Adverse Event Types and Discontinuation Rate of Alzheimer's Medication Approved by United States Food and Drug Administration (USFDA)
Author(s)
Almutairi R1, Sanogo V2, Diaby K3
1MCPHS UNIVERSITY, Boston, MA, USA, 2Northcentral University, GAINESVILLE, FL, USA, 3Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Presentation Documents
BACKGROUND: Alzheimer's Disease and related dementia (ADRD) is a public health emergency affecting the aging population in the US. By 2023, 6.7 million Americans 65 and older are estimated to have Alzheimer's. Pharmacological management of Alzheimer's includes inhibition of acetylcholinesterase and N-methyl-D-aspartate receptors. AChEIs like donepezil, galantamine, and rivastigmine treat mild and severe AD.
OBJECTIVES:
This study aims to identify Discontinuation Adverse Events (AEs) type per treatment for all formulations of Drugs approved by the US FDA for treating AD as of May 31, 2023.METHODS:
The safety information about Adverse Events (AEs), discontinuation types, and rates were collected from FDA product labels and clinical trial data for Alzheimer's disease. Descriptive analyses were used to classify AEs resulting in product discontinuation. AE rates were calculated by dividing the number of events by the sample size for a specific period.RESULTS:
AD management has three main classes, including 6 FDA-approved NMEs between 2001 and 2023. Cholinesterase inhibitors (3, 42.8%) were the most common therapeutic category. The largest number of AEs leading to discontinuation occurred in Galantamine (7), Donepezil (4), Rivastigmine (4), and Lecanemab (1). The most common AEs were GI upset (nausea, vomiting, diarrhea, decreased appetite), CNS AEs (dizziness, headache), and decreased weight. Cholinesterase inhibitors were the most common class leading to AEs discontinuation.CONCLUSIONS:
Immunotherapies had the most common AEs as infusion-related reactions managed by other treatments.Conference/Value in Health Info
2023-11, ISPOR Europe 2023, Copenhagen, Denmark
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
EPH75
Disease
Drugs, Neurological Disorders