Table 3.
Sensitivity analyses of the association between desloratadine (DL) exposure and first seizure
| DL exposure | Number (N) | Follow-up time (PY) | Unadjusted | Adjusted | ||||
|---|---|---|---|---|---|---|---|---|
| IR per 100,000 PY | IRR | 95% CI | IR per 100,000 PY | IRR | 95% CI | |||
| Non-febrile seizures in children aged 0–5 yearsa | ||||||||
| Yes | 110 | 110,315 | 99.7 | 1.59 | (1.28–1.97) | 117.8 | 1.46 | (1.17–1.83) |
| No | 315 | 501,771 | 62.8 | 1 | Ref. | 80.7 | 1 | Ref. |
| Febrile seizures in children aged 0–5 yearsa | ||||||||
| Yes | 307 | 109,820 | 279.5 | 1.99 | (1.74–2.28) | 319.9 | 2.19 | (1.90–2.51) |
| No | 700 | 499,182 | 140.2 | 1 | Ref. | 145.5 | 1 | Ref. |
| Restricting study period to years before OTCb | ||||||||
| Yes | 503 | 732,684 | 68.7 | 1.73 | (1.57–1.92) | 42.0 | 1.47 | (1.32–1.63) |
| No | 1539 | 3,886,038 | 39.6 | 1 | Ref. | 28.6 | 1 | Ref. |
| Restricting to individuals without other antihistamine prescription redemptions before inclusion | ||||||||
| Yes | 595 | 654,147 | 91.0 | 1.84 | (1.68–2.01) | 42.8 | 1.51 | (1.37–1.65) |
| No | 2180 | 4,404,922 | 49.5 | 1 | Ref. | 28.4 | 1 | Ref. |
| Alternative definition of DL exposure | ||||||||
| Following prescription redemption numberb | ||||||||
| 1 | 411 | 366,722 | 112.1 | 2.83 | (2.55–3.14) | 39.6 | 1.79 | (1.60–1.99) |
| 2 | 99 | 180,073 | 55.0 | 1.39 | (1.14–1.70) | 27.9 | 1.26 | (1.03–1.54) |
| ≥ 3 | 235 | 619,327 | 37.9 | 0.96 | (0.84–1.10) | 26.2 | 1.18 | (1.03–1.35) |
| No | 2627 | 6,634,828 | 39.6 | 1 | Ref. | 22.2 | 1 | Ref. |
| Weeks after prescription redemptionb | ||||||||
| 0–4 | 298 | 399,940 | 74.5 | 1.88 | (1.67–2.12) | 31.2 | 1.57 | (1.39–1.77) |
| 5–8 | 224 | 353,666 | 63.3 | 1.60 | (1.40–1.83) | 26.9 | 1.35 | (1.17–1.55) |
| 9–16 | 448 | 595,249 | 75.3 | 1.90 | (1.72–2.10) | 31.2 | 1.57 | (1.41–1.74) |
| 17–26 | 402 | 597,738 | 67.3 | 1.70 | (1.53–1.89) | 25.6 | 1.28 | (1.15–1.43) |
| ≥ 27 | 2627 | 6,634,828 | 39.6 | 1 | Ref | 19.9 | 1 | Ref |
Values are expressed as numbers (N), follow-up time in PY, IR per 100,000 person-years, and IRR with corresponding 95% CI for the unadjusted and adjusted analyses
CI confidence interval, IR incidence rate, IRR incidence rate ratio, OTC over-the-counter, PY person-years
aAdjusted for sex, country, calendar year (1-year categories), seasonality, asthma, and chronic urticaria. Data from Norway are not included as seizures could not be divided into type of seizure
bAdjusted for age (5-year age categories), sex, country, calendar year (1-year categories), seasonality, asthma, severe rhinitis, and chronic urticaria