Trial | Formoterol | No Formoterol | ||||||||
Patientsn | Follow-up TPY | Deathsn | Death rate per TTY | Patients with SAEs# n (%) | Patientsn | Follow-up TPY | Deathsn | Death rate per TTY | Patients with SAEs# n (%) | |
No LABA comparator groups | ||||||||||
Asthma-related events | 28409 | 12.7 | 2 | 0.16 | 189 (0.67) | |||||
Cardiac-related events | 28409 | 12.7 | 1 | 0.08 | 61 (0.21) | |||||
Other deaths | 28409 | 12.7 | 9 | 0.71 | ||||||
Total deaths | 28409 | 12.7 | 12 | 0.94 | ||||||
RELIEF: overall results | ||||||||||
Asthma-related events | 8924 | 4.3 | 3 | 0.70 | 106 (1.19) | 8938 | 4.3 | 2 | 0.47 | 120 (1.34) |
Cardiac-related events | 8924 | 4.3 | 6 | 1.40 | 20 (0.22) | 8938 | 4.3 | 7 | 1.63 | 30 (0.38) |
Other deaths | 8924 | 4.3 | 4 | 0.93 | 8938 | 4.3 | 2 | 0.47 | ||
Total deaths | 8924 | 4.3 | 13 | 3.02 | 8938 | 4.3 | 11 | 2.56 | ||
RELIEF: BL ICS use | ||||||||||
Asthma-related events | 5821 | 2.8 | 2 | 0.72 | 81 (1.39) | 5803 | 2.8 | 1 | 0.36 | 90 (1.55) |
Cardiac-related events | 5821 | 2.8 | 5 | 1.80 | 13 (0.22) | 5803 | 2.8 | 4 | 1.43 | 23 (0.40) |
Other deaths | 5821 | 2.8 | 3 | 1.08 | 5803 | 2.8 | 1 | 0.36 | ||
Total deaths | 5821 | 2.8 | 10 | 3.60 | 5803 | 2.8 | 6 | 2.15 | ||
RELIEF: no BL ICS use | ||||||||||
Asthma-related events | 3103 | 1.5 | 1 | 0.67 | 25 (0.81) | 3135 | 1.5 | 1 | 0.67 | 30 (0.96) |
Cardiac-related events | 3103 | 1.5 | 1 | 0.67 | 7 (0.23) | 3135 | 1.5 | 3 | 1.99 | 7 (0.22) |
Other deaths | 3103 | 1.5 | 1 | 0.67 | 3135 | 1.5 | 1 | 0.67 | ||
Total deaths | 3103 | 1.5 | 3 | 2.03 | 3135 | 1.5 | 5 | 3.32 |
TPY: 1,000 person-yrs; TTY: 1,000 treatment-yrs; SAEs: serious adverse events; LABA: long-acting β2-agonist; RELIEF: Real life effectiveness of Oxis Turbuhaler as needed in asthmatic patients during 6-month trial; BL: baseline; ICS: inhaled corticosteroid. #: at least one nonfatal SAE per patient (defined using International Conference on Harmonisation recommendations).