Table 2.

Incidence of neuropsychiatric adverse events (NPAEs) and association with varenicline compared with NRT in general population with and without psychiatric disorders within follow-up of 24 weeks

NPAEs	Psychiatric cohort Varenicline (n=1427) versus NRT (n=1200)			Non-psychiatric cohort Varenicline (n=4480) versus NRT (n=1970)
	Events (n, %)*	Crude OR (95% CI)	Adjusted OR† (95% CI)	Events (n, %)*	Crude OR (95% CI)	Adjusted OR‡ (95% CI)
Overall	1074 (75.3): 942 (78.5)	0.83(0.69 to 1.00)	0.82(0.68 to 0.99)	469 (10.5): 248 (12.6)	0.81(0.69 to 0.96)	0.85(0.72 to 1.00)
Depression	629 (44.1): 548 (45.7)	0.94(0.80 to 1.09)	0.90(0.77 to 1.05)	148 (3.3): 57 (2.9)	1.15(0.84 to 1.56)	1.15(0.84 to 1.57)
Anxiety	456 (32.0): 472 (39.3)	0.72(0.62 to 0.85)	0.71(0.61 to 0.84)	215 (4.8): 110 (5.6)	0.85(0.67 to 1.08)	0.90(0.71 to 1.15)
Insomnia	372 (26.1): 352 (29.3)	0.85(0.72 to 1.01)	0.89(0.75 to 1.06)	147 (3.3): 105 (5.3)	0.60(0.47 to 0.78)	0.63(0.49 to 0.82)

*Varenicline: NRT.

†Adjusted for age, gender, socioeconomic status, heart failure, ischaemic heart disease and cancer.

‡Adjusted for age, socioeconomic status, heart failure, ischaemic heart disease, hypertension, diabetes, osteoporosis, peptic ulcer and GORD, rheumatic arthritis, anaemia, glaucoma and gout.

GORD, gastro-oesophageal reflux disease; NPAEs, neuropsychiatric adverse events, defined by new or naive prescription of related medications for depression, anxiety, or insomnia within 24 weeks after index date; NRT, nicotine replacement therapy.