- 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 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.
- 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.