Abstract

AbstractBackgroundAccess to Medicare claims provides a unique opportunity to broadly characterize diseases affecting US adults 65+ years of age. This can provide insights into real world populations and a basis of comparison to those in clinical trial populations. To this end, this study characterizes demographics, comorbidities and co‐medications in patients newly diagnosed with Alzheimer’s Disease (AD).MethodsThis study utilized Medicare Part A and B claims (Fee‐For‐Service and Medicare Advantage) limited to patients with at least one 2019 medical encounter. The study’s source population was limited to those 65+ years of age with Medicare Part D coverage and 1‐year pre‐encounter continuous enrollment. From this source population, three newly diagnosed AD cohorts were compiled; cohort 1 utilized the 1‐year Bynum‐Standard Alzheimer’s disease and related dementia (ADRD) claims algorithm, cohort 2 adapted the ADRD algorithm to include only specific AD diagnoses, and cohort 3 was selected based on new use of cholinesterase inhibitors (irrespective of ADRD diagnosis). Demographics, comorbidities, and co‐medications present in the 1‐year pre‐cohort qualification are described.ResultsFrom 53,890,958 patients with at least one 2019 medical encounter, 33,315,038 qualified for the source population. Of these patients, 861,727 (2.6%) were newly diagnosed with ADRD (cohort 1), 373,798 patients (1.1%) were newly diagnosed with AD (cohort 2), and 395,319 patients (1.2%) were new users of cholinesterase inhibitors (cohort 3). The cohorts were not mutually exclusive. Overall, the three cohorts were similar in terms of demographics (table 1) with 75.1‐85.3% of patients aged 75+ and 61.5‐66.4% female. Common comorbidities (table 2) across the 3 cohorts include cardiovascular (CV) comorbidities such as myocardial infarction (34.1‐41.9%) and heart failure (39.8‐51.4%), diabetes (38.5‐41.6%), arthritis (44.0‐46.6%), stroke (28.9‐34.4%) and anxiety/depression (48.6‐54.5%). Co‐medications received (table 3) such as anti‐hypertensives, lipid modifying drugs, anti‐diabetics, systemic corticosteroids, and anti‐depressants reflect these conditions.ConclusionExtensive understanding of a drug’s real‐world target population can inform generalizability of clinical trial results and highlight unaddressed risk. This study stresses the importance of studying new AD drugs in populations with a history of CV risk, diabetes and stroke as well as those that may be immunocompromised due to treatments with systemic corticosteroids.

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