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#
| Formoterol | No Formoterol | RR (95%CI)+ | |||||||||
| Patientsn | Follow-up TPY | Deaths/ SAEs¶ n | Death rate per TTY | SAEs% | Patientsn | Follow-up TPY | Deaths/ SAEs¶ n | Death rate per TTY | SAEs% | ||
| Asthma-related death | |||||||||||
| Maintenance ICS | 11773 | 6.2 | 3 | 0.48 | 8102 | 4.4 | 0 | 0 | ∞ (0.29–∞) | ||
| No ICS | 800 | 0.4 | 0 | 0 | 1058 | 0.6 | 0 | 0 | |||
| Cardiac-related death | |||||||||||
| Maintenance ICS | 11773 | 6.2 | 1 | 0.16 | 8102 | 4.4 | 2 | 0.45 | 0.34 (0.058–6.61) | ||
| No ICS | 800 | 0.4 | 0 | 0 | 1058 | 0.6 | 0 | 0 | |||
| Asthma-related SAEs | |||||||||||
| Maintenance ICS | 11773 | 6.2 | 76 | 0.65 | 8102 | 4.4 | 76 | 0.94 | 0.69 (0.49–0.96) | ||
| No ICS | 800 | 0.4 | 3 | 0.38 | 1058 | 0.6 | 3 | 0.28 | 1.32 (0.18–9.9) | ||
| Cardiac-related SAEs | |||||||||||
| Maintenance ICS | 11773 | 6.2 | 21 | 0.18 | 8102 | 4.4 | 15 | 0.19 | 0.96 (0.47–2.01) | ||
| No ICS | 800 | 0.4 | 1 | 0.13 | 1058 | 0.6 | 0 | 0 | NC | ||
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.