Table 2.
Efficacy and safety results from included trials
|
Katz, 199925
|
De Deyn, 199924
|
Chan, 200123
|
Brodaty, 200322
|
Street, 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 specified
|
CMAI total aggression score*
|
≥50% reduction in NPI-NH core total score*
|
|||||
| No (%) who achieved end point | 67 (45) | 53 (33†) | 62 (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† | — | — |
| CMAI
|
Raw 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 symptoms
|
19 (13)
|
12 (7‡)
|
17 (15)
|
13 (11‡)
|
Raw data not provided†
|
39 (23)
|
27 (16§)
|
Raw data not provided‡
|
||
| Any adverse event
|
121 (82)
|
138 (85)
|
88 (77)
|
83 (73)
|
NR
|
157 (94)
|
157 (92)
|
NR
|
||
| Serious adverse events
|
24 (16)
|
21 (13‡)
|
NR
|
NR
|
28 (17)
|
15 (9§)
|
NR
|
|||
| Withdrawals | 45 (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.