Table 5 AEs and SAEs
Drug | Duration | na | Number of patients with AE, n (%) | Number of patients with SAE, n (%) | ||
|---|---|---|---|---|---|---|
Active | Comparator | Active | Comparator | |||
LABAs added to ICS versus ICS | ||||||
Berger 2010 Budesonide/formoterol pMDI 320/9 μg BID | 26 weeks | 186 | 104 (84.6) | 54 (85.7) | 2 (1.6) | 1 (1.6) |
Eid 2010 Budesonide/formoterol 160/18 μg daily | 12 weeks | 184 | 120 (65.2) | 100 (59.2) | 2 (1.1) | 1 (0.6) |
Eid 2010 Budesonide/formoterol 160/9 μg daily | 12 weeks | 168 | 104 (61.9) | 100 (59.2) | 3 (1.8) | 1 (0.6) |
Langton Hewer 1995 Salmeterol 100 μg BID | 8 weeks | 24 | 10 (91) | 9 (75) | NR | NR |
Malone 2005 Salmeterol/fluticasone 50/100 μg BID | 3 months | 203 | 101 (59) | 102 (57) | NR | NR |
Morice 2008a Budesonide/formoterol 160/9 μg DPI BID | 12 weeks | 419 | 100 (47) | 81 (39) | 2 (0.9) | 0 |
Morice 2008b Budesonide/formoterol 160/9 μg MDI BID | 12 weeks | 410 | 92 (45) | 81 (39) | 3 (1.5) | 0 |
Murray 2011 Salmeterol/fluticasone 50/100 μg BID | 4 weeks | 231 | 20 (18) | 25 (21) | 0 | 0 |
Pearlman 2009 Salmeterol/fluticasone 50/100 μg BID | 4 weeks | 248 | 37 (30) | 35 (28) | 0 | 0 |
SD 0390718 Formoterol/budesonide 9/80 μg BID | 12 weeks | 273 | 90 (70.3) | 92 (63.4) | 0 | 0 |
Verberne 1998a Salmeterol/beclomethasone dipropionate 50/200 μg BID | 54 weeks | 117 | 59 (98) | 52 (93) | NR | NR |
Russell 1995 Salmeterol 50 μg BID | 12 weeks | 206 | 74 (75) | 81 (76) | 10 (10) | 13 (12) |
SD 0390714 Formoterol/budesonide 4.5/160 μg BID | 12 weeks | 270 | 66 (49) | 65 (49) | 1 (0.7) | 1 (0.7) |
SAM40012 Salmeterol/fluticasone propionate 50/100 μg BID | 6 months | 362 | 99 (55) | 111 (61) | 2 (1) | 1 (< 1) |
Pearlman 2017 | 12 weeks | |||||
Budesonide/formoterol 160/9 μg BID | 18 | 42 (46.7) | 40 (44.4) | 0 | 2 (2.2) | |
Budesonide/formoterol 160/4.5 μg BID | 183 | 41 (44.1) | 40 (44.4) | 0 | 2 (2.2) | |
Oliver 2016 | 4 weeks | |||||
Vilanterol 6.25 μg QD | 229 | 33 (29) | 25 (22) | NR | NR | |
Vilanterol 12.5 μg QD | 228 | 37 (33) | 25 (22) | |||
Vilanterol 25 μg QD | 229 | 32 (28) | 25 (22) | |||
Tiotropium added to ICS vs ICS | ||||||
Hamelmann 2016 | 48 weeks | |||||
Tiotropium 5 μg QD | 272 | 84 (62.7) | 82 (59.4) | 3 (2.2) | 2 (1.4) | |
Tiotropium 2.5 μg QD | 263 | 79 (63.2) | 82 (59.4) | 2 (1.6) | 2 (1.4) | |
Vogelberg 2018 | 48 weeks | |||||
Tiotropium 5 μg QD | 266 | 82 (60.7) | 89 (67.9) | 1 (0.7) | 6 (4.6) | |
Tiotropium 2.5 μg QD | 266 | 86 (63.7) | 89 (67.9) | 3 (2.2) | 6 (4.6) | |
Tiotropium added to ICS with other controllers vs ICS with other controllers | ||||||
Hamelmann 2017 | 12 weeks | |||||
Tiotropium 5 μg QD | 265 | 43 (33.1) | 48 (35.6) | 2 (1.5) | 0 | |
Tiotropium 2.5 μg QD | 262 | 42 (33.1) | 48 (35.6) | 1 (0.8) | 0 | |
Szefler 2017 | 12 weeks | |||||
Tiotropium 5 μg QD | 264 | 56 (43.1) | 66 (49.3) | 4 (3.1) | 2 (1.5) | |
Tiotropium 2.5 μg QD | 270 | 59 (43.4) | 66 (49.3) | 2 (1.5) | 2 (1.5) | |
LTRAs added to ICS vs ICS | ||||||
Simons 2001 Montelukast 5 mg | 4 weeks (crossover trial) | 279 | 277 (42) | 270 (45) | NR | NR |