BPSD - Devon Partnership NHS Trust

Appendix 1
Decision aid for specialist treatment strategies: Severe BPSD
There is a lack of high quality clinical trial evidence to support the effectiveness of medication for BPSD
(with evidence base generally based on Alzheimer’s dementia rather than vascular/stroke related, frontotemporal
lobe, mixed or DLB), however increasingly there is information which questions their safety. The
table below is designed to provide you with a summary the available evidence for drugs used for the
management of BPSD (specific to aggression, agitation and/or psychosis), along with a summary of
possible side effects and precautions required.
ANTIPSYCHOTICS
Evidence of efficacy in BPSD, though limited, is greatest for risperidone and olanzapine, however, clinical
efficacy is at best only modest and this must be balanced against elevated risk of cerebrovascular adverse
events, mortality, upper respiratory infections, oedema, extrapyramidal symptoms and an increase in overall
mortality rate which applies to ALL ANTIPSYCHOTICS (first and second generation) and not just
risperidone and olanzapine as originally reported in the Committee of Safety of Medicines alert (2004).
Summary of risks and benefits for treating1000 people with dementia for BPSD over a 12 week period with
an second generation antipsychotic would result in;
91-200 people with behavioural disturbance showing clinically significant improvement in symptoms
10 deaths
(Evidence suggests that risk of mortality increases over time, therefore longer term treatment may result in
up to 167 additional deaths over a 2 year period
18 CVAEs of which ~50% would be severe
(Evidence from observational studies suggests increased risk of CVAE may be confined to the 2-3 month
period typically encompassed in RCT follow-up studies, therefore extrapolation of data in the original CSM
alert, 2004, proposing that NNH of 37 would translate to NNH of 6.3 over 1 year, resulting in an additional
159 CVAEs per 1000 people treated, may be an over-estimation).
No additional falls or fractures
58-94 people with gait disturbance
Intervention
Risperidone
Olanzapine
(Off-license use)
Amisulpride
(Off-license use)
Aripiprazole
(Off-license use)
Quetiapine
(Off-license use)
First Generation
antipsychotics
(Off-license use)
Rationale
(Where stated, doses derived from published studies)
Licensed for the short-term treatment (up to 6 weeks) of persistent
aggression in patients with moderate to severe Alzheimer's dementia
unresponsive to non-pharmacological approaches and when there is a risk of
harm to self or others (500micrograms- 2mg/daily).
Significant improvement in aggression & psychosis compared to placebo
Significant improvement in aggression compared to placebo (5-10mg/daily)
ONLY consider as a 2nd line option where risperidone not appropriate/not
tolerated
Reported doses prescribed 200mg/daily. Preliminary observation suggests
that amisulpride may be useful to control agitation and disruptive behaviours.
RCT (open prospective) demonstrated equivalent efficacy to risperidone.
Only small open-label studies available. Evidence weak.
Improvement in psychosis demonstrated with 2-15mg/day compared with
placebo (Schneider et al 2006; NNT=13.8)
Reported doses prescribed: 50-200mg/day. 200mg/day reported superior to
placebo for agitation where 100mg/day not superior to placebo, BUT showed
harm compared with placebo at 26 weeks for severe impairment battery (SIB)
Potential risks outweigh possible benefits: (Associated with increased risk of
CVE and mortality (mortality risk ≥ second generation antipsychotics)
DPT use
approved
YES
YES
NO
NO
NO
NO
PG 14 – Pharmacological Management of BPSD
Approved by Drug and Therapeutics Committee: September 2013
Review date: September 2015
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