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

VariablesExposed in hazard periodExposed in control periodCrudeAdjustedP value for interaction*
N/N(%)N/N(%)OR (95% CI)†OR (95% CI)‡
 Total3 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
 0–2422/3285(12.85)1655/13 140(12.60)1.03(0.90 to 1.17)1.18(1.03 to 1.34)
 3–5940/12 976(7.24)3644/51 904(7.02)1.05(0.96 to 1.14)1.21(1.11 to 1.33)
 6–91076/22 671(4.75)4253/90 684(4.69)1.02(0.94 to 1.10)1.17(1.08 to 1.28)
 10–12226/5948(3.80)889/23 792(3.74)1.02(0.86 to 1.22)1.25(1.05 to 1.50)
 13–19904/19 920(4.54)3192/79 680(4.01)1.19(1.09 to 1.30)1.44(1.32 to 1.58)
Gender0.9691
Male2294/39 257(5.84)8782/157 028(5.59)1.07(1.01 to 1.13)1.25(1.18 to 1.32)
 Female1274/25 543(4.99)4851/102 172(4.75)1.07(1.00 to 1.15)1.28(1.19 to 1.38)
Season<0.0001
 Spring903/14 256(6.33)3038/57 024(5.33)1.29(1.18 to 1.42)1.47(1.34 to 1.61)
 Summer733/17 573(4.17)3233/70 292(4.60)0.87(0.79 to 0.96)1.08(0.98 to 1.19)
 Autumn1206/19 111(6.31)3996/76 444(5.23)1.31(1.21 to 1.42)1.53(1.41 to 1.65)
 Winter726/13 860(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 NPAEs differently depending on age group, gender, and season.

  • †Calculated by conditional logistic regression.

  • ‡Calculated by conditional logistic regression adjusted for concomitant medications.

  • NPAEs, neuropsychiatric adverse events.