Table 3—

Rates and rate ratios(RRs) of cause-specific deaths and serious adverse events (SAEs) across randomised controlled trials comparing formoterol with non-long-acting β2-agonist (non-LABA) stratified by known maintenance inhaled corticosteroid (ICS) use#

FormoterolNo FormoterolRR (95%CI)+
PatientsnFollow-up TPYDeaths/ SAEs nDeath rate per TTYSAEs%PatientsnFollow-up TPYDeaths/ SAEs nDeath rate per TTYSAEs%
Asthma-related death
 Maintenance ICS117736.230.4881024.400∞ (0.29–∞)
 No ICS8000.40010580.600
Cardiac-related death
 Maintenance ICS117736.210.1681024.420.450.34 (0.058–6.61)
 No ICS8000.40010580.600
Asthma-related SAEs
 Maintenance ICS117736.2760.6581024.4760.940.69 (0.49–0.96)
 No ICS8000.430.3810580.630.281.32 (0.18–9.9)
Cardiac-related SAEs
 Maintenance ICS117736.2210.1881024.4150.190.96 (0.47–2.01)
 No ICS8000.410.1310580.600NC
  • CI: confidence interval; TPY: 1,000 person-yrs; TTY: 1,000 treatment-yrs; NC: not computable. #: all trials except Real life effectiveness of Oxis Turbuhaler as needed in asthmatic patients during 6 months trial (ICS treatment during the trial not recorded) and trials without a non-LABA comparator; : at least one nonfatal SAE per patient; +: as calculated using StatXact 8.0.0 (Cytel® Inc., Cambridge, MA, USA) 27.