A pharmacovigilance study on Memantine: signal detection of Rhabdomyolysis and death

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Date

2023-02

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BRAC University

Abstract

Alzheimer's Disease (AD) is a complex and common neurological disorder and dementia's leading cause. Memantine works to treat moderate to severe AD. This study focused on Food and Drug Administration Adverse Event Reporting System (FAERS) data with the purpose to determine its effect on adverse events of Death and Rhabdomyolysis based on two comparators; the whole database and drug class. To conduct this disproportionality analysis, we have incorporated ROR and 95% CI values. We figured out that memantine possesses a higher mortality benefits ratio than other drugs enlisting both the comparators; whole database and drug class with a value of (ROR = 0.68; CI 95% = 0.46–1.00; P = 0.0483) and (ROR = 0.19; CI 95% = 0.13–0.28; P <0.0001) respectively. In addition, in the cases of rhabdomyolysis, we also find out that memantine has a lower profile assigning both comparators 8.10 (4.48 to 14.67; p < 0.0001); whole database and 2.25 (1.11 to 4.54; P = 0.0241); drug class.

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Cataloged from the PDF version of thesis.
Includes bibliographical references (pages 42-48).
This thesis is submitted in partial fulfillment of the requirements for the degree of Bachelor of Pharmacy, 2023.

Keywords

Alzheimer’s disease, Neurological disorder, Dementia, FAERS database, FDA adverse event reporting system, Rhabdomyolysis

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