Table 2

Efficacy and safety results from included trials

Katz, 199925De Deyn, 199924Chan, 200123Brodaty, 200322Street, 200026
Risperidone (1 mg/day) (n=148)Placebo (n=163)Risperidone (n=115)Placebo (n=114)Risperidone (n=29)Haloperidol (n=29)Risperidone (n=167)Placebo (n=170)Olanzapine (5 mg/day) (n=55)Placebo (n=45)
Efficacy
Clinical end point≥50% reduction in BEHAVE-AD total score*≥30% reduction in BEHAVE-AD total score*Not specifiedCMAI total aggression score*≥50% reduction in NPI-NH core total score*
No (%) who achieved end point67 (45)53 (3362 (54)54 (47)36 (66)16 (36)
Change in total scores*:
BEHAVE-AD−6.5−4.2−8.6−6.2−6.8−2.3
CMAIRaw data not provided−8.3−4.9−8.1−10.0−7.5−3.1
NPI-NH−7.6−3.7
No (%) with effect
Extrapyramidal symptoms19 (13)12 (7)17 (15)13 (11)Raw data not provided39 (23)27 (16§)Raw data not provided
Any adverse event121 (82)138 (85)88 (77)83 (73)NR157 (94)157 (92)NR
Serious adverse events24 (16)21 (13)NRNR28 (17)15 (9§)NR
Withdrawals45 (30)44 (27§)47 (41)40 (35§)2 (7)1 (3§)45 (27)56 (33)11 (20)11 (24)
  • BEHAVE-AD=behavioural pathology in Alzheimer's disease rating scale; CMAI=Cohen-Mansfield agitation inventory; NPI-NH=neuropsychiatric inventory-nursing home version; NR=not reported.

  • * From baseline to end point.

  • † Significant improvement with risperidone or olanzapine v control (haloperidol or placebo) (P<0.05 considered to be significant).

  • ‡ No significant difference.

  • § Significance not reported.