Valproate preparations for agitation in dementia

Edmund Lonergan; Jay Luxenberg

doi:10.1002/14651858.CD003945.pub3

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Analysis 1.1

Comparison 1 Divalproex vs placebo, Outcome 1 Brief Psychiatric rating scale Total score. Change from baseline at 6 weeks (ITT).

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Analysis 1.2

Comparison 1 Divalproex vs placebo, Outcome 2 BPRS agitation factor. Change from baseline at 6 weeks (ITT).

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Analysis 1.3

Comparison 1 Divalproex vs placebo, Outcome 3 BPRS hostility factor. Change from baseline at 6 weeks (ITT).

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Analysis 1.4

Comparison 1 Divalproex vs placebo, Outcome 4 Overt aggression scale total score. Change from baseline at 6 weeks (ITT).

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Analysis 1.5

Comparison 1 Divalproex vs placebo, Outcome 5 Cohen‐Mansfield Agitation Index. Total Score. Change from baseline at 6 weeks (ITT).

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Analysis 2.1

Comparison 2 Divalproex vs placebo, Outcome 1 Total number of patients who suffered from sedation at 6 weeks.

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Analysis 2.2

Comparison 2 Divalproex vs placebo, Outcome 2 Total number of patients who suffered from nausea, vomiting, or diarrhea at 6 weeks.

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Analysis 2.3

Comparison 2 Divalproex vs placebo, Outcome 3 Total number of patients who suffered from an urinary tract infection by 6 weeks.

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Analysis 2.4

Comparison 2 Divalproex vs placebo, Outcome 4 Total number of patients who suffered falls without injury by 6 weeks.

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Analysis 2.5

Comparison 2 Divalproex vs placebo, Outcome 5 Total number of patients who suffered falls with injury by 6 weeks.

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Analysis 2.6

Comparison 2 Divalproex vs placebo, Outcome 6 Total number of patients who suffered postural instability by 6 weeks.

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Analysis 2.7

Comparison 2 Divalproex vs placebo, Outcome 7 Total number of patients who suffered weakness by 6 weeks.

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Analysis 2.8

Comparison 2 Divalproex vs placebo, Outcome 8 Total number of patients who suffered cardiovascular problems by 6 weeks.

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Analysis 2.9

Comparison 2 Divalproex vs placebo, Outcome 9 Total number of patients who suffered edema by 6 weeks.

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Analysis 2.10

Comparison 2 Divalproex vs placebo, Outcome 10 Total number of patients who suffered a fever by 6 weeks.

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Analysis 2.11

Comparison 2 Divalproex vs placebo, Outcome 11 Total number of patients who suffered a respiratory problem by 6 weeks.

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Analysis 2.12

Comparison 2 Divalproex vs placebo, Outcome 12 Total number of patients who suffered any adverse effect by 6 weeks.

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Analysis 2.13

Comparison 2 Divalproex vs placebo, Outcome 13 Total number of patients who suffered from ataxia at 6 weeks.

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Analysis 2.14

Comparison 2 Divalproex vs placebo, Outcome 14 Total number of patients who suffered from a skin problem at 6 weeks.

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Analysis 2.15

Comparison 2 Divalproex vs placebo, Outcome 15 Total number of patients who suffered other gastrointestinal problem by 6 weeks.

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Analysis 2.16

Comparison 2 Divalproex vs placebo, Outcome 16 Total number of patients who suffered trauma (other than falls) by 6 weeks.

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Analysis 2.17

Comparison 2 Divalproex vs placebo, Outcome 17 Total number of patients who suffered joint problems by 6 weeks.

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Analysis 2.18

Comparison 2 Divalproex vs placebo, Outcome 18 Total number of patients who suffered other infection by 6 weeks.

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Analysis 2.19

Comparison 2 Divalproex vs placebo, Outcome 19 Total number of patients who suffered hallucinations by 6 weeks.

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Analysis 2.20

Comparison 2 Divalproex vs placebo, Outcome 20 Total number of patients who suffered accidental injury by 6 weeks.

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Analysis 2.21

Comparison 2 Divalproex vs placebo, Outcome 21 Total number of patients who suffered anorexia by 6 weeks.

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Analysis 2.22

Comparison 2 Divalproex vs placebo, Outcome 22 Total number of patients who suffered weight loss by 6 weeks.

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Analysis 2.23

Comparison 2 Divalproex vs placebo, Outcome 23 Total number of patients who suffered dehydration by 6 weeks.

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Analysis 2.24

Comparison 2 Divalproex vs placebo, Outcome 24 Total number of patients who suffered thrombocytopenia by 6 weeks.

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Analysis 2.25

Comparison 2 Divalproex vs placebo, Outcome 25 Total number of patients who suffered serious adverse events by 6 weeks.

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Table 1. Baseline Characteristics

Name	Country	Population	Mean Age	% Female	Intervention	Diagnoses	Mean MMSE
Porsteinsson 2001	United States	Multicentric, Institutionalised; Alzheimer's dementia, vascular dementia and other dementias	85.0	61.0%	Valproic acid (N=28); placebo (N=28). divalproex sodium titrated to mean dose of 826mg/d; 6 wk course.	Dementia: MMSE; DSM IV; NICDS‐ADRDA. Agitation: CMAI; Aggression: CMAI sub scale. Global: CGI.	6.8
Sival 2002	The Netherlands	Institutionalised, Alzheimer's dementia, vascular dementia, and other dementias.	80.4	59.5%	Valproic acid (N=42); placebo (N=42); Sodium valproate 480mg/d; 3 wk course.	Dementia: MMSE; DSM IV; NINCDS‐ADRDA,Clinical Dementia Rating Scale. Agitation: BPRS subset. Aggression: Patel's method; SDAS‐9 sub scale; CGI; GIP. Global: CGI
Tariot 2001	United States	Multicentric, Institutionalised; Alzheimer's dementia, vascular dementia, and other dementias.	83.3	64.0%	Valproic acid (N=87); placebo (N=85); Divalproex sodium (delayed release); patients titrated to target dose of 20mg/kg/d; median dose 1000mg/d; 6 wk course.	Dementia: MMSE; DSM IV. Agitation: CMAI. Aggression: CMAI sub scale. Global: CGI	7.4
Tariot 2005	United States	Multicentric, Institutionalized, Alzeheimers' Dementia	84.0	68.6%	Divalproex (N=48). placebo (N=78);patients titrated to target dose of 750mg/day; 6 wk course	Alzheimer's Dementia (probable or possible) diagnosed on basis of National Institute of Neurological and Communicative Disorders and Stroke ‐Alzheimr's Disease and Related Disorders Criteria (NINDCDS‐ADRDA). Agitation and hostility, uncooperativeness measured by Brief Psychiatric Rating Scale (BPRS).	10.8
Herrmann 2007	Canada	Multicentric, institutionalized;Alzheimer's Dementia	85.6	42.8%	Valproate (N=14); placebo (N=13); Valproate titrated to dose of 1500mg/day; 6 wk course	Alzheimer's Dementia diagnosed by NINDCDS‐ADRDA criteria;Agitation/aggression diagnosed by Cohen‐Mansfield Agitation Inventory (CMAI).	<15

Table 1. Baseline Characteristics

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Table 2. Outcomes, Instruments, and Studies

Outcomes	Instruments	Studies
Agitation	Cohen‐Mansfield Agitation Inventory (CMAI)	Porsteinsson 2001
	CMAI	Tariot 2001
	CMAI	Tariot 2007
	CMAI	Herrmann 2007
	Brief Psychiatric Rating Scale Subset (BPRS)	Porsteinsson 2001
Aggression	CMAI	Porsteinsson 2001
	CMAI	Tariot 2001

	Social Dysfunction and Aggression‐9 Scale (SDAS‐9)14	Sival 2002
	Clinical Global Impression Scale (CGI)	Sival 2002
	Nurse Observation Scale	Sival 2002
	Patel's Method	Sival 2002
	Overt Aggression Scale	Porsteinsson 2002
Other Types of Disturbed Behavior	Behavior Scale for Intramural Psychogeriatric Patients (GIP)	Sival 2002
Global Impression	CGI	Porsteinsson 2001
	CGI	Sival 2002
	CGI	Tariot 2001
	CGI	Tariot 2005
Cognitive Function	Mini‐mental State Examination (MMSE)	Porsteinsson 2001
	MMSE	Sival 2002
	MMSE	Tariot 2001
	MMSE	Tariot 2005
	MMSE	Herrmann 2007
Side Effects	Number of Adverse Reactions (checklist)	Porsteinsson 2001
	Number of Adverse Reactions (checklist)	Sival 2002
	Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART 1989)	Tariot 2001
	Number of Adverse Reactions (checklist)	Tariot 2005
	Number of Adverse Reactions (checklist)	Herrmann 2007

Table 2. Outcomes, Instruments, and Studies

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Comparison 1. Divalproex vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Brief Psychiatric rating scale Total score. Change from baseline at 6 weeks (ITT) Show forest plot	2	202	Mean Difference (IV, Fixed, 95% CI)	0.23 [‐2.14, 2.60]

2 BPRS agitation factor. Change from baseline at 6 weeks (ITT) Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐2.73, 0.13]

3 BPRS hostility factor. Change from baseline at 6 weeks (ITT) Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐1.12, 1.32]

4 Overt aggression scale total score. Change from baseline at 6 weeks (ITT) Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐3.42, 3.62]

5 Cohen‐Mansfield Agitation Index. Total Score. Change from baseline at 6 weeks (ITT) Show forest plot	3	216	Mean Difference (IV, Fixed, 95% CI)	‐2.20 [‐6.38, 1.99]

Comparison 1. Divalproex vs placebo

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Comparison 2. Divalproex vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total number of patients who suffered from sedation at 6 weeks Show forest plot	3	241	Odds Ratio (M‐H, Fixed, 95% CI)	2.48 [1.37, 4.47]

2 Total number of patients who suffered from nausea, vomiting, or diarrhea at 6 weeks Show forest plot	2	208	Odds Ratio (M‐H, Fixed, 95% CI)	7.09 [1.73, 29.02]

3 Total number of patients who suffered from an urinary tract infection by 6 weeks Show forest plot	2	227	Odds Ratio (M‐H, Fixed, 95% CI)	3.02 [1.04, 8.80]

4 Total number of patients who suffered falls without injury by 6 weeks Show forest plot	3	222	Odds Ratio (M‐H, Fixed, 95% CI)	1.70 [0.84, 3.44]

5 Total number of patients who suffered falls with injury by 6 weeks Show forest plot	2	82	Odds Ratio (M‐H, Fixed, 95% CI)	1.57 [0.38, 6.41]

6 Total number of patients who suffered postural instability by 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	4.33 [0.45, 41.55]

7 Total number of patients who suffered weakness by 6 weeks Show forest plot	1	55	Peto Odds Ratio (Peto, Fixed, 95% CI)	8.00 [1.06, 60.16]

8 Total number of patients who suffered cardiovascular problems by 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	2.0 [0.17, 23.44]

9 Total number of patients who suffered edema by 6 weeks Show forest plot	1	55	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.69 [0.77, 77.21]

10 Total number of patients who suffered a fever by 6 weeks Show forest plot	1	55	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.69 [0.77, 77.21]

11 Total number of patients who suffered a respiratory problem by 6 weeks Show forest plot	1	55	Peto Odds Ratio (Peto, Fixed, 95% CI)	8.34 [1.35, 51.60]

12 Total number of patients who suffered any adverse effect by 6 weeks Show forest plot	4	394	Odds Ratio (M‐H, Fixed, 95% CI)	1.99 [1.29, 3.08]

13 Total number of patients who suffered from ataxia at 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	1.33 [0.27, 6.61]

14 Total number of patients who suffered from a skin problem at 6 weeks Show forest plot	2	227	Odds Ratio (M‐H, Fixed, 95% CI)	1.27 [0.45, 3.58]

15 Total number of patients who suffered other gastrointestinal problem by 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	2.08 [0.35, 12.45]

16 Total number of patients who suffered trauma (other than falls) by 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.62 [0.09, 4.01]

17 Total number of patients who suffered joint problems by 6 weeks Show forest plot	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.30 [0.03, 3.04]

18 Total number of patients who suffered other infection by 6 weeks Show forest plot	3	380	Odds Ratio (M‐H, Fixed, 95% CI)	1.30 [0.70, 2.45]

19 Total number of patients who suffered hallucinations by 6 weeks Show forest plot	1	55	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.13 [0.14, 359.55]

20 Total number of patients who suffered accidental injury by 6 weeks Show forest plot	1	172	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.52 [0.79, 2.92]

21 Total number of patients who suffered anorexia by 6 weeks Show forest plot	1	172	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.40 [0.95, 6.07]

22 Total number of patients who suffered weight loss by 6 weeks Show forest plot	1	172	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.56 [0.76, 8.66]

23 Total number of patients who suffered dehydration by 6 weeks Show forest plot	1	172	Peto Odds Ratio (Peto, Fixed, 95% CI)	3.13 [0.82, 11.94]

24 Total number of patients who suffered thrombocytopenia by 6 weeks Show forest plot	2	186	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.91 [1.92, 32.57]

25 Total number of patients who suffered serious adverse events by 6 weeks Show forest plot	3	235	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.34 [0.74, 2.45]

Comparison 2. Divalproex vs placebo

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