Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial

Research output: Research - peer-reviewArticle

Abstract

Background/Objectives: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's). Design: Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States. Setting: Four memory care practices within four healthcare systems in the greater Indianapolis area. Participants: Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs. Intervention: Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks. Measurements: Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event. Results: 196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant. Conclusions: This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management.

LanguageEnglish (US)
JournalJournal of the American Geriatrics Society
DOIs
StateAccepted/In press - 2017

Fingerprint

Pragmatic Clinical Trials
Cholinesterase Inhibitors
Caregivers
Alzheimer Disease
Costs and Cost Analysis
donepezil
Rivastigmine
Galantamine
Disease Management
Marketing
Telephone
African Americans
Delivery of Health Care
Population
Therapeutics

Keywords

  • Alzheimer's
  • Clinical care
  • Dementia

ASJC Scopus subject areas

  • Geriatrics and Gerontology

Cite this

@article{3205b524c84a44f5bd83f632010805eb,
title = "Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial",
abstract = "Background/Objectives: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's). Design: Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States. Setting: Four memory care practices within four healthcare systems in the greater Indianapolis area. Participants: Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs. Intervention: Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks. Measurements: Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event. Results: 196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant. Conclusions: This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management.",
keywords = "Alzheimer's, Clinical care, Dementia",
author = "Campbell, {Noll L.} and Perkins, {Anthony J.} and Sujuan Gao and Skaar, {Todd C.} and Lang Li and Hendrie, {Hugh C.} and Nicole Fowler and Callahan, {Christopher M.} and Boustani, {Malaz A.}",
year = "2017",
doi = "10.1111/jgs.14827",
journal = "Journal of the American Geriatrics Society",
issn = "0002-8614",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - Adherence and Tolerability of Alzheimer's Disease Medications

T2 - Journal of the American Geriatrics Society

AU - Campbell,Noll L.

AU - Perkins,Anthony J.

AU - Gao,Sujuan

AU - Skaar,Todd C.

AU - Li,Lang

AU - Hendrie,Hugh C.

AU - Fowler,Nicole

AU - Callahan,Christopher M.

AU - Boustani,Malaz A.

PY - 2017

Y1 - 2017

N2 - Background/Objectives: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's). Design: Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States. Setting: Four memory care practices within four healthcare systems in the greater Indianapolis area. Participants: Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs. Intervention: Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks. Measurements: Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event. Results: 196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant. Conclusions: This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management.

AB - Background/Objectives: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's). Design: Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States. Setting: Four memory care practices within four healthcare systems in the greater Indianapolis area. Participants: Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs. Intervention: Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks. Measurements: Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event. Results: 196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant. Conclusions: This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management.

KW - Alzheimer's

KW - Clinical care

KW - Dementia

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DO - 10.1111/jgs.14827

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JO - Journal of the American Geriatrics Society

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