What are the FEV1 (Forced Expiratory Volume in 1 second) criteria?

From the Guidelines

Patients should have an FEV1 less than 80% of predicted value after bronchodilator use to be considered for Ohtuvayre prescription, with a focus on those with moderate to severe COPD, as indicated by an FEV1 between 30% and 80% of predicted value 1.

Key Considerations for Ohtuvayre Prescription

• The diagnosis of COPD should be confirmed through spirometry, demonstrating airflow obstruction after bronchodilation with a threshold of forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <0.7 1.
• The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends using pre-BD spirometry to rule out COPD and post-BD measurements to confirm the diagnosis, reducing clinical workload while ensuring accurate diagnosis 1.
• Post-BD results close to the threshold should be repeated to ensure a correct diagnosis is made, and post-BD measurements are crucial for identifying volume responders who might be overlooked with pre-BD spirometry alone 1.

Mechanism of Action and Treatment Response

• Ohtuvayre, a combination of indacaterol and glycopyrronium, works by targeting different mechanisms to improve lung function in COPD patients, with indacaterol acting as a long-acting beta-2 agonist and glycopyrronium as a long-acting muscarinic antagonist 1.
• Regular follow-up spirometry is essential to assess treatment response and disease progression, allowing for adjustments in therapy as needed to optimize patient outcomes 1.

Patient Selection and Monitoring

• Patients with asthma or those requiring acute bronchospasm relief are not indicated for Ohtuvayre, highlighting the need for precise diagnosis and patient selection based on spirometric criteria and clinical presentation 1.
• The medication's effectiveness and safety profile support its use in patients with moderate to severe COPD, provided that spirometric criteria are met and regular monitoring is performed to adjust treatment as necessary 1.

From the Research

Ohtuvayre FEV1 Criteria

The FEV1 criteria are used to assess lung function, particularly in relation to asthma and chronic obstructive pulmonary disease (COPD).

• FEV1 is defined as the forced expiratory volume in one second, which is the amount of air a person can exhale in one second 2.
• According to the guidelines for the prevention and management of bronchial asthma, a bronchial provocation test should be considered when FEV1 is ≥70% predicted, excluding respiratory infections within the past 4 weeks 2.
• The guidelines also recommend that diagnostic anti-inflammatory therapy may be initiated to confirm the diagnosis if FEV1 variability is ≥12% and absolute change is ≥200 ml between two prior tests, excluding respiratory tract infections within the past 4 weeks 2.
• In patients with asthma, FEV1 can be used to assess the severity of airflow limitation and to monitor the response to treatment 2.
• A study published in the American Journal of Respiratory and Critical Care Medicine found that FEV1/FVC ratio is a more robust measure of airflow obstruction than FEV1% predicted, and proposed a new severity classification scheme for COPD using FEV1/FVC ratio 3.
• Another study published in the International Journal of Chronic Obstructive Pulmonary Disease found that FEV1 is a stronger predictor of mortality than FVC in patients with moderate COPD and increased risk for cardiovascular disease 4.

FEV1 Criteria in Asthma Management

• The guidelines for the prevention and management of bronchial asthma recommend the use of FEV1 to assess lung function and to monitor the response to treatment 2.
• FEV1 can be used to diagnose asthma, particularly in patients with symptoms suggestive of asthma but without a clear diagnosis 2.
• The guidelines also recommend the use of FEV1 to assess the severity of airflow limitation and to monitor the response to treatment in patients with asthma 2.
• A study published in the Journal of Clinical Medicine Research found that tiotropium bromide, a long-acting antimuscarinic bronchodilator, can be used to treat difficult-to-control asthma and may have a beneficial role in the treatment of asthma-COPD overlap syndrome (ACOS) 5.

FEV1 Criteria in COPD Management

• The guidelines for the management of COPD recommend the use of FEV1 to assess lung function and to monitor the response to treatment 6.
• FEV1 can be used to diagnose COPD and to assess the severity of airflow limitation 6.
• The guidelines also recommend the use of FEV1 to monitor the response to treatment in patients with COPD 6.
• A study published in the American Journal of Respiratory and Critical Care Medicine found that FEV1/FVC ratio is a more robust measure of airflow obstruction than FEV1% predicted, and proposed a new severity classification scheme for COPD using FEV1/FVC ratio 3.