Evaluation of fluticasone propionate/salmeterol for the treatment of COPD: a systematic review

ABSTRACT

Introduction

Recently, the generic formulation of FP/SAL FDC has been approved in COPD. Although FP/SAL FDC has been the first long-acting FDC approved in COPD, no systematic review assessed the effect of this combination for the treatment of COPD by considering specifically Phase IV studies. The aim of this review was to systematically assess the effect of FP/SAL FDC in COPD patients enrolled in Phase IV studies.

Areas covered

The question of this systematic review was to examine the evidence regarding the impact of FP/SAL FDC for the treatment of COPD by searching for Phase IV studies in the ClinicalTrials.gov database.

Expert opinion

Generic drugs represent an effective cost-saving step for health-care budgets in the treatment of COPD and should be used in agreement with current recommendations and prescription accuracy. FP/SAL FDC is recommended for the initiation therapy just in a small percentage of symptomatic patients that are at high risk of exacerbation with blood eosinophil counts ≥300 cells per μl. At follow-up, FP/SAL FDC can be escalated to triple ICS/LABA/LAMA combination or switched to LABA/LAMA combination by considering symptoms, exacerbations, lack of response to ICS, inappropriate original indication, and ICS-related adverse events such as pneumonia.

KEYWORDS:

• Fluticasone propionate
• salmeterol xinafoate
• COPD
• phase IV
• lung function
• exacerbation
• safety
• generic

Article Highlights

• Although less than 20% of COPD patients should be treated with an ICS/LABA FDC, most COPD patients are prescribed an ICS/LABA FDC representing more than 50% of the total costs of inhaled therapy.

• Recently, the generic formulation of fluticasone propionate/salmeterol FDC has been approved.

• Although generic drugs may permit to reduce the therapeutic cost in the treatment of COPD, their use should be encouraged in agreement with current recommendations and prescription accuracy.

• Switching from ICS/LABA FDC to LABA/LAMA FDC seems to be appropriate before escalating to triple therapy.

Declaration of Interest

L Calzetta has participated as an advisor in scientific meetings under the sponsorship of Boehringer Ingelheim and Novartis, received non-financial support from AstraZeneca, a research grant partially funded by Chiesi Farmaceutici, Boehringer Ingelheim, Novartis and Almirall, and is or has been a consultant to ABC Farmaceutici, Recipharm, Zambon, Verona Pharma and Ockham Biotech. His department was funded by Almirall, Boehringer Ingelheim, Chiesi Farmaceutici, Novartis and Zambon. MG Matera reports personal fees from Boehringer Ingelheim, grants and personal fees from Novartis, personal fees from AstraZeneca, personal fees from Chiesi Farmaceutici, personal fees from Almirall, personal fees from ABC Farmaceutici, personal fees from GlaxoSmithKline, outside the submitted work. M Cazzola has participated as a faculty member and advisor in scientific meetings and courses under the sponsorship of Almirall, AstraZeneca, Biofutura, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Menarini Group, Lallemand, Mundipharma, Novartis, Pfizer, Verona Pharma, and Zambon; is or has been a consultant to ABC Farmaceutici, AstraZeneca, Chiesi Farmaceutici, Edmond Pharma, Lallemand, Novartis, Ockham Biotech, Verona Pharma, and Zambon; and his department was funded by Almirall, Boehringer Ingelheim, Novartis, and Zambon. P Rogliani participated as a lecturer and advisor in scientific meetings and courses under the sponsorship of Almirall, AstraZeneca, Biofutura, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Menarini Group, Mundipharma, and Novartis. Her department was funded by Almirall, Boehringer Ingelheim, Chiesi Farmaceutici, Novartis, and Zambon. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.