Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study

Rogers, Sherise C.; Friedhoff, Lawrence

doi:10.1016/s0924-977x(97)00079-5

Cited by 262 publications

(137 citation statements)

References 18 publications

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“…The inhibitors of acetylcholineesterase had been in use for an average of 238 days. The cognitive improvement, i.e., of Donepezil, returns to baseline after an average of 38 weeks (Rogers and Friedhoff, 1998), so that a treatment effect of these drugs also seems less likely. No persons with diabetes mellitus were part of the study population.…”

Section: Discussionmentioning

confidence: 99%

Alpha-lipoic acid as a new treatment option for Azheimer type dementia

Häger¹,

Marahrens²,

Kenklies³

et al. 2001

Archives of Gerontology and Geriatrics

167

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Oxidative stress and energy depletion are characteristic biochemical hallmarks of Alzheimer's disease (AD), thus antioxidants with positive effects on glucose metabolism such as thioctic (a-lipoic) acid should exert positive effects in these patients. Therefore, 600 mg a-lipoic acid was given daily to nine patients with AD and related dementias (receiving a standard treatment with acetylcholinesterase inhibitors) in an open study over an observation period of, on avarage, 337 980 days. The treatment led to a stabilization of cognitive functions in the study group, demonstrated by constant scores in two neuropsychological tests (mini-mental state examination: MMSE and AD assessment scale, cognitive subscale: ADAScog). Despite the fact that this study was small and not randomized, this is the first indication that treatment with a-lipoic acid might be a successful 'neuroprotective' therapy option for AD and related dementias.

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Section: Discussionmentioning

confidence: 99%

Alpha-lipoic acid as a new treatment option for Azheimer type dementia

Häger¹,

Marahrens²,

Kenklies³

et al. 2001

Archives of Gerontology and Geriatrics

167

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“…Data on the long-term use of donepezil comprise open-label extension studies of randomized, controlled trials (RCTs) [79][80][81] and placebo-controlled data for use up to 1 year. 82,83 Doody et al 79 presented results from 763 patients enrolled in a 144-week, open-label extension of 2 preceding RCTs.…”

Section: Long-term Symptomatic Efficacymentioning

confidence: 99%

Cholinesterase Inhibitors for the Treatment of Alzheimer's Disease:

Grossberg

2003

Current Therapeutic Research

304

156

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Background: Cholinesterase (ChE) inhibitors currently used in the treatment of Alzheimer's disease (AD) are the acetylcholinesterase (AChE)-selective inhibitors, donepezil and galantamine, and the dual AChE and butyrylcholinesterase (BuChE) inhibitor, rivastigmine. In addition to differences in selectivity for AChE and BuChE, ChE inhibitors also differ in pharmacokinetic and pharmacodynamic properties, and these differences could significantly impact on safety, tolerability, and efficacy.Objective: The aim of this article was to provide an overview of the ChE inhibitors widely used in AD, focusing on key pharmacologic differences among agents and how these may translate into important differences in safety, tolerability, and efficacy in clinical practice.Methods: Using published literature collected over time by the author, a review was conducted, focusing on the pharmacology and clinical data of donepezil, galantamine, and rivastigmine.

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“…Adverse effects on sleep have been noted in patients receiving conventional AChE inhibitors (8,46). In a study assessing the efficacy and tolerability of galantamine in patients switched from previous donepezil treatment, PSQI scores were significantly improved within 6 weeks of commencing galantamine therapy (43).…”

Section: Benefits Of Galantamine On Sleep Qualitymentioning

confidence: 99%

“…Furthermore, in a progressive condition such as AD, postponing long-term decline in any of these areas may represent a more important benefit than transient short-term improvements (66). Published data from openlabel extension studies of two currently available cholinesterase inhibitors, donepezil and rivastigmine, indicate that cognitive abilities, as assessed using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog) fell below baseline after 38 and 40 weeks, respectively (15,46).…”

Section: Introductionmentioning

confidence: 99%

Galantamine — a Novel Cholinergic Drug with a Unique Dual Mode of Action for the Treatment of Patients with Alzheimer's Disease

2002

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Galantamine hydrobromide is a tertiary alkaloid drug that has been developed and approved in a number of countries including the USA and several countries in Europe as a treatment for mild-to-moderate Alzheimer's disease (AD). Galantamine has a unique, dual mode of action. It is a reversible, competitive inhibitor of acetylcholinesterase (AChE), and is the only drug actively marketed for the treatment of AD with proven activity as an allosteric modulator of nicotinic acetylcholine receptors (nAChRs). This latter activity is thought to be particularly important since decreases in the expression and activity of nAChRs make a large contribution to the reduction in central cholinergic neurotransmission in patients with AD. Galantamine exhibits favorable pharmacokinetic characteristics including predictable linear elimination kinetics at the recommended maintenance doses (16 and 24 mg/day), a relatively short half-life (approximately 7 h) and high bioavailability. It is extensively metabolized in numerous pathways, mainly in the liver via cytochrome P450 enzymes CYP2D6 and CYP3A4, and has a low potential for clinically significant drug-drug interactions. During four large randomized, double-blind, placebocontrolled trials of up to 6 months duration, galantamine 16 and 24 mg/day significantly benefited cognitive and global function, ability to perform activities of daily living (ADL) and behavior, relative to placebo and baseline, for up to 6 months. Caregiver burden (time spent by caregivers supervising patients or assisting them with ADL), and caregiver distress (related to patients' behavioral symptoms) were also reduced. Cognitive and functional abilities were preserved at or near baseline for at least 12 months in patients who re- 159CNS Drug Reviews Vol. 8, No.2, pp. 159-176 © 2002 Neva Press, Branford, Connecticut Address correspondence and reprint requests to: Sean Lilienfeld, MBBCh, FCP(SA), MMed(Neuro), Janssen Pharmaceutica Inc, Janssen Research Foundation, Div of Janssen Pharmaceutica Ltd, 1125 Trenton Harbourton Road, Titusville NJ 08560. Tel.: +1 (609) 730-3414; Fax: +1 (609) 730-2441; E-mail: slilien1@janus.jnj.com ceived galantamine 24 mg/day for 12 months in a long-term US study. These benefits were maximized by early and continued galantamine treatment and, again, were associated with significant reductions in caregiver burden. Trials of the efficacy of galantamine in dementia related to cerebrovascular disease have also yielded positive results. There are no safety concerns associated with the use of galantamine. The incidence of adverse events, particularly cholinergically mediated events affecting the gastrointestinal system, is generally low and can be minimized using the recommended slow dose-escalation scheme. Galantamine may, therefore, help to reduce the overall burden and cost involved in caring for dementia patients. Taking all evidence into account, galantamine has the potential to become a first-line therapy for dementia.

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Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study

Cited by 262 publications

References 18 publications

Alpha-lipoic acid as a new treatment option for Azheimer type dementia

Alpha-lipoic acid as a new treatment option for Azheimer type dementia

Cholinesterase Inhibitors for the Treatment of Alzheimer's Disease:

Galantamine — a Novel Cholinergic Drug with a Unique Dual Mode of Action for the Treatment of Patients with Alzheimer's Disease

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