A 24-Week, Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of 13.3 mg/24 h Rivastigmine Patch in Patients With Severe Alzheimer Disease

Farlow, Martin R.; Grossberg, George T.; Sadowsky, Carl; Meng, Xiangyi; Velting, Drew M.

doi:10.1097/wad.0000000000000073

Cited by 12 publications

(9 citation statements)

References 15 publications

(13 reference statements)

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“…While a small dose-related increase in gastrointestinal-related AEs was seen, the high dose patch did not markedly reduce tolerability. In the subsequent openlabel extension study, patients who continued on their original 13.3 mg/24 h rivastigmine patch reported a similar incidence of AEs compared with patients who up-titrated from 4.6 mg/24 h to 13.3 mg/24 h [38].…”

Section: Rivastigminementioning

confidence: 83%

The Use of Cholinesterase Inhibitors Across All Stages of Alzheimer’s Disease

2015

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Current pharmacological therapy for Alzheimer's disease (AD) includes the cholinesterase inhibitors (ChEIs) donepezil, rivastigmine, and galantamine and the N-methyl D-aspartate receptor antagonist memantine. Based on the results of randomized controlled trials and several meta-analyses, ChEIs appear to show modest but statistically significant improvements on several measures, including cognition and global functioning. Given their modest effects, there is a lack of consensus among clinicians regarding issues related to initiation, optimal duration, and discontinuation of ChEI therapy across the spectrum of AD. There is evidence from long-term observational controlled studies that early initiation and persistent exposure to AD therapy lead to delays in nursing home admission and significantly slower rates of cognitive and functional impairment. In the moderate to severe stages of AD, therapeutic trials of higher dose ChEIs and the addition of memantine are recommended for patients who are no longer responding to lower doses. While side effects are generally mild and gastrointestinal in nature, these events can lead to significant morbidity in more susceptible patients with advanced disease. Patients should thus be regularly monitored for any potential serious side effects of ChEI therapy, which also may include syncope and bradycardia. At the terminal stages of AD, such as when patients become hospice eligible, attempts to cautiously discontinue all medications not necessary for quality of life, including AD drugs, should be made.

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Section: Rivastigminementioning

confidence: 83%

The Use of Cholinesterase Inhibitors Across All Stages of Alzheimer’s Disease

2015

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“…In an open-label extension study conducted for 24 weeks, there were not any significant clinical side effects while using rivastigmine in both low and high dose of transdermal rivastigmine in patients with mild to moderately severe AD [63] . However, the high transdermal dose has shown more positive impact on cognitive function in patients with AD, and it might be useful in the treatment of dementia of severe AD [63] .…”

Section: Introductionmentioning

confidence: 91%

“…However, transdermal rivastigmine, especially high transdermal dose, might give more improvement in AD dementia over oral rivastigmine because of the few reported incidents of forgetting doses in case of oral administration [62]. In an open‐label extension study conducted for 24 weeks, there were not any significant clinical side effects while using rivastigmine in both low and high dose of transdermal rivastigmine in patients with mild to moderately severe AD [63]. However, the high transdermal dose has shown more positive impact on cognitive function in patients with AD, and it might be useful in the treatment of dementia of severe AD [63].…”

Section: Introductionmentioning

confidence: 99%

The role of acetylcholinesterase inhibitors such as neostigmine and rivastigmine on chronic pain and cognitive function in aging: A review of recent clinical applications

Eldufani

Blaise

2019

A&D Transl Res & Clin Interv

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Chronic pain in patients with Alzheimer's disease or dementia is a complex issue in the medical field; these patients suffer from the common causes of chronic pain, especially in geriatric medicine. To ensure the correct type and level of given treatment, medical care should be taken to avoid the contribution of chronic pain and cognitive impairment in the elderly population. Acetylcholinesterase inhibitors (AChE-Is) have been proven as an efficient therapeutic resource for significant improvement in dementia of Alzheimer's disease and chronic pain due to the fact that cholinergic deficit is considered as an early finding in cognitive impairment and persisting pain. Some AChE-Is are investigated here in terms of treatment of dementia and chronic pain management. Neostigmine has been used as an adjunct analgesic in the postoperative period and in combination with other analgesic medications in an intrathecal approach. Rivastigmine has, over the past ten years, become the approved agent for the management of dementia of mild to moderate Alzheimer's disease and has gained approval for treating different types of non-Alzheimer's dementia. In this review, we will focus on the two types of AChE-Is (rivastigmine and neostigmine) in the development of their clinical use and their respective mechanisms of actions on improving cognitive function and managing chronic pain.

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“…In a 24-week, open-label extension of the ACTION study (N=397), there were no clinically relevant differences in safety and tolerability between patients who were up-titrated from the 4.6 mg/24h rivastigmine patch to receive the 13.3 mg/24h patch, and patients who continued on the 13.3 mg/24h patch. However, a greater decline was observed in patients with delayed up-titration to the high-dose 13.3 mg/24h patch compared to patients who continued on the high-dose patch from the double-blind phase to the extension phase [ 33 ]. This indicates the importance of early and sustained intervention with the high-dose patch to achieve maximum clinical benefit.…”

Section: Dose Up-titrationmentioning

confidence: 99%

Strategies for Continued Successful Treatment in Patients with Alzheimer’s Disease: An Overview of Switching Between Pharmacological Agents

Blesa

Toriyama

Ueda

et al. 2018

CAR

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Introduction: Alzheimer’s disease (AD) is the most common cause of dementia, characterized by a progressive decline in cognition and function. Current treatment options for AD include the cholines-terase inhibitors (ChEIs) donepezil, galantamine, and rivastigmine, as well as the N-methyl-D-aspartate receptor antagonist memantine. Treatment guidelines recommend the use of ChEIs as the standard of care first-line therapy. Several randomized clinical studies have demonstrated the benefits of ChEIs on cogni-tion, global function, behavior and activities of daily living. However, patients may fail to achieve sus-tained clinical benefits from ChEIs due to lack/loss of efficacy and/or safety, tolerability issues, and poor adherence to the treatment. The purpose of this review is to explore the strategies for continued successful treatment in patients with AD.Methods: Literature search was performed for articles published in PubMed and MEDLINE, using pre-specified search terms. Articles were critically evaluated for inclusion based on their titles, abstracts, and full text of the publication.Results and Conclusion: The findings of this review indicate that dose up-titration and switching between ChEIs may help to improve response to ChEI treatment and also address issues such as lack/loss of effica-cy or safety/tolerability in patients with AD. However, well-designed studies are needed to provide robust evidence.

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A 24-Week, Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of 13.3 mg/24 h Rivastigmine Patch in Patients With Severe Alzheimer Disease

Cited by 12 publications

References 15 publications

The Use of Cholinesterase Inhibitors Across All Stages of Alzheimer’s Disease

The Use of Cholinesterase Inhibitors Across All Stages of Alzheimer’s Disease

The role of acetylcholinesterase inhibitors such as neostigmine and rivastigmine on chronic pain and cognitive function in aging: A review of recent clinical applications

Strategies for Continued Successful Treatment in Patients with Alzheimer’s Disease: An Overview of Switching Between Pharmacological Agents

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