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Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial
Author(s) -
Campbell Noll L.,
Perkins Anthony J.,
Gao Sujuan,
Skaar Todd C.,
Li Lang,
Hendrie Hugh C.,
Fowler Nicole,
Callahan Christopher M.,
Boustani Malaz A.
Publication year - 2017
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/jgs.14827
Subject(s) - medicine , tolerability , discontinuation , donepezil , galantamine , adverse effect , randomized controlled trial , rivastigmine , dementia , physical therapy , disease
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 ( AC h EI 's). Design Pragmatic randomized, open label comparative trial of AC h EI '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 AC h EI . 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 AC h EI s. Intervention Participants were randomized to one of three AC h EI s 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 AC h EI s. Interventions improving adherence and persistence to AC h EI s may improve AD management. Trial Registration: Clinicaltrials.gov: NCT 01362686 ( https://clinicaltrials.gov/ct2/show/NCT01362686 ).