Safety of fluticasone propionate/formoterol fumarate vs other FDC ICS/LABA therapies

  • Price DB & al.
  • Drugs
  • 20 Nov 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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  • In patients with asthma who received a prescription for a fixed-dose combination (FDC) inhaled corticosteroid/long-acting β2-agonist (ICS/LABA), fluticasone/formoterol (FP/FORM) was associated with a similar or lower incidence of adverse outcomes than the licensed comparators.

Why this matters

  • FP/FORM has been shown to have a comparable safety and tolerability profile to that of futicasone plus formoterol when administered separately and other FDC ICS/LABA therapies.

Study design

  • Study included 241,007 patients who were prescribed an FDC ICS/LABA using data from the UK Clinical Practice Research Datalink (CPRD).
  • 41,609 adults (aged ≥18 years) were diagnosed with asthma and were prescribed either FP/FORM or FDC ICS/LABA.
  • Primary outcome: incidence of new adverse outcomes after initiation of ICS/LABA.
  • Funding: Mundipharma Research Ltd.

Key results

  • The incidence rate of new adverse outcomes was significantly lower for FP/FORM (24.75 per 1000 person-years [TPY]) vs:
    • fluticasone/salmeterol metered-dose inhaler (28.86 per TPY; HR, 1.14; 95% CI, 1.04-1.25),
    • fluticasone/salmeterol dry powder inhaler (31.19 per TPY; HR, 1.18; 95% CI, 1.08-1.29),
    • budesonide/formoterol (25.16 per TPY; HR, 1.13; 95% CI, 1.03-1.25) and
    • beclometasone/formoterol (25.47 per TPY; HR, 1.14; 95% CI, 1.04-1.25).
  • FP/FORM (13.85 per TPY) had a lower prescribing rate compared with FDC ICS/LABA comparators (20.30-28.13 per TPY).
  • Of patients prescribed FP/FORM, 80.8% (aged ≥18 years) were with asthma, 9.2% were without asthma or COPD, 6.2% were with COPD and 3.8% (aged
  • Off-label prescribing rate for FP/FORM was low (7%) for patients (aged


  • Data on medications during hospitalisation, specialist care, provided by a hospital following patient discharge were not recorded in patients’ medical records.