OBJECTIVES: We searched ALOIS (the Cochrane
Dementia and Cognitive Improvement Group's Specialized Register) on 12 February 2013 using the terms:
rivastigmine,
exelon, "
SDZ ENA 713". ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases (The Cochrane Library, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS), numerous trial registries and grey literature sources.
SELECTION CRITERIA: Two reviewers extracted and assessed data independently, and agreement was reached after discussion. They noted results concerning adverse effects.
MAIN RESULTS: Three trials, with a total of 800 participants, were identified for inclusion. The participants in one trial did not have
dementia, while the other two studies included participants with
dementia of different severities. The dose of
rivastigmine was different in each study. No pooling of study results was attempted because of these differences between the studies.One trial included 40 participants with
subcortical vascular dementia (age range 40 to 90 years) with a mean mini-mental state examination (MMSE) score of 13.0 and 13.4 in the
rivastigmine and placebo arms, respectively. Treatment over 26 weeks was limited to 3 mg
rivastigmine twice daily, or placebo. No significant difference was found on any outcome measure relevant to cognition, neuropsychiatric symptoms, function or global rating, or in the number of withdrawals before the end of treatment.Another trial included 710 participants with
vascular dementia, including subcortical and cortical forms (age range 50 to 85 years). Over 24 weeks, a mean dose of
rivastigmine of 9.4 mg/day was achieved versus placebo. Baseline MMSE was identical for both groups, at 19.1. Statistically significant advantage in cognitive response (but not with global impression of change or non-cognitive measures) was seen with
rivastigmine treatment at 24 weeks (MMSE change from baseline MD 0.6, 95% CI 0.11 to 1.09, P value 0.02;
Vascular Dementia Assessment Scale (VaDAS) change from baseline MD -1.3, 95% CI-2.62 to 0.02, P value 0.05 ). Significantly higher rates of
vomiting,
nausea, diarrhoea and
anorexia and withdrawals from treatment were noted in the participants randomized to
rivastigmine compared with placebo (withdrawals
rivastigmine 90/365, placebo 48/345, OR 2.02, 95% CI 1.38 to 2.98) (withdrawals due to an adverse event
rivastigmine 49/365, placebo 19/345, OR 2.66, 95% CI 1.53 to 4.62, P value 0.0005).The third study included 50 participants (age range 48 to 84 years) with mean MMSE scores of 23.7 and 23.9 in the
rivastigmine and placebo arms, respectively. Over a 24-week period, participants labelled as having
cognitive impairment but no
dementia (CIND) following
ischaemic stroke were given up to 4.5 mg
rivastigmine twice daily, or placebo. Primary and secondary outcome measures showed no statistically significant difference when considering neurocognitive abilities, function, neuropsychiatric symptoms and global performance. One participant in the
rivastigmine group and two in the placebo group discontinued their medication because of an adverse effect.
AUTHORS' CONCLUSIONS: