Table 5.
AEs in patients receiving LAMA therapy, compared with placebo, in double-blind, randomized, placebo-controlled studies ≥6 months in duration
| Study | Treatments | Typical anticholinergic AEs (% patients)
|
||
|---|---|---|---|---|
| Dry mouth | Constipation | UTI | ||
| Tiotropium (via HandiHaler® device) | ||||
| Casaburi et al (2002)18 | Tiotropium 18 μg qd/placebo | 16/2.7 | NR | NR |
| Donohue et al (2002)19 | Tiotropium 18 μg qd/placebo | 10/NR | NR | NR |
| Niewoehner et al (2005)20 | Tiotropium 18 μg qd/placebo | NR | NR | NR |
| Chan et al (2007)21 | Tiotropium 18 μg qd/placebo | 3.5/3.6 | NR | NR |
| Tashkin et al (2008) (UPLIFT)22 | Tiotropium 18 μg qd/placebo | 1.7/0.9a | 1.6/1.3a | 2.1/2.0a |
| Troosters et al (2014)23 | Tiotropium 18 μg qd/placebo | 1.3/0.9 | NR | NR |
| Kerwin et al (2012) (GLOW2)27 | Tiotropium 18 μg qd OL/placebo | 1.5/1.9 | NR | 6.0/3.0 |
| Tiotropium (via Respimat® device) | ||||
| Bateman et al (2010)24 | Tiotropium 5 μg qd/placebo | 7.2/2.1 | NR | NR |
| Bateman et al (2010)25 | Tiotropium 5 μg qd/placebo | 3.1/1.4 | NR | NR |
| Glycopyrronium | ||||
| D’Urzo et al (2011) (GLOW1)26 | Glycopyrronium 50 μg qd/placebo | NR | NR | NR |
| Kerwin et al (2012) (GLOW2)27 | Glycopyrronium 50 μg qd/placebo | 3.0/1.9 | NR | 2.7/3.0 |
| Umeclidinium | ||||
| Donohue et al (2013)28 | Umeclidinium 62.5 μg qd/placebo | NR | NR | NR |
| Aclidinium | ||||
| Jones et al (2012) (ATTAIN)29 | Aclidinium 400 μg bid/placebo | NR | NR | 0.7/0.7 |
| Singh et al (2014) (ACLIFORM)30 | Aclidinium 400 μg bid/placebo | NR | NR | NR |
| D’Urzo et al (2014) (AUGMENT)31 | Aclidinium 400 μg bid/placebo | 0.6/0.3 | 2.1/1.8 | 3.3/3.0 |
Notes:
a
Incidence rate per 100 patient years.
Abbreviations: AEs, adverse events; bid, twice daily; LAMA, long-acting muscarinic antagonist; NR, not reported; OL, open label; qd, once daily; UTI, urinary tract infection.