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. 2024 Sep 9;8(1):e002483. doi: 10.1136/bmjpo-2023-002483

Table 7. Risk of NPAEs associated with the use of pranlukast in the previous 7 days, stratified analysis according to age group, gender and season.

Variables Exposed in hazard period Exposed in control period Crude Adjusted P value for interaction*
N/N (%) N/N (%) OR (95% CI) OR (95% CI)
 Total 3 568/64 800 (5.51) 13 633/259 200 (0.05) 1.07 (1.02 to 1.12) 1.26 (1.21 to 1.32)
Age group (years) 0.5798
 0–2 422/3285 (12.85) 1655/13 140 (12.60) 1.03 (0.90 to 1.17) 1.18 (1.03 to 1.34)
 3–5 940/12 976 (7.24) 3644/51 904 (7.02) 1.05 (0.96 to 1.14) 1.21 (1.11 to 1.33)
 6–9 1076/22 671 (4.75) 4253/90 684 (4.69) 1.02 (0.94 to 1.10) 1.17 (1.08 to 1.28)
 10–12 226/5948 (3.80) 889/23 792 (3.74) 1.02 (0.86 to 1.22) 1.25 (1.05 to 1.50)
 13–19 904/19 920 (4.54) 3192/79 680 (4.01) 1.19 (1.09 to 1.30) 1.44 (1.32 to 1.58)
Gender 0.9691
 Male 2294/39 257 (5.84) 8782/157 028 (5.59) 1.07 (1.01 to 1.13) 1.25 (1.18 to 1.32)
 Female 1274/25 543 (4.99) 4851/102 172 (4.75) 1.07 (1.00 to 1.15) 1.28 (1.19 to 1.38)
Season <0.0001
 Spring 903/14 256 (6.33) 3038/57 024 (5.33) 1.29 (1.18 to 1.42) 1.47 (1.34 to 1.61)
 Summer 733/17 573 (4.17) 3233/70 292 (4.60) 0.87 (0.79 to 0.96) 1.08 (0.98 to 1.19)
 Autumn 1206/19 111 (6.31) 3996/76 444 (5.23) 1.31 (1.21 to 1.42) 1.53 (1.41 to 1.65)
 Winter 726/13 860 (5.24) 3366/55 440 (6.07) 0.81 (0.74 to 0.89) 0.96 (0.88 to 1.06)
*

Joint test for exposure and strata variable interaction, indicating whether montelukast affects NPAEDs differently depending on age group, gender, and season.

Calculated by conditional logistic regression.

Calculated by conditional logistic regression adjusted for concomitant medications.

NPAEsneuropsychiatric adverse events