Dataset Information

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.

Trial registration

Clinicaltrials.gov: NCT01362686 (https://clinicaltrials.gov/ct2/show/NCT01362686).

SUBMITTER: Campbell NL

PROVIDER: S-EPMC6604617 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Campbell Noll L NL Perkins Anthony J AJ Gao Sujuan S Skaar Todd C TC Li Lang L Hendrie Hugh C HC Fowler Nicole N Callahan Christopher M CM Boustani Malaz A MA

Journal of the American Geriatrics Society 20170314 7

<h4>Background/objectives</h4>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).<h4>Design</h4>Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States.<h4>Setting</h4>Four memory care practices within four healthcare systems in the greater Indianap ...[more]

PMID: 28295141

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Dataset Information

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

Background/objectives

Design

Setting

Participants

Intervention

Measurements

Results

Conclusions

Trial registration

Publications

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

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