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies

et al. 2021

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Introduction Budesonide-formoterol taken as needed is an emerging treatment for mild asthma. Objective We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide. Methods SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. Patients were randomized to As-needed budesonide-formoterol 200/6 μg, twice-daily budesonide 200 μg as maintenance plus As-needed terbutaline 0.5 mg, and As-needed terbutaline 0.5 mg (SYGMA 1 only). Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations from corresponding treatment groups in both studies were pooled. SYGMA 1 data were used for comparisons with As-needed terbutaline alone. Results The pooled analysis included 3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively. Common AEs included viral upper respiratory tract infection (viral URTI) and URTI. SAE, DAE, and asthma-related discontinuation rates were similar with As-needed budesonide-formoterol and maintenance budesonide. Potential local and systemic corticosteroid class effects were reported in ≤ 1% of patients for each budesonide-containing regimen. In SYGMA 1, AEs were more common in the As-needed terbutaline ( n = 1277) than As-needed budesonide-formoterol ( n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%). Conclusions Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile similar to that of daily budesonide. No new safety signals were identified. ClinicalTrial.gov Identifiers NCT02149199 (SYGMA 1) and NCT02224157 (SYGMA 2). Supplementary Information The online version contains supplementary material available at 10.1007/s40264-020-01041-z.

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Section: Discussionmentioning

confidence: 99%

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies

et al. 2021

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“…The outcomes of several recent large clinical trials and systematic reviews demonstrated that the risk of serious asthma-related adverse events with ICS/LABA was comparable to that for ICS monotherapy, [34][35][36][37][38][39][40] and as a result in December 2017 the FDA removed the boxed warning about asthma-related death from the drug labels of medicines containing the combination. [40][41][42][43] The most recent Global Initiative for Asthma (GINA) document supports the first strategydmaintaining the patient on an ICS/LABA combination with a lower dose of ICSdwith the rationale that continuing the LABA provides better symptom control than ICS alone. 1,44 Based on the available data and their clinical experience, the authors favor tapering the dose of ICS/LABA either by using a lower-dose ICS in combination or switching to once-daily dosing of the combination product.…”

Section: Patients Using Low-dose Ics/labamentioning

confidence: 99%

The Asthma Controller Step-down Yardstick

Chipps

Bacharier

Murphy

et al. 2019

Annals of Allergy, Asthma & Immunology

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Asthma guidelines recommend a control-based approach to disease management in which the assessment of impairment and risk is linked to step-based therapy. Using this model, controller treatment is adjusteddupward or downwarddaccording to a patient's level of asthma control over time. Strategies for stepping up controller therapy are well described, and the adult and pediatric Asthma Yardsticks provide operational recommendations based on patient profiles. Strategies for stepping down controller treatment are less clear, although stepping down to the minimum effective therapy is important and should be considered when a patient's asthma has been well controlled for an adequate period as defined by risk and impairment. This Yardstick presents recommendations for when and how to step down asthma controller therapy according to guideline-defined control levels. The objective is to provide clinicians who treat patients with asthma with a practical and clinically relevant framework for implementing a step-down in controller therapy.

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“…LABAs have the same mechanism of action as SABAs, but they have a longer half‐life, with sustained activity for at least 12 hours . LABAs historically have been avoided when possible because of a reported increased risk of asthma‐related death associated with their use; however, these initial studies were performed with individuals who may not have also been using an inhaled corticosteroid . More recent studies have not found an increased risk of asthma‐related death when LABAs are used in combination with inhaled corticosteroids, and in December 2017, the FDA removed the asthma‐related black box warning from the combination medications …”

Section: Stepwise Approach For Managing Asthmamentioning

confidence: 99%

Diagnosis and Treatment of Asthma in Nonpregnant Women

Esden¹,

Pesta-Walsh²

2018

J Midwife Womens Health

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Asthma is a common condition affecting 8.3% of the adult population in the United States. The disease is characterized by chronic airway inflammation that leads to airway hyperresponsiveness and obstruction that results in coughing, wheezing, shortness of breath, and a feeling of chest tightness. The diagnosis and classification of asthma is based on reported symptoms, physical examination findings, and spirometry. Pharmacologic therapy is prescribed using a stepwise approach that begins with inhaled short-acting beta 2 -agonists for intermittent asthma with the addition of daily inhaled corticosteroids for more persistent cases. Individuals with asthma are reevaluated on a regular basis to monitor symptoms, and pharmacologic treatments are adjusted as needed. Familiarity with the stepwise approach for asthma management and confidence in the efficacy and safety profiles of inhaled medications will assist clinicians in successful management of asthma in the primary care setting. a low-dose inhaled corticosteroid in addition to a shortacting beta 2 -agonist to use as needed for acute symptoms. The clinician demonstrated inhaler usage, provided teaching on avoiding asthma triggers, and developed a written asthma action plan with C.E. A follow-up appointment was scheduled for 4 weeks.Note: This case summary is a composite of elements from different individuals. PATHOPHYSIOLOGYThe pathophysiology of asthma is complex in nature. The primary feature is airway inflammation caused by 18 1526-9523/09/$36.00

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Inhaled Corticosteroids and LABAs — Removal of the FDA’s Boxed Warning

Cited by 22 publications

References 4 publications

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies

The Asthma Controller Step-down Yardstick

Diagnosis and Treatment of Asthma in Nonpregnant Women

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