Table 7.
IRs (per 100 patient-years) and RRs for potential anticholinergic AEs
| Placebo n=11,626
|
Tiotropium n=12,929
|
RR (95% CI) | |||
|---|---|---|---|---|---|
| n (%) | IR | n (%) | IR | ||
| Eye disordersa | 418 (3.6) | 3.05 | 471 (3.6) | 3.09 | 1.01 (0.88, 1.15) |
| Glaucomab | 38 (0.3) | 0.27 | 41 (0.3) | 0.26 | 0.97 (0.62, 1.52) |
| Vision blurredc | 67 (0.6) | 0.47 | 62 (0.5) | 0.39 | 0.80 (0.57, 1.14) |
| Gastrointestinal disordersa | 1,569 (13.5) | 12.65 | 2,082 (16.1) | 15.58 | 1.20 (1.13, 1.29)d |
| Abdominal painc | 206 (1.8) | 1.47 | 246 (1.9) | 1.57 | 1.04 (0.86, 1.25) |
| Constipationc | 185 (1.6) | 1.32 | 264 (2.0) | 1.69 | 1.28 (1.06, 1.54)d |
| Dry mouthc | 196 (1.7) | 1.40 | 519 (4.0) | 3.39 | 2.35 (1.99, 2.77)d |
| Dyspepsiac | 376 (3.2) | 2.73 | 515 (4.0) | 3.38 | 1.21 (1.06, 1.38)d |
| Dysphagiac | 24 (0.2) | 0.17 | 33 (0.3) | 0.21 | 1.21 (0.71, 2.08) |
| Gastroesophageal reflux diseasec | 261 (2.2) | 1.87 | 374 (2.9) | 2.42 | 1.25 (1.06, 1.46)d |
| Gastrointestinal obstructione | 33 (0.3) | 0.23 | 64 (0.5) | 0.40 | 1.76 (1.16, 2.69)d |
| Stomatitisc | 36 (0.3) | 0.25 | 49 (0.4) | 0.31 | 1.12 (0.73, 1.73) |
| Metabolism and nutrition disordersa | 639 (5.5) | 4.76 | 663 (5.1) | 4.41 | 0.92 (0.83, 1.03) |
| Dehydrationc | 32 (0.3) | 0.22 | 40 (0.3) | 0.25 | 1.14 (0.71, 1.82) |
| Hyperglycemia/new-onset diabetes mellitusf | 212 (1.8) | 1.52 | 225 (1.7) | 1.44 | 0.94 (0.78, 1.13) |
| Nervous system disordersa | 1,051 (9.0) | 8.02 | 1,233 (9.5) | 8.51 | 1.02 (0.94, 1.11) |
| Dizzinessc | 280 (2.4) | 2.01 | 333 (2.6) | 2.15 | 1.03 (0.88, 1.21) |
| Headachec | 398 (3.4) | 2.88 | 475 (3.7) | 3.09 | 1.00 (0.88, 1.14) |
| Sleep disturbancec | 204 (1.8) | 1.46 | 242 (1.9) | 1.55 | 1.05 (0.87, 1.26) |
| Syncopec | 72 (0.6) | 0.51 | 85 (0.7) | 0.54 | 1.06 (0.77, 1.45) |
| Psychiatric disordersa | 533 (4.6) | 3.90 | 615 (4.8) | 4.06 | 1.01 (0.90, 1.14) |
| Anxiety symptoms/fearsc | 194 (1.7) | 1.38 | 203 (1.6) | 1.29 | 0.89 (0.73, 1.09) |
| Cognitive impairmentc | 2 (0.0) | 0.01 | 1 (0.0) | 0.01 | 0.46 (0.04, 5.09) |
| Confusionc | 22 (0.2) | 0.15 | 18 (0.1) | 0.11 | 0.70 (0.37, 1.31) |
| Insomniac | 184 (1.6) | 1.31 | 227 (1.8) | 1.45 | 1.10 (0.90, 1.34) |
| Restlessnessc | 13 (0.1) | 0.09 | 12 (0.1) | 0.08 | 0.65 (0.29, 1.46) |
| Depression and self-injuryg | 173 (1.5) | 1.23 | 209 (1.6) | 1.33 | 1.08 (0.88, 1.32) |
| Renal and urinary disordersa | 341 (2.9) | 2.46 | 396 (3.1) | 2.56 | 1.04 (0.90, 1.20) |
| Dysuriac | 23 (0.2) | 0.16 | 52 (0.4) | 0.33 | 2.07 (1.26, 3.39)d |
| Renal failurec | 68 (0.6) | 0.48 | 73 (0.6) | 0.46 | 0.97 (0.70, 1.36) |
| Urinary retentionc | 36 (0.3) | 0.25 | 62 (0.5) | 0.39 | 1.56 (1.03, 2.36)d |
| Urinary tract infectionc | 287 (2.5) | 2.06 | 350 (2.7) | 2.26 | 1.08 (0.92, 1.26) |
Notes:
a
Primary SOC.
b
SMQ glaucoma (narrow).
c
PV endpoint (see Table S1 for details).
d
Significantly different from 1.
e
SMQ gastrointestinal perforation, ulceration, hemorrhage, or obstruction.
f
SMQ hyperglycemia/new-onset diabetes mellitus (narrow).
g
SMQ depression and self-injury (excluding suicide and self-injury) (narrow).
Abbreviations: AE, adverse event; CI, confidence interval; IR, incidence rate; PV, pharmacovigilance; RR, rate ratio; SMQ, standardized Medical Dictionary for Regulatory Activities queries; SOC, system organ class.