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Randomized Controlled Trial
. 2005 Jan 19:5:3.
doi: 10.1186/1471-2318-5-3.

Rivastigmine: an open-label, observational study of safety and effectiveness in treating patients with Alzheimer's disease for up to 5 years

Martin R Farlow  1 , Mary L Lilly; ENA713 B352 Study Group
Affiliations
Randomized Controlled Trial

Rivastigmine: an open-label, observational study of safety and effectiveness in treating patients with Alzheimer's disease for up to 5 years

Martin R Farlow et al. BMC Geriatr. .

Abstract

Background: Rivastigmine, a butyl- and acetylcholinesterase inhibitor, is approved for symptomatic treatment of Alzheimer's disease (AD). Data supporting the safety and efficacy of second-generation cholinesterase inhibitors, such as rivastigmine, are available for treatment up to 1 year, with limited data up to 2 1/2 years. The purpose of this report is to present safety and effectiveness data for rivastigmine therapy in patients with mild to moderately severe AD receiving treatment for up to 5 years.

Methods: An observational approach was used to study 37 patients with originally mild to moderate AD receiving rivastigmine as a therapy for AD in an open-label extension (ENA713, B352 Study Group, 1998).

Results: The initial trial demonstrated rivastigmine was well-tolerated and effective in terms of cognition, global functioning and activities of daily living. In this open label extension, high-dose rivastigmine therapy was safe and well tolerated over a 5-year period. Two thirds of the participants still enrolled at week 234 were in the original high-dose rivastigmine group during the double-blind phase, suggesting that early therapy may confer some benefit in delaying long-term progression of symptoms.

Conclusions: Long-term cholinesterase inhibition therapy with rivastigmine was well tolerated, with no dropouts due to adverse effects past the initial titration period. Early initiation of treatment, with titration to high-dose therapy, may have an advantage in delaying progression of the illness.

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Figures

Figure 1
Figure 1
Reason for termination stratified by original group.
Figure 2
Figure 2
Kaplan-Meier analysis of time to dropout from week 26 to week 234
Figure 3
Figure 3
Mean scores on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) for weeks 26–234.
Figure 4
Figure 4
Change in Clinician's Interview-Based Impression of Change for weeks 26–56.
Figure 5
Figure 5
Mean scores on Geriatric Deterioration Scale for weeks 26–234.
Figure 6
Figure 6
Mean scores on Progressive Deterioration Scale for weeks 26–156.
Figure 7
Figure 7
Mean scores on Mini-Mental Status Examination for weeks 26–234.
See this image and copyright information in PMC

References

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