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. 2006 Jan 25;2006(1):CD004747.
doi: 10.1002/14651858.CD004747.pub2.

Cholinesterase inhibitors for Parkinson's disease dementia

I Maidment  1 , C Fox, M Boustani
Affiliations

Cholinesterase inhibitors for Parkinson's disease dementia

I Maidment et al. Cochrane Database Syst Rev. .

Abstract

Background: The loss of cholinergic, dopaminergic and noradrenergic innervations seen in Parkinson's Disease Dementia (PDD) suggest a potential role for cholinesterase inhibitors. Concerns have been expressed about a theoretical worsening of Parkinson's disease related symptoms particularly movement symptoms.

Objectives: To assess the efficacy, safety, tolerability and health economic data relating to the use of cholinesterase inhibitors in PDD.

Search strategy: The trials were identified from the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 19 April 2005 using the search term parkinson*This register contains records from major health care databases and many ongoing trial databases and is updated regularly.Comprehensive searches of abstracts from major scientific meetings were performed. Pharmaceutical companies were approached for information regarding additional and ongoing studies.

Selection criteria: Randomized, double-blind, placebo-controlled studies assessing the effectiveness of cholinesterase inhibitors in PDD. Inclusion and exclusion criteria were stated to limit bias.

Data collection and analysis: Two reviewers (IM, CF) independently reviewed the quality of the studies utilising criteria from the Cochrane Collaboration Handbook. Medications were examined separately and as a group. The outcome measures assessed were in the following domains: neuropsychiatric features, cognition, global impression, daily living activities, quality of life, burden on caregiver, Parkinsonian related symptoms, treatment acceptability as determined by withdrawal from trials, safety as determined by the frequency of adverse events, institutionalisation, death and health economic factors.

Main results: A detailed and systematic search of relevant databases identified one published randomized, double-blind, placebo-controlled study (Emre 2004) involving 541 patients that compared rivastigmine with placebo. Rivastigmine produced statistically significant improvements in several outcome measures. On the primary cognitive measure, the ADAS-Cog, rivastigmine was associated with a 2.80 point ADAS-Cog improvement [WMD -2.80, 95% Cl -4.26 to -1.34, P = 0.0002] and a 2.50 point ADCS-ADL improvement [95% Cl 0.43 to 4.57, P = 0.02] relative to placebo. Clinically meaningful (moderate or marked) improvement occurred in 5.3% more patients on rivastigmine, and meaningful worsening occurred in 10.1% more patients on placebo. Tolerability appeared to be a significant issue. Significantly more patients on rivastigmine dropped out of the study due to adverse events [62/362 versus 14/179, OR 2.44, 95% Cl 1.32 to 4.48, P = 0.004]. Nausea [20/179 versus 105/362, OR 3.25, 95% Cl 1.94 to 5.45, P < 0.00001], tremor [7/179 versus 37/362, OR 2.80, 95% Cl 1.22 to 6.41, P = 0.01] and in particular vomiting [3/179 versus 60/362, OR 11.66, 95% Cl 3.60 to 37.72, P < 0.0001] were significantly more common with rivastigmine. However, significantly fewer patients died on rivastigmine than placebo [4/362 versus 7/179, OR 0.27, 95% CI 0.08 to 0.95, P = 0.04]

Authors' conclusions: Rivastigmine appears to improve cognition and activities of daily living in patients with PDD. This results in clinically meaningful benefit in about 15% of cases. There is a need for more studies utilising pragmatic measures such as time to residential care facility and both patient and carer quality of life assessments. Future trials should involve other cholinesterase inhibitors, utilise tools to analyse the data that limit any bias and measure health economic factors. It is unlikely that relying solely on the last observation carried forward (LOCF) is sufficient. Publication of the observed case data in the largest trial would assist (Emre 2004). Adverse events were associated with the cholinergic activity of rivastigmine, but may limit patient acceptability as evidenced by the high drop out rate in the active arm.

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Conflict of interest statement

Ian Maidment has received honoraria and hospitality from Eisai/Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb, Shire Pharmaceuticals, and Astra Zeneca. He holds no shares in the pharmaceutical industry. Chris Fox has received honoraria and hospitality from Eisai/Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb, Shire Pharmaceuticals, Lundbeck, J‐C and Astra Zeneca. He holds no shares in the pharmaceutical industry. Malaz Boustani has received honoraria and hospitality from Pfizer and Lundbeck. He holds no shares in the pharmaceutical industry.

Figures

1.1
1.1. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 1 ADAS‐Cog (change from baseline at 24 weeks) LOCF.
1.2
1.2. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 2 ADCS‐CGIC (change from baseline at 24 weeks) LOCF.
1.3
1.3. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 3 ADCS‐ADL (change from baseline at 24 weeks) LOCF.
1.4
1.4. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 4 NPI‐10 (change from baseline at 24 weeks) LOCF.
1.5
1.5. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 5 MMSE (change from baseline at 24 weeks) LOCF.
1.6
1.6. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 6 CDR (change from baseline at 24 weeks) LOCF.
1.7
1.7. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 7 D‐KEFS (change from baseline at 24 weeks) LOCF.
1.8
1.8. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 8 Withdrawals before end of treatment at 24 weeks.
1.9
1.9. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 9 Withdrawals due to adverse event before end of treatment at 24 weeks.
1.10
1.10. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 10 Number of deaths before end of treatment at 24 weeks.
1.11
1.11. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 11 At least one adverse event before end of treatment at 24 weeks.
1.12
1.12. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 12 At least one adverse event of nausea before end of treatment at 24 weeks.
1.13
1.13. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 13 At least one adverse event of vomiting before end of treatment at 24 weeks.
1.14
1.14. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 14 At least one adverse event of tremor before end of treatment at 24 weeks.
1.15
1.15. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 15 At least one adverse event of diarrhoea before end of treatment at 24 weeks.
1.16
1.16. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 16 At least one adverse event of anorexia before end of treatment at 24 weeks.
1.17
1.17. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 17 At least one adverse event of a fall before end of treatment at 24 weeks.
1.18
1.18. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 18 At least one adverse event of dizziness before end of treatment at 24 weeks.
1.19
1.19. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 19 At least one adverse event of hypotension before end of treatment at 24 weeks.
1.20
1.20. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 20 At least one adverse event of constipation before end of treatment at 24 weeks.
1.21
1.21. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 21 At least one adverse event of hallucinations before end of treatment at 24 weeks.
1.22
1.22. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 22 At least one adverse event of confusion before end of treatment at 24 weeks.
1.23
1.23. Analysis
Comparison 1 Rivastigmine (3‐12mg/day) vs placebo, Outcome 23 At least one adverse event of orthostatic hypotension before end of treatment at 24 weeks.
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Update of

  • doi: 10.1002/14651858.CD004747

References

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