Mental status changes during elexacaftor/tezacaftor / ivacaftor therapy.
Suyeon Heo1, David C Young2, Julie Safirstein3
1Chicago State University College of Pharmacy, 9501 S. King Drive Douglas Hall 206, Chicago, IL 60628, United States.
Summary
Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) may cause mental fogginess in cystic fibrosis patients. This case series highlights patient-reported mental status changes, prompting further investigation into this potential side effect.
Area of Science:
- Pharmacology
- Neurology
- Pulmonology
Background:
- Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a novel Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator.
- Previous CFTR modulators have been associated with mood changes and headaches.
- No prior reports document mental status changes with ELX/TEZ/IVA during clinical trials or post-marketing surveillance.
Purpose of the Study:
- To describe a series of patients experiencing mental fogginess or other mental status changes after initiating ELX/TEZ/IVA therapy.
- To document patient-reported adverse effects not previously observed with this CFTR modulator.
Main Methods:
- A case series approach was used.
- Six cystic fibrosis (CF) patients reporting mental status changes after starting ELX/TEZ/IVA were identified.
- Patient-reported symptoms and management strategies were documented.
Main Results:
- Six CF patients reported "mental fogginess" or similar cognitive changes within three months of starting ELX/TEZ/IVA.
- The exact mechanism underlying these patient-reported side effects remains unknown.
- Management approaches varied among CF care teams, emphasizing patient-centered decision-making.
Conclusions:
- ELX/TEZ/IVA may be associated with patient-reported mental status changes, including cognitive fogginess.
- Further research is needed to elucidate the mechanism of these reported effects.
- A patient-centered approach is crucial for managing these concerns in clinical practice.
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