What is the first line treatment for Gold E Chronic Obstructive Pulmonary Disease (COPD)?

From the Guidelines

The first-line treatment for COPD according to the GOLD guidelines is a long-acting muscarinic antagonist (LAMA) or a long-acting beta-agonist (LABA) for patients with low symptom burden, while those with higher symptom burden or frequent exacerbations may benefit from combination therapy with LAMA + LABA 1.

Patient Assessment

When determining the first-line treatment for COPD, it's crucial to assess the patient's symptom burden and exacerbation risk. The GOLD guidelines categorize patients into different groups based on these factors. For instance, patients in Group A, who have low symptom burden and low exacerbation risk, may be started on a bronchodilator and evaluated for response 1.

Treatment Options

The treatment options for COPD include:

• Long-acting muscarinic antagonists (LAMAs) such as tiotropium, umeclidinium, or glycopyrronium
• Long-acting beta-agonists (LABAs) such as formoterol, salmeterol, or indacaterol
• Combination therapy with LAMA + LABA for patients with higher symptom burden or frequent exacerbations
• Inhaled corticosteroids (ICS) may be considered for patients with features of asthma-COPD overlap or a history of frequent exacerbations despite appropriate bronchodilator therapy 1

Individualized Treatment

Treatment should always be individualized based on symptom severity, exacerbation history, comorbidities, and patient preference regarding inhaler devices. The goal of treatment is to alleviate symptoms, improve exercise tolerance, and reduce the risk of exacerbations. As stated in the GOLD guidelines, LAMA + LABA combination therapy is preferred over LABA/ICS combination due to increased efficacy and reduced risk of pneumonia associated with ICS 1.

From the FDA Drug Label

The efficacy of STIOLTO RESPIMAT is based primarily on two 4-week dose-ranging trials in 592 COPD patients and two confirmatory active-controlled 52-week trials (Trials 1 and 2) in 5,162 COPD patients. In both Trials 1 and 2, STIOLTO RESPIMAT demonstrated significant improvements in FEV1 AUC0-3hr and trough FEV1 after 24 weeks compared to tiotropium 5 mcg and olodaterol 5 mcg

First line treatment for Gold E COPD is not explicitly stated in the provided text, however, Tiotropium is mentioned as a treatment option.

• The provided text does discuss the efficacy of STIOLTO RESPIMAT (a combination of tiotropium and olodaterol) in treating COPD patients.
• Tiotropium is compared to olodaterol and the combination STIOLTO RESPIMAT in the clinical trials. 2

From the Research

First-Line Treatment for GOLD Group E COPD

The first-line treatment for GOLD group E COPD patients involves the use of inhalation therapies. According to the study 3, patients with COPD in GOLD group E should be further stratified to determine the appropriate initial inhalation therapy.

Inhalation Therapies for GOLD Group E COPD

The following inhalation therapies are used for GOLD group E COPD:

• Long-acting muscarinic antagonist (LAMA)
• Long-acting β2-agonist (LABA) + inhaled corticosteroid (ICS)
• LABA + LAMA
• LABA + LAMA + ICS

Comparison of Inhalation Therapies

The study 4 compared the benefits and harms of LAMA+LABA versus LABA+ICS for treatment of people with stable COPD. The results showed that:

• The odds of having an exacerbation were similar for LAMA+LABA compared with LABA+ICS
• The odds of having a serious adverse event were also similar
• Participants receiving LAMA+LABA had a similar improvement in quality of life, as measured by the SGRQ, to those receiving LABA+ICS
• LAMA+LABA showed a greater improvement in trough FEV1

Treatment Responses Among Different Inhalation Therapies

The study 3 evaluated the treatment responses among different inhalation therapies in GOLD group E patients stratified by the COPD assessment test (CAT) scores and forced expiratory volume in one-second percentage of predicted (FEV1%pred). The results showed that:

• Patients treated with LABA+LAMA or LABA+LAMA+ICS had a lower incidence of exacerbations and frequent exacerbations compared with the patients treated with LAMA or LABA+ICS in the FEV1%pred <50% and CAT≥10 groups

Triple Therapy for COPD

The study 5 presented the clinical evidence that led to the approval of triple therapies, which include an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). The results showed that:

• Triple therapy decreased the risk of exacerbations and improved lung function and health status, with a favorable benefit-to-harm ratio
• Triple therapy showed a promising signal in terms of improved survival

Initial Triple Therapy in COPD

The study 6 identified the optimal cut-off values for considering triple therapy as first-line treatment in patients with COPD. The results showed that:

• A baseline FEV1 of ≤42%, an initial CAT score ≥ 18, and AE ≥ 2 last year were considered the optimal cut-off values
• Triple therapy may be considered as first-line treatment in patients experiencing more than 2 times moderate to severe AEs of COPD in the previous year and who have blood eosinophil counts ≥100 cells/μL, reduced lung function (FEV1 ≤ 42%), and more symptoms (CAT score ≥ 18) 6.

Key points to consider when selecting a first-line treatment for GOLD group E COPD include:

• The patient's lung function, as measured by FEV1
• The patient's symptoms, as measured by the CAT score
• The patient's history of exacerbations
• The patient's blood eosinophil count
• The potential benefits and harms of each inhalation therapy, as reported in studies 4, 3, 5, 7, 6.