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. 2013 May 31;2013(5):CD004744.
doi: 10.1002/14651858.CD004744.pub3.

Rivastigmine for vascular cognitive impairment

Jacqueline Birks  1 , Bernadette McGuinness, David Craig
Affiliations

Rivastigmine for vascular cognitive impairment

Jacqueline Birks et al. Cochrane Database Syst Rev. .

Abstract

Background: Vascular dementia represents the second most common type of dementia after Alzheimer's disease. In older patients, in particular, the combination of vascular dementia and Alzheimer's disease is common, and is referred to as mixed dementia. The classification of vascular dementia broadly follows three clinico-pathological processes: multi-infarct dementia, single strategic infarct dementia and subcortical dementia. Not all victims fulfil strict criteria for dementia and may be significantly cognitively impaired without memory loss, when the term vascular cognitive impairment (VCI) is more useful. Currently, no established standard treatment for VCI exists. Reductions in acetylcholine and acetyltransferase activity are common to both Alzheimer's disease and VCI, raising the possibility that cholinesterase inhibitors - such as rivastigmine - which are beneficial in Alzheimer's disease, may also be beneficial for VCI.

Objectives: To assess the efficacy of rivastigmine compared with placebo in the treatment of people with vascular cognitive impairment (VCI), vascular dementia or mixed dementia.

Search methods: 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: All unconfounded randomized double-blind trials comparing rivastigmine with placebo in the treatment of people with VCI, vascular dementia or mixed dementia were eligible for inclusion.

Data collection and analysis: 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: There is some evidence of benefit of rivastigmine in VCI from trial data from three studies. However, this conclusion is based on one large study. Rivastigmine is capable of inducing side effects that lead to withdrawal in a significant proportion of patients.

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Conflict of interest statement

None known

Figures

1.1
1.1. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 1 VaDAS (change from baseline at 24 weeks) ITT.
1.2
1.2. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 2 MMSE (change from baseline at 24 weeks) ITT.
1.3
1.3. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 3 ADAS‐Cog (change from baseline at 24 weeks) ITT.
1.4
1.4. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 4 ADCS‐CGIC 24 weeks ITT.
1.5
1.5. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 5 GDS global deterioration scale (change from baseline at 24 weeks) ITT.
1.6
1.6. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 6 Behavioural disturbance NPI‐12 (change from baseline at 24 weeks) ITT.
1.7
1.7. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 7 ADCS‐ADL (change from baseline at 24 weeks) ITT.
1.8
1.8. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 8 Withdrawals before end of treatment at 24 weeks.
1.9
1.9. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 9 Withdrawals due to adverse event by 24 weeks.
1.10
1.10. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 10 Deaths by 24 weeks.
1.11
1.11. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 11 At least one adverse event of nausea by 24 weeks.
1.12
1.12. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 12 At least one adverse event of vomiting by 24 weeks.
1.13
1.13. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 13 At least one adverse event of diarrhoea by 24 weeks.
1.14
1.14. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 14 At least one adverse event of dizziness by 24 weeks.
1.15
1.15. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 15 At least one adverse event of a fall by 24 weeks.
1.16
1.16. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 16 At least one adverse event of hypertension by 24 weeks.
1.17
1.17. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 17 At least one adverse event of hypotension by 24 weeks.
1.18
1.18. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 18 At least one adverse event of headache by 24 weeks.
1.19
1.19. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 19 At least one adverse event of anorexia by 24 weeks.
1.20
1.20. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 20 At least one adverse event of bradycardia by 24 weeks.
1.21
1.21. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 21 At least one serious adverse event by 24 weeks.
1.22
1.22. Analysis
Comparison 1 Rivastigmine (3‐12 mg/day) vs placebo for probable vascular dementia, Outcome 22 At least one serious adverse event due to, or potentially due to a cerebrovascular accident by 24 weeks.
2.1
2.1. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 1 MMSE (change from baseline at 26 weeks) ITT.
2.2
2.2. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 2 FAB (change from baseline at 26 weeks) ITT.
2.3
2.3. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 3 Global function CDR sum of boxes (change from baseline at 26 weeks) ITT.
2.4
2.4. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 4 Behavioural disturbance NPI‐12 (change from baseline at 26 weeks) ITT.
2.5
2.5. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 5 IADL (change from baseline at 26 weeks) ITT.
2.6
2.6. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 6 Withdrawals before end of treatment at 26 weeks.
2.7
2.7. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 7 At least one adverse event by 26 weeks.
2.8
2.8. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 8 At least one adverse event of recurrent stroke by 26 weeks.
2.9
2.9. Analysis
Comparison 2 Rivastigmine (6 mg/day) vs placebo for subcortical vascular dementia, Outcome 9 Deaths by 26 weeks.
3.1
3.1. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 1 Clock drawing (change from baseline at 24 weeks) ITT.
3.2
3.2. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 2 Color trails 1.
3.3
3.3. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 3 Color trails 2.
3.4
3.4. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 4 ADAS‐Cog (change from baseline at 24 weeks) ITT.
3.5
3.5. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 5 Behavioural disturbance NPI (change from baseline at 24 weeks) ITT.
3.6
3.6. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 6 GDS depression scale (change from baseline at 24 weeks ) ITT.
3.7
3.7. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 7 ADCS‐ADL (change from baseline at 24 weeks) ITT.
3.8
3.8. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 8 Withdrawals before end of treatment at 24 weeks.
3.9
3.9. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 9 At least one adverse event by 24 weeks.
3.10
3.10. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 10 At least one serious adverse event by 24 weeks.
3.11
3.11. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 11 Deaths by 24 weeks.
3.12
3.12. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 12 At least one adverse event of nausea by 24 weeks.
3.13
3.13. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 13 At least one adverse event of headache by 24 weeks.
3.14
3.14. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 14 At least one adverse event of gastrointestinal upset by 24 weeks.
3.15
3.15. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 15 At least one adverse event of breathlessness by 24 weeks.
3.16
3.16. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 16 At least one adverse event of diarrhoea by 24 weeks.
3.17
3.17. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 17 At least one adverse event of dizziness by 24 weeks.
3.18
3.18. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 18 At least one adverse event of vomiting by 24 weeks.
3.19
3.19. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 19 At least one adverse event of chest pain by 24 weeks.
3.20
3.20. Analysis
Comparison 3 Rivastigmine (3‐9 mg/day) vs placebo for MCI and CIND, Outcome 20 At least one adverse event of accidental fall by 24 weeks.
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