The Use, Benefits, and Costs of Cholinesterase Inhibitors for Alzheimer's Dementia in Long-Term Care: Are the Data Relevant and Available?

Khang, Peter; Weintraub, Nancy; Espinoza, Randall

doi:10.1016/s1525-8610(04)70131-0

Cited by 11 publications

(3 citation statements)

References 53 publications

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“…RCTOLEX studies have additional limitations that include potential confounds due to possible effects of differential attrition, unblinding, and the absence of a control group for comparison during the open-label phase [24]. …”

Section: Resultsmentioning

confidence: 99%

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer’s Disease: Comparison of Efficacy and Effectiveness Studies

Atri¹,

Rountree

López

et al. 2012

Neurodegener Dis

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Background: Randomized controlled efficacy trials (RCTs), the scientific gold standard, are required for regulatory approval of Alzheimer’s disease (AD) interventions, yet provide limited information regarding real-world therapeutic effectiveness. Objective: To compare the nature of evidence regarding the combination of approved AD treatments from RCTs versus long-term observational controlled studies (LTOCs). Methods: Comparisons of strengths, limitations, and evidence level for monotherapy [cholinesterase inhibitor (ChEI) or memantine] and combination therapy (ChEI + memantine) in RCTs versus LTOCs. Results: RCTs examined highly selected populations over months. LTOCs collected data across multiple AD stages in large populations over many years. RCTs and LTOCs show similar patterns favoring combination over monotherapy over placebo/no treatment. Long-term combination therapy compared to monotherapy reduced cognitive and functional decline and delayed time to nursing home admission. Persistent treatment was associated with slower decline. While LTOCs used control groups, adjusted for multiple covariates, had higher external validity, and favorable ethical, practical and cost considerations, their limitations included potential selection bias due to lack of placebo comparisons and randomization. Conclusions: Naturalistic LTOCs provide complementary long-term level II evidence to complement level I evidence from short-term RCTs regarding therapeutic effectiveness in AD that may otherwise be unobtainable. A coordinated strategy/consortium to pool LTOC data from multiple centers to estimate long-term comparative effectiveness, risks/benefits, and costs of AD treatments is needed.

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Section: Resultsmentioning

confidence: 99%

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer’s Disease: Comparison of Efficacy and Effectiveness Studies

Atri¹,

Rountree

López

et al. 2012

Neurodegener Dis

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“…Functional ability loss can also have a profound impact on the quality of life for AD patients and usually must be compensated for by the caregiver. This caregiver burden, including the financial, physical and emotional distress of caring for an adult family member with a mentally disabling condition, often becomes overwhelming and can also contribute to the decision to institutionalize (Khang et al ., 2004). There is some evidence that sustained treatment with CHEIs in AD may delay institutionalization (Geldmacher et al ., 2003; Lingler et al ., 2005) but then no significant benefits were seen in institutionalization in the AD2000 study (Courtney et al ., 2004).…”

Section: Discussionmentioning

confidence: 99%

The effect of cholinesterase inhibitors on decline in multiple functional domains in Alzheimer's disease: a two-year observational study in the Sunnybrook dementia cohort

Behl

Lanctôt

Streiner

et al. 2008

IPG

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“…In a recent review, the authors noted that studies of cholinesterase inhibitors in nursing home patients have yielded mixed results and suggested that the efficacy measures for community-dwelling patients may not be appropriate for measuring outcomes in nursing home patients. 66 The authors suggested that outcomes such as decreased hospital admissions, prevented falls, reduced staff turnover, and reduced use of pharmacologic and/or physical restraints may be more useful measures of efficacy in this population.…”

Section: Patients In Nursing Homesmentioning

confidence: 99%

Treatment Strategies for the Behavioral Symptoms of Alzheimer's Disease: Focus on Early Pharmacologic Intervention

Beier

2007

Pharmacotherapy

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The impact of behavioral symptoms associated with Alzheimer's disease is substantial. These symptoms contribute to diminished quality of life for patients and caregivers and increase the cost of care in nursing homes. Early recognition of behavioral symptoms and appropriate treatment are important for successful management. Nonpharmacologic strategies remain the cornerstone of the management of Alzheimer's disease-related behavioral symptoms. However, nonpharmacologic strategies may not be effective for problem behaviors, and pharmacologic intervention may be necessary. Relevant articles were identified through various MEDLINE searches with no date restrictions, with an emphasis on recent studies that used cholinesterase inhibitors and memantine. Additional reports of interest were identified from the reference lists of these articles. To facilitate cross-study analyses in the review of cholinesterase inhibitors and memantine, the database search was limited to randomized, placebo-controlled trials that used the Neuropsychiatric Inventory to assess behavioral symptoms of Alzheimer's disease. Overall, evidence from trials of cholinesterase inhibitors and memantine suggests that when these agents are optimized for the various stages of Alzheimer's disease, they can also prevent the emergence of neuropsychiatric symptoms. Although results from the literature are not uniformly positive, cholinesterase inhibitors have been shown to produce significant improvements in behavioral symptoms in patients with both mild- to-moderate and moderate-to-severe Alzheimer's disease. Evidence also indicates that memantine might be of benefit as an adjunct to long-term cholinesterase inhibitor treatment in patients with moderate-to-severe Alzheimer's disease and that memantine monotherapy may have some beneficial effects on behavior in patients with mild-to-moderate disease. Of importance, although no direct comparisons have been performed, these agents seem to have an improved safety and tolerability profile compared with the frequently used antipsychotic drugs. When nonpharmacologic strategies are deemed insufficient to ease problem behaviors in patients with Alzheimer's disease, treatment with cholinesterase inhibitors, alone or in combination with memantine as appropriate for the stage of disease, may be considered as a first-line option in the early pharmacologic management of Alzheimer's disease-related behavioral symptoms.

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The Use, Benefits, and Costs of Cholinesterase Inhibitors for Alzheimer's Dementia in Long-Term Care: Are the Data Relevant and Available?

Cited by 11 publications

References 53 publications

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer’s Disease: Comparison of Efficacy and Effectiveness Studies

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer’s Disease: Comparison of Efficacy and Effectiveness Studies

The effect of cholinesterase inhibitors on decline in multiple functional domains in Alzheimer's disease: a two-year observational study in the Sunnybrook dementia cohort

Treatment Strategies for the Behavioral Symptoms of Alzheimer's Disease: Focus on Early Pharmacologic Intervention

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