麻豆传媒

Treatment with once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) triple therapy appears to be more efficacious in reducing severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) than the standard twice-daily inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination of budesonide plus formoterol (Symbicort). This was among the presented at , the American College of Chest Physicians annual meeting.

In this exclusive 麻豆传媒 video, study author Reynold Panettieri Jr., MD, vice chancellor for Translational Medicine and science director of Rutgers Institute for Translational Medicine in New Brunswick, New Jersey, discusses the findings and clinical implications of the analysis.

Following is a transcript of his remarks:

This post-hoc analysis really examined the severe exacerbations in the study. And the FULFIL study was a very large study of about 900 patients total where they looked at hospitalizations or emergency room visits with patients who are on triple therapy that would have been vilanterol, fluticasone, and umeclidinium versus budesonide/formoterol. And the studies were really quite interesting.

What was shown is that triple therapy was better than double therapy with regard to preventing severe hospitalizations and exacerbations. And also that the FEV1, an objective measure of airflow, was better with triple therapy versus double therapy.

So, what's the importance of this study? Well, the common therapies -- budesonide/formoterol -- are used in COPD. They are in the eyes. The other triple therapy is a dry powder inhaler that is used once a day. And if you did a head to head in this study, you can see that the addition of an anticholinergic to an inhaled corticosteroid and a long-acting beta agonist was better than using a long-acting beta agonist and an ICS inhaled steroid by itself.

So I think there is some takeaway to consider triple therapy in preventing severe exacerbations, especially in those patients with COPD that are prone to exacerbation.

So you might say, well, who are they? Well, those are the individuals who've had exacerbations before. So if you have had an exacerbation, you're more likely to get another exacerbation.

So it stands to reason using triple therapy in that group as shown by the FULFIL ad-hoc study, we could diminish further exacerbations.

Even though this triple therapy decreased exacerbations, this kind of head-to-head comparison was never done as fully as it was for registration purposes. They had two duplicate studies to be registered for the FDA versus the control therapy. This study, a post-hoc analysis, really did a dive down into the severe exacerbation.

The previous FDA registration was for exacerbations in general. Most exacerbations, gratefully so, don't end up in hospitalizations. They require oral steroids and antibiotics, and that's what the registration studies showed. This was a deep dive into the severe exacerbations.

And remember an exacerbation leading to a hospitalization in COPD is really quite detrimental. Matter of fact, there's a significant mortality after you've had a hospitalization for COPD in the outlying years. So mortality goes up, and it's really a harbinger of a severe case of COPD. So we want to really decrease those subsequent exacerbations.

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