Table 4

Risk of NPAEs associated with the use of montelukast in the previous 14 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)‡
Total17,080/161 386(10.58)63,578/645 544(9.985)1.13(1.10 to 1.15)1.28(1.25 to 1.31)
Age group (years)0.1821
0–21173/5332(22.00)4586/21 328(21.50)1.04(0.96 to 1.13)1.16(1.07 to 1.27)
3–53433/21 312(16.11)13 165/85 248(15.44)1.08(1.03 to 1.14)1.23(1.17 to 1.30)
6–96293/49 079(12.82)23 526/196 316(11.98)1.12(1.08 to 1.16)1.29(1.24 to 1.34)
10–121896/21 026(9.02)7103/84 104(8.45)1.11(1.04 to 1.19)1.37(1.28 to 1.47)
13–194285/64 637(6.63)15 198/258 548(5.88)1.19(1.15 to 1.24)1.43(1.37 to 1.50)
Gender0.8972
Male10 965/94 049(11.66)41 073/376 196(10.92)1.12(1.09 to 1.15)1.32(1.28 to 1.36)
Female6115/67 337(9.08)22 205/269 348(8.36)1.14(1.10 to 1.18)1.36(1.31 to 1.41)
Season<0.0001
Spring3989/35 912(11.11)13 309/143 648(9.27)1.35(1.29 to 1.42)1.53(1.46 to 1.60)
Summer3231/43 872(7.36)15 729/175 488(8.96)0.73(0.69 to 0.76)0.89(0.85 to 0.93)
Autumn5679/47 157(12.04)16 089/188 628(8.53)1.80(1.69 to 1.83)2.08(1.99 to 2.16)
Winter4181/34 445(12.14)18 451/137 780(13.39)0.85(0.81 to 0.88)1.02(0.97 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 medication.

  • NPAEs, neuropsychiatric adverse events.